FDA Remains Concerned Over Bayer's Oral Contraceptive
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U.S. drug regulators will discuss reports of blood clots and the safety of the Yasmin (Yaz) brand contraceptive pills containing drospirenone on December 8 after several conflicting studies about its risks.
Already, more than 100 lawsuits have blamed drug maker Bayer for allegedly glossing over the drug’s clotting effects and misleading patients.
The U.S. Food and Drug Administration announced the meeting Monday that will involve two committees to “discuss the risks and benefits and specifically the risk of blood clots.”
According to two BMJ articles published in April, Drospirenone was found to have 2-to-3 fold greater risk for VTE’s (Venous Thromboembolisms).
The pills – known colloquially as Yaz and Yasmin, are now subject to over 129 lawsuits against Bayer alleging that they glossed over the blood clotting effects, overstated the drugs’ approved uses and misled patients into believing that it was safe.
Following this, an FDA funded study was launched to find out the thrombotic and thromboembolic risks in May.
These have been shown to cause a tentative increase – 1.5-fold – through still a risk, the figure remains low:
"Given the conflicting nature of the findings from six 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,” the FDA said in a drug-safety communication released today.