ADELPHI, Md. — 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.
Panel members said the data presented was difficult to understand, but most agreed that there appeared to be an increased relative risk, although the absolute risk remains small.
“The safety findings are contradictory and disturbing,” argued Elaine Morrato, DrPH, of the University of Colorado in Denver. But, she added, “it does appear that if there is an increased risk, the absolute incidence rate is still very rare.”
The risks, she said, remain “significantly less than (those in) pregnancy and the postpartum period.”
But Peter Kaboli, MD, of Iowa City Veterans Administration Medical Center in Iowa City, Iowa, said the issue is that the drugs have “no clear benefit” leading to an infinite number needed to treat.
“The number needed to harm – regardless of how small it is — is all harm,” he said.