Several serious side effects are associated with the use of Yaz, including heart attack. Drospirenone, a synthetic hormone that has a similar biochemistry to natural progesterone, is present in this birth control pill and makes it particularly dangerous. As such, it is also an effective hormone replacement and was an extremely popular drug before additional safety reports regarding Drospirenone were published. In addition to safety reports, the drug’s manufacturer, Bayer, has also been chastised by the Food and Drug Administration (FDA) for its research and marketing efforts regarding the medication.
After reviewing many epidemiologic studies associated with Drospirenone use, the FDA has concluded that there is a much higher risk of women suffering a thromboembolism while taking the drug. Compared to women not taking a contraceptive pill, the risk of thromboembolism is six to seven times higher. The risk was found to be two to three times higher than women taking another popular form of birth control (levonorgestrel pills). A thromboembolism is the medical term for a blood clot, and women who experience one while taking Yaz may experience a heart attack during a thrombotic event. Drospirenone is known to increase potassium levels in the blood, which can result in a thrombotic event. A blood clot can also result in other life-threatening or severe complications, including stroke or organ failure.
Soon after it was placed on the market in 2006, Drospirenone became one of the most popular birth control options available for women. However, in 2008, Bayer was cited by the FDA after many commercials advertising the drug made claims to its effectiveness that were overstated. Bayer specifically omitted information about the medication’s adverse effects, making it seem safer than it was. The commercials also suggested the drug was effective at treating premenstrual dysphoric disorder, which has never been shown to be true. In response to the FDA’s statement, Bayer was required to release additional information clarifying the effectiveness and risks associated with Drospirenone.
In 2009, Bayer was criticized again by the FDA for releasing low quality shipments of the drug, to which the manufacturer responded by stating that it only monitors the average quality of all batches shipped out, not the quality of each batch. In late 2011, the FDA funded a study that checked the risks of thromboembolism in patients. The results of the study prompted Bayer to update label information regarding the chances of severe side effects while taking Yaz, including heart attack.
The lawsuits filed against Bayer, cited many allegations. Most claims assert that Bayer’s marketing overstated the drug’s benefits and understated its risks. Many suits also point to Bayer’s poor and possibly deceptive safety research prior to the medication’s release. Internal documents released to news agencies show attempts by Bayer to hide the name of the author, because he was associated with the company. This suggests that Bayer did not want its safety reports to be verified by other companies. Also, many suits assert that Bayer’s reluctance in recalling the drug in the face of updated safety reports constitutes negligence on behalf of the business. Bayer has set aside hundreds of millions of dollars for Drospirenone lawsuit settlements.
Anyone who has taken Drospirenone and suffered a major thrombotic event or other medical complications should consider speaking to a drug injury lawyer to review options for legal representation.