Over the past few months, the FDA has repeatedly issued communications to the public, health care providers and “prescribers” of the popular family of DRSP (DROSPIRENONE) containing birth control pills. Recently, on October 27, 2011, FDA released findings from a study it funded that confirmed a significantly higher risk of YAZ SIDE EFFECTS in the form of blood clots. This risk is estimated as 75% higher by FDA.
The FDA’s series of communications in 2011 may be summarized as follow:
- May 31, 2011 – “FDA Drug Safety Communication: Safety Review of Possible Increased Risk of Blood Clots with Birth Control Containing DRSP (DROSPIRENONE” – At the time, two (2), recently released studies in the British Medical Journal (BMJ) raised questions about the increased risk DRSP (DROSPIRENONE) pills posed. These studies pointed to a 2x-3x higher risk of blood clots.
- September 26, 2011 – “FDA Drug Safety Communication: Safety Review Update on the Possible Increased Risk of Blood Clots with Birth Control Pills Containing DRSP (DROSPIRENONE)” - FDA announced it had yet to reach a conclusion but “remains concerned” over the potential increased risk of blood clots from DRSP (DROSPIRENONE) containing birth control pills. FDA cited to growing body of studies, including 2009 BMJ studies that noted a 1.5x-2.x risk of blood clots. Given conflicting nature of findings in studies, as well as preliminary findings in FDA funded study, FDA scheduled a joint meeting of Reproductive Health Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee for December 8, 2011. FDA hearings are pending 12.8.11.
- October 27, 2011 -FDA MedWatch The Safety Information and Adverse Event Reporting Program, issues “Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots” and advised healthcare professionals of release of Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints Final Report confirming publicly that FDA funded study found “another positive finding to the increasing body of evidence linking DRSP to increased risk[s]“. DRSP (DROSPIRENONE) containing pills were “associated with a significantly higher risk of VTE” relative to other low-estrogen pills. Notably, DRSP (DROSPIRENONE) was linked to a significantly higher risk of VTE (venous thromboembolism), blood clots in the veins, as well as ATEs which were defined as: AMI (hospitalized acute myocardial infarction) and included arterial thrombotic events and ischemic strokes. Estimated increased risk is 75% or 1.74 in comparison to other birth control pills.