Product News and Recalls

FDA Panel: Yaz/Yasmin Birth Control Labeling Should Reflect Risks

A Food and Drug Administration panel of experts ruled that the labeling of the popular birth-control pills Yaz and Beyaz should be updated to reflect recent data showing the drug poses a higher risk of causing blood clots than older contraceptives.

Already, 10,458 lawsuits have been filed in federal court against pharmaceutical giant Bayer AG, maker of the contraceptives Yaz, Beyaz, and Yasmin. Plaintiffs claim they weren’t warned of the drug’s harmful side effects, according to the Southern District of Illinois’s U.S. District Court. Bayer also manufactures Ocella, a generic form of Yasmin marketed and distributed by Teva Pharmaceuticals.

On Dec. 8, 2011, panelists at a joint meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee voted 21 to 5 that the current labeling of Yaz and other popular birth-control pills using the manmade hormone progesterone is inadequate in warning users of its potentially deadly side effects.

During the early part of the marathon meeting, panel members heard testimony from patients and their family members who say Yaz or Yasmin lead to deadly blood clots.

One of those individuals was a mother who talked about the last conversation she had with her daughter, who died on Christmas Eve of 2008 because of a blood clot that traveled to her lung.

The mother assured the panel of experts that if her daughter had been aware of the Yasmin’s risks, she would have opted to take a safer birth-control pill.

In October of 2011, the FDA issued a statement warning the general public that women taking Yaz or any contraceptive with drospirenone were 74 percent more likely to develop potentially fatal blood clots than those who used other contraceptives.

If you or someone you love developed a blood clot, stroke, or pulmonary embolism while taking Yaz, Yasmin, or Ocella, you may be eligible to recover damages. Please contact Lopez McHugh for a FREE consultation with a qualified and trusted attorney who can answer your questions and ensure your legal rights are protected. Call today because if you wait too long, you may be barred from recovering for your injuries by your state’s time limits.

See a transcript of the meeting here:

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM288721.pdf