FDA Wants More Warning Label Information for Yaz

A panel at the U.S. Food and Drug Administration (FDA) recommended that the labels for certain popular birth control pills, including the pill marketed as Yaz, should be updated to include new data that suggest an elevated risk of blood clots. The affected drugs are manufactured by Bayer. A panel of experts met for over nine hours on Thursday, December 8, to discuss data regarding blood clot risks with contraceptives containing the synthetic hormone drospirenone. It ultimately voted 21-5 to urge Bayer to update its labels. The panel had earlier voted 15-11 in support of keeping drospirenone-containing drugs on the market, a vote of confidence that the drugs still offer a benefit to patients. A full third of the panel voted against that recommendation. The FDA did not set a timetable for Bayer to change its labeling.

Bayer first released Yaz in 2006, and within a year its annual sales had reached $2 billion. This was boosted by an aggressive advertising campaign targeting women in their 20’s and touting the overall health benefits of the drug. In addition to its contraceptive benefits, ads claimed that Yaz could provide relief from PMS and acne. Millions of women started taking the drug, but by 2008 the possible health risks were becoming clear. Five studies conducted since 2009 have suggested a higher risk of potentially fatal blood clots, with one finding a 75 percent higher chance of developing blood clots as compared to patients taking older contraceptive drugs.

ABC News reports on a 24 year-old woman in Madison, Wisconsin who started taking Yaz in 2007 after seeing its ads on television. Within three months, she began to feel pain in her legs, which she attributed to time spent on her feet in her job as a nurse. The pain quickly turned out to be blood clots that traveled to her lungs, where they caused a pulmonary embolism. She spent almost two weeks in a coma, and when she woke up she had lost her sight. Whether her blindness is in anyway related to the drug is not known, but her blood clots are consistent with the findings of numerous studies of drugs containing drospirenone.

The Associated Press has a report on a 20 year-old California woman who died on Christmas Eve 2008 of a blood clot that had traveled to her lung. She had started taking Yaz two months earlier.

In 2008, the FDA sent a letter to Bayer regarding their advertisements for Yaz. FDA studies had shown that Yaz was not an effective treatment for PMS, and that it was not very effective at treating acne. State health authorities also made allegations of false advertising regarding Yaz’s supposed health benefits. Bayer reached a settlement in which it agreed to launch an expensive series of “corrective” television ads. These ads stated that Yaz could treat premenstrual dysphonic disorder (PMDD), a severe form of PMS, but was not indicated for the treatment of regular PMS.

Between 4,000 and 6,000 patients have filed lawsuits against Bayer for injuries allegedly sustained as a result of taking Yaz and other drospirenone-based medications. Bayer denies any connection between its products and the claimed injuries. Without a clear deadline for action from the FDA, it is unlikely that doctors will change how they prescribe Yaz anytime soon.

The Maryland pharmacy error attorneys at Lebowitz & Mzhen can assist you if you have been injured by drugs prescribed or administered incorrectly. Contact us today online or at (800) 654-1949 to see if you may recover damages.

Web Resources:

Warning Letter dated October 3, 2008, Food and Drug Administration to Bayer HealthCare Pharmaceuticals, Inc. (PDF file)

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