ZKB Law pleased that FDA vote will force Bayer to change Yaz warning label

Yesterday’s highly-anticipated FDA meeting on the controversial drospirenone-containing birth controls Yaz, Yasmin and Ocella ended in a victorious vote that could quite possibly save the lives of women taking the drug.

The FDA’s Reproductive Health Drugs Advisory Committee and their Risk Management Advisory Committee met yesterday at the University of Maryland University College in Adelphi, Maryland, to weigh the risks of the hormone, drospirenone (DRSP), that is only found in Bayer’s Yaz family of pills.

The panels voted 21-5 in favor of changing the labeling on the drug packaging, in hopes to heighten awareness about the serious side-effects of the pill.

"Clearly the wording is inadequate and incomplete," said Dr. Richard Bockman of New York's Hospital for Special Surgery. "Adverse events have to be made graphic so physicians and patients are aware of the consequences."

Previous FDA studies found that women taking the DRSP drugs are 75% more likely to suffer from serious blood clots than women who are taking the older generation pills. Serious blood clots can lead to strokes and pulmonary embolisms, and even death.

Families from across the country came to speak to the panel on behalf of women who lost their lives as a result of taking Yaz, and sadly they are just a small percentage of the 10,000 women and families who have filed lawsuits against the mega pharmaceutical company, Bayer, for misleading labels ands advertisements.

ZKB Law applauds the FDA panel for choosing to better-educate women about the dangers that Yaz, Yasmin, Ocella and their generics pose to their health, and look forward to the label change. Currently there is no timetable or deadline set for Bayer to make this change.

For more information on health problems related to Yaz, Yasmin and Ocella, or to obtain immediate answers to your questions, contact us toll-free at 888.841.9623 or via email at Anneke@ToledoLaw.com.