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Deep Vein Thrombosis on the Birth Control Pill

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Deep vein thrombosis birth control pill

I got divorced in May 2012. My life was pretty stressful, and I had a very demanding job that took up a lot of my time. I had been getting hormonal migraines for over 10 years when in February 2013, I finally mentioned the migraines to my nurse practitioner. I was desperate for relief. She said, “Why don’t you go on the pill and get rid of your period and then you won’t get the migraines anymore.” I was reluctant since I’m not a band aid type person. I don’t like getting rid of the period to get rid of the migraine. I’d rather go to the source and get rid of it that way, but no one was buying that the migraines were hormonal.

So I began the birth control pills (Loestrin) in February 2013. I was relieved because I had no more headaches! However, I didn’t really feel well despite that. In June, my daughter graduated high school and I looked horrible. Looking back now, my health was going downhill, but I’m not sure exactly what it was due to since I had a lot going on.

We had a busy summer that included a vacation with a long car trip of about 14 hours, split up over two days, to get to our destination, and the same coming home. In retrospect this may have contributed to the blood clots that I developed later in the summer.

On Friday August 2, 2013, I was getting ready for work and started experiencing some pain in my groin, but blew it off. That pain got worse as the day went on. I couldn’t put pressure on my left leg at all. That evening, when I got home from work, my leg was so swollen from my hip to my calf, that I needed help getting my pants off. I couldn’t get out of bed all weekend. On Monday, I faked feeling better because I couldn’t afford to take time off from work for a little pain. I’m a good minimizer of pain. However, on Tuesday, when I went to work and still had a painful and swollen leg, my boss forced me to go to urgent care since I couldn’t find a doctor that could see me.

The doctor at the urgent care couldn’t find anything wrong with me and was just about to send me on my way when he asked if I had family history of clots. I said no. He asked if I was on birth control. I said yes. He sent me for an ultrasound. There was the absolute minimal amount of blood traveling through my left leg because it was so overcome with multiple clots. The doctor wanted to send me to the hospital, but thinking of my kids and being a single mom, I said I couldn’t go. So he gave me Xarelto, an anticoagulant, and I agreed to bed rest until Friday and then I’d see my primary care doctor to see if I was any better.

When I went to my primary care doctor, I was still swollen and could barely put any pressure on my leg. She didn’t even run tests. She sent me straight to the hospital without me knowing what the plan was once I got there. I got out of the car in the hospital parking lot and started walking to the door and fell. My legs gave out. I’m still unclear if that was related to the clots.

When the hospital started admitting me, I was shocked and had to call my daughter to let her know what was going on. I thought I was just getting a bit of treatment at the hospital and going home. I didn’t really realize how serious this was. I asked my kids to meet me at the hospital after school and by the time they got to the hospital, I had undergone surgery to remove the clots and put in two stents to keep the veins open and hopefully clot free.  The next day, they did an ultrasound and saw most of the clots gone, but not all. This was Saturday. So I had to wait until Monday for another surgery.

During all of this they also discovered that I have May-Thurner syndrome, which is when a vein in the pelvis gets compressed by an artery passing over top of it. This causes narrowing and decreased blood flow through the vein that is affected, which increases the risk of deep vein thrombosis in the leg.

I was in the hospital for a week. My hemoglobin levels dropped too low to be released. After being released and going home with a walker to get used to walking again. I started having neurological issues. I ended up in two more hospitals and later found out I had an underlying neurological condition that was now in full force. By October 2013 an ultrasound showed that all of the clots in my leg were gone, but now with my neurological condition, I have a lot more to deal with. To make sure I don’t get another deep vein thrombosis, I also have to be careful with flying or on long car trips to wear compression stockings and make sure I move around every two hours, and of course I won’t be using hormonal birth control again.

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.

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Hormonal Birth Control: Who Is At Risk of Serious Side Effects?

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Birth Control Blood Clots Study

Almost two months ago, Lucine Health Sciences and Hormones Matter started a new research project called the Real Risk Study: Birth Control and Blood Clots. The purpose of this research is to assess the breadth and depth of blood clot risks and other side effects associated with hormonal contraception. We believe that a deeper understanding of medical and lifestyle influences is crucial to providing women with a complete picture of their personal risk for blood clots while taking these medications.

To date we have collected data on 64 to 87 women (depending on which section of the survey we are analyzing) who have suffered from blood clots while taking hormonal birth control. These blood clots include deep vein thrombosis and pulmonary embolism, as well as strokes. Many women in the study have had long lasting effects even after they recover from the initial effects of the blood clot. And some women, unfortunately, have suffered from fatal blood clots, and a family member participated in the study on their behalf.

Risk Based on How Long Hormonal Contraception Has been Used

It is generally thought that the risk of developing a blood clot is highest within the first year of starting or restarting hormonal birth control. However, in a previous article we reported on some of the early data we had obtained, and we found that most of the women in our study had been on hormonal contraception longer than one year when they developed a blood clot. In our current data set, we have data from 87 women, and the same trend continues. Seventy-five percent of women developed clots after the first year on the medication, and only 25% developed clots within the first year. In some cases, women developed blood clots even after up to 21 to 30 years on hormonal contraception.

Risk for Blood Clots Based on Smoking History

One of the goals of the study is to provide a clearer picture of who is at risk for developing a blood clot related to hormonal contraceptive use. In the information provided by pharmaceutical companies, smoking and being over age 35 are highlighted as being risk factors. For example, the package insert for Beyaz/Yaz, the most popular birth control pill in the U.S., states:

Who should not take Beyaz or YAZ?

Do not use Beyaz or YAZ if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke or heart attack. This risk increases with age and number of cigarettes smoked.

In the previous article reporting on some early results of the study, we analyzed data from a question asking women whether they were smokers when they developed a blood clot. Using data from 87 women, the trend previously reported from our smaller data set was borne out again in a larger data set. Ninety-four percent of women in our study were not smoking at the time of the blood clot, and 78% had never been smokers. So although smoking does increase the risk, not smoking does not mean you are not at risk.

Risk for Blood Clots Based on Genetic or Acquired Blood Clotting Disorders

It is known that having a blood clotting disorder significantly increases the risk of developing a blood clot while on hormonal contraception. These disorders can be genetic, meaning that they are encoded in the genes and the person is born with them, or acquired, meaning that they are a result of an environmental factor occurring during a person’s life, such as a drug exposure or another disease. With genetic blood clotting disorders, there may also be a family history of blood clots in other relatives. Genetic disorders include Factor V Leiden mutation, protein S deficiency, and prothrombin mutation. Acquired disorders include antiphospholipid syndrome, hyperhomocysteinemia (which may also be present as a result of MTHFR mutation), and heparin-induced thrombocytopenia.

We asked if study participants had a family history of blood clots, and if so, which relative had a blood clot. Fifty-eight percent of the women in our study had no family history of blood clots, and therefore, no reason, from a family history perspective, to suspect they would be at increased risk for a blood clot. In participants for whom there was a family history, parents and grandparents were the most common relatives to have had blood clots, at 14% and 12% respectively. Less common was a history of blood clots in an aunt or uncle, sibling or cousin. These results are depicted in the bar graph below. For a parent or grandparent to be the most commonly reported relative with a blood clot is expected, because the risk of blood clots increases with age.

Family History of Blood Clots in Study Participants

Birth control and blood clots - clotting factors 3

Having a family history of blood clots makes it more likely that there is a genetic disorder that increases the risk of blood clotting running in that family.  We asked the women in our study whether they had been tested for blood clotting disorders before starting hormonal contraception. As can be seen below, 89% of the women in our study did not have such testing prior to starting hormonal contraception, and a further 9% did not know if they had any testing. Only 2% of the women were able to state with certainty that they had been tested.

Testing for Genetic Blood Clotting Disorders Prior to Starting Hormonal Contraception

Birth control and blood clots - clotting factors 2

We also asked if the participants if they had a known clotting disorder, recognizing that some women would have been tested for clotting disorders after their blood clot experience, and thus, even if they did not know about a clotting disorder prior to starting hormonal contraception, they may have learned about it afterwards. Only 20% of the women in our study had a known clotting disorder, as can be seen in the chart below. For the other 80% who answered “not that I know of,” it may be that they were never tested for a clotting disorder, or that they were tested and were negative for all known clotting disorders. So far, we do know from follow up interviews with study participants that in some cases, this testing was done and was negative. Upon completion of the study, we will know how many women were definitively negative for all known clotting disorders. Of the 20% of women who did have a known clotting disorder, none were tested for it before starting hormonal contraception.

Study Participants With Clotting Disorders

Birth control and blood clots - clotting factors family

Of the women that did have known clotting disorders, Factor V Leiden mutation was the most common common disorder, found in approximately 9% of study participants. This is consistent with what is known about Factor V Leiden mutation: it is known to be the most common blood clotting disorder. Other blood clotting disorders were found with low frequency in our study, as can be seen in the bar graph below.

Blood Clotting Disorders Present in Study Participants

Birth control and blood clots - clotting factors

Summing Up

So far, our preliminary data suggest that many of our study participants did not have known factors that would increase their risk of developing a blood clot while on hormonal contraception. The majority of women in our study were not smokers, and did not have a known clotting disorder, and a significant number of women did not even have a family history of blood clots. In addition, most women developed blood clots after the first year of medication use. We will be continuing to assess these and other known risk factors as we continue with our study, as well as trying to identify if there are any previously unrecognized risk factors. However, it seems that any woman using hormonal contraception could potentially be at risk. This makes it especially important to learn the warning signs and symptoms of all types of blood clots, and make an informed choice of whether hormonal contraception is right for you, knowing the risks.

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.

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Weight Gain and Hormonal Contraceptives

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The Pill and Weight Gain

Once upon a time, a 26-year-old woman went to her doctor and asked to be put on the new birth control pill that allowed women to only have four periods a year. She had seen it advertised on television. Four months later, 15 pounds heavier and suffering from mild depression, she returned to the doctor feeling miserable. The doctor told her the weight gain and depression were not from the pill because those were not side effects of hormonal birth control. This left the young woman feeling like it was her fault she had gained weight. Needless to say, that didn’t help with the depression. But she switched back to her original birth control pill and lived happily (but heavily) ever after. Well, until it gave her a stroke two years later.

I’ve written a lot about my stroke and about blood clots and birth control pills, but there are many other side effects from hormonal birth control. More often than not, we are told that these side effects do not exist; that they are all in our heads. Are they? Or are we simply being ignored and lied to?

What Does The Research Show?

When researching my thesis, I was interested in finding out what women knew about the risks associated with birth control pills. I created a survey based on a published study by researchers in this field. The original study outlined which side effects were and were not associated with birth control pills. The survey used in my thesis demonstrated the following:

“When the women were asked to select which risk factors were associated with birth control pills, most women, 76.7% of the 313 who answered the question, selected blood clots. Weight gain, which is not considered a health risk or even a side effect of birth control pills, was the selection most chosen (79.9%).”

The number one answer most women chose was weight gain, yet all the research I read said that weight gain was not a side effect of birth control pills. My own doctor had told me it wasn’t a side effect when I stood before her 15 pounds heavier after switching pills. Even as I wrote my thesis, I wondered how we could all be so wrong. Well, it turns out we weren’t. The pill can cause weight gain. And they knew it could, even back in 1970. The following is testimony from the Nelson Pill Hearings.

Dr. Francis Kane (page 6453): [In a Swedish study of 344 women] Of the 138 women who stopped using the medication, weight gain and emotional disturbances were the most frequently reported, 26.1 percent and 23.9 percent.

Dr. Louis Hellman (page 6203): My private patients… come off the pill because of a host of minor reactions. The most prevalent one is weight gain. The modern American girl just does not want to gain 5 or 10 pounds if she can help it.

What About Today’s Birth Control Pills?

I took another look at what I could find out about weight gain and hormonal contraception now. According to WebMD:

“When birth control pills were first sold in the early 1960s, they had very high levels of estrogen and progestin. Estrogen in high doses can cause weight gain due to increased appetite and fluid retention. So, 50 years ago they may indeed have caused weight gain in some women. Current birth control pills have much lower amounts of hormones. So weight gain is not likely to be a problem.”

Maybe larger doses of hormones cause more weight gain. But I don’t think that means that smaller doses cause none. And what about taking that smaller dose for a decade or more?

Most current medical information dismisses weight gain completely. On the Mayo Clinic website’s FAQ page for birth control pills it says:

“Do birth control pills cause weight gain? Many women think so. But studies have shown that the effect of the birth control pill on weight is small — if it exists at all.”

That’s right, ladies. Just like your menstrual cramps, weight gain on the pill probably doesn’t exist. But wait, the Mayo Clinic says there are studies that show hormonal contraceptives don’t cause weight gain. Where are these studies?

Inconclusive? Or Incorrect?

A recent meta-analysis (2014) conducted by Cochrane (an independent group that reviews randomized controlled trials and organizes medical research information) found the following:

Available evidence was insufficient to determine the effect of combination contraceptives on weight, but no large effect was evident. Trials to evaluate the link between combination contraceptives and weight change require a placebo or non-hormonal group to control for other factors, including changes in weight over time.

You mean to tell me in the 40+ years since the Nelson Pill Hearings we haven’t been able to conduct one conclusive study to determine how hormonal contraception affects weight? Perhaps it’s time to start asking why. All those studies that provided insufficient evidence, who funded them and who might stand to lose if they were conclusive? I don’t know for sure but I do know that one of the few things women fear as much as an unintended pregnancy is weight gain. Even the staunchest feminists among us often fret over our figures.

According to Naomi Wolfe’s The Beauty Myth, “thirty-three thousand American women told researchers that they would rather lose ten to fifteen pounds than achieve any other goal.” Setting aside how disturbing that is, we can easily see how the fact that hormonal birth control can cause weight gain might adversely affect the pharmaceutical industry’s bottom line (pardon the pun).

At the Nelson Pill Hearings, there were at least a half dozen experts–doctors specifically chosen to testify before Congress–that mentioned weight gain as a side effect of the birth control pill. Including ones who admittedly worked for the pharmaceutical industry. But now, nearly five decades later, the research is inconclusive. Doctors are telling patients that hormonal contraceptives are not responsible for weight gain, yet 80% of women surveyed thought that weight gain was a side effect. Like so much surrounding the pharmaceutical industry, something doesn’t add up here. And who is paying the difference? Women. Yet again we are being told that it’s all in our heads. Have you had experience gaining weight on hormonal birth control?

Further Testimony on Weight Gain

This testimony from the Nelson Pill Hearings just scratches the surface of the side effects caused by hormonal contraceptives. I’ll be expanding more on a lot of this testimony in future articles. But perhaps Dr. Victor Wynn explained most succinctly how these side effects manifest when he testified (page 6303):

When I say these changes occur, I mean they occur in everybody, more in some than in others, but no person entirely escapes from the metabolic influence of these compounds. It is merely that some manifest the changes more obviously than others.

Dr. Robert Kistner (page 6082): I tell her about the side effects plus a weight gain edema and I may even give her a prescription for this.

Dr. John Laragh (page 6165): We do not have any firm clues. But it does look as though those who accumulate salt and water and gain weight on the oral contraceptives might be especially vulnerable [to increased hypertension].

Dr. Francis Kane (page 6449): Complaints of moodiness, being cross and tired, alterations in sexual drive, weight gain, edema, and insomnia were commonest in the group using the estrogen-progestin group.

At the hearings, Dr. Herbert Ratner (page 6737) was asked by James Duffy, minority council:

Mr. Duffy: You use the word “disease” here. Disease to me seems to be a pretty strong word and I am just curious why you would consider weight change to be a disease?

Dr. Ratner: You realize that obesity is one of our major problems in this country.

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.

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Fatal Pulmonary Embolism with No Warning Signs

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As a recent 23 year old college graduate, our daughter was entering into an exciting new phase in her life, when it was tragically cut short by a pulmonary embolism caused by her birth control pill.

In April 2013, Alex graduated from the University of Pittsburgh with a double major in communications and writing. At the beginning of that year she had entered into a relationship. So, during her Spring Break visit to her family home in Houston, she and her mother visited a doctor where she was prescribed Lutera for birth control. She seemed to feel well on it and never complained of any alarming symptoms to her mother or me. Following graduation she found work with an oil and gas marketing company in Pittsburgh and decided to stay up there, moving into a house with several other young women.

On the afternoon of October 30th of 2013, whilst waiting for the elevator with a co-worker, she suddenly collapsed. The co-worker called an ambulance and she was taken to St. Clair hospital, the closest facility. Her co-worker said that she was having shortness of breath, chest pain, and heart palpitations before she collapsed. During the drive there, the EMT called us in Houston and advised that our daughter had had some sort of seizure and was being taken to hospital. Her co-worker told us not to worry too much as it seemed to be an epileptic fit or similar and that she’d be fine.

About one hour after the first call we received a call from the emergency room doctor who advised that, if at all possible, we should get up to Pittsburgh STAT. By this time her boyfriend and a good friend of ours had arrived at the hospital, so we were able to get regular updates as we rushed to the airport. The main issue seemed to be that they wanted to life-flight her to the main hospital campus, but that it was proving difficult to stabilize her. A CT scan had confirmed a pulmonary embolism in her lung. We arrived in Pittsburgh approximately six-and-a-half hours after the first call, but she had died two hours before our arrival.

In talking with her boyfriend he told us that everything had been fine, although on the morning of her death she’d mentioned that her ‘butt’ felt like it had a pulled muscle. In addition, Alex had eaten dinner with our friend the night before, and had apparently mentioned that she felt tired. But there were really very few warning signs that could have alerted her or us that something was wrong leading up to her death.

This sudden loss has devastated us, forever changing our lives. It’s vital that all women who consider birth control of any sort should be aware of the risks, particularly those arising from the use of hormonal-based contraceptives. There are too many tragedies like that of Alex’s.

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.

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Shattering Myths: Birth Control and Blood Clots Study Early Results

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Birth Control Blood Clots Study

Lucine Health Sciences and Hormones Matter launched an important new research project one month ago. The Real Risk Study: Birth Control and Blood Clots is a multi-phased project designed to assess the breadth and depth of blood clot risks and other side effects associated with hormonal birth control. The current phase of the research involves collecting survey data and case reports from women who have suffered from blood clots while using hormonal birth control. Although data collection is still in the early stages (we have data from 42-50 participants, depending on the question), some important trends are already beginning to emerge.

Are Newer Users Really More At Risk?

One of the statements often made in medical publications, and even stated in the pharmaceutical companies’ own package inserts, is that the risk of developing a blood clot on hormonal birth control is the highest among new users or those restarting (within the first year of use or re-use). In our study, we are asking the question “How many total or cumulative months or years had hormonal contraceptives been used prior to the clot?” In our preliminary data set of 50 women, only 22 percent developed blood clots within the first year of use. The majority of women, 78 percent, developed blood clots after the first year. From our data, it does not seem true that the risk of blood clots is highest within the first year of use.

Seventy-Eight Percent of Hormonal Birth Control Induced Blood Clots Develop After One Year

Birth Control and Blood Clots: Preliminary Results

We further analyzed the data set to refine our understanding of when blood clots were developing relative to length of time on hormonal contraceptives. The chart below shows the percentage of women in our preliminary data set that developed clots after various lengths of time. The size of each box is proportional to the number of women in that group. Because the data is preliminary, and the number of women in each group is still small, we cannot really compare the sizes of the groups to each other until we have more data. However, we can say that women are developing clots after a wide range of time on hormonal contraceptives, even after up to 21-30 years on the medication.

Hormonal Birth Control Induced Blood Clots Develop More Frequently in Years 1-10

Birth Control and Blood Clots: Preliminary Results

Cigarette Smoking as a Risk Factor for Blood Clots

We are also asking survey questions about known risk factors and possible risk factors, to try to get a clearer picture of all of the factors contributing to a woman’s risk of a blood clot while on hormonal contraception. Cigarette smoking is known to increase the risk of developing a blood clot, and it is referenced in the package inserts that come with birth control pills. In the information for Yaz, the most popular birth control pill in the U.S., the warning states:

WARNING TO WOMEN WHO SMOKE: Do not use YAZ or Beyaz if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke, or heart attack. This risk increases with age and number of cigarettes smoked.

However, it has been pointed out that the risk communication by pharmaceutical companies in these inserts employs language that is misleading about the true level of risk, and the message most women who read the inserts come away with is that if they don’t smoke and are not over age 35, they are not really at risk.

In our survey we are asking the question: “Were you a smoker at the time of the blood clot(s)?” So far we have collected data from 42 participants for this question. In our data set, 79 percent of women who suffered from blood clots while on hormonal contraception had never been smokers. Another 12 percent had smoked previously, but were not smokers at the time of the blood clots. Altogether, 91 percent of women in our study were not smoking at the time when they develop the blood clot(s). This means that women cannot be confident that they are not at risk just because they do not smoke.

While these results are very preliminary and will have to be confirmed with the larger sample pool and the additional validation studies we anticipate, the data collected thus far seem to suggest that risks described by the industry do not correspond to the reality of what women experience. Although some women develop clots soon in the weeks and months after initiating hormonal birth control, the vast majority do not. Similarly, although smoking is certainly a risk, not smoking does not equate with lack of risk. So what causes the blood clots in some women and not in others? That is what we are trying to determine with this study.

Birth Control and Blood Clots Is about the Chemistry

We know from the basic chemistry that hormonal contraceptives skew coagulation factors in favor of blood clotting in all who take them. The research on this is pretty clear. These synthetic hormones increase the coagulation factors by 170%, almost three times their normal levels. Simultaneously, hormonal contraceptives decrease the anti-clotting cascades by 20%. This alone is sufficient to create blood clots and yet, not all women who take hormonal birth control develop clots or develop them very quickly. In some cases, it is years before the clotting becomes problematic.

What causes some women to develop clots soon after starting hormonal contraception, versus those who develop clots after many years? What causes some women without any known risk factors to develop massive DVTs and/or massive bilateral pulmonary embolisms, and die in their twenties? Is it determined by genetics, by medication interactions, by lifestyle variables, or by various combinations of risk factors? We do not know. No study to date has been sufficiently comprehensive to determine those risks. The Real Risk Study is.

Participate in Research

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.

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Sharing My Story, Feeding the Hope

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death by hormonal birth control

When I took this job—combing through the Nelson Pill Hearings, researching and writing about the risks with hormonal birth control, working on the Real Risk study—my mother said to me, “Are you sure you want to do that? Are you sure you want to dig up all that stroke stuff?”

“Mom,” I said, a little exasperated. “It’s been 10 years. I’m fine with it.” Duh was close to what I was thinking but didn’t say. The weird thing is, my mom may have been right. Okay, that’s not entirely fair. My mom WAS right. (NEWSFLASH: My mom is right sometimes!) This job has been hard, and not just because reading congressional testimony is draining and because I’m so passionate about this work. It has been hard because it has forced me, nearly every day since November, to examine what happened to me.

I had a stroke because of hormonal birth control and for a long time I believed my doctors (and much of the research I found when writing my thesis) when they said that I was special. That this sort of thing didn’t happen much. Because I thought I was an anomaly, I was able to bury my head comfortably in the sand and call that “dealing with it.”

It hit me that I had not been dealing with it when I sat in a room with Karen Langhart and the parents of four other young women who had died while using hormonal birth control. As they shared their stories, tears slid down my face. I knew I was not an anomaly. It could have easily been my mom sitting in that room and not me.

I’ve written about how important it is to share patient stories. And we’ve written about the importance of the Real Risk Study. I’ve participated in the study. I’ve written my story (all three parts of it: Part 1, Part 2, Part 3). But it has not been easy for me. Which means it has taken unfathomable courage and strength for the families who have lost their daughters. I had to face a sadness that was buried deep under a layer of “getting on with life.” But for these families, the sadness isn’t buried because there is no “getting on with life.” It’s right there, out in the open, raw and exposed. Their lives will never look remotely the same.

When we publish an article about a health crisis or a death related to hormonal birth control it is not because we are alarmists. It is not because we are whiny or dwelling in the past. It is because this work is important. This study is important. I was not an anomaly. The young ladies who were killed by hormonal birth control are not anomalies. They are daughters, wives, sisters. They could be you or someone you love. We share because we are not alone. We are a group of survivors and advocates.

One of the most amazing things that has happened to me from taking this job is that, despite the challenges, it has helped give meaning to what happened to me. I’ve met and connected with amazing people. While much of it has been cloaked in sadness, the thing that shines even brighter in these interactions is hope. And hope is healing. By sharing my story and participating in this research, I am feeding that hope.

It is my wish that you will help feed that hope, too. If you are a survivor of a blood clot or a family member of someone killed by a blood clot and you have been hesitant to participate, now is the time. If you aren’t, I guarantee that you know someone (a friend or relative or a friend of a friend) who has been affected by a blood clot while on hormonal birth control. Now is the time to share this link. Because there is hope in sharing. And healing in hope.

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.

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What Everyone Needs to Know About Hormonal Birth Control

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birth control and blood clots

My only child, Theresa, came to me a month before her sixteenth birthday and told me she had sexual intercourse for the first time. I was not happy about it, but I was very happy we were close enough that she knew she could come to me about it. I spoke my mind about how I felt she was too young, but I also knew deep down my words would not prevent her from having sex again. Theresa asked about going on the birth control pill. I had been on the pill in my 20’s and had no side effects from it. I told her I would make an appointment with my OBGYN that also delivered her, and we would discuss the options with her first.

Starting the Birth Control Pill

Theresa had an exam by the doctor and then I joined them in the doctor’s office to discuss birth control. Our doctor mentioned the pill first. My first reaction was to ask about other contraceptives but the doctor felt the pill would be the best for Theresa. She said she would put her on one of the lowest dose pills, called Ortho-Cept. I was aware of some of the side effects of the pill like gaining weight, blood clots, and danger if you smoke (Theresa did not smoke). Our doctor did not go over any of the side effects with us or what to look for if something were to go wrong. I trusted my OBGYN because I have been with her for most of my life and she had four children so I never felt she would put Theresa in any kind of harm. She also was aware of my family medical history and that my mother had a stroke at 32 years old.

Theresa was on the pill for a month and a half and never complained to me about it. On August 15th, 2010, Theresa and I spent the whole day at the mall putting the final touches on her Mardi Gras Sweet 16 party. She was having her party in October instead of her birthday month in July because she wanted all her friends back from summer vacation so they could attend. Theresa always dreamed about her sweet 16 party; it was the day she felt she would be a princess and her start of becoming an adult. That night after shopping we stayed up all night ordering the masks for her Mardi Gras party. When I went to bed that night I had no clue our lives would end the very next day. That instead of watching my daughter’s dream party happen, it would be a memorial concert on her party date instead.

The Day that Changed our Lives Forever

August 16th, 2010 started out as a normal day. I woke up and got ready for work. Theresa was still asleep so I did not wake her to say goodbye. Around 1:00 in the afternoon she called me at work to ask if she could go out with two of her friends. I said yes and that her dad or I would pick her up at 9:00 PM. I told her I love you and we hung up. Those were the last words ever spoken with her.

Her dad decided he would pick her up that night. I remember just getting out of the shower when my phone rang. It was her dad telling me Theresa was sick and he had called an ambulance.  I did not even wait for details; I got in my car and headed to the pizzeria he told me they were at. We later found out that Theresa had complained of a headache about an hour before the ambulance was called, and then became delirious, and vomited. I was there within 10 minutes and saw a huge crowd outside the pizzeria along with an ambulance. I rushed into the pizzeria and saw Theresa on the stretcher out cold. I remember looking around the pizzeria and it being packed with people. As soon as we got into the ambulance I saw the paramedics rip open Theresa’s shirt and start CPR. I was in a daze and in shock. I had no clue what was happening, but I knew I was losing my child.

When we got to the hospital the doctor on call continued CPR and made my ex-husband and I leave the room. A couple of minutes later the nurse came out to tell me to come in and hold her hand. I already knew Theresa was gone. The doctor then had me go out of the room and told us Theresa was gone. He said her pupils were not dilated, and there was no indication it was caused by any kind of substance. That I already knew: Theresa hated drugs and did not do them.

I remember walking back in the room to be with my daughter. She was lying on the table with her eyes wide open. I will never forget that picture. Theresa had the most beautiful green eyes and she was so proud of them. I remember blurting out I wanted to donate them. Everything after that is a total blur. My 16 year old daughter was dead and I had no clue why. She was a very healthy, athletic, young girl. I always thought we were blessed because if I took her to the doctor more than once a year for feeling ill, that was a lot.

I called our OBGYN the next day to tell her Theresa died. I still had no thought in my head that the pill had anything to do with her death. I actually thought she had an aneurysm because her friends said she complained about a headache an hour before she died. Two days after her death our OBGYN called me that the autopsy results were already in. She said Theresa died from a blood clot that burst in her leg and caused a pulmonary embolism.

Factor V Leiden, The Risk Factor that We Were Not Aware Of

I was then told Theresa had a blood clotting disorder called Factor V Leiden. Dr. Melgar told me that everyone in my immediate family and my ex-husband’s immediate family had to be tested for it because this disorder is genetic. She told me a simple blood test would determine if anyone in the family carries this disorder. I immediately went and had blood work done and found out I have Factor V Leiden also. Theresa got it from me, and I never even knew this disorder existed. My sister had her four children tested for it and two of her children turned out to be positive. My nephew has it and one of my nieces has it from both her parents, which is very serious.

I started doing research on this and that was when I found out the pill Theresa was put on was not the same kind of pills I was on in my 20’s. Hormonal contraceptives now have different types of progestins in them, and classified into second and third generation pills by the type of progestin. Women using third generation progestins have an even higher risk of developing a blood clot than women using second generation progestins.  I also learned if Theresa had a blood test before she went on the pill, the doctor would have known about her having a blood clotting disorder, and she would have never been allowed on any kind of birth control.

After reading all this I drove straight to the doctor’s office to find out why the blood test was never mentioned. Dr. Melgar explained to me that the medical opinion is that blood clotting disorder is rare and insurance companies will not pay for the blood work so doctors do not mention it to their patients. She did not even give us the option to pay for it out of pocket. The insurance companies feel it is not cost effective to run this test on people going on birth control cause only 5-7 out of 10,000 die from it.

A simple blood test (that I would have paid for) would have saved Theresa’s life. Instead, she died from this. Theresa’s life, to the medical and pharmaceutical industry, did not matter. She is now just a statistic to them. For Theresa she lost her life, her future. She was a promising young woman that wanted to either become a veterinarian or work as a social worker with Project Children. She wanted to make a difference in this world.

As for her father and I, we might be living, but we are both dead inside. We lost the only important person in our life. We will not see our daughter graduate from college this year, get married, or ever have any grandchildren. The medical/pharmaceutical industry stole everything from Theresa and us, just by not mentioning a simple blood test.

Since Theresa’s death I have been trying to spread the word to others about this blood test. I am not against birth control at all, but I am against the facts not being revealed. I feel people need to know about this blood test. In Theresa’s memory I will tell people about this test over and over again. Many people I have talked to have had this test done after hearing of Theresa’s death. So many people have turned out positive for Factor V Leiden. I have come to find that this disorder is not as rare as the medical industry wants us to believe it is.

Actually talking to different doctors, I have found they are very ignorant about this disorder, and they have not been educated about it. It is up to us to fight for this blood test and make it mandatory for all females to be tested for it. Unfortunately a lot more people will probably die before it does become mandatory. I am hoping by telling Theresa’s story, this will bring awareness to others. Please insist on the blood test if you or anyone you know is going on any kind of hormonal birth control. Being a carrier (having one mutation, instead of two) also increases your risk of having a blood clot.

You need to watch all signs in your body for complications. Have you had many miscarriages? A swollen leg, that’s painful, red, and warm to the touch? Trouble breathing? These are all signs that you might have this disorder or a danger sign about your birth control. The number of people having strokes, pulmonary embolism, and dying have been increasing every year and the third generation birth control pills are contributing to this problem. The medical industry no longer cares about saving lives. They have teamed up with pharmaceutical companies to get as many profitable drugs on the market so they can benefit from it, instead of patients benefiting from it. They need to be stopped and only we can do that with our voice being heard.

Since Theresa’s death I have met many other parents that have lost their children to birth control and we are all trying to spread the word together. In conclusion, if one person’s life is saved from sharing Theresa’s story, then at least her death will not be in vain. I miss my child every second of every day. I lost my future, my best friend, my child and WHY? Because the medical industry felt she was not important.

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.

 

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Risk Communication and Hormonal Contraceptives

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When it comes to the dangers associated with hormonal contraceptives, how is risk communicated to women? Back in the 1960s when the pill first came out, only the doctors and pharmacists received the information pamphlet included with birth control pills. The burden was on them to decide what information to share with women and what information to omit. This was a central theme of the 1970 Nelson Pill Hearings. What are the risks of the birth control pill and how do we inform women of these risks? Here is testimony from several experts about the issue of informed consent.

Dr. Hugh Davis (page 5928): “In many clinics, the pill has been served up as if it were no more hazardous than chewing gum. The colorful brochures, movies, and pamphlets which are used to instruct women about the pill say next to nothing about possible serious complications. The same can be said for the veritable flood of articles in popular magazines and books which have convinced many women that there are few satisfactory alternatives to these steroids and that careful studies have proved there is little or no risk to life or health in the pill… It can be argued that the risk benefit ratio of the oral contraceptive justifies their use under certain circumstances, but it cannot be argued that such a powerful medication should be administered without the fully informed consent of each woman.”

Dr. Roy Hertz (page 6039): “My view would be that the application of these medications in their present state of knowledge constitutes a highly experimental undertaking. That the individual called upon to take these materials, particularly for prolonged period of time, should be regarded as, in effect, a volunteer for an experimental undertaking. I think she should be so informed.”

Dr. John Laragh (page 6167): “I think we have to do everything we can to simplify communication, to use education, to use techniques of repetition, to simplify the package insert. We can only go ahead in this area, and with many other powerful drugs… by full disclosure.”

With so many doctors insisting that women be informed of the risks of using hormonal birth control, we now have concise, unbiased, and easy-to-read risk information that comes with every package. Or do we?

Modern Risk Communication for Hormonal Birth Control

Because of my experience of having a stroke caused by hormonal birth control, I used my master’s thesis to investigate how drug manufacturers communicate the risks of taking birth control pills with respect to blood clots. Specifically, I was interested in determining whether the package inserts fully disclosed the risks for blood clots and whether/how women were informed of these risks by their physicians. The first part of my research assessed the risk communication, provided by the manufacturers, for three different types of hormonal birth control. This included reviewing the warning materials included with each packet of pills and determining whether the following information was included:

  • Did the information state that blood clots are a risk of taking this medication?
  • If so, did the information state that genetic disorders can increase the risk of blood clots?
  • Did the information list symptoms of a blood clot?
  • Did the information tell women with symptoms of a blood clot what to do in that situation (i.e. go to the emergency room, etc.)?

In addition to these questions, each insert was given a general overview of content, design, and language. Language and design play important roles in the understanding of risk and benefit. “Risk information typically is presented in often-ignored smaller print; as part of a large, undifferentiated block of text… or simply hidden in plain view… Even when found and read, risk information often is missing key pieces of information that consumers need to evaluate drug risks” (Davis). Unfortunately for women, this is the case with oral contraceptives.

How are Risks Communicated?

  • All of the inserts were text heavy, used extremely small font, and were designed in such a way that the paper would need to be rotated at least twice to access all of the information.
  • All three inserts had a larger portion and a smaller, perforated portion (presumably for a woman to tear off the larger section and keep the smaller) which means a woman would have to thoroughly read both sections of the inserts fully for all of the risk information (something that is unlikely due to the redundancy of much of the rest of the information).
  • Technically, each of the inserts lists all four points of information that were examined in this study, however, clotting disorders are only mentioned in the smaller sections, while symptoms of blood clots are only listed in the larger sections.
  • Each insert has statistical information about the risks involved with taking the medication but without the disclaimer that it is based on studies run by the very company who makes the medication. (Research has shown that studies funded by pharmaceutical companies that make oral contraceptives produced more favorable results than independent studies of the same medications.)

In general, the most highlighted information on any risk communication for birth control pills is a version of this:

Do not use [pill type] if you smoke and are over age 35. Smoking increases your risk of serious side effects from the Pill, which can be life-threatening, including blood clots, stroke or heart attack. This risk increases with age and number of cigarettes smoked.

I didn’t smoke and I was only 28 when I had my stroke from birth control pills. But the way this is worded leads women to believe that they are only at risk if over 35 and smoke. Which is patently false. All women who use hormonal contraception are at risk for blood clots. In fact, “the reality is that the estrogenic effects of combine hormonal contraceptives increase the risk of a potentially life threatening blood clot (venous thromboembolism or VTE) by between 400% – 700% for ALL women at any age including those that don’t smoke and those that do smoke. (Comparing Annual VTE Impact across 2nd-4th Generation CHC’s in the U.S. 2013).”

As Joe Malone points out in Five Half-truths of Hormonal Contraceptives, these types of warnings (being over 35 and a smoker) infer that if you are neither, hormonal contraceptives are perfectly safe for you. They are not. They weren’t safe for me and they weren’t safe for his daughter.

Another problem with these warnings is the conditional language stating that serious side effects “can be life-threatening.” A stroke, a heart attack, a blood clot—these things ARE life threatening. But as the research shows, conditional language like that helps give the patient confidence in the medication. After all, something like that can’t happen to me…

Would women feel as confident in their choice to use hormonal birth control if the warning accurately read: “This medication increases your risk of life-threatening blood clots by 400-700%”? Doubtful.

The Right To Know

Over 40 years ago, Dr. Edmond Kassouf testified at the Nelson Pill Hearings (pg 6121) about the information the drug companies were providing about birth control pills:

“Some of the pamphlets mislead and misinform, others are frankly dangerous, but all have one thing in common—they all seem to disparage the reader’s right to know.”

I wonder, how much has really changed?

By creating documents that are so text heavy, with dense language couched in conditional terms, in font barely large enough to read, pharmaceutical companies are clearly not designing for their audience, or any audience for that matter. But perhaps that is their intention.

 

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.

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yaz

Why Does Yaz Get a Pass?

In the early days of hormonal birth control, many physicians and politicians seemed extraordinarily indifferent to the side effects linked

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