On October 27, 2011, FDA released the final report of the FDA funded study thatevaluated the risk of blood clots in users of several different hormonal contraceptives – “Report: Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints“. The results of the FDA funded study were presented for discussion at the joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011.
The joint hearings highlighted the fact that only studies that were linked to the Pharmaceutical industry, and the manufacturer, provided evidence that DRSP(DROSPIRENONE) containing birth control pills presented a risk profile similar to other forms of birth control. FDA’s study confirmed a significantly higher risk of blood clots that was not clearly warned about or communicated to either prescribers of users. The increased risk of blood clots from a DRSP (DROSPIRENONE) containing birth control pills per the FDA’s own study is 75%-77% higher than other available birth control pills.
YAZ BLOOD CLOT LAWSUITS allege that women were not adequately warned of increased risks of blood clots that have now been repeatedly confirmed by independent studies and the FDA funded study. The manufacturer has repeatedly disputed findings of increased risk despite a growing body of evidence to the contrary and the fact that such studies have been ‘tied’ to the company or promotion of the DRSP (DROSPIRENONE) containing pills.
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