The Food and Drug Administration (FDA) said it is reviewing the safety of birth control pills like Bayer’s Yaz and Yasmin because of concerns that they may raise women’s risk of blood clots more than other pills.
Although all hormonal birth control pills raise the risk of clots, the FDA’s review focuses on those containing the hormone drospirenone. The agency cites two studies, published in April in BMJ, that found that women aged 15-44 taking drospirenone-containing birth control pills were two to three times more likely to develop venous thromboembolism — blood clots that develop in the deep veins of the legs — than women using older pills containing the progestin levonorgestrel.
European regulators said last week that they would revise prescribing information for relevant products to include the new findings. The FDA is investigating whether or not to do the same, but the agency remains cautious because past data contradict the newest research.
“Other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills,” the agency said Tuesday.
Brand names of drospirenone-containing products include Bayer’s Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda and Zarah), Beyaz and Safyral.
This is not the first time Yaz has come under fire. The popular pill made headlines in February 2009 when the FDA required Bayer to correct its advertising campaign for the drug. Regulators said Bayer’s ads overstated Yaz’s ability to control premenstrual symptoms and prevent acne, so in an agreement with the FDA and with the attorneys general of 27 states, the company agreed to spend $20 million on a new campaign clearing up the confusion and more explicitly stating the true benefits and risks of the medication.
For now, the FDA is not recommending that women taking drospirenone-containing medications stop using them without consulting their doctor. Women are advised to watch for symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath, and contact their doctors if symptoms occur. Although birth-control pills raise the risk of blood clot, the absolute risk is still very low.
However, women who smoke, are over 35 or have a family history of blood clots are most at risk and should not take combination oral contraceptives, the FDA said.