FDA Schedules Joint Meeting to Discuss Birth Control Pill Clot Risk

The FDA has scheduled a joint meeting with the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to discuss the risks of the drospirenone-containing birth control pills.

The US FDA said in a safety announcement on Monday that preliminary results of a study that it funded, involving 800,000 women, suggested an approximately 1.5-fold increase in the risk of blood clots for women who use the drospirenone-containing birth control pills compared with users of other hormonal contraceptives.

The FDA has scheduled a joint meeting with the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on 8 December to discuss the risks and benefits of the pills.

The agency has completed its review of two studies evaluating the risk of blood clots in women, but has not reached a conclusion yet.