On October 27, 2011, FDA released the final report of the FDA funded study that evaluated 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.
FDA’s Advisory Committee Materials are now available on-line and include the “Meeting Minutes”, as well as a 440 Page Transcript that outlines the voting process and presentations. Arguably, the voting process reveals that DRSP (DROSPIRENONE) containing birth control pills survived a “market withdrawal” or “recall” by an extremely small margin. In fact, only in a 15-11 vote the voting members decided the pills benefits (i.e.> prevention of pregnancy) outweighed the increased risk of blood clots. Sadly, the transcript reveals confusion among voting members, and raises more questions, about the entire DRSP (DROSPIRENONE) family of contraceptives. At the hearings, members were asked to abstain from voting or participating in the vote if they had any financial ties to the manufacturer – BAYER HEALTHCARE PHARMACEUTICALS.
As illustrated above, advisory committee members did not respond to a request to identify themselves if they in fact had financial ties to the manufacturer. Sadly, reports have emerged in a number of publications that allege several members involved in the voting process had ties to BAYER that were not publicly disclosed (as illustrated above) or the subject of FDA conflict of interest waivers. This has lead to a request by public watchdog groups for a ‘re-vote’ and additional investigations.
In a 21-5 vote the FDA Advisory Committee agreed that the pills current labeling and warnings do not properly communicate risks associated with DRSP (DROPSIRENONE) containing birth control to prescribers and users. Rather, the labels present confusing information and the manufacturer’s ongoing claim that studies finding higher risk are either unreliable or unfounded. Hopefully, this will now be put to rest by FDA’s study and the vote finding the labels have inadequately warned of blood clot risks for over a decade.
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