The U.S. Food & Drug Administration (FDA) announced today that it is evaluating the safety of birth control pills, such as <"https://www.yourlawyer.com/topics/overview/YAZ">Yaz and Yasmin, that contain a synthetic form of progestin called drospirenone. The FDA safety review was prompted by the publication of two new studies which reported that women who use drospirenone birth control pills faced a greater risk of suffering dangerous, and often deadly blood clots compared to those taking pills made with levonorgestrel, another synthetic progestin.
In addition to Yaz and Yasmin, drospirenone is found in birth control pills sold under the brand names Beyaz and Safyral. The hormone is also an ingredient in generic forms of Yaz (Gianvi, Loryna) and Yasmin (Ocella, Syeda, and Zarah).
All birth control pills increase the likelihood that a user may suffer a blood clot. However, two studies that recently appeared in The British Medical Journal reported a two- to three-fold greater risk of venous thromboembolic events (VTEs) – including life threatening deep vein thrombosis (DVT) and pulmonary embolism (PE) – in women using oral contraceptives containing drospirenone rather than levonorgestrel.
Previous studies examining the risk of blood clots and drospirenone contraceptives have had conflicting results, according to the FDA. Two postmarketing studies required by the FDA or European regulatory agencies did not report any difference between birth control pills containing drospirenone and those containing levonorgestrel. However, two other studies published in 2009 reported that the risk of blood clots is higher in women using drospirenone-containing products than in women who use levonorgestrel-containing products.
According to the FDA, information from the four earlier studies is already noted in the “Warnings and Precautions” section of current labels for drospirenone-containing birth control pills.
In a Drug Safety Communication issued this afternoon, the FDA said it is currently evaluating the conflicting results from all of these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. Any additional information will be communicated to the public as it becomes available.
The Drug Safety Communication also noted that an additional large study investigating the link between blood clots and hormonal contraception has been commissioned by FDA. The results of that study are currently being finalized and reviewed. This study includes over 800,000 US women and is designed to look at thrombotic and thromboembolic risks including VTE in a number of hormonal contraceptive products.
Today’s FDA announcement follows a decision made by European regulators last week to revise the labels of drospirenone birth control pills regarding the risk of VTE. The decision by the European Medicines Agency (EMA) was based on the same two studies that prompted today’s FDA Drug Safety Communication.
Drospirenone birth control pills, including Yaz, Yasmin and their generic counterparts, have been named in more than 6,000 U.S. lawsuits claiming the drugs caused users to suffer dangerous side effects, including blood clots, heart attacks, and strokes. Many of those lawsuits have been consolidated in a multidistrict litigation in federal court in the Southern District in Illinois.
