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Beyaz the Subject of New FDA Adverse Events Report

By September 24, 2012July 16th, 2019Uncategorized

According to a recent FDA report analyzing information from the adverse events database to see if teens were suffering from serious adverse side effects after taking the controversial birth control pill Beyaz, the pill was not found to cause any specific safety concerns.

While the FDA is said to be looking into ways that they can fully understand the drug’s serious links to blood clots, the agency appears to be ignoring what the numerous research studies have shown. Blood clots have been a hot button issue for the drospirenone-based pills (Yaz, Yasmin and Beyaz). The blood clots have also been the subject of thousands of lawsuits after patients started suffering from deep vein thrombosis and pulmonary because of Yaz use.

However, following an FDA pediatric advisory committee meeting on September 11, the agency released a report (PDF) that summarizes the post-marketing reports of Beyaz complications. Beyaz is Yaz but with added folate (folic acid). The post-marketing reports released by the FDA were sent to the agency’s Adverse Event Reporting System (AERS). The Beyaz review was conducted in order for the agency to evaluate pediatric deaths and reports that talked about the potential risks of the drug that might not be on the drug’s warning label. On the original Yaz warning labels, the FDA posted risks of blood clots and clot-related injuries. Yaz is also known to cause heart attacks, strokes and gallbladder disease.

Bayer’s answer to the dangers linked to Yaz was to create Beyaz, which is just Yaz with extra folic acid in it. The company hoped that this would lessen the controversy surrounding the side effects from Yaz and Yasmin by claiming that the folate makes the pills healthier to take. While that marketing tactic may have worked for some people, it didn’t fly for anyone who knows the risks involved with the fourth generation pills.