The Food and Drug Administration is considering additional warning labels for Bayer’s birth control drug, Yaz, and other newer birth control methods.
Attorneys suing Bayer on behalf of patients, say evidence has come to light that these potentially dangerous drugs increase a patient’s risk of forming blood clots, which can be fatal. Blood clots are known to cause heart attacks, strokes and blockages in the lungs.
In the United States, Yaz sold better than any other birth control pill in 2008 and 2009. The drug seems to reduce bloating and mood swings, which were common side effects with older birth control pills.
However, evidence in the products liability lawsuit against Bayer indicates Bayer may have kept evidence of an increased risk of blood clots from the FDA. One study, which was not submitted to the FDA, showed Yasmin, the predecessor to Yaz, had a significantly higher risk of blood clots than other birth control pills.
Later studies, which were submitted to the FDA, did not seem to show an increased risk of blood clots. FDA analysis indicates 10 out of every 10,000 women using the newer contraceptives will experience a blood clot. In comparison, six out of every 10,000 women using older birth control pills will have a blood clot.
The FDA is also reviewing Johnson & Johnson’s Ortho Evra weekly patch. It already has warning labels for increased risk of blood clots when compared with birth control pills. Some studies indicate patch users may be twice as likely as non-users to develop blood clots.
The issue is a complicated one because all hormone-based drugs increase the risk of blood clots. Smoking, obesity and family history can also increase a woman’s risk of developing a clot.
Roughly 4,000 lawsuits are pending against Bayer. The plaintiffs say the company should have made the newer drug’s risks clear to the public.
Source: The Associated Press, “FDA revisits safety of newer birth control drugs,” Matthew Perrone, Dec. 5, 2011