blood clots - Page 3

Patients Are Not Statistics: The Case for Personal Stories in Medical Research

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Lucine Health Sciences and Hormones Matter have begun an important new research project to investigate the relationship between hormonal birth control and blood clots. They are surveying and interviewing women and the families of women who have suffered blood clots while using hormonal contraceptives. A big part of this study includes publishing the personal health stories of these women. (You can read my story here.) Hormones Matter has always been a place to question the status quo in healthcare and believes that one of the most powerful ways we can do that is by allowing patients to have a voice.

Patient stories, or case studies, are vital to the conversation about the safety of medications and they help drive research about health issues. I believe they are the proverbial canary in the coal mine. How else will doctors and researchers know what’s going on? Should they rely solely on the drug companies to share information that may be detrimental to their bottom line? I don’t think so, but over the years many doctors and scientists have dismissed patient stories as anecdotal and therefore not pertinent to the research conversation. They claim that the only valid forms of medical research are the double-blind placebo controlled trial or the large epidemiological investigations and nowhere is there room for the patient experience of his or her symptoms. But these studies are often cost-prohibitive or take many years (sometimes decades) to complete. What about the patients suffering now?

Case Studies Dismissed in Hormonal Birth Control Research

In my research involving birth control safety and the politics and policies surrounding hormonal birth control, the disregard for patient experience, let me rephrase that, human experience, is striking and entrenched. Even back in 1970 at the Nelson Pill Hearings, Dr. Joseph W. Goldzieher, one of the physicians testifying, was so adamant that case stories had no value that he impugned the entire British Medical Journal, the official publication of the British Medical Society and counterpart to the Journal of the American Medical Association. His claim was based on their willingness to publish an article about cervical cancer and the birth control pill when he felt that other journals “would turn it down as proving nothing.” Perhaps it is no coincidence that the British Medical Journal was the first to call attention to the problem of blood clots and the birth control pill. Dr. Goldzieher’s testimony is as follows (from page 6375 of the Nelson Pill Hearings).

Senator McIntyre: Does this statement, the statement that this journal—I am now referring to the British Medical Journal—this journal is noted for its lack of editorial discrimination, represent simply your own opinion, or is it based on some evidence?

Dr. Goldzieher: No, sir. It is my opinion exclusively, and it is based on the fact that this particular journal publishes large numbers of letters of an anecdotal nature, which are perhaps amusing, but are of dubious scientific merit, but which are then used for purposes which are not admissible. Having crept into the scientific literature as information—any statistician would call it anecdotal information—it then gets quoted and re-quoted. This is of questionable value to the medical community.

Senator McIntyre: Doctor, is it not true that letters to medical journals might very well be a manner and a way of detecting problems that may be occurring?

Dr. Goldzieher: I think there are better ways, Senator… This raw information should not, in my opinion, appear in a journal of this type… It should go to somebody which knows what to do with this information. Printing it in the British Medical Journal is no way to handle this kind of information.

Of course statistics are important. And of course we cannot make claims for all women based on the experience of one, or even a few, but in the case of hormonal birth control and blood clots (or really any of the side effects from hormonal contraception or other drugs), we are not talking about a few exceptional cases. Hundreds of thousands of people are harmed every year from medication adverse events. In fact, prescription pharmaceuticals are the fourth leading cause of death in the United States. How hormonal birth control contributes to that risk is unknown. We see from the testimony of doctors, scientists, and researchers that even in 1970 the drug manufacturers knew there were far more side effects with synthetic hormones than had been studied prior to their approval. Imagine what might have happened if more case studies were published instead of dismissed as anecdotal. Would that have driven more research and more awareness of risks?

Case Studies Drive Research

A doctor that testified after Dr. Goldzieher completely refuted Goldzieher’s stance on case studies and the British Medical Journal.

Dr. Philip A. Corfman said (in Nelson Pill Hearings, page 6400.):

“I believe the thromboembolism story provides a good example of what kinds of studies are needed. The story started with clinical observations, letters to the British Medical Journal, and case reports in Sweden and American literature. These observations brought this problem to the attention of medical science, but it was not for several years, five or six at least, until well-designed, carefully controlled studies were undertaken to show that there is indeed a positive relationship between the use of pills and [blood clots].”

 

“We are still in the early stage with the other problems that have been discussed, such as cancer, hypertension, and diabetes.”

Clearly, it takes patient stories to help detect these problems. We cannot afford to wait for an observable statistical jump in the mortality of young women or any group of people before we start investigating whether these medications are really safe. We really cannot trust the drug manufacturers to make this decision for us.

Pharmaceutical Companies Against Case Studies

Perhaps it is no surprise that when Senator McIntyre asks Dr. Goldzieher if he had ever worked for the drug companies, his response was, “I am a consultant at various times to various drug companies.”

So maybe it boils down to Dr. Clark’s testimony upon being asked if he would give his daughter the pill.

“There are two sensible answers to that. The first is, my daughters are both college age now and they would not do anything I told them to anyway. The second answer, I think, is that in a survey such as this, one is dealing with statistics. These have to be looked at in the light of a group of other statistics. When you come down to a question of the patient, that patient is no longer a statistic.” -Nelson Pill Hearings, page 6152.

Patients are Not Statistics

Patients are NOT simple statistics. This is why sharing personal stories is so vital and why we make that a priority at Hormones Matter. The manufacturers and many astute doctors and researchers knew over 40 years ago that hormonal contraceptives needed much more research. In 2016 we still don’t fully understand the risks for deadly blood clots and other serious side effects. Had women not been silenced then, perhaps we’d know more today; perhaps fewer women and their families would suffer the consequences of hormonal birth control related blood clots.

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

 

5 Things Not to Say to a Stroke Survivor

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Before I had a stroke at 28 from hormonal birth control (you can read my story here), I didn’t really know what a stroke was. And I certainly didn’t understand the implications or ramifications of what it meant to have an “insult to the brain.”

I knew I had physical and mental limitations, that I needed to learn how to walk again, to put on my socks, to bathe myself. But they also told my family that I may have an entirely different personality. Can you imagine? You wake up one day, have a brain injury, and your personality is completely different? And would you be able to recognize how your own personality had changed or would it be something people would whisper about when they thought you weren’t listening? My sister must have been particularly worried about my personality. I remember one morning she had to butter my biscuit for me after I had tried unsuccessfully several times. “I’ll butter your biscuit for you for the rest of your life,” she said. “I’m just so glad you’re still in there.” At least most of me was. That is to say, I still had my struggles with who I was and who I had been. But really, who doesn’t?

The interesting thing about surviving a stroke is learning what you can and cannot do. To others, even others that are informed about brain injuries, you may look so similar to your pre-stroke self that they take for granted you are the same. But you may not be.

So as a public service announcement for Stroke Awareness Month, here is a list of 5 things not to say to a person who has had a stroke (or any brain injury).

1. “Hold this.”

The disconnect between mind and body when you have a traumatic brain injury is a constant surprise. The first time they handed me the receiver to talk on the telephone, I held it backwards. One time I put a Cheeto in my ear instead of my mouth. When my mother asked me if I wanted to put on some lipstick, I took the tube from her, put it on my lips (or near them), then put the cap back on the raised stick of lipstick, crushing it. In the ICU, when they had me brush my teeth and rinse with a paper cup of water, the nurse instructed me to spit the dirty water back in the cup. I nodded. “Of course,” I thought. Then I promptly swallowed it. One of the most surprising things, and this was long after I’d been discharged from the hospital (and if I’m being completely honest, even now sometimes), is how things get lost in my left hand. I can literally be holding my keys in my left hand and be looking around the house for them.

But it’s not just the things in my left hand. Sometimes I will stand before a trash can with a pen in one hand and a tissue in the other and tell myself, “throw away the tissue, throw away the tissue, throw away the tissue.” Then I always have to bend down and pick the pen out of the trash.

2. “Lift your leg.”

During my rehabilitation, I was a bit of a challenge for my therapists. Most stroke survivors have damage to either the right or the left side of the body. But the damage from my stroke went down both sides of my brain and consequently affected my left arm and my right leg. One of the exercises the physical therapist asked me to do was to raise my left arm while all on all fours. I did. Then he asked me to raise my right leg. I did. “Raise your right leg,” he said again. So I raised it again. “Kerry, raise your right leg,” he said, like I might not have realized he was talking to me. “Right leg. Right leg,” my mom added. “I am raising my right leg,” I said, exasperated. What is wrong with them? I wondered. I looked behind me with complete certainty that I would see my leg raised. Of course I didn’t, but I did catch an expression on my mom’s face. It was the same expression she was wearing when we played Boggle in recreational therapy and I only found a few words. It was the same expression she wore when I smashed her tube of lipstick. It was an expression that seemed to say she wasn’t quite sure who I was.

3. “Write this down.”

A day or two after I got out of ICU, my mom asked me if I thought I could still write. You would think after the sock incident, I might have had my doubts. But I’m clearly a slow learner, because I said, “Sure, I can.” She handed me a notebook and a pen. I recently found that notebook, the picture is above. (My mom would continue to lovingly document these little milestones, just like she had when I was a baby.) When I wrote that, I thought I had done a pretty good job. And considering what my brain had been through, it was amazing I could even hold a pen. But when I look at it now, it breaks my heart a little bit. I’m so lucky that I write flawlessly now. Just kidding! My writing, while mostly legible and mostly on the lines of the paper, is still a mess. Until a few weeks ago, I didn’t even realize that messing up every third word, leaving letters out, adding letters where they don’t belong—that isn’t just how everyone writes. After a highly scientific study of asking a few of my friends, it seems that’s not normal. The first paper I wrote in graduate school, I typed the words male and female as “mail” and “femail.” Every. Single. Time. Even when I would remind myself, it still came out wrong. To this day, I have trouble with homonyms but I usually catch the mistake before I send the email or publish the story. But sometimes I don’t. I hope you’ll bare with me… haha.

4. Glare at them when they park in a handicapped spot.

In fairness, glaring at someone is not saying anything to them, but so much of communication is nonverbal that I had to include it. After my stroke, they gave me a temporary handicapped decal for my car. And while I may have looked relatively normal, I assure you I was not. I couldn’t walk long distances. I found any remotely crowded place to be extremely stressful. I had to sit down halfway through a trip to the grocery store. Day-to-day things that used to be easy were difficult and frustrating. But even more frustrating were the looks that people would give me when we parked in handicapped parking. One woman glared at me in such obvious disgust as we got into our car. She waited to comment until we had closed our doors so I didn’t hear what she said, but I’m pretty sure she heard me when I rolled down my window. As my husband sped quickly out of the parking lot, I hung my head out of the car and yelled, “I had a stroke!” at the top of my lungs. Not one of my finer moments, to be sure. The lesson that remains, and one even I frequently have to remind myself of, is that you really never know what a person is going through just by looking at them.

5. “My (insert friend or relative)’s experience was much worse than yours.”

A few months after I got out of the hospital, I was at dinner with friends when a woman I had just met (a friend of a friend) was surprised to learn that I had recently had a stroke. “My grandfather just had a stroke,” she said excitedly. “But his was way worse than yours. He’s still in the hospital.” Of course, what she meant was that I looked like I was fully recovered while he was still having visible problems. And of course, she probably didn’t mean to be dismissive. But it really bothered me. I had a massive stroke. I didn’t just have blood clots in my brain (an ischemic stroke, which accounts for 87% of all strokes). I also had bleeding in my brain (a hemorrhagic stroke—a much less common and far more deadly stroke). In my mind, I had actually survived two strokes. Yes, I was extremely lucky and I know my recovery was nothing short of miraculous. But that didn’t negate what happened to me nor what I was continuing to deal with. This woman knew nothing of my struggle to get to dinner that night, nor the struggle of the months before (and certainly not of the subsequent years), yet she made a value judgment on what had happened to me based on her grandfather’s experience. As human beings, it’s natural for us to draw comparisons and to find patterns. After all, common experiences and sharing stories are the major ways we connect to one another. And when you are interacting with someone who has had a traumatic brain injury, or any health crisis, it is completely fine to ask questions. But then just try to listen.

If you’ve ever had a health crisis, and many of us have, what have people unwittingly said to you? Or have you ever put your foot in your mouth when dealing with a friend or loved one’s health crisis? I know I have! Leave your answers in the comment section below.

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

Birth Control and Blood Clots: Where Do We Go from Here?

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When I was 28 years old, I had a massive stroke (a cerebral venous thrombosis in the sagittal sinus area) from a combination of birth control pills and a fairly common clotting disorder, Factor V Leiden. You can read my story here (Part 1, Part 2, and Part 3).

As I mentioned in a previous article, I’ve recently been contacted by an amazing group of people who are making it their mission to research and share information about the safety of hormonal birth control and other women’s health issues. In looking for answers about her daughter’s death from the Nuva-Ring, Dru West came across my thesis online and contacted me about my research. After a series of equally serendipitous events, I was then invited to be part of a research team who will further study blood clots and hormonal birth control. I’m embarking on this journey to share what I find—the good, the bad, and the ugly. I’m embarking on this journey with the hope that we can prevent what happened to me from happening to other women. I’m embarking on this journey for the countless women who lost their lives by taking these drugs for birth control, for irregular periods, for acne, or the myriad other reasons for which they have been prescribed.

My role in this project includes sharing my own story, the research from my thesis, and combing through 1500 pages of congressional testimony from the 1970 hearings about birth control pills. These documents, the Nelson Pill Hearings, have been fascinating and overwhelming. And more than anything they’ve made me want to know more. I want to find out what was known about hormonal birth control back then and how the research has or hasn’t changed since. I want to know why synthetic estrogen was banned in chickens because it caused cancer in animals at the same time it was approved for women (at 100,000 times the quantity). I also want to understand why no women were allowed to testify at these hearings (they were kicked out). And I can’t wait to share what I find with you.

Like so many issues, women’s healthcare is complicated and multi-faceted. And I plan to explore all the possible strings tied up in this knot. Starting with the research from my thesis, I’ll be writing pieces about risk communication, clotting disorders, what women really know, and what they need to know. I’ll be sharing what I find in the Nelson Pill Hearings. And I’ll be investigating other women’s health issues as they come up, or as you bring them to my attention. At times I may get angry, I may get snarky, I may get overwhelmed. But I promise I will try to be as thorough, honest, and real as I can. We may be a small community—those of us who know there are far more dangers in these drugs than the pharmaceutical companies want us to believe—but we are smart and we are strong. And when we all come together to share knowledge, we are powerful. I hope that you will join me on this journey. Unlike corporations who have no problem putting a dollar value on the life of a person, I believe that if we can save just one woman from what happened to Julia, to Brittany Malone, to Erika Langhart and so many others, then all of this work will be worth it.

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

A Stroke from Hormonal Birth Control: Part 2

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When I was 28 years old, I had a massive stroke (a cerebral venous thrombosis in the sagittal sinus area) from a combination of birth control pills and a fairly common clotting disorder, Factor V Leiden. You can read the first part of my story here.

Recovering from a Stroke

The repercussions of what having a stroke meant began to sink in after I was moved out of the intensive care unit.

Once in a regular hospital room, a therapist came by to do some tests. She pulled my blankets aside and asked me if I could take off my sock. This test seemed ridiculously easy, but I was willing, just happy that my head no longer hurt. I leaned forward and confidently pulled the sock off my foot. “Great,” she said. “Now put it back on.” So I put the sock back on my foot. Only I didn’t. Because I couldn’t. I stared at the sock in my hand and then I stared at my foot, knowing that I should be able to complete such a simple task, yet unable to.

This was the first of thousands of tests during my recovery. And it was the first of a thousand times when I knew I used to be able to do something that I could no longer do. It is one of the strangest sensations I have ever experienced.

I spent a week in the hospital and another week in an in-patient rehabilitation facility. Before I was discharged to go home (for another month of out-patient rehab), the psychologist told me that things would feel like “Christmas at the mall” instead of say, an ordinary Tuesday afternoon. It was an appropriate analogy for how overwhelming everyday life would be and one that I would come to understand the first time I broke into sobs when I dropped a bowl of cereal on the floor. I was cautioned against trying things like swimming alone, as I might not remember how and accidentally drown myself. They also told me that I had lost millions, maybe billions, of brain cells that I would never get back. And that I might never be able to work a “real” job again.

At home, I set about re-learning things like how to hook my bra, tie my shoes, and wash my own hair. Once I mastered these, I began to wonder what else I could do. I was extremely lucky that I made progress every day, but some days it felt like I’d never be back to normal. I wasn’t sure what normal even was anymore. After the warning from the psychologist, I was scared that I wouldn’t be able to handle a full-time job. And because of the seizures, I could not drive for six months which was devastating and isolating, especially for someone as independent as I had always been. Since I was stuck at home, it seemed like a good time to force myself to relearn math (yet another thing I knew I had been good at but could no longer do). I began to study for the GRE and less than six months later, I was accepted to graduate school.

Searching for Answers

When it came time to write my thesis, I decided to use my stroke as an inspiration for my research. I wanted to know why I had had a stroke, why no one had ever told me the risks involved with taking hormonal birth control, why I never knew there was a possibility that I had a clotting disorder which would greatly increase my risk. In short, I was looking for a smoking gun; someone or something I could point my finger at and say, “Aha! That is where the breakdown occurred. This is who should be blamed!”

But what I found was much more complicated. What my doctors had told me, that I was an anomaly, seemed to be supported by the research that I found. Studies show that most people get a blood clot within a year of starting hormonal birth control. Mine happened 10 years later. I learned that Factor V Leiden is fairly common but that women aren’t tested for it before being prescribed hormones because testing that many women would be expensive. I also found research that said pregnancy is more dangerous than birth control.

Putting aside the false dichotomy that the only two choices a woman has are to be pregnant or be on hormonal birth control, the message I took away from all of my research was that my stroke was an acceptable risk to save countless women from pregnancy. That even though my stroke could have been prevented by a simple blood test before I was even prescribed birth control pills, my value as a human woman was not worth the greater expense. As a child of the 80s and a product of American capitalism, this didn’t shock me as much as it probably should have. After all, I lived in a world of the Ford Pinto. What I didn’t realize at the time and would only come to understand years later, was that I began to internalize the blame for what happened to me. Maybe it was my fault for not knowing the dangers, for not understanding the risks, for being so stressed out that my body failed me.

Was It My Fault?

In researching my thesis, I discovered that pharmaceutical companies intentionally make the risk communication in advertising, and especially in the package with the birth control, dense and confusing. And I also found that women who have taken hormonal birth control don’t adequately understand the potential side effects, nor do they even know the symptoms of blood clots. There is very little accurate information about clotting disorders online. Even if my situation was rare, these facts are extremely troubling. But what I have since come to learn is that my stroke was actually not so rare.

Recently I’ve been contacted by an amazing group of people; researchers, families who have lost their daughters to hormonal birth control, fellow survivors, writers, and scientists. They’ve helped make it clear to me that I’m not just an anomaly. As you can see from the other stories on this site, hormonal birth control has very real, very harmful risks. And we have lost far too many amazing young women to stand idle any longer. Our standard must be higher than accepting these women’s lives as collateral damage. Together with this group of health advocates, we are embarking on a journey to give women what they need-information to make the right choice for them. Because what happened to me was not my fault. It’s time to stop blaming myself. Yet even as I write these words, I still have some doubt. And that doubt shows me that I haven’t fully recovered from my stroke yet. I still have work to do on this journey. And that work may take me the rest of my life. For more on what long-term recovery from a traumatic brain injury looks like, see Part 3 of the series.

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

Blood Clots With Hormonal Contraception

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Over 80 percent of American women use hormonal contraception at some point in their lives. Many women who have taken birth control pills, or used other hormonally-based birth control methods such as implants, patches, vaginal rings, and hormone-emitting IUDs are probably familiar with the common side effects like fatigue, loss of libido, mood effects, headaches and breast pain. However, many women may not be aware that taking almost any form of hormonal contraception increases their risk of developing blood clots, a condition that can range in severity from asymptomatic to fatal.

The risk of developing a blood clot varies depending on the type of hormonal birth control used. One might assume that the newer methods would be safer, but in fact, they are more dangerous. The newer birth control pills (formulations containing drospirenone, desogestrel, gestodene and dienogest) confer a higher risk of blood clots than older formulations (containing norethindrone acetate or levonorgestrel, as well as the newer norgestimate). And the risk from patches and vaginal rings are the highest of all. It seems that regulatory agencies are willing to lower safety for the sake of user convenience, something that most women using hormonal contraception probably would not agree with, if they knew they were being put at risk.

The overall risk is considered low, with about 1 in 10,000 reproductive age women per year developing a blood clot. However, the older birth control pills increase the risk by about four-fold, and the newer birth control pills by five to seven-fold compared to non-users of hormonal contraception. There has been a substantial increase in the incidence of blood clots for the period of 2001 to 2009, compared to the years prior, likely because of the increase in use of newer hormonal birth control pills and the vaginal ring (Nuvaring). And because approximately 20 million American women use hormonal contraception, these relatively small risks translate into significant numbers of cases each year.

Every woman who is using hormonal contraception deserves to know accurately what the risks are, in order to make an informed choice of method of contraception, yet these risks are not often being communicated by doctors. And considering that taking any form of hormonal birth control at all raises the risk of developing a blood clot, every woman on hormonal contraception should know what the warning signs are, and seek medical help if they experience those signs or symptoms. Knowing these warning signs could save your life. Described below are signs of blood clots in various locations in the body.

Blood Clots In Legs, Arms, and Lungs

Blood clots can develop in any vein but most commonly develop in the leg, and sometimes in the arm. This type of blood clot is called a venous thromboembolism (VTE). These clots can break off from the spot where they initially form in the body, and travel to the lungs, causing a pulmonary embolism (PE), which is fatal in about 10 percent of cases within the first hour, and 30 percent of cases subsequently. Sometimes the VTE leading to the pulmonary embolism was asymptomatic or undiagnosed, and PE is the first indication of the presence of a blood clot. Even pulmonary embolism is often misdiagnosed at first.

Signs of VTE include pain or tenderness only in one leg or arm, swelling and/or red or blue discoloration of the affected limb or an area of the limb, and the leg or arm may be warm to the touch. Signs of a PE include sudden shortness of breath, chest pain that is sharp or stabbing and may get worse with deep breathing, rapid heartbeat, and cough (sometimes with bloody mucous). For information about how VTE and PE are diagnosed, see How is DVT Diagnosed? and How is PE Diagnosed?.

Blood Clots In the Veins of the Brain

Cerebral venous thrombosis (CVT), which is a type of stroke, is caused by blood clots in the veins of the brain. This condition is even more under recognized than DVT and PE, and comprises about one percent of all strokes. Using oral contraceptives has been shown to increase the risk of CVT up to 22-fold. This study is on the older side, performed before more widespread use of newer birth control pills, so the risk is likely even higher. In the past, this condition was fatal much more often, but now the diagnosis has been improving, and the mortality in various studies ranges from 5 to 30 percent. About 15 percent of patients who survive can have continued neurological impairment. CVT can be diagnosed using a combination of clinical signs and symptoms, and imaging such as MRI.

Signs and symptoms of CVT can vary depending on where the clot is in the brain. Headache is a common symptom, sometimes accompanied by nausea and vomiting. Seizures can also occur. In addition, neurological problems can be present, such as: paralysis or weakness on one side of the body, decreased vision on one side, difficulty speaking, or dizziness.

Blood Clots In Arteries

Like in veins, blood clots can form in almost any artery in the body. And similar to venous blood clots, clots that initially formed in one artery can break off and travel to arteries within almost any organ in the body. A blood clot in an artery in the brain causes a stroke (just like a blood clot in a vein in the brain), and a blood clot in an artery in the heart causes a heart attack. Hormonal contraception also increases the risk of these types of blood clots. In some cases larger strokes are preceded by smaller strokes, called transient ischemic attacks (TIA)—this occurs when a blood vessel is blocked temporarily by a blood clot. The incidence of stroke has increased significantly, especially in young people, from 1995 to 2008.

Symptoms of strokes caused by a blood clot in an artery are similar to those described above for CVT. Early treatment of a stroke results in significantly better outcomes; therefore the American Heart and Stroke Association has developed the following acronym to help people recognize the early warning signs: F.A.S.T.

  • F: Face drooping
  • A: Arm weakness
  • S: Speech difficulty
  • T: Time to call 911.

Warning signs of a heart attack in women include:

  • Chest pain—can feel like uncomfortable pressure, squeezing, fullness or pain in the center of the chest.
  • Pain or discomfort in one or both arms, back, neck, jaw or stomach.
  • Shortness of breath with or without chest discomfort.
  • Nausea, light-headedness, or breaking out in a cold sweat.

It should be noted, that women may experience the signs of a heart attack differently than men and diagnosing heart attacks in women is sometimes more complicated requiring great persistence on the part of the patient and the family. An example of this can be found here.

Other Factors That Increase Risk

An individual’s risk of getting a blood clot depends on a combination of genetic factors, acquired conditions, and environmental/lifestyle factors. Although many women may be familiar with the oft-cited risk factors of being overweight, smoking, and being over age 35, many women might be surprised to realize that some of the seemingly innocuous factors described below, or undiagnosed genetic conditions, can combine to increase the risk substantially.

Genetic Factors

Certain inherited conditions, known as inherited thrombophilias, can increase the risk of developing a blood clot. Many people with these inherited conditions have no signs or symptoms of a blood clotting disorder until an environmental or acquired risk factor or factors comes into the picture (such as a hormonal contraceptive), at which point their risk of developing a blood clot increases substantially. These inherited thrombophilias include antithrombin deficiency, protein C deficiency, protein S deficiency, Prothrombin (factor II) mutation, factor V Leiden mutation and hyperhomocysteinemia (which can be caused by MTHFR mutation). The effect of the increased risks from hormonal contraceptives and inherited thrombophilias is synergistic, meaning the risk is much larger than the risk of the two added together; for example, in hormonal contraceptive users carrying a factor V Leiden mutation, the risk of a blood clot is increased 35 fold. Inherited thrombophilias can be detected by genetic testing, but are not routinely screened for. More information about inherited thrombophilias can be found on the National Blood Clot Alliance website.

Acquired Conditions

The acquired condition that is most commonly associated with an increased risk for blood clotting is an autoimmune condition called anti-phospholipid syndrome (and less commonly anti-cardiolipin antibodies, or anti-B2 glycoprotein 1 antibodies). These antibodies can occur on their own, in the absence of other autoimmune diseases, or they can occur secondary to autoimmune diseases such as lupus. These conditions can cause other symptoms in addition to blood clots, such as miscarriage and migraine. Cancer, especially metastatic cancer, is also a recognized risk factor for thrombosis. Hyperhomocysteinemia can also be an acquired condition due to nutritional deficiencies, some chronic illnesses, and medications. Chronic inflammatory conditions such as Crohn’s disease also increases the risk of blood clots.

Environmental or Lifestyle Factors

Certain lifestyle factors are also known to increase the risk of blood clots, including:

The risk of developing a blood clot also increases with increasing age.

It must be stressed that one does not need to have a genetic or acquired risk factor to develop a blood clot, or even to have a fatal blood clot. Following are just a few of many stories of young, healthy women who were seriously affected or died from blood clots while on hormonal contraception.

These women unfortunately did not realize that their choice of birth control was putting them at increased risk. For these women, knowing that they were at increased risk, and knowing the warning signs of a blood clot, could have saved their lives. That is why we are urging all women to become aware of these warning signs, investigate your personal risk, make smart, informed choices of birth control methods, and seek medical attention immediately if you are experiencing signs of a blood clot.

In Memory

This article was inspired by and written in memory of Karen Langhart, who tragically took her own life four years after her young, healthy, vibrant daughter Erika, died suddenly from bilateral massive pulmonary embolisms caused by the Nuvaring. Since Erika’s death, Karen had worked tirelessly to ensure that other families would not suffer the tragedy that hers did.

Hormones Matter will be covering this important topic in more detail in the coming months, so please follow this website, or follow us on Facebook and Twitter at and @HormonesMatter. If you have experience with contraceptive induced blood clots and would like to contribute a personal story or research article, please consider writing for Hormones Matter.

Image by starline on Freepik

Brain Grenade: Hormonal Contraceptives, Migraine and Stroke

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On Sunday, April 14, 2013 I woke up with a headache.

This wasn’t unusual for me; I had battled chronic headaches and occasional migraines for over ten years. I had tried almost every available solution, but never found relief.

This headache was worse than normal, but since I had already made plans with my dad to hike the Manitou Springs Incline that day, I resorted to my usual option; suck it up, smile, and push through the pain. I got to my dad’s house and he could see in my eyes that my headache was getting worse. He offered up the option to go to Barnes & Noble, get a latte at Starbucks and look through travel magazines instead. I conceded because I was in pain, and also because this was another one of my favorite ways to spend time with him.

While flipping through pages of Conde Nast’s Traveler magazine with a chai tea latte in my hand, I felt a pain that I will not soon forget strike through my right eye and up through my skull. It felt like a white hot bolt of lightning electrocuting my brain.

For Harry Potter fans out there, my Voldemort was close.

Hunched over in pain and grasping my head, my dad rushed me over to the nearest chair. The excruciating pain subsided, but left me really scared. That had never happened before. I told him that I needed to go home and find some migraine medication to take before it got worse. He offered to drive me home, but being as stubborn as I am, I told him I’d be fine driving myself. There were a few times on the drive back that my vision was altered, but that’s not something I wanted to admit to anyone, even myself.

Thinking it was just a severe migraine, I took a prescription migraine medication called Frova, crawled into bed and switched on Netflix…waiting for it to pass.

It never did. It only got worse…

I called in sick to work the next day and continued lying in bed with inadequate pain killers and trashy TV. I didn’t tell anyone about my lightning bolt pain or altered vision because I didn’t want to admit it was worse than my typical migraines. However, that afternoon the pain was so bad that I decided to go to the ER.

The ER staff put me in a dark room with a warm blanket and a lot of narcotics. That usually does the trick. Morphine and anti-nausea injections are the go-to solution for migraines. Adequately doped up, my mom and stepdad took me back home so the morphine hibernation could kick in and knock me — and my migraine — out cold.

Hours of drugged and dreamless sleep passed, and I woke up only to increased pain and foggy consciousness, coupled with dehydration and weakness from skipping meals.

Without any resistance or say in the matter, my parents took me back to the ER the next day. The doctors decided that a CT scan was the next step in figuring out my pain. I barely remember getting off my hospital bed and onto the CT table for the scan.

In addition to the CT scan and more narcotics, they also injected the base of my skull with a numbing agent like Novocain. Let me tell you, no matter how drugged and doped up you are from days of a steady stream of narcotics, hearing a needle and its contents being injected into the base of your skull right next to your ear, will wake you up with a searing certainty.

Back home I went, praying that this drug slumber would finally do the trick. Three more days passed without any relief; the pain didn’t let up, no matter how much medication my body consumed. Eventually, I couldn’t even keep food or water down without instantly getting sick. I couldn’t stand up without holding onto a wall or piece of furniture.

My worried parents called their primary care physician and explained the situation. I got an appointment with her that day and walked into her office like a brainless zombie. At that point, being a brainless zombie sounded quite appealing. The doctor asked my mom a few questions while I looked blankly at the wall. She scheduled an emergency MRI and within one hour, I was wearing an ugly medical gown lying inside a noisy, confining white tube as a machine snapped a picture of my brain.

We went back home and not long after I got settled on the couch with some of my mom’s chicken noodle soup, I received a call from the Radiologist telling me that I had a Cerebral Sinus Venous Thrombosis. (Say that five times fast!) It was located in my sagital sinus. In layman’s terms, I had a blood clot in my brain.

{A blood clot in my brain}

I was instructed to get up immediately and go directly to the hospital in downtown Colorado Springs. The radiologist already called and they were expecting me. Funny to think that I had reservations at a hospital. I had to go to the hospital downtown because that’s where the best brain surgeons in the city were. “Just in case something ‘bad’ were to happen,” the nurse said, matter-of-factly.

Despite that dramatic comment and the reality-shifting diagnosis, I was very calm. I thanked her, hung up and looked at my parents, explaining what I had just heard. I was relieved that I finally had an answer to what was causing this pain. My unrelenting lightning bolt brain pain might be coming to an end!

Everything started moving very quickly. My parents mobilized with military-like precision…feeding the dog, calling my grandparents, texting my brother, packing an overnight bag for me, wrapping me in a blanket and putting me in the car.

We got to the ER and I walked directly into a room they had waiting for me. VIP status baby! 😉 A very handsome blonde doctor came in and explained that I needed to have another MRI with contrast this time so they could see the blood clot in more detail. This meant that I needed to get a special dye injected in my veins so they could see exactly where the clot was located.

A hot male nurse came in to the room and stuck a toothpick-sized needle in the biggest vein in the crease of my right arm. Of course McDreamy & McSteamy had to be my doctor and nurse while I looked like a brainless zombie with unwashed hair, zero makeup and hairy legs.

But I guess life isn’t an episode of Grey’s Anatomy.

I was wheeled up to a room on the fourth floor of the hospital, where I was greeted by a sweet RN who hooked up a large bag of fluid to the IV tube in my right arm and told me that I would be on a heavy dose of Heparin, a blood thinning medication that would help reduce the size of the clot in my head.

As I was slowly adjusting to the sterile smell of my hospital room, the beeping machines connected to my bed, and the strange reality of being in the hospital, a doctor came in to explain what was happening.

Based on my age (I had turned 28 two months prior), coupled with the fact that I was a physically fit, non-smoker, the only viable reason why I was sitting in this room with a clot in my head was because of the birth control that I was currently taking. This was happening because I switched my birth control method almost four months prior from the oral contraceptive, Yaz, to the vaginal ring, Nuvaring.

And the reason why I switched four months earlier? I heard commercials on TV about women who were hurt using Yaz/Yasmin and how they could be eligible for compensation in class-action lawsuits. I did NOT want to be one of those women, so I thought I was being smart and safe.

Oh the irony…

I had to immediately remove the Nuvaring and was told by my doctor I would never again be allowed to use hormonal contraceptive methods again. My future pregnancies may even be high-risk and I would have to be heavily monitored and put on a blood thinner called Lovenox once I got pregnant. She told me that I would have to stay in the hospital for five more days while they pumped a high-dose of Heparin through my veins to prevent further clotting or a possible stroke. I would then go on an oral blood thinner named Coumadin for six months once I got out of the hospital to further shrink the clot. No surgery would be needed, thank God.

The next five days were filled with the highs of family and friends visiting, sending flowers and showing love, the lows of self-pity, frustration and cabin fever, as well as the strange experiences that naturally occur from staying in a hospital room for that long.

One of strangest had to be sleeping on a bed that was meant for someone who was more at risk for bed sores than I was. The bed was constantly shifting my weight around by filling with air in different places. It was like an air mattress pump would come on every few minutes, making it practically impossible to sleep. Once I did finally go to sleep (with the help of Ambien) a nurse would come in and wake me up every four hours to check my blood levels. I would hide from the bright lights underneath my blanket while she poked my fingertips and squeezed blood into vials.

Showering was a whole other story. My room didn’t have a shower, so my nurse told me I could use one that was down the hall. I rolled my IV stand down the hallway, only to find basically a broom closet with an RV-sized shower in it. I had to hold my right arm out of the shower because my IV couldn’t get wet. All I wanted to do was shave my legs, but razors were a definitely no-no with blood as thin as mine.

While the list of repercussions of being on Nuvaring for less than four months continued to grow, so did my gratitude for finding this clot when I did.

I know many women were not as lucky as I was and suffered through strokes and long-term health defeats. Some women even tragically lost their lives.

I made it through the following six months with as much grace as I could muster. But there definitely were times when I was annoyed that I had to wear an ugly medical alert bracelet in case of emergencies, that I was covered in bruises from my blood being so thin, and that I had to go to the Coumadin clinic every week to get my finger pricked to check my blood levels. I felt defeated and ashamed as my body awkwardly readjusted to getting off hormonal birth control by gaining weight and breaking out in acne that I thought I had happily left back in 8th grade. Even now, I still get worried and anxious when thinking about what I’ll have to go through once I get pregnant.

But even with all of that, I count my lucky stars that this is in the past, that I’m healthy and happy, and that I can share my story.

I want women to think through their options, know the risks of Yaz, Nuvaring, and other forms of hormonal contraceptives, and realize there are other ways of taking care of themselves and their family.

Real Risk Study: Birth Control and Blood Clots

This story is one of a series about women who have developed blood clots while using hormonal contraception. These articles are part of the Real Risk Study: Birth Control and Blood Clots, a research project to help women gauge their actual risk with hormonal birth control. For more information, or to participate click here.

Five Half-truths of Hormonal Contraceptives – The Pill, Patch and Ring

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Have you ever wondered if the pharmaceutical companies and doctors are telling you the whole truth about the risks for side effects with the drugs they sell or prescribe? Do the side effect warnings seen in advertisements or on prescription inserts make any sense to you? If you are like me, probably not. In fact, if you’re like me you probably don’t give side effects much thought at all. Or at least I didn’t, until my daughter suffered from a serious side effect of a common medication, a medication millions of women take every day for years. My daughter died last year from hormonal contraceptive induced blood clots. You can read her story here: Brittany Malone. Now, I have made it my mission to educate other women and families about the very real risks associated with hormonal contraceptives and the incredible lack of data and information available to women to make an informed choice.

Playing Fast and Loose with the Numbers: Hormonal Contraception Carries Real Risks

For too long, the pharmaceutical industry and most likely your doctor, have been telling you what they want you to know about birth control drugs; instead of educating you with the information that you need to know to help you choose the birth control method that works best for you.

The communication of risk and benefit is a core component of health care counseling and should begin with the most fundamental principles of medicine: “First, do no harm.” I am not sure that is what is happening now. It didn’t with our daughter and many of the women and families we have met who have suffered similar tragedies.

What women really need to know is how a particular contraceptive drug or method compares to other types of contraception in terms of safety and effectiveness. In more personal terms, you need to know what the chances are that a particular contraceptive formulation or device will adversely affect your health. What I have learned since my daughter’s death is that this information is not easy to come by. In fact, it either doesn’t exist entirely or the manner in which it is presented is so convoluted that it is indecipherable and utterly useless.

The terms used by pharmaceutical companies as well as some leading contraception experts to describe these risks are either gross simplifications of the actual risk to life, or are enveloped in complex statistical and/or medical jargon that the lay person and even the physicians prescribing these meds cannot understand.

Here is what I mean. Below is a list of the most common half-truths regarding hormonal contraceptives and the risk for deadly blood clots.

Half-truth # 1: Blood Clots with Combined Hormonal Contraceptives are Rare

The increased risk of developing a dangerous blood clot when using combined hormonal contraceptives (CHCs) is a well-recognized, serious and potentially fatal adverse event associated with these medicines. A recent study published in the British Medical Journal (abstract) says there are even higher rates of blood clots than previously thought see Fresh Evidence Confirms Links between Newer Contraceptive Pills and Higher Risk of Venous Thromboembolism.[1] Unfortunately, most patients are unaware of this potential risk and if they are aware, they have no idea that a blood clot “cardiovascular event” can lead to their death. More studies can be found here on Birth Control Safety.  Any time a drug is prescribed that is proven to cause death, even if it is associated with a small percentage of the users, the provider is responsible for explaining the risks factually, and in terms a lay person can understand. Consider these data:

  • On average, 307 women die in the U.S. every year due to a pulmonary embolism (blood clot in the lung) as a direct result of the use of the pill, patch or ring – a combined hormonal contraceptive.
  • Up to 2,600 women in the U.S. will develop a pulmonary embolism (blood clots in the Lung) as a result of the pill, patch or ring. Pulmonary emboli are potentially catastrophic and can lead to death.
  • Up to 7,700 non-fatal cases of deadly blood clots in the U.S. occur each year, due to the effects of the pill, patch or ring.

If you are like most doctors and all patients, you will be shocked to learn how many women are harmed annually by hormonal contraceptives.

For a full report, see Birth Control Safety.  This report compares the estimated impact of blood clots across 2nd, 3rd and 4th Generation Combination Hormonal Contraceptives.

Unfortunately, most doctors leave their patients believing that combined hormonal contraceptives (the pill, patch and ring) are safe. As you can see from the data stated above, these drugs are safe for some people and very dangerous for others.

Half-truth #2: Only Smokers and Women Over 35 are at Risk for Blood Clots

The reality is that the estrogenic effects of combine hormonal contraceptives increase the risk of a potentially life threatening blood clot (venous thromoboembolism or VTE) by between 400% – 700% for ALL women at any age including those that don’t smoke and those that do smoke.[2] (Comparing Annual VTE Impact across 2nd-4th Generation CHC’s in the U.S. 2013). The risk of smoking increases that risk by 40% compared with non-smokers [3]. That means, the increased risk of blood clots effects all users by 400-700% and the risk associated with smokers and for women over the age of 35 is even higher. This form of warning is misleading as many who read this think, “I don’t smoke and I’m under the age of 35, so this cardiovascular risk doesn’t apply to me. I’m safe to use it.” Even worse, this false sense of security is proven to mask the early warning signals of a potentially deadly blood clot.

The following is included as a “black box” warning in the most recent version (2013) of the NuvaRing patient information and reads as follows:

“Who should not use the NuvaRing?” Cigarette smoking increases the risk of serious cardiovascular side effects when you use combination oral contraceptives. This risk increases even more if you are over age 35 and if you smoke 15 or more cigarettes a day. Women who use combination hormonal contraceptives, including NuvaRing®, are strongly advised not to smoke.”

This statement infers that if you are a non-smoker and under the age of 35, that you should be able to safely use the NuvaRing. It also infers that if you are a smoker, even though you need to be concerned, you don’t need to be too concerned unless you smoke 15 cigarettes a day AND are over 35. This is misleading; intentionally misleading, I think.

In the same 2013 NuvaRing package insert, under the heading “What is the most important information I should know about the NuvaRing? Comes the answer:

“Do not use the NuvaRing if you smoke cigarettes AND are over 35 years of age. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from combination hormonal contraceptives (CHC’s), Including death from heart attack, blood clots or stroke. The risk increases with age and the number of cigarettes you smoke.”

Again, I think this statement falsely misleads women who do not smoke about their risks for blood clots. A more appropriate warning label might say something like this:

The estrogenic effects of combined hormonal contraceptives increase the risk of potentially life threatening blood clots by between 400% – 700%.

Hormonal Contraceptive Risk Counseling Misses Real Risks

Below are three videos that exemplify the lack of appreciation physician give to the real risks of blood clots with hormonal contraceptives. These are videos used to train physicians, nurses, pharmacists and other healthcare practitioners.

The Contraceptive Counseling Training Video below is a perfect example of how doctors and nurses are being taught to promote the effectiveness and safety of the pill, patch and ring without counseling women on the fact that these drugs to cause great harm, even death to some users.

Contraceptive Counseling Training Video

I find it very interesting that time is taken to review the side effects of spotting, bloating, nausea and breast tenderness, but the discussion of the dangerous side effects like blood clots, strokes, heart attacks which can lead to death don’t even come up. This has to change. Given the reoccurring annual loss of life attributed to these drugs, the true risks and early wanting signals of a dangerous blood clot need to be reviewed and thoroughly understood.

This next video is a great example of a typical visit with a nurse practitioner can unfold with zero safety information being shared relative to the increased risk of blood clots. Even worse, the question is asked “do you smoke at all,” and when the patient says I used to smoke and the nurse responds with the doctor’s advised you that you shouldn’t smoke while using the pill, the patient responds with yes. This is a great example of how the pharmaceutical companies have brainwashed doctors and nurses to highlight the risks associated with smoking, which leave a non-smoking patient to believe they are not at all exposed to any increased risk of developing a potentially catastrophic blood clot.

Brenda Oral Contraceptive Pill Counseling

In this final video, a patient shares that she smokes 10-15 cigarettes a day and the recommendation of the doctor/nurse is as follows “I’ve reviewed your family history and is it quite safe for you to take the pill. What I suggest is that you take the combined oral contraceptive pill. This is an example of the clinical issues that are putting our loved ones and friends’ lives at risk. Given that the increased risk of blood clots with CHC’s is well recognized, serious and potentially fatal, this practice of uninformed counseling is dangerous and needs to change before more women are killed.

A Contraception Consultation in Pharmacy

In each of these practitioner training videos, the real risks for blood clots associated with hormonal contraceptives is minimized. Women are not given the data needed to make informed decisions. As a result, when these risks turn to reality, they often go unrecognized. There are hundreds of stories of young women that were perfectly healthy and didn’t smoke that died suddenly from massive blood clots linked to the pill, patch and the ring. Birth Control Safety: Women’s Stories.

Half-truth # 3: All Hormonal Birth Control Methods are Equally Safe

Evidence confirms that newer contraceptive drugs have a higher risk of blood clots. In fact, the 3rd and 4th generation contraceptives (Yasmin, Yaz, Ocella, NuvaRing etc.) increase the overall risk by an additional 200% – 300%, above and beyond the risk for blood clots associated with earlier formulations. I think women should know this before choosing a method of contraception. I think physicians should make this information very clear to their patients. Unfortunately, I don’t think this is happening. Most patients and physicians alike do not understand the different risk profiles that each formulation of hormonal contraceptive carries. Prescribers especially should be aware and consider how the risk of blood clot with a particular combined hormonal contraceptives compares with other methods (see table 1) and help their patients make informed decisions. Currently available data provides compelling evidence that both 3rd and 4th Generation CHCs have higher risk of venous thromboembolism (see table 1) than the older 2nd Generation drugs, despite attempts to develop safer contraceptives for women.

Table 1. Risk for Blood Clots with Different Hormonal Contraceptives

Table 3- Comparing Annual VTE rate

Half-truth # 4: Blood Clots are more Common During Pregnancy and Postpartum

Pharmaceutical companies maintain the enormous market for hormonal contraceptives by telling doctor’s and women that it’s safer to use the pill, patch or ring than it is to get pregnant. This is a false comparison and here’s why. These dangers are of an unnatural substance interfering with body processes. Pregnancy however is a natural process, which the body is prepared to deal with. The pill, patch or eing actually introduce cardiovascular disease (blood clot) into your body (Confessions of a Medical Heretic, p29)[4]. Women who have already made the decision to use contraception have taken pregnancy off the table, so the real question is, how does the pill, patch and the ring compare to other forms of contraception in terms of both safety and effectiveness?

Women in the U.S. have on average of 2 births in their lifetime. The risk of these two period of life, pregnancy and postpartum periods, that total 30 months of time, cannot be compared to the risk that a women experiences while using a combined hormonal contraceptive continuous over the course of their child bearing years which may be as long as 25 years. This type of comparison (that the risk of a blood clot or other complication is many times greater during pregnancy), defies both logic and science. Comparisons of contraceptives should be between the various methods of birth control as this helps women make the most informed decision of which method of birth control works best for them. They have already made the decision to control birth (not get pregnant), so there is no need to compare these drugs to pregnancy.

Pregnant women often pay more attention to their bodies because they are concerned about their own health and the health and safety of their unborn child. Medical professionals more closely monitor pregnant women than hormonal contraceptive users. The identification of a venous thromboembolism is more likely to occur in a pregnant woman, as she has more frequent contact with the medical community. When a healthy woman is prescribed birth control, there is a “set it and forget it” treatment plan where the health provider may say, “Call me if you have any problems and come back in a year.”

This false comparison of risk of VTE in pregnancy versus the pill, patch and ring creates a false sense of safety with hormonal contraceptives compared to pregnancy. It minimizes the possibility that something terrible could happen while using a combined hormonal contraceptive. This is like warning someone to watch out for the charging elephant but failing to pay attention to the charging buffalo. Yes, an elephant’s foot may be bigger and heavier, but if a buffalo charges you will still have a problem.

The oversimplified and inappropriate presentation of the risk during pregnancy minimizes the increase rate of risk between 2nd, 3rd and 4th generation combined hormonal contraceptives. Newer is not better. In fact, the newer 3rd and 4th generation drugs increase the life threatening risk of blood clots and bring no incremental benefits outside of expanded choice.

Half-truth # 5: Double a Rare Event is Still a Rare Event

Healthcare professionals need to stop using that phrase “Double a rare event is still a rare event” when it comes to women’s lives. This is a statistical view of the mathematics that make up traditional risk management practices that minimizes the very risk of serious side effects, including fatality, associated with these medications. Even if these side effects develop in a small percentage of the users, the patient needs to understand these risks and it is the provider that is responsible for explaining the risks factually and in context that patients can comprehend.

In reality, if we double the rate of venous thromboembolism and pulmonary emboli, the number of related deaths grows from an average of 307 to 614 per year. The number of women impacted by the most dangerous type of blood clot, a pulmonary embolism, which has a 12% mortality rate, grows from an average of 2,560 to 5,120 women annually. Pulmonary embolism survivors are subject to additional treatment, which typically includes anticoagulant medications (blood thinners) and varies in type of treatment and duration based on severity. Some women need immediate emergency treatment, others can be treated as an outpatient. Patients are typically treated for 3-12 months, but some must remain on blood thinners for extended period of time.

As you can imagine, this dismissive, although witty, statement does not attune the health care community to pay serious attention to the possibility that real people will die or be permanently injured. Furthermore, when you multiply a small number by a large number of users the impact of these “rare events” equates to many more deaths than anyone realizes. Rare events DO happen and they happen to real human beings! It is also an insult to the thousands of women (and their families) who have been injured or died particularly when there are much safer and more effective alternatives available

The Bottom Line: Hormonal Contraceptives Carry Significant Risks

FACT – Combination hormonal contraceptives dramatically increase the risk of dangerous blood clots.
FACT – Blood clots (acute thrombotic events) are known to lead to sudden death or lifelong problems.
FACT – Pulmonary embolism (blood clot in the lungs) are the most dangerous form of thromboembolism which has a 12% mortality rate.
FACT – 20%-25% of pulmonary embolism related deaths present as sudden death (No Warning) [5].
FACT – A woman is 20 times more likely to become pregnant if she uses birth control pills, a patch or a ring than if she uses an IUD or an implant [6].

References

  1. Jick S, Fresh evidence confirms links between newer contraceptive pills and higher risk of venous Thromboembolism BMJ 2015;350:h2422 doi: 10.1136/bmj.h2422 (Published 26 May 2015).
  2. Comparing Annual VTE Impact across 2nd-4th Generation CHC’s in the U.S. 2013 – Birthcontrolsafety.org).
  3. Goldhaber S, The Clot Blog of Medscape.com, VTE risk in women who smoke; http://www.medscape.com/viewarticle/801689 last sourced 9-15-2015.
  4. Mendelsohn S, Confessions of a Medical Heretic, Chapter 2, page 28.
  5. Beckman M, Hooper WC, Critchley S, Ortel T. Venous thromboembolism: a public health concern. Am J Prev Med. 2010;38(4 Suppl):S495-501.
  6. American College of Obstetricians and Gynecologists, Frequently Asked Questions FAQ#184 Contraception: Long-Acting Reversible Contraception (LARC): IUD & Implant.

Blood Clots while on Hormonal Contraceptives: Fact or Fear Mongering?

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A few weeks ago, someone posted a news article on Facebook about another young woman who almost died from her hormonal birth control. One Facebook commenter made a remark that she hated the fear mongering that goes on about hormonal birth control in the news. I, on the other hand, truthfully wish more women knew what to fear. My 29-year-old daughter Julia died in 2013 from massive bi-lateral pulmonary embolisms while using NuvaRing as her birth control. We had just celebrated her marriage to a wonderful young man. Julia had been married exactly five weeks on the day she died. I cannot even begin to describe the grief we feel about her death to this day.

That Facebook comment made me think about what I now see as the fear mongering that the medical community engages in when they insist that the risk of blood clots during pregnancy and postpartum (after delivery) must always be mentioned to put the risk of blood clots “in perspective.” I began to wonder if we really know enough about the risks of blood clots with hormonal contraceptives.

Beyond Fearmongering: Learning from the Families who Lost Loved Ones to Hormonal Contraceptives

My daughter’s death led me to meet Joe Malone whose 23-year-old daughter Brittany died in 2012, also while using NuvaRing. Our daughters’ deaths have taken us on a long and frustrating journey to learn more about combination hormonal contraception (CHCs) and why our daughters died.

Joe and I understand why the medical community wants to make sure that women use some form of birth control. Maternal mortality is very high, especially in third-world countries. There are many health complications and dangers for women during pregnancy and in the weeks after delivery from a variety of causes. The risk of a blood clot is high. However, we now see how the information given about the risks for blood clots during pregnancy and postpartum is presented in such a way that seems intent on scaring women into taking hormonal contraceptives. There is little discussion about safety between the various types of hormonal birth control (pill, patch, ring, IUD or shot), or other options, such as a copper IUD or other non-hormonal methods. Every hormonal contraceptive and every formulation is pronounced safe and the risk of a serious event is declared rare.

Women are told to talk with their healthcare provider about these risks to learn more. We have found that this suggestion is insufficient because many of these providers themselves, do not understand the different risks associated with each contraceptive formulation/brand.

Inevitably, accompanying any mention of risk from a hormonal contraceptive is the stark warning that the danger of a venous thromboembolism (VTE) – a blood clot in leg or lung) is higher while pregnant or postpartum. We have learned the hard way that the risk of a blood clot may be higher, but the possibility of death from a PE while using combined hormonal contraception is even greater.

Risk for Blood Clots with Hormonal Contraceptives versus Pregnancy or Postpartum

After careful review of data from various governmental and independent agencies (see below for discussion), we now believe that the overemphasis on the risk of VTE in pregnancy creates a false sense of security regarding the safety of combined hormonal contraceptives compared to pregnancy. It minimizes the reality that something very dangerous can happen to a small, but recognizable, percentage of women who use hormonal contraceptives. Women are led to believe that hormonal contraceptives are much safer than being pregnant due to the VTE risk in pregnancy. Women are not instructed on how to recognize the early warning signs of a dangerous and potentially deadly blood clot, and sadly, we also discovered that neither are their doctors. According to data from the CDC,

more U.S. women died from pulmonary embolisms while using a combination hormonal birth control than from pulmonary embolisms while pregnant or postpartum in 2011.

There were approximately 69 deaths in the U.S. from pulmonary embolisms during pregnancy and post-partum in 2011 (the latest date for which these numbers are available), compared with approximately 307 deaths due to pulmonary embolisms for women who used a combined hormonal contraceptive pill, patch or ring in 2013 in a recent analysis Joe and I completed. A full analysis is posted on BirthControlSafety.org.

We believe the reason there are fewer deaths from a pulmonary embolism during pregnancy is that most women who are pregnant or have recently given birth are monitored much more carefully than women who use hormonal contraceptives. A woman who utilizes birth control pills, patches or a ring is seen only annually by her physician and very rarely advised of the signs and symptoms of blood clots.

When signs of potential blood clots emerge, such as chest pain, difficulty breathing or leg pain, women are told that they have bronchitis, pneumonia, asthma or a pulled muscle. You can read first-hand accounts from both men and women on a site called stoptheclot.org. When you read these stories, you hear how the medical community has a very difficult time diagnosing deep vein thrombosis or pulmonary emboli. People who go to their doctor with the symptoms of a blood clot in their lungs or leg, are more likely than not, told to take an antibiotic, a pain reliever or muscle relaxant and come back later. For many, later is often too late.

Women Who Die from Contraceptive Induced Blood Clots

Our review of the data suggest more U.S. women die from VTEs while using a combined hormonal contraceptive than during pregnancy or postpartum. This is in contrast to what is commonly reported.

Tragically, a significant number of women do die during pregnancy and the postpartum period, but they die from a variety of reasons that have nothing to do with a pulmonary embolism. You can read the list of other reasons that women die while pregnant or postpartum in the list from the CDC website. Some of the reasons for these deaths are preeclampsia, hemorrhage, and complications of caesarean section: many conditions that only occur during pregnancy or postpartum.

A 2015 study by Vinogradova, Coupland, and Hippisley-Cox published in the British Medical Journal on the use of combined oral contraceptives and risk of venous thromboembolism [8] put the risk at an even higher rate than the rates we used from the European Medicines Agency (EMA). So it is likely that we underestimated death rates associated with contraceptive induced blood clots.

Next time you read the disclaimer that “Pregnancy and the postpartum period puts a woman at higher risk for a VTE” maybe you’ll remember that this claim may not be entirely true. From what we can tell, more women die of a pulmonary embolism while using combination hormonal birth control than while pregnant or in the postpartum. Hopefully, women will become better educated to take care of their health issues before, during, and after pregnancy. In the meantime we need to educate every woman about what combined hormonal contraceptives do to a woman’s body.

Calculating the Risk for Death by Venous Thromboembolism

The CDC monitors Maternal Mortality and publishes figures on their website. For all deaths reported in 2011, “702 were found to be pregnancy-related.” This total includes deaths that occurred for a full year after childbirth [1] they also report that 9.8% of maternal deaths during pregnancy and postpartum are attributed to thrombotic pulmonary embolism. We calculated that a 9.8% rate equaled 69 deaths in 2011. At present, there are no published mortality figures from the CDC for 2013.

It is difficult to find the number of women who die from a blood clot in their lungs while using a hormonal contraceptive. The FDA’s Adverse Event database is voluntary, inconsistent and difficult to interpret. Some columns, such as the Outcome column are left blank. Even the FDA has acknowledged in the past that only 10 to 15% of adverse events are reported [2]. The FDA requires that pharmaceutical companies report adverse events, but no one else is required to report to the FDA or even to the pharmaceutical companies. Many healthcare professionals do not bother to report to the FDA, and it is unknown if they report anything to the pharmaceutical companies.

To try to understand the number of deaths caused by blood clots in the lungs, we relied on the VTE rates that the European Medicines Agency (EMA) publishes. In 2014, the EMA circulated a table of VTE rates [3].  This table gives a range for each type of progestin hormone involved in each of the combined hormonal contraceptives.

In the U.S., the FDA allows companies to put a chart on the package inserts listing estimates of venous thromboembolism which are currently estimated at 3-12 events per 10,000 women, but that number is lumped together for all formulations of hormonal contraceptives. By combining the rate of blood clot for each of the different types of hormonal contraceptive, it is impossible to look more deeply at the figures, especially at which hormones might be causing more blood clots. The EMA information allows this type of review.

We also purchased the prescription data from IMS Health and used information from the CDC to determine the number of women in 2013 that used different combination hormonal birth control products. IMS Health is a leading global information and technology services company, providing prescription drug data to a variety of corporations, and groups, including the FDA. The EMA gives a range of VTE rates based on the type of progestin hormone used, illustrated in Table 1.

Table 1: EMA Risk of Developing a Blood Clot.

Table 1- EMA Risk of developing a blood clot (VTE) in a yearBecause the number of deaths while using a combined hormonal contraceptive is unknown, we decided to calculate how many women might die. We used information from the reference book Contraception Technology [3], which says that 66% of women with a VTE will have a deep vein thrombosis and 33% with a VTE will have a pulmonary embolism. They cited a death rate of 6% for women with a DVT, and a death rate of 12% for women with a pulmonary embolism.

Using the data for contraceptive methods published in 2013, which is very similar to the CDC’s 2011 data, we calculated that there were approximately 11,000,000 women using a hormonal contraceptive that contained an estrogen and a progestin. The basic information is shown in Table 2.

Table 2: Comparing VTE Impact (estimated) across 2nd – 4th Generation Combination Hormonal Contraceptives for U.S. Women in 2013.

Table 2 Data Points

Next we calculated the estimated number of women potentially affected with a VTE, DVT, or PE using both the low and high EMA rates. We then calculated an average of these numbers. The estimated average number of deaths in 2013 from a pulmonary embolism is 307 deaths. This does not include deaths from a deep vein thrombosis, stroke, cerebrovascular accident, or hemorrhage or any other cause triggered by a combined hormonal contraceptive. Table 1 looks at the estimated rate of VTEs for different generations of contraceptives while Table 3, shows our calculations for VTEs, DVTs or PEs events [5].

Table 3: Calculations for VTEs based on type of progestin.

Table 3- Comparing Annual VTE rate

Joe Malone recently calculated the number of deaths in another way. He took the number of U.S. births in 2013, published by the National Center for Health Statistics[6], and numbers from a study by A.H. James [7] who stated that “VTE accounts for 1.1 deaths per 100,000 deliveries, or 10% of all maternal deaths.”

Using information from James’ study, Joe calculated that approximately 43 women died because of a VTE in 2013. (See Table 4). This number is far lower than the 307 women we calculated to have died in our analysis of women on combined hormonal contraceptives. The lower number of deaths in James’ study may be due to several factors. For example, James’ study was of deliveries, not pregnancies. The number of deliveries likely is lower than the number of women who become pregnant. Another factor might be that the number of deaths reported on the CDC website of pregnant women includes women who died up to one full year after giving birth, which would result in higher totals.

Table 4: Comparison of VTE Related Deaths – Pregnancy & CHC Use

Table 4 Pregnancy & CHC deathsBy whatever numbers we used, however, the death rate attributed to blood clots was higher in women using hormonal contraceptives than in pregnancy or postpartum. Moreover, the death rate was significantly higher. By continuing to suggest that the risk for blood clots, and indeed, death as a result of those blood clots, is higher in pregnant and postpartum women than in women using hormonal contraceptives, we place the health and well-being of millions of women in danger; and for some, this risk is deadly.

When I think about the fear mongering comment made in regards to an article about hormonal contraceptive safety, I cannot help but wonder if more information were made available, fewer families would experience the loss of a daughter, wife or mother. Understanding the real risks associated with a medication shouldn’t be considered fearmongering, just the opposite. In fact, to elevate the risk of death due to blood clots in pregnancy or postpartum above those of the medication, is not only fear mongering but dangerous.

Real Risk Study: Birth Control and Blood Clots

Lucine Health Sciences and Hormones Matter are conducting research to investigate the relationship between hormonal birth control and blood clots. If you or a loved one have suffered from a blood clot while using hormonal birth control, please consider participating. We are also looking for participants who have been using hormonal birth control for at least one year and have NOT had a blood clot, as well as women who have NEVER used hormonal birth control. For more information or to participate, click here.

References and Resources

  1. Pregnancy Mortality Surveillance System, Centers for Disease Control and Prevention, Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion. Updated December 23, 2014. http://www.cdc.gov/reproductivehealth/MaternalInfantHealth/PMSS.html/.
  2. Hazell, L. & Shakir, S. A. W. Under-Reporting of Adverse Drug Reactions A Systematic Review. Drug Safety 2006; 29 (5): (pp. 385-396). Retrieved from https://www.eecs.berkeley.edu/~daw/teaching/c79- s13/readings/AdverseDrugReactions.pdf
  3. European Medicines Agency. (2013). Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation,. Press Release dated 11/22/2013. Retrieved from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/20 13/11/ news_detail_001969.jsp&mid=WC0b01ac058004d5c1
  4. A. L. Nelson, M.D. & C. Cwiak, M.D., MPH, (2011). Combined Oral Contraceptives (COCs). In Hatcher, R. D., MD, Trussell, J., PhD., Nelson, A. L., M.D., Cates Jr., W., M.D., MPH, Kowal D., M.A., P.A., Policar, & M. S., MD, MPH. Contraception Technology (20th Edition). Chapter 11, (pp.249-275). Bridging the Gap Communications.
  5. Malone, J., West, D. & West, J. (2015) Retrieved from www.birthcontrolsafety.org, http://www.birthcontrolsafety.org/data–references.html and www.Nuvaringtruth.com, http://nuvaringtruth.com/women-injured-or-died-from-combination-hormonal-birth-control-in-2013/
  6. NCH Data Briefs, Number 175, December 2014. Births in the United States, 2013. Retrieved from http://www.cdc.gov/nchs/data/databriefs/db175.pdf
  7. James, A. H. (2009). Venous thromboembolism in pregnancy. Arteriosclerosis, thrombosis,and vascular biology, 29(3), 326-331. Retrieved from http://atvb.ahajournals.org/content/29/3/326.full
  8. Vinogradova Yana, Coupland Carol, Hippisley-Cox Julia. Use of combined oral contraceptives and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases BMJ 2015; 350: h2135. Retrieved from http://www.bmj.com/content/350/bmj.h2135