Two FDA Safety Committees will hold public meetings about the risks of Yaz on December 8, 2011. The two committees to meet are (1) the 13-member Reproductive Health Drugs Advisory Committee and (2) the 13-member Drug Safety and Risk Management Advisory Committee.
The Safety Committee is comprised of experts in obstetrics, gynecology, endocrinology, pediatrics, epidemiology or statistics and related specialties. The Risk Management Committee is comprised of experts in risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk management, and drug abuse.
The agenda: “to discuss the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel.” The FDA intends to post the background material on its website no later than December 6, two days prior to the meeting. If it is unable to post the material prior to the meeting, the materials will be available at the meeting, which will be held in the ballroom of the Marriott Inn at the University of Maryland.