birth control PE

Birth Control Induced Pulmonary Emboli: Sudden and Slow

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Birth control induced pulmonary emboli

Pulmonary emboli are notoriously difficult to diagnose clinically, especially in otherwise healthy young women. The early signs include such nondescript symptoms as breathing difficulties, chest or back pain, and fatigue; symptoms that are easily attributable to a host of viral and bacterial infections or other less serious respiratory conditions. As a result, and more often than not, it is not until complete hemodynamic collapse that PE is considered; a point at which survival is significantly less likely. Even then, for young women the prospect of pulmonary emboli is not always on the differential. We saw this repeatedly in our pilot study, the Real Risk Birth Control and Blood Clots study where the prospect of birth control induced blood clots was rarely considered. From a review of records and case stories, blood clots seemed only to be considered after everything else was ruled out. That is, they were near the bottom, if not absolutely last, on the diagnostic differential. When the emboli were in the lungs, this refusal to consider contraceptive induced hyper-coagulation has deadly consequences.

When we consider that the most commonly recognized risk associated with hormonal birth control are blood clots, one cannot help but wonder why birth control-induced blood clots are not automatically ruled out when women present to the ER in crisis, but they are not. Time and time again, the early signs of an imminent crisis were dismissed by healthcare practitioners. Neither the deep vein thrombi that frequently preceded the pulmonary emboli by as much as a month, nor the pulmonary emboli were immediately recognized. And as we reported previously, recognition was equally labored in women who developed cerebral venous thrombi, brain clots, often requiring 2-3 ER visits before the diagnosis is even considered. I am not sure why there is such a total break down in clinical acuity when it comes to birth control-induced blood clots, but by all accounts, there is.

Perhaps our familiarity with these drugs has bred a false sense of safety; one so firmly entrenched that even when faced with evidence to the contrary, when life or death hang in balance, we cannot bring ourselves to acknowledge their risks. Perhaps so strong is our desire and need to have effective birth control options, that we employ a sort of willful ignorance about the risks. Or more cynically, perhaps we have simply been duped by Madmen inspired, pharmaceutical funded half-truths and platitudes.

Whatever the reasons, the patient reports suggest that when confronted with evidence of blood clots, all involved tend to dismiss the possibility until all other causes are ruled out. Physicians especially seem reticent to consider blood clots, forgetting entirely that hormonal birth control hyperactivates blood coagulation cascades in favor of clotting – in all women, not just some women, but in all women. They increase pro-clotting factors by 170% and decrease anti-clotting factors by 20%, a change in hemodynamics that all but guarantees a propensity toward body-wide clotting, especially when other health or lifestyle variables are present. No matter the chemistry, however, when clots happen, we all seem genuinely surprised. If the results of this study show anything, it is that birth control induced blood clots are real and should be ruled out first, not last.

Sudden and Slow: The Two Faces of Pulmonary Emboli

One of the key goals of the Real Risk Birth Control Blood Clots study is to identify early warning signs of clotting. To that end, the women who took the survey were asked to identify the presence and severity of 35 symptoms commonly attributed to blood clots, at a month out, a week out, the day before, and the day of, the crisis. Although we found significant linear trends in the escalating severity of many symptoms across time for the group as a whole, more telling were the patterns that emerged when we divided the groups by diagnosis (DVT,  DVT + PE, stroke, etc.). There we see distinct patterns in the type of symptoms as well as the trajectory of expression and severity.

For example, when we look at the patterns of early warning signs of pulmonary emboli, we see two, possibly three, trends emerging. In some women, pulmonary emboli seem to appear suddenly with few if any warning signs. In other women, symptoms either increased over time or waxed and waned (or both), sometimes for months, until reaching an apex of severity. For the latter group, the waxing and waning seemed related to the movement of the clot(s) from the periphery to the lungs. That is, the localized pain, swelling, and temperature changes, either in the legs, pelvis, abdomen, or collarbone regions, would be severe for a week or a month before the event and then dissipate entirely, only to re-emerge as the crushing pain associated with the pulmonary embolism. We will be reporting more details in subsequent articles, but preliminarily, the data and the personal accounts suggest the possibility that PEs may be preventable, if the signs of deep vein thrombosis (DVT) are more readily recognized.

Listed below are descriptions of the events leading up to the crisis reported by women with pulmonary emboli who completed Phase 1 of the Real Risk Birth Control and Blood Clot survey. A similar report was published for women who survived strokes.

Sudden Onset

“my chest hurt to the point I could not lay down or move without excruciating pain” – during the crisis – no symptoms prior.

CS2 reports severe right thigh pain the day of the crisis, as well as moderate chest pain, shortness of breath and fatigue and mild back pain, but nothing before that point. The PE caused low blood pressure. Doctors were unable to detect blood pressure in her right arm.

JR began to experience mild discomfort the day before her crisis. The day of her crisis, she explains, “the symptoms [severe shortness of breath, chest pain, irregular heartbeat, dizziness, blackouts, fatigue, and mild to moderate headache, nausea, difficulty speaking, and stomach pain] worsened as the day went on.” She goes on to say that “right before I passed out and then once when I woke up, it was crushing burning pain and my heart was beating so fast that I couldn’t catch my breath.”

RF’s clots originated in the pelvis and legs and experienced severe pain and swelling in the pelvis the day before her crisis.

Tales of Traveling DVTs

“…right lower calf was swollen and warm to the touch, pain felt like a Charley horse. Chest pain was unbearable. It hurt to breathe and my heart was racing so fast that it hurt.” – per her data, leg pain developed a week before but disappeared; chest and heart pain appeared the day of the crisis; fatigue was moderate to severe from week before.

Twenty year old CS  reported moderate to severe right shoulder and chest pain a month before the crisis, along with moderate fatigue from a week out. The day of the crisis, the pain moved to lower chest. She describes the chest pain as: “Every time I took a breath in it felt like a knife was being stabbed into my chest on the right side.” Like so many others, she was sent home from doctor’s office day of crisis only to return to ER that night to discover her right lung was riddled with clots, necrotic in places.

KM had very few symptoms leading up to her PE, except a “sharp pain deep in my calf – I thought I had a badly pulled muscle or strain my Achilles tendon (up high) while jogging. The pain got much worse if I was standing for long periods of time, but got much better if I exercised.” She also reports shortness of breath climbing stairs or when giving a presentation.

ES described her symptoms: “leg pain felt like a bad cramp, almost as the back of the leg had seized up. I thought it was a pulled muscle because I lacked other symptoms. The PE pain was a crushing, hot pain in my chest, worse when breathing in.” Her leg pain began a month prior to the PE, peaked a week before and then dissipated entirely. While the pain from the PE began a week prior to the crisis and escalated.

FH rates all of the symptoms leading up to the crisis as mild, even though some of the symptoms emerged months before. She chalked up her leg pain to occasional muscle cramps and the shortness of breath to sinus issues.  It wasn’t until she began blacking out that she suspected something more serious was wrong. She notes on the day of the crisis she was cold and her blood pressure was extremely low.

KG reports that “a month before the clots my toes on the right side got red and swollen and felt throbbing. After working out at the gym had chest pain, shortness of breath, [my] ribs hurt, heavy chest that felt like extreme gas pains.”

KD describes how the pain seemed to move with the clot. “The pain in my left quad felt like an injury. Then when it moved to the ribs, it felt like I had pulled ribs. Then when it moved to the right side, it felt like a kidney stone and only hurt bad when I was lying flat on my back. My leg pain, after the clot had already exploded into my lungs, was like a bad Charley horse. My lungs had clots everywhere.”

SD reports severe leg pain 3-4 weeks before experiencing the difficulty breathing associated with her PE.

Waxing and Waning Symptoms

For 43 year old DW symptoms like dizziness, blackouts, and vomiting had emerged a week prior and then dissipated until the day of the event, when they returned along with severe shortness of breath, chest pain and heart palpitations. She describes the pain as “tight legs, stabbing pain and then collapsed. All happened within 5 minutes.”

For DD the DVT that preceded the pulmonary emboli “felt exactly like a Charley horse. When it lasted more than two days and I started limping, I knew I needed to consult a nurse at the ER.” She too had symptoms that waxed and waned over the month preceding the crisis.

R indicated that she experienced breathing difficulties and chest pain that would wax and wane over the six months prior to her PE diagnosis and that it wasn’t until a few days before the crisis, that it became severe. “On the second night when I tried to sleep, I had severe pain in my upper back and left side of my chest, which started to radiate up to my neck and left shoulder. I experienced more pain in my chest if I tried to inhale deeply.”

Unremitting Fatigue as a Key but Non-Specific Symptom

Uncharacteristic and unremitting fatigue was one of the most consistently reported symptoms across all time points and diagnoses.

LL reports severe fatigue for at a least a month prior to the crisis as the leading symptoms. She notes the fatigue appeared well before the pain. “The fatigue leading up to this was very bad. It was such a struggle to get out of bed or do anything. It was there a good while before the pain.” She also reports restless legs, and “severe stabbing pains in my back” especially when “bending down to pick something up.”

Breathlessness and Speaking Difficulties

As one would anticipate with pulmonary emboli, difficulty breathing was a cardinal symptom of the impending crisis.

Breathing Difficulties

“felt like I had become rapidly, extremely unfit. Could not walk up the stairs in one go. Was struggling to get enough oxygen.”

J believes her symptoms emerged months before the crisis. She reports a “hairball-like cough” for months that was continually diagnosed as allergies. It was persistent and would not respond to allergy medicine. She experienced moderate to severe fatigue for the month leading up to the crisis, along with moderate to severe shortness of breath, irregular heartbeat, heart palpitations, cough, dizziness and nausea.

LT said “chest wall pain two weeks before diagnosis felt like soreness from lifting weights. When the back pain localized to my side and upper back, it felt like I had pulled muscles in those areas. The shortness of breath felt like I was getting out of breath way too easily; walking 30 feet felt like I had been running for half a mile, and slowly climbing the long escalator out of the subway station felt like I was trying to run up the stairs.”

SM experienced severe shortness of breath for at least a month prior to her diagnosis. She says she felt as though “…the middle of my chest was being pressed or squeezed.”

Speaking Difficulties

Many women report difficulty breathing in the months, week and day before the crisis. Speaking, because of the breathing difficulties, becomes increasingly labored.

NB said she would gasp for breath and was “only able to get 1-2 syllables between gasps.” She said she felt like she “had run for her life and just couldn’t catch my breath.”

JZ felt “very winded, even in casual conversations,” but otherwise didn’t report any symptoms.

Conclusion

These and other personal accounts of birth control-induced blood clots suggest that for many women, early signs are present but not recognized. Similarly, blood clots appear to be distributed throughout the body. This is consistent with the fact that hormonal birth control induces systemic changes in hemodynamics. To fully delineate the risks, however, we need more data. If you or someone you know has suffered from a birth control induced blood clot, please consider participating in the study.

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter. 

This article was published originally on November, 2016. We subsequently lost funding to finish this study. Nevertheless, we are still accepting stories about birth induced blood clots. If you’d like to share your story, send us a note: Write for us. Other stories and articles about birth control and blood clots can be read here.   

Photo: autopsy of birth control induced pulmonary emboli in a young woman.  

 

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Birth Control Fatalities Show Unexpected Characteristics

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Birth Control Blood Clot Study

Over the better part of the last year we have been collecting data about birth control induced blood clots. This work is part of a multi-phased project to determine a more realistic appraisal of clotting risk than those currently marketed by industry. We know that the synthetic hormones used in birth control increase blood coagulation factors by 170% and decrease anti-coagulation factors by at least 20% in all women who use these products. What we do not know is why some women develop clots relatively quickly after commencing with these medications and others can withstand the changes in hemodynamics for years, sometimes decades, before the clots become problematic.

Industry safety pamphlets tell us that clot risk is increased in women over the age of 35 years, who smoke and/or are overweight, suggesting that for everyone else the risk of clotting is minimal. Similarly, there is a recognition that women with known clotting disorders are at increased risk of birth control induced blood clots (though very rarely are these tested before commencing hormonal birth control). Beyond that however, the major medical societies routinely proclaim the safety of these medications for all women, even women with health issues that should logically preclude the use of hormonal birth control, like those with migraines, high blood pressure, and diabetes.

How is it possible that a class of medications known to alter hemostasis and affect over 50 metabolic reactions (Nelson Pill Hearings, pg. 6311) be considered safe for all, or for anyone really? Politics aside (and yes, we are pro-women’s rights, choice and health), it is difficult to reconcile the very real changes in chemistry with any legitimate conversation about safety. The chemistry predicates the clotting, incontrovertibly. Eventually, the alterations in chemistry induced by hormonal contraceptives are bound to create problems. The only questions that remain are when and with what degree of severity?

These are important questions that one should have answers in advance of deciding to use hormonal contraceptives. Indeed, these questions should have been answered decades ago, but they were not, leaving women to make these decisions based more on faith than on facts. Our mandate for this project is to answer those questions. With Phase 1, the pilot study now complete, patterns are emerging, that if confirmed in Phase 2, may flip what we think we know about hormonal birth control and blood clots, upside down. Namely, who gets clots, the over 35 smoker or the otherwise healthy younger woman? And once those clots develop, who is likely to survive them?

What We Found

Contrary to what we expected, the results from our study showed that it was younger, more active women who developed clots in general, but also who subsequently died from those clots. Our sample size was small and these trends may change with the larger sample size anticipated in Phase 2, but for now, our results are in direct conflict with the stated risks. The women who survive blood clots were older, less active, heavier, and had more cumulative health risks than those for whom the clots were fatal. In addition, NuvaRing was proportionately more likely to correspond with blood clot fatalities than any of the other contraceptive methods.

Why younger women were more likely to clot and subsequently die from blood clots is not yet clear. Clotting disorders did not explain this finding. Two variables that may be indicative, include exercise and alcohol use. Overall the younger women were more active and in the deceased group activity levels were significantly higher than in the survivor group. Similarly, alcohol use though low overall, was higher in the deceased group as well. Both of those variables are known to favor clotting dynamics; then again, so too are smoking and obesity and neither of those variables was significant. Similarly, it is also possible that NuvaRing was uniquely involved, either because of the progestin and/or because of the route of administration. Since NuvaRing tends to be favored with younger women it may be a factor in the younger ages of those who perished. With the larger sample size anticipated in Phase 2 of this project, we’ll be able to more fully delineate these risks. For now, the results tell us that what we think we know about hormonal contraceptives and clotting may require re-evaluation. Described below are the study details.

Birth Control and Blood Clots Pilot Study Results

General Information

Phase 1 of the research involved collecting survey data and case reports from women who have suffered from blood clots while using hormonal birth control and from family members of women who died from birth control induced blood clots. The survey was advertised via social media and respondents completed the survey online. Case histories were collected online and included phone interviews. The final sample included 87 completed surveys, including 77 self-reports and 10 surveys completed by a family member of a deceased woman. This was from a larger pool of 125 partially completed surveys. Case histories were collected from 26 women or families and continue to be collected as part of the second phase of the project.

Demographics

  • Average age at diagnosis of blood clot: 31 years (range: 15-52)
  • Average duration of birth control usage at time of clot: 8.52 years
  • Race/ethnicity of respondents: 90% Caucasian

Type of Event: Primary Diagnosis

  • Pulmonary Embolism (PE): 33%
  • Deep Vein Thromboembolism (DVT): 19%
  • PE plus DVT: 16%
  • Stroke: 44%
  • Peripheral Artery Disease: 3%

Which Contraceptives Are More Dangerous?

While the small sample size and the possibility of an availability bias in participant recruitment precludes answering this question with confidence, the early trends suggest that the NuvaRing and the drosperinone-based oral contraceptives may pose a higher risk for thrombotic events and NuvaRing may pose a higher risk for fatality. Notably, a significantly higher proportion of the women who died from blood clots were using NuvaRing at the time of their clot than those who survived, 66.7% versus 19.2%, respectively [ X2(2, N=87) =9.985, p = .007]. As the sample size increases in Phase 2 of this project, these data may change and results will become clearer.

  • NuvaRing (etonogestrel) -21
  • Drospirenone based oral contraceptive (Yaz, Yasmin, Ocella) – 15
  • Levonorgestrel based oral contraceptive (LevLen, Seasonale, Amethia, Lovara, Microgynon, Camrese) -12
  • Norethidrone base oral contraceptive (Loestrin, Microestrin, Gildess, Estrostep, norethindrone, micronor) – 15
  • Norgestimate based oral contraceptive (OrthoTriCyclen) – 10
  • Desogestrel based oral contraceptive (Marvelon, Viorele, Mircette) – 7
  • Cytoproterone based oral contraceptive (Dianette, Diane) – 4
  • DepoProvera shot – 3

Risk for Clotting: Stated Versus Actual

We know from the chemistry that all hormonal contraceptives induce system-wide changes in hemodynamics. From this standpoint, one would expect that all women who use these medications would develop clotting issues at some point, that longer duration increases risk, higher dosages induce clotting more quickly, and additional health risks expedite the time frame to clotting event. These trends have not been born out with any consistency in the decades since the associations were first observed, suggesting that how we look at the risk factors for clotting may be incomplete or incorrect. Some of our preliminary data suggest that the marketed risk factors are not as clearly impactful, from a population standpoint, as expected. That is, the commonly stated risk factors occurred in very small percentage of the test sample suggesting that other, yet to be identified variables may contribute more heavily to risks.

All contraceptive risk labeling includes four primary risk factors: genetic clotting disorders, obesity, smoking, and age. Absent those risk factors, contraceptives are marketed as safe.

Genetic Clotting Disorders

  • Only 9% of the total sample had a clotting disorder, all identified after developing a clot and there was no significant difference in the proportion of women with clotting disorders between the groups.

Obesity

Obesity was measured using the body mass index (BMI) calculation. A BMI of greater than 25 is considered overweight and one greater than 30 is considered obese. It should be noted, however, that BMI calculation, though a standard measure, has several limitations including overestimating obesity status in athletic, highly muscular women. Overall, the women tended to be overweight, but not obese, with a large variability in weight across the sample.

  • The average BMI for the sample was 28.33, SD=7.6
  • There was no statistical difference in BMI between the women who survived and those who did not, although the average BMI of the women who died tended to be lower (M=25.27, SD = 2.6) than those who survived (M=28.8, SD =.87).

Smoking

  • Only 17% of the study sample had ever been smokers
  • Only 8% of the women were smokers at time of their clot crisis
  • 75% had never been smokers
  • There was no statistically significant difference between the proportion of women who smoked, developed blood clots, and survived, and those who did not.

Age

  • Risk literature emphasizes that women over 35 are at greatest risk; however, in our survey population the average age of women at the time of their blood clots was 31 years; nearly 70% of the women who developed clots were under the age of 35.
  • Women who died from blood clots were significantly younger (M=24.78 years, SD =5.80) than those who survived [(M=32.5 years, SD =8.9), t(65)= 2.518, p=.014]. This is in direct opposition to what would be expected e.g. that older women would have a reduced likelihood of survival. With a larger sample size, this trend may change.

Contributing Lifestyle Variables

Long periods of sitting as would occur with extended travel is a known risk for clotting, across all populations. Early researchers noted that exercise naturally increased clotting factors and recent research suggests that alcohol use also increases the propensity to clot (in men). Additionally, one might expect the use of other medications would impact clotting and survival. As part of the pilot study, we assessed those risks to see if these variables were contributing factors.

Travel

  • 6% of the women reported extended travel in the three months leading up to their blood clots.

Exercise and Activity Level

Survey respondents rated their activity level based upon the following scale. Over half of the total respondents were somewhat to very active.

  • Completely inactive – 1%
  • Not very active – rarely exercise -40%
  • Somewhat active – moderate or vigorous intensity exercise 150 minutes per week – 34%
  • Active – moderate or vigorous intensity exercise 300 minutes per week – 22%
  • Very active or athlete- intense physical exercise 6-10 hours per week – 2.35%

When we compared the activity levels of the women who died versus those who survived another striking pattern emerged. The women who died (M= 2.5, SD =.93) were significantly more active than those who survived (M=1.78, SD =.84), [F 1, 83) = 5.274, p =.024].

Alcohol Intake

Respondents were asked several questions about alcohol intake over the three months preceding the clots. These included average days per month that alcohol was consumed, average number of drinks per day, and maximum drinks in any one 24-hour period. While alcohol consumption was relatively low over all, there was a significant difference in the number of drinks per day between women who died versus those who survived. The deceased group drank an average of 2.11 drinks per day (SD =.46), while the survivors group consumed only .65 drinks per day (SD = .11), [t(85)=4.056, p=.000].

Medication Use

A number of medications increase clotting while others may increase bleeding. How most medications interact with each other and with hormonal birth control to influence clotting is unknown. Delineating those interactions is important for women. The small sample size in the pilot study prevents us from addressing individual medication interactions. Nevertheless, we decided to assess the overall trend in medication use and propensity to clot; more specifically, whether the use of fewer medications would contribute to survivability. What we found was surprising. A significantly smaller proportion of women who died (33%) versus those who lived (67%) were using additional over-the-counter and/or prescription medication [X2(2, N=87) =10.233, p = .006].

Combined Risks

While we cannot yet determine what combination of risks predict clotting overall, we ran some preliminary analyses to see if an accumulated number of lifestyle factors increase or decrease the survivability of clots. Unexpectedly, the women with fatal blood clots had a non-significantly lower number of accumulated risks (M=3) than those who survived (M=4). The limitations of this study preclude any definitive conclusions, but this trend could indicate either that how we tabulate risk is incorrect and/or that it is simply and solely the hormonal contraception that increases the risk.

Time to Clot

One of the pervading myths surrounding birth control induced blood clots is that they develop early on. The suggestion is that if one makes it through so many months or years without clotting, clotting is unlikely. This is partly because of the substantially increased risk of thrombosis in women with genetic clotting disorders and the assumption that those events will develop at the onset of hormonal contraceptive use. We cannot yet answer the question of whether those with clotting disorders develop clots more quickly compared to women without (the numbers are still too small, only 9% of our sample reported a genetic clotting disorder). However, we can say that most women in our study developed clots after at least a year of use.

  • 75% of the women developed clots after a year or more of use

Early Warning Signs

Blood clots are notoriously difficult to diagnose as the symptoms often correspond with a myriad of other non-specific health issues. One of our goals for the entire study will be to determine early warning signs. To that end, we asked the respondents to rate the presence/absence and severity of 35 common symptoms of blood clots a month before, a week before, the day before, and the day of the crisis. Although we found significant linear trends in the escalating severity of many symptoms across time for the group as a whole, more telling were the patterns that emerged when we divided the groups by diagnosis (DVT,  DVT + PE, stroke, etc.). There we saw distinct patterns in the type of symptoms as well as the trajectory of expression and severity.

As we reported previously, when we looked at the patterns of early warning signs of pulmonary emboli, we see two, possibly three, trends emerging. In some women, pulmonary emboli seem to appear suddenly with few if any warning signs. In other women, symptoms either increased over time or waxed and waned (or both), sometimes for months (as reported in the comments section), until reaching an apex of severity. For the latter group, the waxing and waning seemed related to the movement of the clot(s) from the periphery to the lungs. That is, the localized pain, swelling, and temperature changes, either in the legs, pelvis, abdomen, or collarbone regions, would be severe for a week or a month before the event and then dissipate entirely, only to re-emerge as the crushing pain associated with the pulmonary embolism. We will be reporting more details in subsequent articles, but preliminarily, the data and the personal accounts suggest the possibility that PEs may be preventable, if the signs of deep vein thrombosis (DVT) are more readily recognized.  With the larger sample size in Phase 2, we may be able to delineate these trends more fully.

Medical Inattention and Dismissal

Among the more disturbing findings was the complete disregard for even the most basic but well-known contraindications when prescribing these medications (age, smoking, and family history of clotting). Also troubling was the dismissal of symptoms by medical professionals once the crisis became imminent.

Ignored Contraindications

If clotting disorders, age and smoking are known risk factors, we would expect those risks to be identified prior to the prescription and in some cases, prevent the use of these medications entirely. This does not appear to be the case.

  • Only 1% of women were tested for clotting disorders prior to receiving the prescription, even when they reported a family history of clotting disorders.
  • 33% of our sample were over the age of 35 at the time of their blood clot crisis; 19% were over the age of 40 and the oldest was 52 years of age at the time of the clot – well past the age when hormonal contraceptives should be used.
  • 8% of the sample population were smokers, smoking is reported as contraindication for hormonal contraceptive use.

Medical Dismissal

A review of the case stories and the comments sections within the survey reveal that a good percentage of women recognized something was wrong, sought medical attention, but were dismissed and sent home, sometimes repeatedly and sometimes over a period of weeks and months. It was often not until arriving via ambulance that the severity of the situation became apparent. Even then, the case stories suggest that the physicians seemed to place the possibility of a birth control induced clot low on the diagnostic differential. Blood clots must be ruled in, rather than ruled out. This is something that has to change.

Final Thoughts

These results, while preliminary, show striking trends; namely that younger, more athletic women may be at a higher risk for clotting and clotting fatalities. To fully delineate and validate these trends we will need more data. If you or someone you know has suffered from a birth control induced blood clot, please encourage them to participate in Phase 2 of our study.

We Need Your Help

More people than ever are reading Hormones Matter, a testament to the need for independent voices in health and medicine. We are not funded and accept limited advertising. Unlike many health sites, we don’t force you to purchase a subscription. We believe health information should be open to all. If you read Hormones Matter, like it, please help support it. Contribute now.

Yes, I would like to support Hormones Matter. 

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Pulmonary Embolism after Four Months on the Pill

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birth control induced pulmonary embolism

I was a sophomore in college when my life changed. I was an active college student who enjoyed going to the gym. One night I was at the gym on the stair climber and something did not feel right. I got off and all of a sudden blacked out. My heart was racing, my chest was tight and I was very scared. I went back to my dorm to try to sleep it off, but I had a hard time falling asleep.

The next morning I tried walking to class, but once I stepped outside I could not breathe. Going to school at the University of Nevada, Reno it was snowing and cold, so I thought I couldn’t breathe because of the chill. Shortly after, I called my mom and she insisted I go to the campus health center. I went and they did a bunch of tests. Finally, the doctors decided to do a blood test. If those results came back positive, I would have to be rushed to the ER.

Sure enough, I had a positive result. I had multiple pulmonary embolisms. I was hospitalized for three days and given many different anticoagulants (blood thinners) to get my levels back to normal.

After this happened, I was scared for a very long time. It took me a while before I could get back on the stair climber at the gym due to the event. Luckily, I am all healthy now. I take a baby aspirin in the morning to prevent any clotting. I am lucky to be alive and I am very thankful for that.

Symptoms Leading up to the Pulmonary Embolism

Looking back, I had some chest pain during the week, but I figured my symptoms were from the cold I had. It was not until I was on the stair climber, working out vigorously and passed out that I thought something was wrong.

Prior to that, I was not taking any other medications, just the birth control. The pill I was on is called Trivora. I was in overall good health.

I started birth control in August of 2013 and I had my PE on December 2, 2013. I was only the pill for 4 months. I took it religiously, every day at the same, for the four months I was on it.

After I was hospitalized, I had to go to a Coumadin clinic to test my blood every week. I also had to see a cardiologist and get an echocardiogram to make sure that my heart was okay with all the Coumadin that I was taking. Luckily, everything came back negative.

The doctors did test me for clotting factors and heredity tests to see if it ran in my family. I was the only woman on birth control in my family. Luckily, those tests came back negative too.

To this day, I continue to work out regularly and listen to my body if I feel something is not right. The biggest aspect that saved my life was going to the doctor. I know many people are afraid of doctors or worried that they will hear bad news, but it can save your life. I tell all my friends who are on birth control that if they feel not right or something is off with their body to seek medical attention right away.

I hope what I experienced never happens to anyone else. It was the scariest experience of my life and I count my lucky stars every day to be alive.

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

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Brittany Malone - Nuvaring precipitated fatal blood clot

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Hormonal Contraceptive Risk Counseling Misses Real Risks

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

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

Contraceptive Counseling Training Video

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

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

Brenda Oral Contraceptive Pill Counseling

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

A Contraception Consultation in Pharmacy

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

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

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

Table 1. Risk for Blood Clots with Different Hormonal Contraceptives

Table 3- Comparing Annual VTE rate

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

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

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

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

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

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

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

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

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

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

The Bottom Line: Hormonal Contraceptives Carry Significant Risks

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

References

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

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