FDA remains concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills, but it is informing the public that it has not yet reached a conclusion, according to an agency announcement.
FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA’s Drug Safety Communication issued on May 31, 2011.
FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.
Given the conflicting nature of the findings from 6 published studies evaluating this risk, as well as the preliminary data from the FDA-funded study, FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011, to discuss the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills.
Approved brand name oral contraceptives containing drospirenone include Ocella, Safyral, Syeda, Yasmin, Zarah, Beyaz, Gianvi, Loryna, and Yaz.
Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, obesity, and family history of blood clots, in addition to other factors that contraindicate use of birth control pills.