DROSPIRENONE BLOOD CLOT RISK | YAZ LAWSUIT UPDATE OCTOBER 2012

DROSPIRENONE CONTAINING BIRTH CONTROL CONFIRMED AS HIGHER RISK PILLS AGAIN.

DROSPIRENONE CONTAINING BIRTH CONTROL PILLS

Since 2009, over 13,000 lawsuits have been filed throughout the United States over DROSPIRENONE (DRSP) containing birth controls sold as YASMIN, YAZ and their generic equivalents OCELLA, GIANVI and ZARAH. Manufactured by BAYER HEALTHCARE PHARMACEUTICALS, the pills were widely popular and gained vaunted Blockbuster status over the past decade.

Legal cases were initiated as scientific studies began being published, in 2009, confirming that the novel progestin DROSPIRENONE (DRSP) was more likely to cause a blood clot than other types of hormonal contraceptives. All of the pills share a common denominator to this day – 3 mg of DROSPIRENONE (DRSP). Yet, in 2010, the U.S. Food & Drug Administration (FDA), approved two more “versions” of the 3 mg DROSPIRENONE-containing pills, BEYAZ & SAFYRAL, which are essentially YAZ & YASMIN plus folate.

In late October 2011, FDA released findings from a study that focused on DROSPIRENONE containing pills and found a higher risk of blood clots, which includes blood clots in the legs or Deep Vein Thrombosis, and blood clots in the lungs known as Pulmonary Emboli. The FDA’s study was released just before a joint panel of experts was convened by FDA to consider the safety profile of the drugs and their future during December 2011. At the time, DROSPIRENONE (DRSP) containing birth control pills narrowly escaped a market withdrawal or DRSP Recall. The hearings resulted in a second updated label change for the pills sending conflicting warnings to prescribers and users despite a growing body of science indicting the safety profile of the popular contraceptive. Governmental watchdog groups called for a re-vote on the YAZ Recall over apparent conflicts of interests and panel members with financial ties to the manufacturer. These cries fell on deaf ears.

At the heart of the litigation is the failure to warn of increased risks of blood clots, or YAZ SIDE EFFECTS, as well as the manufacturer’s alleged disregard in failing to disclose information to FDA, prescribers and consumers. Additional background information on the litigation and history of the pills is available at YAZ Recall. Widespread news reports have confirmed that the manufacturer, BAYER HEALTHCARE PHARMACEUTICALS, has begun settling blood clot cases on a rolling basis. This has proven to be a time consuming process that is taxing the patience of parties and litigants but perhaps not putting off potential civil jury trials.

A study released in October 2012, “Recent Combined Hormonal Contraceptives (CHCS) and the Risk of Thromboembolism and Other Cardiovascular Events in New Users“, has again raised questions and concerns over the safety of all DROSPIRENONE (DRSP) containing birth control pills.

This study found “that the initiation of new use of DRSP-containing” birth control pills were “associated with a 77% increase in the risk of hospitalization” for blood clots and cautioned 1st time users of DROSPIRENONE containing birth control pills. Sadly, the FDA has remained silent as of this writing despite these findings confirming findings it released a year ago in October 2011. Whether information from the latest study will be added to warning label, which has been done in the past, remains to be seen.

Our office continues to represent girls and women that suffered injuries from use of a DROSPIRENONE containing birth control pill. Often referred to as YAZ LAWYERS, our firm is versed in this litigation and the latest scientific studies relating to the future of these pills. FREE CASE EVALUATIONS remain available for any girl or woman interested in pursuing her Path To Justice® following the use of a DROSPIRENONE containing pill where she was not properly or adequately warned of risks by the manufacturer.

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