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U.S. FDA Approves Second Bayer Oral Contraceptive That Also Raises Folate Levels
Date:12/16/2010

regnancy – often before a woman finds out she is pregnant.  As a result, daily folate supplementation is particularly important at least one month before and three months after conception.(2)

"Combining an oral contraceptive with folate is important, because women may become pregnant during OC use or shortly after discontinuation, possibly before seeking preconception counseling from their healthcare providers," said Dr. Anita Nelson, Professor of Obstetrics and Gynecology at the Harbor-UCLA Medical Center, Torrance, California.  "For women who already use YASMIN for contraception, SAFYRAL offers these women a new option to receive daily folate supplementation as part of their OC routine."

Women should not use SAFYRAL if they smoke and are over age 35.  Smoking increases the risk of serious side effects 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.

Patients are advised to alert their healthcare provider if they are taking folate supplements.  SAFYRAL is not indicated during pregnancy.  SAFYRAL has 99 percent contraceptive efficacy when used as directed.  If pregnancy occurs during treatment with SAFYRAL, further intake must be stopped.  If a woman discontinues use of SAFYRAL either with the intention of becoming pregnant or if she discontinues due to pregnancy 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.

SAFYRAL is in a 21/7 day regimen consisting of 21 days of drospirenone 3 mg/ethinyl estradiol 30 mcg with levomefolate calcium 451 mcg (Metafolin®*) followed by seven days of Metafolin only.  SAFYRAL is expected to be available in mid-January 2011 by prescription only.

Women should not use SAFYRAL if they have kidney, liver, or
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SOURCE Bayer HealthCare Pharmaceuticals, Inc.
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