FDA Questions Safety of Birth Control Pills Containing Drospirenone

The U.S. Food and Drug Administration (FDA) is now reviewing studies involving drospirenone-containing birth control pills after recent findings that indicated the drug is associated with an increased risk of blood clot. Two studies among those being evaluated had conflicting results with earlier research regarding the benefits and risks of drospirenone-containing contraceptives.

Blood clotting is a known side effect of all birth control pills, although the overall risk of developing a blood clot from the pills remains small. However, due to safety concerns, the European Medicines Agency recently acknowledged that use of birth control methods containing drospirenone is associated with a higher risk of blood clot (venous thromboembolism) and concluded that warning labels should be updated accordingly. Drospirenone is contained in a number of products being marketed with such brand names as Yaz, Yasmin, Beyaz, Ocella, Loryna, Gianvi, Safyral, Syeda and Zarah.

In a safety communication on the FDA website, the agency noted, “Two post marketing studies required by the FDA or European regulatory agencies did not report any difference in the risk of blood clots between drospirenone-containing products and those containing levonorgestrel or other progestins.”

However, the agency further noted, “Two other publications in 2009, however, reported that the risk of blood clots is higher in women using drospirenone-containing products than in women who use levonorgestrel-containing products.”

The 2009 studies found the increase in risk of serious blood clots associated with drospirenone to be as much as two to three times that of birth control pills that contain other progestins. These study results are already indicated on product labeling for drospirenone-containing contraceptives.

Bayer chemical and pharmaceutical company’s best-selling Yaz contraceptive has been blamed for numerous serious medical issues resulting in lawsuits, including the recent cardiac arrest death of an 18-year-old college student in North Carolina. The official Yaz website now posts that the contraceptive is associated with “increased risks of several serious side effects, including blood clots, stroke, and heart attack.”

According to the FDA, data from another large study involving over 800,000 women that was commissioned by the agency to evaluate clotting risks associated with general oral contraceptive use is now being reviewed, with results expected this summer.

For now, the FDA indicated that drospirenone contraceptives may continue to be prescribed, although it warned that both patients and physicians should be able to recognize symptoms of deep vein thrombosis and VTE, and should discuss the risks associated with drospirenone. The agency assured that the public would be updated by stating that the “FDA will continue to communicate any new safety information to the public as it becomes available.”