Bayer is being widely criticized over Yaz and Yasmin, two similar types of oral contraceptives. The popular birth control pills are reportedly responsible for causing blood-clots, with some instances resulting in death. In light of the evidence, advisors to the Food and Drug Administration (FDA) voted for a label change in favor of stating the blood clot risks more clearly to consumers. Numerous lawsuits are alleging that Bayer purposely hid the risks of deadly blood clots; the first trial was scheduled to take place earlier this year, but a federal judge has postponed the court proceedings, opting for a mediator in the interim.
Yasmin and Yaz were FDA approved in 2001 and 2006, respectively. Originally, it was thought that these drugs were a beneficial alternative to previous birth control pills, supposedly due to improved hormonal regulation. Financially speaking, the heavily marketed drugs were a success. Yaz generated $781 million in 2009, cites Time Magazine. According to the Star Ledger, Yasmin raked in about $329 million in 2008, although sales have decreased since then. Yaz, Yasmin and similar generics such as Ocella prevent pregnancy by utilizing a combination of estrogen ethinyl estradiol and drospirenone.
Drospirenone, a synthetic hormone, has become a primary health concern; medical professionals suspect that the substance significantly increases the risk of blood clots. While Bayer’s researchers denied any elevated risk compared to older oral contraceptives, data from several independent studies indicate otherwise. One FDA-funded study revealed a 75% increased risk in women who received drospirenone-based birth control.
After careful consideration, the prevailing evidence prompted an FDA panel to vote for a label change last December. In a 21 to 5 vote, the advisory group decided that the labels on Yasmin, Yaz, Safyral, Beyaz and its subsequent generics did not properly address the risk of blood clot formation. In place of the current labels, which only mention ambiguous research findings, the updated labels should clearly state the risks of potentially fatal blood clots forming in the lungs and legs as a result of taking the pills. The panel has not, however, indicated a timeline for the new labels.
The influx of litigation against Bayer started in 2009. Now, there are over 10,000 lawsuits claiming that the company hid the known risks when advertising Yaz and Yasmin, failing to mention that their medications are in fact more dangerous than older forms of oral contraceptives. The first trial against the company was originally set for January 9 this year, but US District Court Judge David Herndon has postponed it in favor of mediation. He selected Stephen Saltzburg, a law professor at George Washington University as mediator in attempt to settle the matter outside the courtroom. Bayer has already been rebuked in the past for making unrealistic statements about the effects of the pills on acne and PMS.
Former FDA commissioner David Kessler has also taken a stance against Bayer’s promotion of Yaz and Yasmin. Kessler reprimanded the company, saying that “Bayer violated its duties under FDA regulations and state law by selectively presenting data as to thromboembolic events, which did not adequately inform FDA, doctors or consumers of the thromboembolic risks, from pre-marketing to the present.” cites Pharmalot. Kessler did not make these claims on behalf of the FDA, but as a compensated expert. Nonetheless, his support may prove detrimental to Bayer in upcoming litigations.