This mother’s day marked the 50th anniversary of the Food and Drug Administration’s approval of the birth control pill. The pill has had an enormous impact on reproductive freedoms, enabling women to take control of their own fertility. But some pills have been tied to numerous health drawbacks including strokes, heart attacks, and other serious side effects.
The FDA has been increasingly outspoken in its criticism of two pill manufacturers: Yasmin and Yaz. In 2003, the agency wrote a letter to Berlez Laboratories (Yaz’s former manufacturer) warning that its “TV ad misleadingly overstates the efficacy and safety of Yasmin.” In 2008, the FDA wrote another letter to Bayer (which now manufactures both Yaz and Yasmin) listing the numerous health problems associated with their pill. “The overall effect of the distracting visuals, graphics, concurrent supers and background music,” they wrote, “is to undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that Yaz is safer than has been demonstrated by substantial evidence or substantial clinical experience.”
Lawsuits against Yaz and Yasmin continue to make their way through the courts. Following a hearing last September, the Judicial Panel on MultiDistrict Litigation decided that 32 federal lawsuits filed against Yasmin and Yaz would be folded into multi-district litigation (MDL) in Illinois, meaning plaintiff’s lawyers have more time to collect information on Bayer. But even if the public becomes more aware about the dangerous side effects of these drugs, it could still dodge a recall. “We saw similar fatal side effects with the birth control patch, Ortho Evra,” GJEL managing partner Andy Gillin told US Recall News, “but we did not see an official FDA recall. It remains to be seen what will happen with Yaz and Yasmin.”
Photo credit: Jenny Lee SilverNo related posts