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Contraceptive Containing a Folate Approved

Contraceptive Containing a Folate Approved

09/27/10

MONDAY, Sept. 27 (HealthDay News) -- Beyaz, a combination estrogen/progestin contraceptive that also contains a folate, has been approved by the U.S. Food and Drug Administration.

The folate, levomefolate calcium, is a B-vitamin that's among a class of vitamins recommended for women of childbearing age. Lack of dietary folate has been associated with neural tube birth defects, which involve deformities of the fetal brain or spinal cord. The newly approved drug is designed to help prevent this type of defect among mothers who conceive shortly after discontinuing the drug, the FDA said in a news release.

Beyaz was studied in a multi-center U.S. trial involving 379 women aged 18 to 40. The most frequently reported side effects included uterine bleeding, nausea, breast tenderness and headache. Other serious side effects included blood clots and liver disease, the FDA said.

Women 35 or older should not use Beyaz, which could increase their risk of "serious cardiovascular events," the agency said.

Beyaz is based on the already approved contraceptive YAZ, which includes the same amounts of estrogen and progestin, the FDA said.

The newly approved drug is produced by Bayer HealthCare Pharmaceuticals.

More information

The FDA has more about this approval.

Copyright © 2010 HealthDay. All rights reserved.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.

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