In a lukewarm endorsement, an FDA advisory panel voted 15-11 that the benefits of controversial drospirenone-containing oral contraceptives outweigh the risk of venous thromboembolism.
The Thursday vote came after a day-long hearing in which patients and relatives of patients made emotional calls for the drugs – sold under the brand names Yasmin and Yaz, among others — to be pulled from the market.
But the documentation that accompanies the pills needs to be made more transparent, so that patients and physicians can clearly understand the risks, according to a joint session of the agency’s advisory committees on reproductive health drugs and drug safety and risk management.
The vote on that issue was much clearer, with 21 panel members calling for changes and only five saying the labeling should stand as is.
Although blood clots are a known side effect of all birth control pills, two recent studies suggested that the risk of venous thromboembolism associated with those that contain drospirenone was much higher than with another common contraceptive hormone, levonorgestrel.
In fact, Bayer, the manufacturer of the drugs, is facing legal action from patients and patient groups, complaining that the company knew about the risk but did not make them clear.
The issue heated up this week when a report by a former FDA commissioner, David Kessler, MD, accused the company of hiding data on the blood clot risks. The report was presented in a federal court in Illinois.
During an hour-long open hearing, the joint committee was told that the drugs should be pulled from shelves because they do not have a unique benefit and cause harm.
“These drugs should not be on the market, because there are safer alternatives,” said Diana Zuckerman, PhD, president of the Washington-based National Research Center for Women & Families.
Other participants told stories about the deaths of loved ones, which they blamed on the drugs.
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To read more about the dangers of birth control pills containing drospirenone, click here.