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FDA Approves New Yaz Warning Labels

By April 23, 2012July 15th, 2019Uncategorized

The FDA announced on April 10, 2012 that Bayer’s birth control pills — including Yaz and Yasmin — may now start carrying higher warnings about the risks of patients developing blood clots while taking the pills.

The regulators have approved new labels for Yaz, Yasmin, Beyaz and Safyral as well as the generic versions of these medications since it has been proven that these drospirenone-based pills cause blood clots that can lead to pulmonary embolisms and deep vein thrombosis. Drospirenone is the main medicinal ingredient that makes these pills so dangerous over other pills that do not contain the synthetic progestin.

So far, the FDA said “the revised drug labels will report that some studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, while other studies found no additional risk of blood clots with drospirenone-containing products.”

This decision by the FDA is likely the result of recommendations handed to agency officials by a panel advisory decision given in December after a team of medical experts got together to discuss the blood clot risks associated with Yaz. During that meeting, the panel voted 15-11 to keep the pills on the market and instead issue stronger warnings against the pills instead. The panel decided that the benefits outweighed the risks involved in taking the pills. The fact that the panel’s recommendation went under scrutiny after panel members were found to have financial ties to Bayer seems to be moot at this point.

Yaz and Yasmin have long been linked to various serious side effects that also include heart attacks, strokes and gallbladder disease. Many people are hoping that the pills will just be removed from the market all together, but at this point, that is not likely to happen. Instead, patients are filing thousands of lawsuits in the wake of the illnesses that these pills are causing. So far, Bayer has already agreed to settle at least 70 Yaz lawsuits for the plaintiffs. There is no word on if the company will settle any more.