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New FDA Safety Warning for YAZ Drospirenone

The FDA made a safety announcement today regarding birth control pills containing Drospirenone and the new label change, that these products may be associated with a higher risk for blood clots.


FDA indicated that it had completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. According to the FDA, drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.

What is Drospirenone

Drospirenone is a synthetic version of the female hormone, progesterone, which also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.

New Warning Label for Drospirenone

The revised drug labels will state that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, and other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.

The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

Bayer Now Settling YAZ Lawsuits

Bayer Healthcare reports that it has reached agreements to settle Yaz and Yasmin deep vein thrombosis and pulmonary embolism lawsuits brought by at least 70 women.

The YAZ product liability lawsuits have been consolidated in the Southern District of Illinois. The judge overseeing he MDL litigation, ordered that the bellwether trials been postponed, the bell-wether trial were scheduled for April and now are moved out to June 2012.

Bayer continues to face about 11,300 additional claims in federal court by women who have suffered serious and fatal injuries, allegedly caused by their popular birth control pills.

Bayer has indicated that they are continuing to consider settling lawsuits on a case-by-case basis. Women injured by the drugs are pursuing compensation from Bayer through a Yaz lawsuit or Yasmin lawsuit, alleging that the drug maker failed to adequately warn about the increased risk of blood clots and other serious injuries.

Drospirenone was first introduced in Yasmin birth control by Berlex Laboratories, which was later acquired by Bayer. Yaz is an updated version of the birth control pill, and Bayer recently introduced a third variation, marketed as Beyaz, which also includes a folate supplement.

Earlier this year, the federal judge presiding over all lawsuits filed in U.S. District Courts throughout the United States ordered Bayer and plaintiffs’ lawyers to engage in Yaz settlement negotiations before the first cases are submitted to a jury.

Known as bellwethers, those early trial dates are often used to facilitate discussions to settle other lawsuits, and may help the parties gauge how juries are likely to respond to evidence that is likely to be introduced in multiple cases.

Generic versions of Yaz and Yasmin are also now available from other manufacturers, including Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah.

FDA Recommendation

The FDA recommends that women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

The FDA recommends that healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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