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FDA Approves Combination Contraceptive Containing a Folate
Date:9/24/2010

elevated for several weeks following discontinuation of Beyaz.  Safety and efficacy data for contraception, PMDD, and acne indications were obtained from previous YAZ clinical trials.

The most common side effects reported by users of combined oral contraceptives are irregular uterine bleeding, nausea, breast tenderness, and headaches. Other serious side effects include vascular events (blood clots) and liver disease.  Women over age 35 who smoke should not use this product as cigarette smoking increases further the risk of serious cardiovascular events.  The common adverse events for Beyaz are expected to be the same as those for YAZ.  There were no findings from the clinical trials with Beyaz to suggest a change in the overall safety profile compared to that of YAZ.

Beyaz is manufactured by Bayer HealthCare Pharmaceuticals Inc., the U.S.-based business arm of Bayer HealthCare LLC, a subsidiary of Bayer AG.

Approved Drugs: Questions and Answers http://www.fda.gov/Drugs/ResourcesForYou/Consumers/UCM054420

Contact: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov


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SOURCE U.S. Food and Drug Administration
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