A recent meeting of a special FDA panel set up to review the safety of new generation contraceptives addressed labeling of the patch, and they voted 20-3 in favor of making the labeling more clear - that it should state the risks associated with using the patch. This will make the fourth time Janssen has changed its labeling on the patch since 2005. Earlier this year the FDA added a boxed warning to the contraceptive saying that one study found the risk for VTE to be significantly greater with Ortho Evra than with lower-estrogen birth control pills.
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The FDA panel also addressed safety issues related to birth control that contains drospirenone, such as Yaz/Yasmin, Beyaz and Safyral, voting overwhelmingly to strengthen the warnings on drospirenone-containing birth control, to warn patients about the risk of blood clots associated with the contraceptives. This followed an FDA released a safety announcement (September 2011) indicating a 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives. Bayer, the makers of YAZ/Yasmin, are also facing a raft of lawsuits.