Studies have found that Yaz and Yasmin are no more effective than other leading birth control pills, but carry a higher risk of blood clotting. Though the pills were marketed as a safe and effective way to prevent pregnancy, treat PMS, and cure severe acne, thousands of women have developed life-threatening, deadly side effects — including pulmonary embolism, stroke, and heart attack.
What is the Problem?
Yaz and Yasmin belong to a new class of birth control pills that contain one controversial ingredient: drospirenone, a new synthetic chemical that mimics the female sex hormone progestin. Older types of birth control pills contain levonorgestrel, which is also a synthetic form of progestin. All birth control pills that contain progestin increase a woman’s risk of developing a blood clot. With levonorgestrel, the risk was approximately 6 per 10,000 women who took the pills. With drospirenone, the risk increased to approximately 10 per 10,000 women. Though, numerically, the risk is still very small, millions and millions of women use these medications every day to prevent pregnancy. A slightly increased risk translates to tens of thousands more women who suffered from blood clots. Many have died.
Blood clots often form in the large vessels in the legs or arms. Usually, they resolve on their own and cause no problems or symptoms. Sometimes, however, a blood clot breaks loose (called an “embolism”), traveling through the body. If it becomes trapped in an internal organ, it can cause death or permanent disability very quickly. Bloods clots trapped in the heart, brain, or lungs can cause heart attacks, strokes, and pulmonary embolisms.
FDA Reviews Safety of Yaz and Yasmin
Former FDA commissioner Dr. David A. Kessler is now working for Yaz lawyers who are suing Bayer. They accuse the drug-company of concealing safety information from the FDA during the approval process. The lawsuits against Bayer accuse the company of selectively presenting data regarding blood clots, leading Kessler and the FDA to approve the drug on incomplete safety data. Kessler maintains that if he had been aware of the safety data, he would have asked Bayer to conduct further safety research.
Bayer, the company responsible for Yaz and Yasmin, maintains that the medications are safe and effective.
However, some independent experts find it noteworthy that the studies funded by Bayer have shown no difference in risk for women taking Bayer’s drug, whereas all four of the independent studies have found an increased risk.
”Misleading” Advertising Campaign
When Yaz and Yasmin were launched a decade ago, they were popularly advertised as “miracle drugs” that could treat PMS, acne, and prevent pregnancy. Yaz sales skyrocketed to approximately $2 billion per year after it was released in 2006. The FDA, however, quickly sent Bayer warning letters stating that the claims were “misleadingly overstated.”
Partly due to the massive advertising campaign, millions of women believed that the new birth control pills were superior to the older pills, and they chose to switch to the new pills. Unfortunately, scientific data painted a different picture: Yaz and Yasmin were equally effective at preventing pregnancy as birth control pills already on the market, but they had a slightly higher risk of serious, life-threatening side effects.
Bayer denied that it had done anything wrong during its advertising campaign for Yaz and Yasmin. However, they agreed to pay $20 million to run a corrective advertising campaign with television advertisements. The Yaz ads clarified that the medication had only been approved by the FDA for treating mild acne and the symptoms of Premenstrual Dysphoric Disorder (PMDD), a severe mood disorder that accompanies some women’s menstrual cycles.
By the time the advertising campaign ran, however, millions of women had been taking Yaz and Yasmin.
FDA Meeting to Discuss Safety
In December 2011, an FDA panel met to discuss the Yaz and Yasmin safety information that had recently emerged. One panel voted 21-5 that the safety labeling information needed to be updated to include information about the increased risk of developing a blood clot. Another panel voted 15-11 that the benefits of Yaz and Yasmin remained a “beneficial” option for preventing pregnancy.
It was later discovered that several members of the panel that voted that Yaz and Yasmin were “beneficial” had ties to Bayer. Some of these members had conducted research for Bayer or its affiliated companies, or had directly received thousands of dollars in payments from the drug-company.
Officials at the FDA determined that there was no “conflict of interest” in allowing experts to vote on the panel who had been paid or employed by companies involved in the production of Yaz and Yasmin.
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