[09-26-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 2011. FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the 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.

"It is unknown at this time whether the reported VTE risk applies to all drospirenone-containing products," the FDA indicated.    Drospirenone-containing products with the higher estrogen dose include Yasmin, Zarah, Syeda, Safyral, and Ocella.   Those with the lower amount of estrogen include Yaz, Loryna, Gianvi, and Beyaz.

Given the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study, 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 and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills.

In the meantime, the agency advised health professionals to inform women taking drospirenone-containing products of the potential clotting risk.  Smoking, being overweight, and having a family history of clotting disorders are all risk factors for VTE that should be discussed with patients, the agency noted.

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Comments

It still remains to be seen why Bayes still continues to sell Yaz and Yasmin (both contains drospirenone), in spite of unclear reports regarding manifestations of such serious side effects! K.

I hope that they invent the pill for men. I'm tired of hormones that make me this sick. Unfortunately, condoms are not safe enough. I can´t expect my husband to do a vasectomy. The solution is the pill for men

I think the IUD is a good measure and safe. cost is cheaper than the pill

I hope the FDA comes up with conclusion once they meet on dec. 8,2001. We have to know and tell other women about the potential risk of drospirenone. Lets wait till the FDA finally decide on the case. Thank for the informative update,

I am confused by all of this though. Every medicine I ever hear of on T.V. ad's has worse side effects than what the medicine is even treating. Although millions of people still take them and usually don't experience any of the side effects.. I'snt it true that all birth control pills can cause blood clots?? EDITOR'S COMMENT: Risk of clots has always been a concern but some of the lower dose pills are much less risk prone. This particular recall is only related to the brands that have the named chemical.