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LAWSUITS NEWS & LEGAL INFORMATION

Concerns About Beyaz Being Used to Control Menstruation

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Washington, DCWhen women take Beyaz birth control as a contraceptive, they do so hoping the benefits of preventing pregnancy outweigh the risk of Beyaz side effects. Of course, they can only do this if they have been made fully aware of the side effects of Beyaz. But sometimes, Beyaz is prescribed not to prevent pregnancy but to treat symptoms of menstruation, a use that some critics have serious concerns about.

On September 11, 2012, Dr. Sonia Nagda, of the National Research Center for Women & Families, gave a presentation to the US Food and Drug Administration (FDA) advisory committee on Beyaz and other contraceptives. Dr. Nagda noted in her opening remarks that there are very few studies on Beyaz, so any assumptions made about the drug’s risks were based on studies of other drosperinone-containing contraceptives (including Yasmin and Yaz).

“There are more than 80 oral contraceptives on the market, many with lower VTE [venous thromboembolic] risks than Beyaz and other DRSP [drospirenone] oral contraceptives,” Dr. Nagda said. “Beyaz is safer than pregnancy but less safe than dozens of other pills. Beyaz’s risks cannot be justified for treating irregular or unpleasant menstrual periods.”

Although studies regarding the safety of drosperinone-containing contraceptives show conflicting results, seven recent studies found higher risks in those birth control pills, while only two did not find a higher risk. Dr. Nagda notes that the authors of the two studies that did not find a higher risk in drospirenone-containing birth control had financial ties to the makers of those pills.

Dr. Nagda urged the advisory panel to vote to take drospirenone-containing birth control, including Beyaz, off the market, and also asked the panel to consider warning the FDA about off-label use of the contraceptives for regulating periods. One of the main concerns about using contraceptives to regulate periods is that they are then being prescribed to teenagers, who may not be able to fully understand the risks associated with the contraceptives.

Because newer-generation contraceptives do not have any reported benefits over older contraceptives and because studies suggest the risk of serious side effects is higher in the newer birth control, some experts have called for Yasmin, Yaz and Beyaz to be taken off the market.

So far, the FDA advisory panels have voted to keep the birth control on the market.

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