FDA Acknowledges Concern Regarding Oral Contraceptives

Fourth generation oral contraceptives have received an immense amount of scrutiny for their association with severe blood clots. Recent months have witnessed the U.S. Food and Drug Administration (FDA) acknowledge these problems in multiple Safety Communications. Each of which reveal an increased risk of venous thromboembolism (VTE) for women who use fourth generation birth control pills such as Yaz, Beyaz, Yasmin and Ocella. Researchers believe the main ingredient in these pills, drospirenone, may serve as a mechanism for the association between contraceptives and severe, life-threatening blood clots.

According to a recent FDA Safety Communication, the Agency still remains concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. More specifically, data collected from numerous epidemiological studies have led officials at the FDA to believe that fourth generation contraceptives may not demonstrate a favorable risk/benefit profile.

Due to an influx of adverse events related to the use of fourth generation birth control pills, the FDA conducted an investigation to determine the safety and effectiveness of such products. Their search revealed six published epidemiological studies that evaluated the risk of blood clots in women using birth control pills containing drospirenone. According to their findings, the FDA remains conflicted as to whether or not the birth control pills have benefits that outweigh the risks.

According to two post marketing studies conducted by European and FDA regulatory agencies, there is no significant difference between drospirenone-containing products and those that contain levonorgestrel or other progestins. However, two articles published in 2009 offered conflicting data that opposed the original findings put forth by the previously mentioned regulatory agencies. Subsequently, the two publications each identified a 1.5- to 2-fold higher blood clot risk in women who use drospirenone-containing contraceptives as compared to the risk in women who use levonorgestrel-containing contraceptives. However, two recent articles published in the British Medical Journal identify a 2 to 3-fold greater risk of blood clots in women using oral contraceptives containing drospirenone rather than levonorgestrel.

The conflicting nature of the six published epidemiological studies has led the FDA to reevaluate their position on drospirenone-containing contraceptives. Furthermore, the FDA has not reached a conclusion on the risk for blood clots in women using drospirenone-containing birth control pills, but remains concerned about the potential increased risk. Given the conflicting nature of recently obtained data, the 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. Discussions that take place at this meeting will undoubtedly have overwhelming ramifications for future regulations of oral contraceptives that contain drospirenone.

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Again, if you or a loved one has been injured by drospirenone-containing products, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.