It seems that the fate of Bayer’s new-generation birth control pill, Yaz, is in the hands of the U.S. Food and Drug Administration, as the regulatory agency meets on December 8th in order to determine whether or not the drug should be allowed to stay on the market.
Based on the results of an agency-funded study of drospirenone-contanting contraceptives, Yaz and other similar products were found to carry a 1.5-fold increased risk for causing potentially lethal blood clots compared to older-genration hormonal contraceptives.
To date, almost 10,000 lawsuits have been filed against Bayer, citing that Yaz caused blood-clot related heart attacks, strokes and even death. In fact, more than 190 women have died as a result of taking the drug.
Given the overwhelming evidence in support of the fact that blood clot events are far more likely to occur from pills containing drospirenone than from those containing levonorgestrel, an older progestin ingredient, the FDA will have to determine whether or not these products should remain on the market. This is a complex issue for the pharmaceutical industry, as drug makers contend that patients will still demand additional options, despite the proven risks associated with using a particular finished drug product. Moreover, the sense of urgency surrounding the issue continues to grow now that Yaz has gone off-patent, allowing for increased competition from generic products like Ocella, Safyral, Syeda and Zarah.
One thing remains clear, blood clots are extremely dangerous and unpredictable, which is why the FDA’s December 8th meeting is of the utmost importance.+Frank Eidson