FDA Will Soon Decide Fate of Bayer’s Risky Birth Control Pill, Yaz

It seems that the fate of Bayer’s new-generation birth control pill, Yaz, is in the hand 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 due to the fact 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.

FDA Study Suggests Yaz and Other Drospirenone-Contaning Birth Control Pills More Likely to Cause Blood Clots

The U.S. Food and Drug Administration recently issued an updated safety communication regarding Bayer Pharmaceutical’s widely-used birth control pills, Yaz and Yasmin, citing that women using these drugs are 75 percent more likely to develop blood clots compared to those who use older-generation pills.

As a result of the FDA’s study, which followed 800,000 women between the years 2001 and 2007, researchers from the FDA, Kaiser Permanente, Vanderbilt University and the University of Washington ultimately found that drospirenone-containing birth control pills increased the risk of blood clots, otherwise known as venous thromboembolic events (VTE), by 75 percent over pills containing progestin levonorgestrel.

Additionally, the study’s findings backed several claims raised by thousands of women who have filed Yaz-related lawsuits, all of whom experienced serious blood clots as a result of using drospirenone-containing birth control pills like Yaz, Yasmin, Beyaz, Gianvi, Loryna, Safyral, Syeda Zarah and/or Ocella.

The FDA will present the new data at a December 8th meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.