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Tracy Finken
Tracy Finken
Attorney • (215) 735-0773

FDA Remains Concerned about Yaz and Blood Clots

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The FDA recently announced that it remains concerned about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills such as Yaz or Yasmin.

Although it still hasn’t reached a final conclusion, the FDA issued a statement on September 26, 2011, that preliminary results of an independent FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives. 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 of blood clots with drospirenone-containing birth control pills.

This recent FDA statement is in follow up to a statement that was released in May 2011 indicating its concern with two articles in the British Medical Journal which raised the question as to whether there is greater risk of DVT and PE in women taking combination oral contraceptives containing the progestin drospirenone as compared to the risk in women taking oral contraceptives containing the progestin levonorgestrel. These two studies reported a two- to three-fold greater risk of venous thromboembolic events or VTEs (VTEs include DVTs and PEs) in women using oral contraceptives containing drospirenone rather than levonorgestrel.

A complete listing of the medications that contain drospirenone and the FDA’s statement can be found at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm273039

Thousands of lawsuits have been filed around the country against the manufacturer, Bayer, on behalf of women who have suffered a VTE while ingesting Yaz or Yasmin.