birth control side effects - Page 3

More Side Effects From Birth Control- The Liver and the Gallbladder

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This time of year, the holiday season, can be a time of overindulgence for many of us. And how can we talk about overindulgence without taking a look at the liver? To say the liver is important is an understatement. It is the body’s largest gland and while estimates of the number of functions of the liver vary, many textbooks generally cite around 500. Nearly everything we ingest, from drugs and alcohol to vitamins and nutrients, is metabolized by the liver. The vital role it plays in the functioning of our bodies makes the testimony from the 1970 Nelson Pill Hearings about the effects of oral contraceptives on the liver that much scarier.

Research Presented at the Nelson Pill Hearings

Dr. Victor Wynn was one of the first physicians to testify about the effects of hormonal birth control on the liver.

On page 6341 he states, “if you will take cells out of the liver and examine them under the electromicroscope of women taking oral contraceptive medication, you will find some extraordinary changes.” Of these and other changes caused by the pill, he says: “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.”

Later to testify was Dr. William Spellacy who was specifically called upon to speak about the metabolic effects on the liver. His testimony about the liver begins, “The biochemical effects of the sex hormones on the liver are legion.” Below is a list of liver functions that, based on the research presented in Dr. Spellacy’s testimony, are altered or impaired (NPH 6427):

  • Lowering of total plasma protein level
  • Decrease in the albumin and gamma globulin and increases in other fractions
  • Tests may be abnormal in women on oral contraceptives without disease being present
  • Estrogen (including that in oral contraceptives) interferes with liver function and varies with dosage
  • Some women taking oral contraceptives have abnormally high blood bilirubin levels
  • 1/3 of women who have jaundice on oral contraceptives will get it when pregnant
  • Discontinuation of oral contraceptives “cures” jaundice

He summed up his thoughts on the liver damage caused by hormonal birth control:

“The immediate effects include the alteration of several of the laboratory tests used in medical diagnoses. Aggravation of existing liver disease, if present, to the point where jaundice may be seen has also been shown. There is no answer to the query of will permanent liver damage result from the use of the oral contraceptives.”

The honorary Chairman of the Population Crisis Committee, a “pro-pill” organization focused on population control added his two cents about the effects of oral contraceptives on the women using them. “While metabolic alterations affecting the liver and other organs do result from use of the pill, there is no evidence at this time that they pose serious hazards to health;” General William Draper, Page 6705.

Of course, we shouldn’t assume that just because a medication causes a “legion” of biochemical effects on the livers of otherwise healthy women that there will be any lasting problems, right?

Research Since the Hearings

“Women more commonly present with acute liver failure, autoimmune hepatitis, benign liver lesions, primary biliary cirrhosis, and toxin-mediated hepatotoxicity,” according to a 2013 article in Gastroenterology and Hepatology.

Like I mentioned in my piece about rheumatoid arthritis, whenever a health issue affects women disproportionately, there is often a connection with hormonal birth control. While this study doesn’t specifically mention that, it does call for further studies assess the role of sex hormones and other behaviors on liver problems in women.

These connections were well-documented at the 1970 Nelson Pill Hearings but the subsequent research gets more confusing.

Timeline of Liver Research

1980: Lancet published an article showing the connection between malignant liver tumors and women using oral contraceptives.

1989: The British Journal of Cancer found “confirmation in this population of the association between oral contraceptives and hepatocellular carcinoma” and “the relative risk was significantly elevated in long-term users [of oral contraceptives].”

1992:This study, the largest to date, adds to the number of investigations demonstrating an increased risk of primary liver cancer with use, particularly long-term use, of oral contraceptives.”

2006:Long-term use of oral contraceptives (OCs) and anabolic androgenic steroids (AASs) can induce both benign (hemangioma, adenoma, and focal nodular hyperplasia [FNH]) and malignant (hepatocellular carcinoma [HCC]) hepatocellular tumors.”

Yet a 2015 meta-analysis concluded that “oral contraceptive use was not positively associated with the risk of liver cancer.” However, the analysis also conceded that “a linear relationship between oral contraceptives use and liver cancer risk was found.” And the authors noted the need for further research into specific formulations of oral contraceptives and the duration of usage.

It makes you wonder how we went from pretty convincing and highly damning connections between oral contraceptives and liver cancer to no positive association at all. Did all the scientists from the 1960s to 2006 get it wrong? Or is something else going on here?

What About the Gallbladder?

Perhaps we can look at the liver’s little buddy, the gallbladder, for some more information. The two are intimately connected in that the liver is constantly making bile and sending it to the gallbladder for storage and dispensation. Like problems with the liver, women are more likely to develop gallstones than men. According to the National Institute of Diabetes and Digestive and Kidney Diseases, “Extra estrogen can increase cholesterol levels in bile and decrease gallbladder contractions, which may cause gallstones to form. Women may have extra estrogen due to pregnancy, hormone replacement therapy, or birth control pills.”

This was proven shortly after the Nelson Pill Hearings. According to the revised edition of The Doctors’ Case Against The Pill by Barbara Seaman:

“The Pill also has serious adverse effects on the gallbladder, and women who take the Pill face an increased risk of someday facing surgery for gallstones. Pill use causes higher levels of cholesterol saturation in the bile, according to a study reported in the New England Journal of Medicine in 1976. This high level of fate in the bile is considered ‘an early chemical stage of gallstone disease,” according to Dr. Donald Small of the Boston University School of Medicine… The risk of gallbladder disease rises with the length of time a woman has been on the Pill… In some studies, Pill users are two and a half times as likely to suffer from gallstones as comparable women.”

A meta-analysis conducted in 1993 found “Oral contraceptive use is associated with a slightly and transiently increased rate of gallbladder disease” and “Considering…the rapidly changing formulas of oral contraceptives, the authors suggest that the safety of new oral contraceptives be evaluated by studying bile saturation and biliary function rather than by waiting for gallbladder disease to develop.”

A much more recent study (2011) found that there was even more risk of gallbladder disease with the newer formulations:

  • Long-term use of an oral contraceptive is associated with an increased risk of gallbladder disease compared with no use
  • There was a small, statistically significant increase in the risk of gallbladder disease associated with the use of desogestrel, drospirenone and norethindrone compared with levonorgestrel
  • Both estrogen and progesterone have been shown to increase the risk of gallstones
  • Estrogen has been shown to increase cholesterol production in the liver, with excess amounts precipitating in bile and leading to the formation of gallstones
  • Progesterone has been shown to decrease gall-bladder motility, which impedes bile flow and leads to gallstone formation

The gallbladder shows us that these hormones are damaging the body.

What Now?

So what do you do when you have a gallbladder that’s not functioning properly? The current practice is to take it out! Of course, removing the gallbladder is not the quick fix many think it is and often leads to other health complications like irritable bowel syndrome, acid reflux, and Sphincter of Oddi Dysfunction.

What about when your liver isn’t functioning properly? That’s not as simple. You can’t just take a liver out. How can the gallbladder, an organ so fundamentally connected to the liver, experience drastic and dangerous changes from hormonal birth control but the liver is supposedly unaffected? Have we researched ourselves out of that problem by declaring that it isn’t a problem? Has there been some spin-doctoring going on when it comes to the liver?

As Dr. Wynn said at the hearings, “There are more than 50 ways in which the metabolic functions of the body are modified, and to say therefore that normal physiological function has been demonstrated in the years of oral contraception is to overlook a very large amount of information.”

I think a very large amount of information has indeed been overlooked.

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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.

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Laboratoires Servier, CC BY-SA 3.0, via Wikimedia Commons

This article was first published December 15, 2016.

Lupus: Another Autoimmune Disease Linked to Birth Control

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Half a century ago, the National Institutes of Health sponsored a study on the metabolic effects of hormonal contraceptives. In the committee’s final report, Dr. Salhanick wrote:

“These accumulated data and others suggest that no tissue or organ system is free from a biological, functional, and/or morphological effect of contraceptive steroids.” [ NPH, Page 6567 ]

Fifty years later, the words of Dr. Noel Rose, the Father of Autoimmune Disease, rang with an eerie familiarity as he (almost proudly) proclaimed, “There is an autoimmune disease for every organ in the body.

Atypical Autoimmunity

There’s no such thing as a typical autoimmune disease (AI). Even in their commonalities they like to express their individuality. Like cousins determined to be different, each autoimmune disease has a unique relationship with estrogen. Researchers examining the differences in Multiple Sclerosis (MS) and Systemic Lupus Erythematosus (SLE) found that rising estrodiol levels create a protective effect in an MS patient, while it provokes and enhances flares in a lupus patient. They explained the complex distinctions this way:

“The effects of sex hormones (such as estrogens) on autoimmune diseases cannot be generalized and is context/disease-dependent. It is not surprising that the outcome of estrogen-mediated autoimmune responses is different among autoimmune diseases since estrogens affect all cells of the immune system, and the triggering and pathogenic mechanisms are varied among different diseases.”

Teams of scientists are just beginning to identify the complex stew of variables that contribute to AI diseases. Identification of the specific Tregs (a type of T-cell that modulates the immune system), cytokines (proteins that play an important role in cell signaling), and receptor cells (the soldier cells of the immune system) will help unlock the greatest mysteries of each AI disease. For now, researchers all seem to agree on one thing – estrogen affects EVERY cell in the immune system. One unfortunate stumbling block in this process is the generic use of the term ‘estrogen.’ The word is frequently used interchangeably to describe estradiol (estrogen produce naturally within the body) and the synthetic estrogens used in birth control or hormone replacement therapy. These synthetic molecules differ greatly from natural estradiol, and consequently, have very different affects on our immune systems. We can see the potential impact of synthetic estrogens by examining the evolution of lupus.

The Mysterious Evolution of Lupus

Imagine you are a rheumatologist. You developed a foundational understanding of lupus in medical school, but you really define lupus by what you have seen first-hand in your practice. Everything you know about the onset of disease, the typical patient, when it flares, and when it doesn’t is based on (and somewhat limited by) your time in practice.

Now, forget everything you know about lupus, and look at it through the eyes of a physician practicing in the late 60s.

Everything Dr. Giles Bole Jr. knew about lupus from his time in practice was being challenged. Events he had first classified as anomalies grew more frequent. Through conversations with concerned colleagues, he realized other doctors felt uneasy about birth control pills. Even some medical journals started doubting the ‘miracle pills’ that had been on the market for less than a decade. An editorial in the October 1969 edition of The Lancet said,

“The wisdom of administering such compounds to healthy women for many years must be seriously questioned.” [ NPH p. 6109]

Dr. Bole took up research that landed him before congress at the Nelson Pill Hearings in 1970. He described the phenomenon of young women contracting rheumatoid arthritis and “a much rarer disorder, Systemic Lupus Erythematosus.” He presented several examples of young women who developed symptoms within months of starting The Pill. In many cases, the symptoms reversed when the women stopped taking the synthetic hormones. Scientists at that time were already aware of certain medications causing Drug-Induced Lupus Erythematosus (DILE), but this was different because it was happening in young woman, and in many cases, the symptoms were irreversible.

These weren’t just isolated cases in Dr. Bole’s lab. Later in the hearings, Dr. Herbert Ratner estimated that one of every 2,000 birth control users developed lupus [NPH p. 6737]. Dr. Bole speculated that the synthetic compounds in birth control were to blame, saying that the ability to crossover between synthetic and natural hormones had limitations. He added, “I believe that it is clear to all of us that additional long-term studies relating to the biological effects of these compounds are extremely important.”

Lupus Today

A report published in Arthritis and Rheumatism in 1999 concluded that the incidence of lupus had tripled in the past forty years. An estimated 1.5 million people in the United States currently suffer from lupus (compared to 1.3 million with rheumatoid arthritis), and 90% of them are women. Clearly, something sparked this once rare disease.

In 2009, scientists from McGill University in Montreal released the results of a massive population study. They collected data on 1.7 million women, and found that women on oral contraceptives were 50% more likely to develop lupus. The greatest risk was in the first three months, when there was a 2.5-fold increased risk.

Overwhelming preliminary evidence points to a causal relationship with lupus. Unfortunately, we aren’t much closer to confirming the suspicions today than we were when Dr. Bole testified.

The State of Lupus Research

Instead of developing more extensive trials to investigate The Pill’s role in triggering lupus, researchers gave us the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) trial, which resulted in the study director writing, “Should oral contraceptives be prescribed in SLE? In the last five years, we have come a long way. The answer today is frequently ‘yes’, whereas before, the answer was almost always ‘never.’”

The trial seemed to be designed for the sole purpose of reversing the answer to that question – to identify a new market of hormonal contraceptive users, a subset of SLE patients who could ‘safely’ take The Pill.

The trial’s summary claimed, “The results of the study will show whether it is safe for women with SLE to use the pill.”  This is a very broad statement given the selective group of 183 SLE patients who participated in the trial. To be included, investigators required a patient to have inactive or stable disease requiring less than 0.5 mg prednisone per kg of body weight per day over a 2-year period. They excluded patients with blood pressure higher than 145/95, any history of thrombosis, APL antibodies, hepatic dysfunction, diabetes, or complicated migraines. We’re talking about a very select group of healthy SLE patients being tested. Therefore, it is not surprising their trial concluded ‘that oral contraceptives do not increase the risk of flare among women with SLE whose disease is stable.’ Of course, for those so inclined, it is easy enough to drop the mitigating phrase from the end of that sentence and proclaim The Pill to be safe for SLE patients, period.

The Art of Deception

Studies like these muddy the waters. They give the impression that birth control won’t affect lupus, but read any lupus forum and you will find entries like this one:

“…At this point I decided to stop my birth control because I felt my body needed a break from medications. Within 6 months my hair was growing back, my fatigue went away, as well as the severe swelling. I was able to workout again and live my life! This was 4 years ago and I feel great. I still have flare ups, but it is not constant like it used to be. Recently I tried going on a different type of birth control (lowest hormone levels offered called Loestrin Fe) and had the same side effects within 8 months. I try to find info on birth control and lupus symptoms and how they correlate but have had no luck. Does anyone else have this problem or heard of birth control doing this? My doctor isn’t convinced that it is the birth control, but I think it is. Instead of taking me off the birth control, he is giving me anti-depressants to help me sleep so I’m not tired all the time.”

Let me take a moment to punctuate the absurdity of her situation. She went off The Pill, and her symptoms improved dramatically. Years later, she tried a new formulation of birth control, and the symptoms returned. BUT, her medical professional doesn’t think it’s The Pill. So, he’s prescribing anti-depressants instead!! I really wish I could say I’ve never heard anything like this before, but I have. And, I’ve heard variations of the scenario so frequently that I’m beginning to wonder if this is the new norm.

It doesn’t help when the website for the advocacy group, Lupus Foundation of America, contains information like this:

Many women have more lupus symptoms before menstrual periods and/or during pregnancy when estrogen production is high. This may indicate that estrogen somehow regulates the severity of lupus. However, no causal effect has been proven between estrogen, or any other hormone, and lupus. And, studies of women with lupus taking estrogen in either birth control pills or as postmenopausal therapy have shown no increase in significant disease activity.

No mention of the SLE needing to be stable – no mention of dangerous secondary symptoms to take into consideration – just straight up, “If you have lupus, The Pill is no cause for concern.” Doctors five years ago surely had some reason to tell lupus patients they should ‘never’ take The Pill.

It is true ‘no causal effect has been proven,’ but only because the drug manufacturers don’t want it to be proven. Look up virtually any illness that has been linked to birth control, and you will find someone friendly to the drug companies (and The Lupus Foundation certainly receives enough funding from drug companies to fall into this category) who throws out the ‘not proven’ argument. In his 1969 book, Pregnant or Dead, Dr. Harold Williams described how drug companies already employed this strategy to deny the link to serious thromboembolic issues:

“So long as the data presented could be claimed as “the best available” there was a ready-made defense for any hiatus in the data. As long as The Pill proponents expressed a desire for more complete data – all the while taking steps to thwart its compilation – they were safe…Then came the British. They reported preliminarily that a well-planned study was showing a distinctly higher incidence of thromboembolic disasters among Pill takers…This required some new strategy. Now it became necessary to try to discredit the British work, and at the same time to continue stalling studies in the United States that might yield similar results.” [Pregnant or Dead, pages 59-61]

What’s the Point?

By now, you may think the point of this article is that you can’t trust advocacy groups, the drug industry, or even your doctor, and, to an extent, I guess that’s true. But the most important point is this – trust your questions more than the answers. If an answer doesn’t ring true, you don’t have to accept it just because it came from your doctor, or some online expert.

I have spoken with women who were convinced their autoimmune disease must have been caused by The Pill… until they spoke with a doctor. Afterwards, they were convinced it was genetic. Of course, it’s genetic – estimates say that one in every four people carries a genetic variant that makes them more likely to develop an autoimmune disease [The Autoimmune Epidemic by Donna Jackson Nakazawa, page 71]. A patient must be genetically susceptible to acquire any AI disease, and perhaps some doctors are comfortable letting patients think it ends with genetics. However, environmental triggers that enter our body and mimic estradiol play a huge role in the actual activation of AI diseases like lupus.

Listen to your body. If it tells you that something doesn’t ‘feel right’ about your hormonal contraceptive, pay attention even if your doctor acts like it’s nothing (especially if he/she suggests anti-depressants as the solution).

Trust your questions more than the answers.

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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.

 

Help Us Crowdsource: Birth Control and Blood Clots Study

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A few months ago we began the Real Risk: Birth Control and Blood Clots study. The goal is to determine the real risk of birth control induced blood clots in real women, with real lives, and complicated health histories. The project, like each of our others, relies heavily on patient stories and the patient’s (or patient’s family’s) recollection of health issues preceding the blood clot crisis. This type of self-reporting is messy, complicated, and in many cases, carries with it inherent flaws. For all the difficulties, however, I believe crowdsourced research offers the opportunity for unheralded discoveries, not just because in women’s healthcare medication safety and efficacy evidence is, and has always been, sorely lacking, but also, because I believe in women. I believe in the wisdom of their voices. For too long, women’s voices have been silenced, even where our own bodies are concerned. We aim to change that, one story and study at a time.

Not unexpectedly, however, we have been chided and our efforts blocked by more traditional researchers and patient advocacy groups (especially those sponsored by industry). It is not the kind of research ‘real’ scientists do, we are told. Real research is filtered through the lens of the medical-pharmaceutical establishment. Real research is hierarchical and highly controlled. Real research eliminates as many confounding variables as possible; variables like medication and lifestyle interactions, the very real-life variables we embrace. Most importantly, real research is sanctioned, either by academia or industry. For if it is not, it cannot be real, and it certainly is not valid, no matter the rigor.

What Constitutes Real Research?

One might surprised to find what constitutes real research. Did you know that fewer than 50% of all pharmaceutical treatments have any data supporting efficacy. Of that evidence, much could be suspect given the rampant payments from pharmaceutical and device companies to physicians and other decision-makers, plus the well-documented publishing bias and even fraud plaguing the scientific publishing industry. Real research, conducted by the real scientists and sanctioned appropriately, may be no better than flipping a coin.

In women’s healthcare, matters are even worse. Not only are evidenced-based, clinical practice guidelines nearly non-existent in gynecology (only 30% of practice guidelines based on data), and women still not included in early stage clinical trials in sufficient numbers, but regulatory agencies do not mandate analytics to determine sex-based differences in medication safety or efficacy. The result, post-market adverse events – think death and disabling injury – are more common in women than men. When superimposed upon a deep-seated medical mistrust of women’s symptoms, is it any wonder women’s healthcare is dangerous to women? Again, however, this is the real research that experts speak of so highly.

Women Are Different than Men

Digging a little deeper, it becomes abundantly clear why women’s healthcare is so dangerous for women. Most medications reach the market without having ever done the appropriate testing or analytics to distinguish why women might respond to said medications differently than men. Indeed, prior to 1998, women of childbearing potential were prohibited from participating in clinical trials. So every medication that came to market before these regulations, was not tested on women.

Even in the lab, male rodents are used about 90% of the time, because dealing with the rodent estrus cycle is considered too expensive and too complex. It was only a few years ago that the National Institutes of Health (NIH), the major funding agency for most early stage research, began mandating that female animals be used in all basic research — 2014!!! This was only after a large, media driven, public embarrassment (see Leslie Stahl’s reporting on 60 minutes).  It remains to be seen if the differences between male and female animals will be analyzed, or if, like the continuously eroding 1998 regulations, researchers have only to check a box assuring the presence of female animals in the study design.

Medications for Women Only

What about medications developed specifically for women – like hormonal birth control? Certainly, these types of medications included females?  While it is true, the development of hormonal birth control used female test subjects, the study was small, hugely flawed and completely unethical – women were forced to stay on the pill despite experiencing serious side-effects, including death by blood clot, but also, by suicide. Almost a fifth of the participants suffered serious side effects, side effects that were discussed in the Nelson Pill Hearings but ultimately dismissed and ignored. And now, decades later, we are only just beginning to revisit those side effects.

For the newer formulations of hormonal contraception, only efficacy is ever tested. Safety is largely ignored. As a result, with each change in formulation and administration route (cervical rings, IUDs, patches, etc.), the side effects appear to increase not decrease. The newer generations of birth control are several-fold more clot-inducing than their predecessors, despite marketing admonitions to the contrary.

I think it is important that hormonal contraceptives prevent pregnancy, but it is equally important that they don’t cause blood clots, stroke, heart attack or cancer. And if blood clots, stroke, heart attack or cancer are deemed acceptable risks for birth control (and I don’t think they are), then shouldn’t we know which forms are the most dangerous and which women are most at risk?

One cannot manage, what one does not measure and we don’t measure critical components of women’s health. We also don’t track adverse events or side-effects very well. Question: have you ever reported a side-effect to a doctor? Do you know if he/she reported it to the FDA, the CDC or any other adverse events registry?  Probably not, and that is the problem.

If you knew you had a 20 times higher risk of stroke or heart attack for one medication versus another, would you choose differently? I bet you would, but as medical consumers, we don’t have that information. In many cases, those data don’t exist. We’re collecting those data and we need your help. If you are a woman, please consider taking the birth control and blood clots survey. There are four arms to the survey. It is likely that you fit into one.

Who is Eligible to Participate in the Birth Control and Blood Clots Survey?

  • Women who have experienced a blood clot(s) while using hormonal birth control: take survey now
  • A family member or partner of a woman who has suffered from deadly or disabling birth control induced blood clots: take survey now
  • Women who are currently using hormonal birth control, have used hormonal birth control for at least 1 year, and have not had a blood clot: take survey now
  • Women who have never used hormonal birth control or synthetic hormones of any kind: take survey now

Chances are you know someone who has experienced ill-effects, perhaps even blood clots, from hormonal birth control. Please share on social media.

5 Surprising Reasons Not to Use Hormonal Birth Control

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The following is a list of some the health factors that increase your risk of side effects from taking hormonal birth control. It is by no means a complete list of contraindications but you may find some of these surprising. I know I did.

Five Reasons You May Want to Reconsider Hormonal Birth Control

Reason 1: Smoking and Age

You are probably familiar with these warnings. You may have heard them on television commercials or seen them on magazine advertisements. Or maybe you read my article about risk communication and saw them there. The problem with these warnings is that the wording makes it seem like you are only at risk if you are over 35 and a smoker. But the truth is that these two risk factors stand independent of each other. You are at increased risk if you are over 35 years of age. You are at increased risk if you are a smoker of any age. And if you are a smoker who is over 35, you have an exponentially higher risk for blood clots when using hormonal birth control.

Reason 2: Migraines

According to a 2010 article in the Reviews in Obstetrics and Gynecology, 43% of women in the United States suffer from migraines. That’s a huge number of women. Also, according to the same article, 43% of women using birth control are using hormonal contraception (the pill, rings, shots, implants, etc.). I’m not a statistician but I’m guessing there is some overlap between the women that suffer migraines and the ones using hormonal birth control. This is problematic for two reasons:

  1. A great deal of evidence suggests that migraine, particularly migraine with aura, is associated with an increased risk of ischemic stroke, and that this risk may be further elevated with the use of hormonal birth control. But if you don’t believe me, both the American College of Obstetricians and Gynecologists and the World Health Organization advise that women who suffer migraines with aura should not use hormonal contraception.
  2. Reevaluation or discontinuation of combination hormonal contraception is advised for women who develop escalating severity/frequency of headaches, new-onset migraine with aura, or nonmigrainous headaches persisting beyond 3 months of use.

A 2016 meta-analysis of seven research studies demonstrated “a two- to fourfold increased risk of stroke among women with migraine who use combined oral contraceptives (COCs) compared with nonusers.” But once again, like so many other things about hormonal birth control, the authors of the study report that research is lacking in this area and more studies need to be done.

Reason 3: Family Clotting Disorders

Many people have a clotting disorder and simply don’t know it. When I had my stroke while on birth control pills, I had no idea that I had the fairly common clotting disorder Factor V Leiden (FVL affects between 3-8% of people). But what I did know was that my grandmother had had two strokes. And my aunts and uncle had all had blood clots.

Unfortunately, women are not systematically tested for clotting disorders before they begin using hormonal birth control. This is very dangerous and why it’s so important to give your doctor a thorough family history; something I know I wouldn’t have considered that vital when I was 18 years old.

A lot of health professionals don’t take the time to review your family history, making it even more important that you mention your family history of blood clots and your concerns about hormonal contraception. You might even insist on being tested for clotting disorders before increasing your risk of a dangerous and sometimes deadly blood clot.

Reason 4: Depression and Mental Health

I explore this further in this article but the basics are:

  • Hormonal contraceptives can cause mental health issues
  • Women who suffer from mental health issues are much more likely to suffer from increased symptoms when on hormonal contraception
  • Often the longer hormonal contraception is used, the greater the symptoms
  • Discontinuation of hormonal contraception can usually alleviate mental health symptoms

Reason 5: Diabetes

Dr. Hugh J. Davis, the first doctor to testify at the Nelson Pill Hearings said the following (page 5930):

“A woman, for example, who has a history of diabetes or even a woman with a strong family history of diabetes is not an ideal candidate for using oral contraceptives… [they] produce changes in carbohydrate metabolism which tends to aggravate existing diabetes and can make it difficult to manage.”

Hormonal birth control elevates blood glucose levels, can increase blood pressure, increases triglycerides and cholesterol, and accelerates the hardening of the arteries, among other things. They knew this in 1970. But what about the research now? Well, if you’ve read any of my other articles it probably won’t surprise you that the current research is… wait for it… you guessed it… INCONCLUSIVE! Here’s a look at what I’ve found:

“Cardiovascular disease is a major concern, and for women with diabetes who have macrovascular or microvascular complications, nonhormonal methods are recommended.

There is little evidence of best practice for the follow-up of women with diabetes prescribed hormonal contraception. It is generally agreed that blood pressure, weight, and body mass index measurements should be ascertained, and blood glucose levels and baseline lipid profiles assessed as relevant. Research on hormonal contraception has been carried out in healthy populations; more studies are needed in women with diabetes and women who have increased risks of cardiovascular disease.”

And:

The four included randomised controlled trials in this systematic review provided insufficient evidence to assess whether progestogen-only and combined contraceptives differ from non-hormonal contraceptives in diabetes control, lipid metabolism and complications. Three of the four studies were of limited methodological quality, sponsored by pharmaceutical companies and described surrogate outcomes. Ideally, an adequately reported, high-quality randomised controlled trial analysing both intermediate outcomes (i.e. glucose and lipid metabolism) and true clinical endpoints (micro- and macrovascular disease) in users of combined, progestogen-only and non-hormonal contraceptives should be conducted.

Not enough evidence is available to prove that hormonal contraceptives do not influence glucose and fat metabolism in women with diabetes mellitus.”

As a side note, a recent study demonstrated a link between hormonal contraceptives and gestational diabetes.

Contraception is a very personal choice. I believe all women should research the risks associated with using hormonal contraception, but especially if you experience any of the health conditions above. Should you weigh the risks and benefits of using hormonal birth control and decide it’s still the right choice for you, please take a moment to review the symptoms of the blood clot and seek help immediately if you notice any of these.

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.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Hormonal Contraceptive Risk Counseling Misses Real Risks

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

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

Contraceptive Counseling Training Video

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

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

Brenda Oral Contraceptive Pill Counseling

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

A Contraception Consultation in Pharmacy

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

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

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

Table 1. Risk for Blood Clots with Different Hormonal Contraceptives

Table 3- Comparing Annual VTE rate

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

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

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

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

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

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

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

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

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

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

The Bottom Line: Hormonal Contraceptives Carry Significant Risks

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

References

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