Yaz and Yasmin: An Unacceptable Level of Risk?

2480078234_45c677498fDon’t feel bad if you missed last week’s headline news about the deaths of 23 young women from their birth control. It was a top story for CBC news and a few other Canadian sources, but it was barely a blip on the radar of most U.S. news outlets. Yaz and Yasmin, two similar new-generation birth control pills from Bayer, are suspected in the recent deaths of these young Canadian women.

These are among the best selling oral contraceptives in the world, but this is not the first time Yaz and Yasmin have been suspected of causing death or adverse effects. Earlier this year, Bayer agreed to pay up to $24 million to settle claims from plaintiffs with gall bladder injuries caused by the drugs, and the company set aside $1 billion to settle claims from approximately 4,800 women who have suffered blood clots due to Yaz or Yasmin. As of February, 2013, approximately 10,000 lawsuits against Bayer are still pending in the U.S., and an additional 1,200 unfiled claims are pending. The company anticipates additional lawsuits—and additional settlements—regarding blood clot injuries, such as pulmonary embolisms or deep-vein thrombosis.

The history of the birth control pill and its social impact is well documented. First approved by the U.S. Food and Drug Administration in 1960, it quickly became the world’s first “lifestyle drug,” and it has become the one of the most studied drugs in history. It is considered to be so safe that the American Congress of Obstetricians and Gynecologists (ACOG) recently recommended that oral contraceptives be sold without a prescription.

But all hormonal contraceptives–the pill, the patch, the shot and the vaginal ring–carry a risk of blood clots. For most users, this is a minor concern, affecting approximately six of every 10,000 pill users. For users of new-generation pills—that is, pills containing drospirenone, the fourth-generation synthetic progesterone found in Yaz, Yasmin, Ocella and several other brands—the risk jumps to ten of every 10,000 users, although Bayer maintains that their own clinical studies find the risk comparable to older pills. Note, however, that the risk in most of these studies is compared either to other hormonal contraceptives or to pregnancy, not to using effective non-hormonal contraception. As if women’s only choices were to be pregnant or be on the pill.

And it is this matter of women’s choices that brings me to my main point: Why we have we seen so little media attention to the safety profile of Yaz/Yasmin (and hormonal contraceptives more generally)? This isn’t about just a few unlucky Canadian women: Four women in Finland have died, more than 50 U.S. users of Yaz and Yasmin died in just a few years and France reports 20 deaths per year due to birth control pills between 2001 and 2011, with 14 attributed to the new-generation contraceptives. This is a major consumer safety concern, and a women’s health issue.

In an earlier time, this might have led to Congressional investigations, such as the Nelson Pill Hearings, which resulted in FDA-mandated Patient Package Inserts (PPIs)—the printed information about risks, ingredients and side effects included in pill packets, first required for oral contraceptives and then for all prescription drugs. It is hard to imagine today’s Congress calling for such an investigation. Among many other social changes since 1970, drug manufacturers in the U.S. hold more influence over both legislators and consumers, now spending nearly twice as much on promotion as they do on research and development.

A parallel can be found in the health crisis triggered by an outbreak of Toxic Shock Syndrome (TSS) linked to tampon use in 1980. TSS is a potentially fatal infection caused by bacterial toxin Staphylococcus Aureus. A new brand of superabsorbent tampon was linked with 813 cases of TSS, including 38 deaths, that year. By 1983, the number of menstrual-related cases reported to the CDC climbed past 2,200, and manufacturer Proctor & Gamble had “voluntarily” pulled the product from the market before the FDA forced them to do so. The intense media coverage, public concern and outcry from feminist activists pushed the FDA to reclassify tampons as a Class II medical device, an upgrade which meant tampons would require more specific regulation and possibly after-market surveillance. They were much slower to mandate absorbency standards, but eventually did so under court order. These actions resulted in a documented decrease in menstrual-related TSS, although it is important to note that it has not disappeared.

Today, more than 30 years later, young women are again dying from something purported to help them, something that affects mostly women. Thousands more are experiencing life-threatening, health-destroying side-effects, such as blindness, depression and pulmonary embolism. Canada’s professional association of OB-GYNs defended the drug, suggesting that perhaps the recent deaths could be attributed to non-contraceptive reasons for which it was prescribed, such as PCOS or diabetes, both of which are associated with higher risks of blood clots. But there is little evidence of public concern, outside of Yaz/Yasmin user message boards. Even feminist outlets aren’t always covering these issues as vigorously as we might hope.

Yet the birth control pill in general has never been more politicized in the U.S.: In the last year or so, we’ve seen headlines and public debates about insurance coverage of the pill, access to emergency contraception and so-called personhood bills which have been introduced in legislatures in at least eight states. Feminist activists and health care advocates have been working tirelessly to protect access to the pill along with other forms of birth control, as well as the right to end an unintended pregnancy—and feminist journalists have been writing about these activities.

In the urgency of responding defensively to these political attacks—and we must respond—feminists cannot ignore corporate threats. Just as preserving contraceptive and abortion access is critical to women’s health and well-being, so is protecting contraceptive safety.

Photo by Flickr user Beautiful Lily under license from Creative Commons 2.0.

Comments

  1. I nearly died due to DVT and pulmonary embolism when I was an otherwise healthy 19-year-old from taking birth control pills I was prescribed to manage terrible cramps. I blogged about my experience last week after hearing about these 23 women. My heart just breaks for their families, and I am furious that the medical community, the government and the companies who manufacture these drugs are not doing their utmost to prevent these kinds of deaths and irreversible health problems from occurring.

    Even when we are told of the side-effects, we aren’t told what the symptoms to watch for are, and we are lead to believe that if we are healthy, young, non-smokers, we should be just fine.

    In my case, it was the combination of estrogen with a genetic mutation (Factor V Leiden), which I had no idea I had. Had I known, I would not have made the choice to take estrogen, but we do not test young women and girls for potentially deadly underlying conditions before putting them on the pill.

    It’s absolutely appalling that, Bayer refuses to work to make their product safer for women and girls.

  2. Shawndrea says:

    Thank you Ms magazine

  3. Or you could go totally hormone free with a method that is 99% effective and requires BOTH partners to share responsibility for avoiding pregnancy (AND can be used in reverse to ACHIEVE pregnancy): Natural Family PLanning – it’s not just for Catholics anymore!!

  4. Sadly, this is not news. My mother took the pill for 2 weeks in 1963 and was hospitalized for long periods off and on for the rest of her shortened life due to a blood clot on her lung and phlebitis. Several other women in our neighbourhood died of the same thing and many more had my mother’s symptoms more or less.
    I was too young to notice if the media took any notice but I doubt it. This issue has gone on for far too long. Women need to stop eating this poison.

  5. Dianne Ammons says:

    Our daughter Anne died eight months after she resumed Yaz in 2009. She resumed it when her OB/GYN prescribed it for irregular periods, menstrual cramps, and unchecked for ovarian cysts. When she soon began having symptoms–excessive weight gain, headaches, hair loss, depression, she saw other physicians including an endocrinologist. None of these medical professionals attributed her symptoms to Yaz. On Nov, 7, 2009 my Anne died in her sleep at our home. The police report said “sudden death”; they did not investigate her medications. The medical examiner found a totally healthy body(no heart abnormalities, healthy veins and arteries free of plaque),and a microscopic hear attack. He was not required to report her medications to any government overseeing agency. She did not even receive the FDA warning insert since it is not required to be in one pacts. We attended and spoke at the December FDA hearing on Yaz and other drospirenone birth control pills. The hearing was definitely biased, 4 of the voting physicians had ties to Bayer, court evidence that Bayer had lied to the FDA was ruled inadmissible since it did not meet a November deadline. As we investigate, we find US laws favor the pharmaceutical industry’s profit and do not require safety in patient medication.

  6. Thank you so much for writing this article. I had a massive PE in 2009 and continue to have daily chest pain and shortness of breath. My entire life has changed. This was a direct result of the Yaz birth control and I have been stunned to see so little coverage on this topic, as well as no significant action by the FDA or, as you mention, not even women’s advocacy groups. The lawsuits are a joke, not even considering the fact that I will be sick for the rest of my life. It is just horrifying that woman continue to get sick and die as a result of Yaz/Yasmin!!!

  7. Perhaps it’s time to admit that all hormonal contraception is harmful to women, and all of it is profitable to corporations.

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