birth control blood clots Archives - Page 5 of 5

Endometriosis and the Journey to Advocacy

Published on April 13, 2016

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I will never forget the words the doctor in the ER said to me: “I will not support your habit and I will not prescribe you anything.” These words, so easily said, cut me like a knife. I was no stranger to being told that my endometriosis “shouldn’t cause so much pain”. Or being told I was “a girl who needed to get over it”. But that night changed everything for me.

Let’s go back a bit. My endometriosis journey started when I was 15. I didn’t know what it was that was causing this debilitating pain but I did know that it wasn’t normal. Luckily for me, I had parents who weren’t happy with the answers we were getting either. I can’t even count the number of ultrasounds and CT scans I had trying to diagnose something that no one could see through either of these methods. I was told that my symptoms didn’t make sense by a handful of gastrointestinal specialists and I was refused a referral to a gynecologist because I wasn’t sexually active and therefore “couldn’t possibly have anything wrong with [my] reproductive organs”.

It took me 10 years to finally get the referral I needed. Unfortunately, this is not at all uncommon when dealing with this disease. When I finally got in to see a gynecologist, she diagnosed me with endometriosis by nothing more than just hearing my symptoms. Five minutes after I entered the office, she was ready to send me out with a prescription for birth control pills that were supposed to save me from the pain. I expressed concern with this treatment because by this point I was well versed on how endometriosis was diagnosed and treated, and I knew that birth control pills didn’t treat the disease. I had a family history of blood clotting and was nervous about this potential course of treatment but I was brushed off as being nothing more than a girl who worried too much. At my insistence, I was given a requisition for blood work that had to be paid by myself. I happily did it and 72 hours later was called back in. It was found that I had a genetic blood clotting disorder and that prescription for hormonal birth control would have potentially killed me by causing a lethal blood clot.

I transferred to another gynecologist and again, here was someone who didn’t understand why I wanted a laparoscopy. At this point in my life, I was starting to believe that I perhaps was losing my mind. I needed to know for sure and so I demanded the surgery. On May 31, 2010, I had surgery and was confirmed to have endometriosis on my reproductive organs and bowels. I was relieved. At this point, I thought this was my ticket to real treatment and more answers but instead, I’m really no better off than I have been over the entire course of this disease. I still have severe pain way too often.

I was out one night at a movie with my husband. Afterwards, we were driving home and I was crying. My husband knows that this is a bad sign. I told him I couldn’t make it to our house and he needed to go to my parent’s house immediately (they lived nearby). I began vomiting from the pain. I collapsed on the bathroom floor and couldn’t move. My parents called an ambulance and I was rushed into the ER. Three paramedics were convinced there was something very wrong with me. After two doses of morphine and Gravol, I was still writhing in pain. I felt that as soon as I mentioned the fact that I had endometriosis, I was somewhat written off. This is when the doctor came in to accuse me of being a drug addict looking for a fix. I yelled. I screamed. I demanded treatment and I will never regret the things that I did to stand up for myself. The nurse taking care of me slid me a card for the patient advocate who I contacted the next day. Unfortunately, after a lengthy investigation, I was told by the hospital that the doctor was within his rights and was “trying to educate [me] on the pitfalls of drug abuse”.

It was after this night that I was determined to raise my voice. We need more awareness about this disease. We need doctors to become specialists in this area. We need better treatment. I started a local support group as a result because I don’t believe that anyone should experience something like this without having someone to turn to who truly understands. It has brought me great friends and amazing support – something anyone fighting this disease needs. My advice is simple: never stop fighting for yourself or fighting for awareness. This disease affects too many women for us to remain silent. I hope that my small piece in this world can make a difference for someone else.

If you have endometriosis or any other complex condition and would like to share your story on Hormones Matter, write for us.

A Stroke from Hormonal Birth Control: Part 2

by Kerry Gretchen

Published on March 24, 2016

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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.

Booze, Birth Control, and Blood Clots

by Chandler Marrs, PhD

Published on March 17, 2016

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We’ve been writing a lot about hormonal birth control and the risk for blood clots lately. We think the connection between hormonal birth control and blood clots is significantly under-recognized, especially in young women who, for all intents and purposes, are healthy. Perhaps it’s the marketing of these medications as lifestyle drugs, something we need as modern women to control our unruly bodies, or perhaps, it is the drug labels themselves that assure us only overweight, over 35 year old smokers are at risk for blood clots, whatever the reason, most of us have decided that we are not at risk. In doing so, not only do we not recognize the early signs of impending troubles but we fail to appreciate how other lifestyle choices, even healthy ones, can exacerbate those risks and make it all but inevitable that clots will emerge at some point with long term hormonal birth control use.

With athletic women in particular, the number of blood clot risk factors stacks up pretty quickly just in the course of everyday training, I wrote about the risks Blood Clots, Birth Control and Female Athletes: Are We Missing Important Risk Factors? A colleague of mine, wrote about how clots form and the risks in non-athletic women. And we have begun to publish personal stories from survivors of hormonal contraceptive induced blood clots and from the families who were not so fortunate and lost their loved ones. As we dig deeper into the stories, more connections bubble to the surface, like the one between female athletes and blood clots. Who would have considered that healthy, young female athletes would be at a higher risk than non-athletic women? Not many, but indeed, they may be.

Booze and Blood Clots

Another connection, not formerly recognized might be alcoholic intake. We all recognize the myriad of health risks associated with heavy alcohol intake both chronic and in binge form. What is not recognized as fully are the complex hematological changes associated with alcohol intake. With long term heavy drinking, thrombocytopenia or excessive bleeding is prominent, but with lesser amounts alcohol intake the opposite may occur. It appears that alcohol’s effects on bleeding and clotting vary by dose (how much you drink at a time) and chronicity (how frequently and consistently you drink), and perhaps even by type of alcohol ingested (hard alcohol versus beer versus wine).

Currently, the predominant dogma suggests that regular light drinking may be protective and good for our long term health. This may or may not be the case. A recent study found that regular, light drinking (defined as 2-4 drinks per week) reduced the risk for heart attack or stroke in men.

In contrast, however, any long term protection conferred by light drinking does not include the first 24 hours or so after one drinks. In the hours immediately following light alcohol intake, a cascade of biochemical changes occur that make one more disposed to heart attack or stroke, presumably via increased clotting mechanisms (alcohol intake increases platelet aggregation initially before decreasing and altering platelet structure and function to bleeding over clotting). It seems that compensatory mechanisms may come into play to counteract the short term increase in clotting. In contrast, heavy drinking (6-9 drinks), the risk for stroke and heart attack continues for the entire week (maybe longer).

“Just after drinking, blood pressure rises and blood platelets become stickier, which may increase the risk of having a heart attack or stroke, but regular moderate alcohol consumption is associated with higher HDL cholesterol and reduced blood clotting, which may decrease risk,” Mostofsky said.
However, heavy alcohol drinking was associated with higher cardiovascular risk in the following day (six to nine drinks) and week (19-30 drinks).

Of course, the many of the studies cited were conducted using males (as are most studies of this sort), but let us consider what the impact of drinking might be on a woman, who uses hormonal contraceptives and who may be an athlete and/or have other conditions that predispose her to clotting.

With Birth Control As the Backdrop, Blood Clots Are Imminent

Remember, from our previous posts that the balance between clotting and bleeding is altered significantly in favor of clotting when a woman uses hormonal birth control. In fact, pro-clotting factors increase by some 170% while anti-clotting factors diminish by 20% with hormonal contraceptives. Those changes by themselves are concerning. If in the hours after one drinks alcohol, additional pro-clotting factors are increased, we can imagine that the risks for blood clots might be especially high for women who use hormonal birth control.

Now consider a female athlete, using birth control, has few drinks post competition to celebrate before boarding a bus, train, or plane for a long trip home. That combination of variables which are entirely commonplace in the life of the female athlete, combine to form an incredibly high risk for blood clots. Similarly, binge drinking on college campuses, even amongst athletes has become increasingly common. The combination of alcohol related clotting changes (in addition to all of the other unhealthy aspects of drinking) and birth control related changes in coagulation, could be deadly.

What the actual numbers are for these possibilities, no one knows. (Research protocols are, more often than not, designed to address only a few variables. I am not aware of any that have addressed the cascade of variables associated with blood clots in female athletes, let alone blood clots in female athletes who drink moderately, or conversely, the effects of alcohol on blood clotting in women who use birth control.) What we do know is that hormonal birth control changes blood chemistry in such a way that pro-clotting factors are increased by almost 3X their normal values. That’s troubling. When we add any number of other real world risks that also increase ones propensity to clot, the results can be devastating. If you must use hormonal birth control, perhaps avoiding alcohol is in order. Although, I would argue that before you decide to use hormonal birth control, especially if you are an athlete, consider your health risks carefully. Do your homework and then make a decision.

For the Men

Clotting is a problem not just for women who use hormonal birth control. Men also develop blood clots, especially male athletes, particularly those who have to travel long distances between competitions and now, as we can see, especially those who have a few celebratory beers post competition. Even though that beer tastes fantastic after a race, perhaps if one has a long trek home, it might be wise to postpone the celebration until one’s body recovers and the prospect of sitting immobile for hours has passed. That first 24 hours post alcohol consumption seems to be the most risky. This coincides directly with the increased risk for clotting post training or competition, add immobility to the mix and all sorts of problems are likely to arise. Keep your man safe, celebrate when you get home.

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A Stroke from Hormonal Birth Control: Part 1

by Kerry Gretchen

Published on March 15, 2016

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Stroke from hormonal birth control - Kerry Gretchen

I opened my eyes and saw my husband, Josh, holding my hand, looking very serious. He was telling me that we would get through this, that even if I had to learn to walk again, that whatever it took, we would be okay. I remember thinking, “It’s okay, honey. I just have a headache.” We had been married for a year. The next time I opened my eyes Josh was leaning over me. I was on my side in the emergency room and the doctor had just asked him to hold me steady while he gave me a spinal tap to check for meningitis. Josh held me so firmly, terrified by the risks of a misplaced needle, that his arms were shaking from the strain. I tried to tell him, “Don’t worry about holding me. I can’t move anyway.” I had lost the use of my limbs hours before, maybe even days. And now it seemed my power of speech was gone, as well.

The headache had started a month earlier. I remember exactly when because it woke me in the middle of night and I had never had that happen before. We were visiting friends in New York right before Christmas. I got up and took some ibuprofen and didn’t give it much more thought. But it never really went away. I saw a chiropractor. I took more ibuprofen. I checked out a book on meditation. By the time I saw a gynecologist, I also had an unexplainable pain in my left thigh. The gynecologist told me the pain in my leg was probably just a muscle strain and she prescribed Imitrex for the headache, a migraine medication that shrinks the blood vessels in the brain.

The migraine medication made the headache go from dull and persistent to unbearable. I visited a health clinic where the doctor suggested an appointment with a neurologist the following week. That night my left arm started to go numb. I called a local pharmacist who said it might be my birth control pills. That’s crazy, I thought. I’ve been on them for 10 years. I slept on the couch because I couldn’t bear the thought of having to move to the bedroom. The music that had been on the television roared in my head like it had been trapped there on repeat. The next day I called the health center again and they told me to go to the emergency room.

Over the course of the next two days I would take 3 ambulance rides, be sent home from the emergency room twice, begin to lose all control of my body, and be given a very stern lecture by a nurse who thought I needed to learn how to “manage my stress.”

The spinal tap in the emergency room was not the first time Josh had to hold me down. Earlier that day, he tried to restrain me while my body thrashed wildly. During the seizure, I told myself that if I just calmed down, it would stop. It must all be in my head since the doctors said it was just a “tension headache.” We locked eyes, both of us terrified of what was happening to me. When the shaking finally subsided, he asked me if he should call 911. Again. All I could do was nod.

I did not have meningitis. There were blood clots in my brain and because they had not been treated right away, one of the veins in my head had burst and was bleeding. I was having a massive stroke.

Later, Josh would tell me about overhearing the neurologist and the neurosurgeon arguing. The neurologist thought they should operate. The neurosurgeon thought it was too risky. Neither wanted to be there. It was Martin Luther King, Jr. day. (I have since learned never to get sick on a holiday weekend.) In the end, they didn’t operate. I don’t remember exactly when they told me that I had had a stroke. But I know I had no understanding of what that meant. (I find that even now, ten years later, I am still learning.) As far as I knew, that was something that happened to old people. I was 28 years old.

At some point, they told me that I had a clotting disorder and that this genetic anomaly coupled with the hormones in my birth control had caused my stroke. This wouldn’t mean much to me until after I learned how to walk again, do math again, shave my own armpits again.

Not long after I was discharged from the hospital, I had an allergic reaction to the anti-seizure medication. I returned to the emergency room at the request of my neurologist. This time they immediately took me to an examination room. When the doctor walked in, the same doctor who had finally diagnosed my stroke, he said, “I’m so glad to see you. I didn’t think you were going to make it.”

That statement stayed with me throughout my recovery. Because though intellectually I understood that the stroke could have killed me, I never really understood the gravity of the situation until he said that to me. And it made me begin to really consider what happened to me and why.

I was first prescribed birth control pills at the university health clinic my freshman year of college. I wasn’t even sexually active at the time, it just seemed like a rite of passage. Why did no one tell me about the dangers of the pill? I wondered. And why didn’t anyone tell me that I could have a clotting disorder without knowing it? How many other women have this clotting disorder? How many other women have had blood clots? How many have actually died from hormonal birth control? Throughout my recovery, I struggled with these questions. Eventually, I even tried to answer some of these questions with my master’s thesis. For more on my recovery and thesis work, see Part 2 of A Stroke from Hormonal Birth Control.

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

by Philippa Bridge-Cook, PhD

Published on January 27, 2016

6852 views

blood clots with hormonal contraceptives

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:

Obesity
Immobility–prolonged inactivity, for example, bed rest, or taking long trips by plan or car
Smoking
Non-steroidal anti-inflammatory medications such as Advil
Other medications such as certain psychiatric drugs
Intense exercise
Certain types of surgery
Pregnancy
Hormonal contraceptives

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

Deadly Blood Clots from the NuvaRing: Erika’s Legacy

by Karen Langhart

Published on October 1, 2015

5384 views

Erika Langhart was planning to make a difference in the world. She was never given that chance.

At just 24 years old Erika was struck down by a massive, double pulmonary embolism (blood clots that had traveled to her lungs), as a direct result (per her pulmonologist) of the NuvaRing. Investigative journalist, Marie Brenner, wrote an in-depth report (“Danger in the Ring”) for Vanity Fair magazine about Erika and her classmate at American University, and Olympic Athlete, Megan Henry regarding the dangers of this drug.

CNN Anderson Cooper 360 was subsequently inspired to air a special report: Families, lawsuits, raise questions about NuvaRing.

It is our greatest hope, with what remains of our lives, to fulfill our daughter’s goal of making a difference in the lives of others by helping to inform women about the dangers of not only the NuvaRing; but all hormonal contraceptive drugs – the pill, patch, ring and implants. We believe women deserve to be informed of the full truth about these powerful drugs.

Erika Langhart’s Case for Wrongful Death was dismissed on September 10, 2015 because we refused to settle with Merck. We never agreed to anything other than having her case heard in front of a jury for the purpose of exposing the truth about the NuvaRing and Merck. Following is our statement read to the Superior Court of the State of California for the County of San Francisco, NuvaRing Products Case #CGC-12-520371.

We were promised that Erika’s case would be filed in the state of Virginia, via the rocket docket, for a jury trial by the end of 2012.
We can only imagine the outcome had this promise been kept. We believe the truth about this drug, and Merck, would have been exposed through this trial and hundreds of women’s lives since 2012 would have been saved. We now have the very dubious honor of being friends with the parents of many of the young women who, unnecessarily, lost their lives to this drug. We hope you try to imagine what that is like for a moment…we can assure you there is nothing more painful to endure than losing a child to, what we view, as murder.
How you were able to convince/coerce the FDA into changing the NuvaRing label to a WEAKER label in October of 2013, all while more and more reports of injury and deaths were being filed with the FDA’s own MedWatch is stunning…and disgusting. Of course by doing so, you have effectively shut down all legal avenues for women who have been injured or who have lost their lives to this drug…
So, Congratulations!…however, we believe Justice will eventually reach you.
May God have Mercy on your souls for allowing, and helping, these tragedies to continue. You are putting money and profits before the very lives of innocent young women – we do not know how you sleep at night…as, we believe, you will certainly, eventually, meet your deserved justice on your own judgment day.
How you are able to defend Merck, and other members of these legal (and we use this word loosely) drug cartel corporations, is beyond us and perhaps you would do well do pay heed to the words of Dr. Benjamin Rush – a signer of the constitution and George Washington’s physician….
“Unless we put medical freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship…To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic and have no place in a republic. The Constitution of this republic should make special privilege for medical freedom as well as religious freedom.” – Benjamin Rush, MD.
You are, in our opinion, facilitating the dangerous, and by principle un-Constitutional, Medical Industrial Complex through your actions…which is unnecessarily taking the lives of an untold number of American citizens, all in the name of Greed.
Merck’s “official statement” in response to being questioned about the danger of the NuvaRing follows:
“Blood clots have long been known as a risk associated with combined hormonal contraceptives. The FDA approved patient information and physician package labeling for NuvaRing include this information. We remain confident in the safety and efficacy profile of the NuvaRing – which is supported by extensive scientific research – and will continue to always act in the best interest of patients,” as published in Vanity Fair.
A more truthful statement of risk might read something like this: (our additions to their statement are in bold)
“Blood clots have long been known as a risk associated with combined hormonal contraceptives”.
We cannot explain, except by pure greed, why these drugs continue to be given to women when there are safe and effective alternatives for Birth Control available.
“The FDA approved patient and physician package labeling for the NuvaRing include this information”,
as negotiated by our highly paid consultant, and former FDA administrator of the Women’s Health division, Dr. Susan Allen, for the benefit of Merck.
“We remain confident in the safety and efficacy profile of the NuvaRing – which is supported by extensive scientific research” –
Paid for by us with expected outcomes supportive of future profits from the NuvaRing but ignores the independent, unbiased, extensive scientific research conducted by Dr. Lidegaard which does not support future profits for Merck from the NuvaRing –
“and will continue to always act in the best interest of patients”,
which we have to admit is a lie as evidenced by our track record with many of our other drugs such as Vioxx.
Congratulations on the continued growth of Merck profits for the NuvaRing at the expense of women’s lives; $723 million last year (K-10 report), alone, achieved in conjunction with the injury and death of hundreds, if not thousands, more women who are apparently just “acceptable risk factors” to Merck.
A $100 million dollar settlement was really a bargain for you to keep these kinds of sales going – the settlement even helped increase sales for Merck! Unbelievable, and criminal, in our opinion.

These words have been spoken in honor and memory of our beloved daughter Erika and the thousands of other young women who have unnecessarily been injured, or have had their lives taken, by Merck’s drug – The NuvaRing.

We would like to note that the judge in this case said that he was truly sorry and could not imagine this kind of loss of life.

Readers may be interested in viewing a short video by Dr. Peter Gotzsche regarding Big Pharma operations.

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.

Hurt by a Generic Drug? Victims have no Recourse unless the FDA Changes Rules

by Lisa Bloomquist

Published on April 13, 2015

5747 views

On Friday March 27, 2015 I testified before the U.S. Food and Drug Administration (FDA) asking them to change a rule that currently prohibits manufacturers of generic drugs from updating the warning labels for the drugs that they make.

Why, you may wonder, should anyone care whether or not generic drug manufacturers are able to update their warning labels?

EVERYONE should care about this issue because as long as generic drug manufacturers are unable to update drug warning labels, NO ONE who is hurt by a generic drug has any recourse against generic drug manufacturers, no matter how badly one is hurt by a generic drug. In 2013 the U.S. Supreme Court decided that, because generic drug manufacturers are required to copy the brand-name drug warning label, they cannot be held responsible for any harm done by the generic drug. People hurt by generic drugs didn’t take a name-brand drug, so they cannot sue the name-brand drug manufacturers. This leaves people hurt by generic drugs unable to hold anyone responsible for the damage done by generic drugs, and people are left without any legal recourse.

IF YOU ARE HURT BY A GENERIC DRUG, YOU CANNOT SUE. YOU HAVE NO RECOURSE WHATSOEVER.

This is appalling. More than 80% of the prescription drugs dispensed in America are generic. Everyone who takes a generic drug is unable to gain any sort of legal compensation, any sort of justice, when injuries are caused by those drugs. Think about that next time you take a generic drug.

Or, better yet, think about the following people, who also testified to the FDA about the harm caused by generic drugs, who are unable to gain any sort of justice or compensation for their losses. Their stories could be your story, or your child’s story, or your parent’s story.

Fluoxetine (Prozac) and Cardiac Malformations

Emily, a 29 year old who was taking fluoxetine, generic Prozac, throughout her pregnancy, gave birth to a baby boy who had a serious heart defect. Her son died when he was 2 weeks old. In 2011, Eli Lilly, the manufacturer of Prozac, admitted that, “there is some evidence of a possible small increase in the risk of cardiac malformations (eg ventricular and septal defects) associated with use of fluoxetine” (source). If Emily had taken Prozac, she would have been able to sue Eli Lilly, and possibly gain some sort of compensation for her losses. However, Emily took generic fluoxetine, so she has no recourse, no possibility of compensation, and no justice.

Metoclopramide (Reglan) and Tardive Dyskinesia

Anthony testified about his partner of 40 years who is suffering from severe tardive dyskinesia after taking metoclopramide, generic Reglan, for 11 years. Anthony’s partner can no longer speak or function independently. He is 100% dependent on Anthony for his care. “Tardive dyskinesia typically affects someone’s face, often causing uncontrolled grimaces and movement in the eyes, lips, tongue and jaw. Arms, fingers, toes, legs, hips and torso are also affected and may twitch and move rapidly and uncontrollably. These random body movements can be uncomfortable and painful as well as embarrassing and difficult to control, making it a social handicap. Severe cases of this disorder can be debilitating and make it difficult to perform simple tasks like talking, walking and eating.” (source) Because generic metoclopramide is what caused harm, neither Anthony nor his partner have any possibility of legal recourse.

Birth Control and Blood Clots

Taylor suffered from life-threatening blood clots at the age of 14 after taking generic birth-control pills. She is now 17 and suffers from permanent health complications because of the blood clots.

Levofloxacin (Levaquin), Tendon Ruptures, Neuropathy and More

Rachel spoke about how levofloxacin, generic Levaquin, caused her to have multiple tendon ruptures, and contributed to her developing a neurodegenerative condition called neurosarcoidosis. In addition to losing her health, Rachel “can no longer afford my home because of increasingly skyrocketing medical expenses and surgeries and I was forced to move. I lost my career that I loved with immeasurable passion and lost good income.” She has no legal recourse because she took generic levofloxacin.

I testified about how Heather was hurt by ciprofloxacin, generic Cipro, and moxifloxacin, generic Avelox. After taking ciprofloxacin and moxifloxacin, Heather suffered from severe nerve pain, central nervous system issues such as panic attacks and brain fog. She had blood sugar regulation problems, irregular heartbeats and more. She lost her career as a massage therapist and had to declare bankruptcy. Her life was devastated because of her severe adverse reaction to these drugs. She is unable to sue the manufacturers of the drugs that hurt her though, because she took the generic versions of the drugs.

I also testified about how Sarah reported this about the effects of ciprofloxacin on her life, “Still suffering and disabled; can’t work, lost profession, lost financial security, lost marriage, lost hope for any reasonable quality of life. Denied by medical profession due to no known diagnostic biomarkers; denied legal recourse due to generic; denied SSDI due to the first two and denial by the FDA and everyone involved, and ultimately, will be denied as the most probable cause of my death.”

Clinoril (Sulindac) and Stevens-Johnson Syndrome

There are many more cases of death and injury caused by generic drugs. Clinoril, generic Sulindac, can cause horrific injuries, such as those suffered by Karen Bartlett, “who lost nearly two-thirds of her skin, was placed in a medically induced coma and is legally blind after suffering a reaction to the medication she took for a sore shoulder” (source). Over-the-counter pain relief pills and antibiotics can cause Stevens-Johnson Syndrome, a severe and life-threatening skin condition in which cell death causes the epidermis to separate from the dermis.

Acetaminphen, Ergotamine, Montelukast and More

Acetaminophen can cause liver injuries that can lead to death. Ergotamine, a drug used to treat migraine headaches, when administered improperly, can cause gangrene and loss of limbs. Montelukast, generic Singulair, can cause Churg–Strauss syndrome, rare form of eosinophilic vasculitis associated with asthma. There are hundreds of other examples of damage that can be caused by drugs.

Adverse Reactions and Generic Drugs – The FDA’s Role

Generic drugs are just as dangerous as name-brand drugs. Those who are hurt by drugs deserve recourse and compensation for their losses. To arbitrarily take away a person’s opportunity for justice, simply because he or she took a generic drug, is ridiculous and wrong. Currently, there is no justice for people who suffer from adverse effects of generic drugs. DO NOT take a generic drug until this situation changes.

The FDA can nullify the Supreme Court’s ruling, and enable those who are hurt by generic drugs to gain justice, simply by changing their rules so that generic drug manufacturers can update their warning labels just like name-brand drug manufacturers can. I hope they do so. I encouraged them to do so in my testimony.

The generic drug manufacturers are arguing that it would be onerous and costly for them to update the warning labels. Seeing as even generic drug manufacturers have billions in profits, that argument seems a bit shallow and disingenuous. The pharmaceutical industry as a whole has proposed to stop the discrepancy in justice between generic and name-brand drug manufacturers by making name-brand drug manufacturers equally inculpable for damage done by their drugs as generic drug manufacturers currently are. If the FDA “fixes” this situation by making all drug manufacturers unable to update their warning labels and therefore exempt from lawsuits, no victim of a pharmaceutical will have any legal recourse against the companies that hurt them, and a vital check on the power of the pharmaceutical industry will be lost.

I hope that the FDA does the right thing, and closes this loophole that is keeping millions of victims of pharmaceuticals from getting justice.

The FDA testimony can be viewed through these links:

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.

Participate in Research

Hormones Matter^TM is conducting research on the side effects and adverse events associated with the fluoroquinolone antibiotics, Cipro, Levaquin, Avelox and others: The Fluoroquinolone Antibiotics Side Effects Study. The study is anonymous, takes 20-30 minutes to complete and is open to anyone who has used a fluoroquinolone antibiotic. Please complete the study and help us understand the scope of fluoroquinolone reactions.

Hormones Matter^TM conducts other crowdsourced surveys on medication reactions. To take one of our other surveys, click here.

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The Yasmin Chronicles: Bad Medicine, Big Money and Bayer

by Chandler Marrs, PhD

Published on May 2, 2014

9656 views

Perhaps you’ve heard of the Yasmin line (Yaz, Ocella, GIanvi, Loryna, Beyaz, Safyral and Zarah) of birth control pills. For a while they were some of the most highly promoted, highly prescribed on the market. Indeed, they were so highly promoted, Bayer, the manufacturer was slapped with not one, not two, but three warning letters by the FDA for mismarketing this contraceptive, specifically suggesting the drug could be used to treat PMS and acne, when it had been approved for neither. Bayer was also cited for downplaying and failing to communicate the risks of these contraceptives. Though Bayer eventually changed their lifestyle ads promoting Yaz and Yasmin, the damage was already done. The perception that these pills were safer and more effective than older birth control pills was cemented in the minds of physicians and patients worldwide and Bayer had garnered 18% of the coveted birth control market share. A mere 100 million women worldwide use oral contraceptives daily. With the Yasmin line, however, there is 3-fold increase of thrombo-embolitic events over the already high risk associated with the older birth control pills. Compared to women not taking oral contraceptives, the risk for these side effects is 6-fold higher; risks not to be taken lightly.

What Makes the Yasmin Line so Dangerous?

The Yasmin line of contraceptives contain the fourth generation progestin, drosperinone. Unlike previous generations of synthetic progestogens (progesterone-like compounds) derived from testosterone, drosperinone is a completely different animal. Drosperinone is analog for a common drug called Spironolactone (Aldactone),an aldosterone receptor antagonist that tells the kidneys to remove water and salt from the body. It’s a diuretic used to treat hypertension, congestive heart failure, kidney disease and cirrhosis of the liver.

Spironolactone comes with a serious list of side effects, including a condition called hyperkalemia or high potassium levels. Unregulated potassium levels, either too high or too low can cause serious heart rhythm irregularities leading to death, and so, physicians are advised to monitor potassium levels in patients using Spironolactone. Have any young woman using either Sprionolactone or Yasmin ever had potassium levels measured? Nope.

Additional side effects of spironolactone include: GI bleeds and gastritis, agranulocytosis, urticaria, maculopapular or erythematous cutaneous rashes, anaphylactic reactions, vasculitis, mental confusion, ataxia, headache, drowsiness, lethargy, renal dysfunction and Stevens Johnson Syndrome; perhaps not something one wants to give to otherwise healthy young women. Indeed, sprironolactone was prescribed for young women with acne, before becoming a birth control pill and then prescribed along with its analog, Yasmin, rather cavalierly.

Drosperinone is a spironolactone analog, meaning drosperinone binds to and blocks the aldosterone receptor just as spironolactone. In fact, binding affinity studies comparing Yasmin to the older generations of contraceptives, showed that it has 500X the anti-mineralocorticoid (aldosterone receptor) binding affinity of the other contraceptives and is equivalent to the 25mg dose of spironolactone. So, from that information alone, one might prescribe this pill a little bit more judiciously, but when we remember that Yasmin is a combination oral contraceptive that comes a dose of ethinyl estradiol, the synthetic estrogen rife with its own side effects (blood clots and stroke), caution should have prevailed. It didn’t, and many women were injured, likely more so that we know of.

Yasmin Lawsuits

Deep vein thrombosis. As of early 2014, Bayer has settled $1.69 billion in lawsuits for deep vein thrombosis and pulmonary embolisms related to Yasmin. These included over 8000 claimants. Yet to be settled, over 4000 suits remain and likely many more as publicity and recognition of the side-effects increase. It’s important to note that, like with most drug settlements, the pharmaceutical company admits no blame, simply pays the settlements and continues with business as usual.

Gallbladder. Gallbladder disease was recently recognized as side effect, and though, Bayer initially denied a relationship, they are now settling cases there too. Only here, the amounts are paltry in comparison. Bayer has set aside $24 million for gallbladder cases; $2000 per case for disease and $3000 per case when gallbladder removal was necessitated. Currently, there are approximately 8000 of these cases pending. Whether more will emerge is unclear.

Stroke. Most recently in Zapalski vs. Aniol et al, a jury awarded Mariola Zapalski $14 million in a suit against her physician for failing to recognize and warn about the risks of Yasmin. Ms. Zapalski suffered a severe stroke two just weeks after her doctor prescribed Yasmin. She suffered permanent brain damage and now requires 24 hour per day medical care. Compared to the class settlements that range approximately $200,000 per claimant and likely include similarly disabled women, the $14 million is significantly higher. To my knowledge, this represents the first case, outside the class-action cases, against an individual physician for failing to recognize and warn of risk. This may be a new trend, but it is too early to tell.

Why is Yasmin Still on the Market?

Money, pure and simple. As I have reported previously,

The Yasmin line of birth control is one of Bayer’s most lucrative product lines with over 4 million women taking these pills monthly in the US alone. Even with the negative publicity surrounding for these products, revenue for the Yasmin line of products neared 1.1 billion for the first nine months of 2012. After 11 years on the market, total revenue for these products was likely well over $10 billion. If the company pays out $1-2 billion in claims, but makes $10-15 billion, the cost-benefit ratio is skewed in favor of maintaining their market presence. The fines become just another cost of doing business.

What about the FDA?

It goes without saying that the FDA has limited power or interest in regulating these drugs. Particularly where women’s health is concerned, the FDA has exhibited an egregious lack of regulation extending back to the DES tragedies and just about every drug or device marketed towards women since. With Yasmin specifically, attempts to include a black box warning on Yasmin were foiled by industry insiders in 2011, despite the medical experts arguing in favor of the warnings. For more details see: The High Cost of Bad Birth Control.

What Should You Do?

As with any medication, it is up to the patient to understand the risks. Do your homework, read the research, make your decision based on the data not the marketing. Drosperinone based contraceptives may not be worth the risk.

Participate in Oral Contraceptive Research – Take a Survey

If you have ever taken oral contraceptives, please take a few minutes to complete this important, anonymous, online survey about oral contraceptives. We’ve had over 800 women complete the survey so far.

You do not have to be currently using oral contraceptives to complete the survey. Please share the link among all your female friends and family. We’re relying on the power of women and social media to help make this survey a success. The Oral Contraceptives Survey.

birth control blood clots - Page 5

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Birth Control and Blood Clots

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Clinoril (Sulindac) and Stevens-Johnson Syndrome

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