Safety Announcement Concerning Birth Control Pills

FDA issued a Safety Announcement regarding birth control pills containing drospirenone.  The announcement comes as a response to conflicting data about the safety of drospirenone and levonorgestrel.  The announcement notes that most birth control pills are a combination of the hormones estrogen and progestin.  Drospirenone is a progestin in such brands as Yaz, Yasmin, Beyaz, Safyral, and several other generics.

The risk of blood clot and subsequent complications is known and accepted in this type of drug.   Previous studies showed similar levels of risk between drospirenone and levonorgestrel.  However, FDA’s announcement is a response to conflicting findings showing a heightened risk to women who take birth control pills containing drospirenone.

FDA stated that it is reevaluating its stance on the safety profile of birth control pills containing drospirenone.  Although primarily developed for contraception, companies sought approval for drospirenone to treat indications such as acne reduction, premenstrual dysphoric disorder, and to increase folate levels.  The agency’s view of the risk-benefit of the drug may be altered regarding indications that are more related to lifestyle or considered not medically necessary.


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