FDA adds clotting data to Bayer's Yaz, Yasmin
Bayer's ($BAYRY.PK) Yaz and Yasmin may be linked to a higher risk of blood clots than other contraceptive pills, the FDA said, but then again, they may not be. To make sure doctors and patients are aware of the potential dangers, the pills' labels will now include study data suggesting as much as a threefold increase in clotting risk. The new labeling applies to all birth-control pills that contain a synthetic form of progesterone known as drospirenone, including generics.
The FDA decision follows an agency review of the safety data and an advisory committee discussion in December. That expert panel recommended revising the pills' labels to clarify the clotting dangers. In a 15-11 vote, the committee also determined that drospirenone contraceptives' benefits outweigh their risks. The revised labels will include data from studies that did not identify higher clotting risks with the drospirenone pills.
The new labeling follows months, if not years, of debate over the pills' safety. It also comes as Bayer is defending Yaz and Yasmin products in hundreds of liability lawsuits. Bayer has maintained that the pills are safe, saying that other risk factors could account for the increased incidence of blood clots in some studies.
The company says it agrees with the label change, however. "Bayer has consistently updated the FDA and other regulatory authorities around the world as new data have become available regarding drospirenone-containing [pills] and has worked with the agencies to make label updates, as appropriate," the company said in a statement (as quoted by The Wall Street Journal).
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