Quoted from http://www.bloomberg.com/news/2012-04-10/bayer-s-birth-control-pills-may-boost-blood-clot-risk-fda-says.html
Bayer Birth-Control Pill May Boost Risks for Blood Clots
By Anna Edney - Apr 10, 2012 4:12 PM ET
Bayer AG (BAYN)’s Yasmin and 10 other birth-control pills may pose a greater risk for blood clots in women using the drugs, and language on the labels must be strengthened to clarify those dangers, U.S. regulators said.
Pills containing drospirenone, a synthetic version of the hormone progesterone, will carry new labels about a review that showed as much as triple the risk for blood clots, the Food and Drug Administration said today in a statement. The research compared the drugs with low-dose estrogen pills. Some studies found no increased risk.
Bayer has faced a wave of lawsuits in the U.S. since 2009 alleging the Leverkusen, Germany-based drugmaker’s birth-control pills, which also include Beyaz and Yaz, caused sometimes fatal blood clots. Lawyers suing the drugmaker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008.
“Bayer has consistently updated the FDA and other regulatory authorities around the world as new data have become available” about drospirenone-containing oral contraceptives, the company said today in a statement. Bayer “has worked with the agencies to make label updates, as appropriate.”
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