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U.S. FDA Approves New Oral Contraceptive That Also Raises Folate Levels
Date:9/24/2010

wareness about the importance of folate and folic acid.   A 2008 March of Dimes survey* found that among 2003 women (aged 18-45) interviewed, 39 percent of women took folic acid daily and only 11 percent knew folic acid should be taken before pregnancy.(5)

Women over 35 years old who smoke should not use Beyaz.  Smoking increases the risk of serious cardiovascular events from the Pill, which can be life-threatening, including blood clots, stroke, or heart attack.  This risk increases with age and number of cigarettes smoked.

Beyaz is the first and only birth control pill approved by the FDA for four indications:

  • Prevention of pregnancy (99% effective when taken as directed)
  • Treatment of symptoms of premenstrual dysphoric disorder (PMDD) for women who choose the Pill for birth control
  • Treatment of moderate acne for women at least 14 years of age, who choose the Pill for birth control, and have started having menstrual periods
  • To raise folate levels in women who choose the Pill for birth control, for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product  

Beyaz is not indicated during pregnancy.  If pregnancy is planned or occurs during treatment with Beyaz, further intake must be stopped.  If a woman discontinues use of Beyaz with the intention of becoming pregnant or if she becomes pregnant while on the product, she is strongly encouraged to speak with her healthcare provider about taking a multivitamin with folic acid or another folate to maintain recommended folate intake levels.

Beyaz is in a 24/4 day regimen consisting of 24 days of drospirenone 3 mg/EE 20 mcg with levomefolate calcium (Metafolin®**) followed by four days of Metafolin only.  Beyaz is expected to be available in October by prescription only.
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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