October 31, 2011

The U.S. Food and Drug Administration (FDA) is raising concerns about the safety of oral contraceptives containing drospirenone following a review of two new studies that found that women taking these medications were at a greater risk to develop venous thromboembolisms than those on older forms of birth control.  Oral contraceptives containing drospirenone include Yaz, Yasmin, Beyaz, and Safyral and may be used to treat endocrine conditions like polycystic ovary syndrome or idiopathic hirsutism.  The FDA is advising healthcare professionals to consider specific patient risks for developing blood clots before prescribing oral contraceptives containing drospirenone.
 
A joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee has been scheduled to discuss these data on December 8. Additional information on the safety review can be found here. The Society will continue to monitor this issue and will alert members as new information becomes available. Should you have questions, please contact Meredith Dyer, Manager, Health Policy, at mdyer@endo-society.org.