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Beyaz, a Combination Contraceptive Tablet, Approved by the FDA
by admin on: June 17th, 2011

Beyaz, an oral contraceptive containing a combination of estrogen and progestin, was approved in September 2010 by the U.S. Food and Drug Administration (FDA). This pharmacologic agent contains the same levels of estrogen and progestin as Yaz, another contraceptive pill. However, in addition to the aforementioned active ingredients, Beyaz also contains a folate (specifically, levomefolate calcium at a dose of 0.451 mg).

Folate and folic acid are both forms of water-soluble vitamin B. Often, women that are pregnant supplement their diet by taking folate (folic acid, vitamin B9), as research has demonstrated that this agent can help prevent birth defects, specifically, a neural tube defect. Neural tube defects are serious conditions that may manifest as spina bifida (defect of the spinal cord) or anencephaly (defect of the brain). These adverse events usually occur at very early stages of fetal development ??? often before a woman may realize that she is pregnant.

Beyaz is approved for prevention of pregnancy, treatment of symptoms associated with premenstrual disphoric disorder (PMDD), and treatment of moderate acne vulgaris in women (14 years of age and older) that also want an oral contraceptive. In addition, Beyaz provides women an alternative oral contraceptive that will raise their levels of folate and potentially reduce the risk of having a neural tube defect, should they become pregnant while taking this medication or shortly after discontinuation.

Of note, Bayer HealthCare Pharmaceuticals, the manufacturer of Beyaz and Yaz, state that both oral contraceptives are 99 percent effective in preventing a woman from becoming pregnant ??? provided the drug is used as directed.

The clinical trials associated with Beyaz reported that this drug displays a safety profile that is similar to that previously seen with Yaz. The most commonly reported side effects associated with Beyaz administration include breast tenderness, headaches, nausea, and irregular uterine bleeding. Other serious side effects associated with Beyaz use included liver disease and blood clot formation.

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