Thomas J. Lamb Drug and Medical Device Litigation Law Blog on Lawyers.com

Early Results Suggest An Approximately 1.5-fold Increase In The Risk For Birth Control Pills With Drospirenone (DRSP)

(Posted by Tom Lamb at www.DrugInjuryWatch.com on September 26, 2011; see

http://bit.ly/qE3j2n)

In a September 20, 2011 Notice published in the Federal Register the FDA announced that on December 8, 2011 the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet to discuss the risks and benefits -- and specifically the risk of blood clots -- of drospirenone-containing birth control pills such as YAZ, Yasmin, and Ocella.

The reason why the FDA took this action as regards these drospirenone (DRSP) birth control pills became apparent on September 26, 2011 when the "FDA Drug Safety Communication: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone" was issued by the FDA.

From the Data Summary part of that FDA Drug Safety Communication regarding YAZ, Yasmin, and Ocella:

FDA has reviewed six published epidemiologic studies that evaluated the risk of blood clots (venous thromboembolism, VTE) in women using birth control pills containing drospirenone. These studies have conflicting findings. Two were postmarketing studies required by the FDA or European regulatory agencies.  These studies did not report any difference in VTE risk between drospirenone-containing products and products containing levonorgestrel or other progestins. Two publications from 2009, however, reported a 1.5- to 2-fold higher VTE risk in women who use drospirenone-containing contraceptives as compared to the risk in women who use levonorgestrel-containing contraceptives.  More recently, two articles published in 2011 in the British Medical Journal reported a 2- to 3-fold greater risk of blood clots in women using oral contraceptives containing drospirenone rather than levonorgestrel. 

Initial data from an FDA-funded epidemiologic study exploring the association of blood clots with several different hormonal contraceptive products, including levonorgestrel-containing contraceptives, appear consistent with results from the 2009 and 2011 published studies. Although FDA's review is ongoing, the preliminary data from the FDA-funded study are consistent with an approximately 1.5-fold increase in the risk of blood clots for users of drospirenone-containing contraceptives compared to users of other hormonal contraceptives....  The full study report of this study, along with the completed FDA review of the results of the study, will be presented and discussed at the joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee in December 2011.  [footnotes omitted]

In that same Drug Safety Communication the FDA provided a list of drospirenone-containing oral contraceptive pills as well as a link to an FDA web questions-and-answers page concerning the possible increased risk of blood clots associated with these pills, such as YAZ, Yasmin, and Ocella.

Some of our articles from the past concerning this DRSP - blood clot safety issue are:

July 2011:  YAZ / Yasmin / Ocella / Beyaz / Safyral: Drug Safety Regulators Focus On Blood Clot Side Effects

April 2011:  Bayer Affirms Safety Of YAZ / Yasmin And Refutes 2011 BMJ Articles About Risk Of Blood Clots

August 2009:  YAZ And Yasmin May Have Higher Risk Of Venous Thrombosis Than Older Birth Control Pills

A venous thromboembolism (VTE), more commonly called a blood clot, can cause pulmonary embolism (PE), deep vein thrombosis (DVT), stroke or cerebrovascular accident (CVA), and heart attack or myocardial infarction (MI) -- any of which can cause death if not detected and treated promptly.

We will continue to monitor the safety profile of YAZ, Yasmin, and Ocella as well as the several other birth control pills containing drospirenone (DRSP).