FDA Says Yaz, Yasmin Blood Clot Risk Still a Concern

U.S. health regulators are still worried about the potential for blood clots posed by drospirenone-containing birth control pills like <"http://www.yourlawyer.com/topics/overview/Yaz-Yasmin-Ocella-Lawsuit-Side-Effects-injury-clots-embolism-dvt">Yaz and Yasmin. In a Drug Safety Communication posted on its website yesterday, the U.S. Food & Drug Administration (FDA) said preliminary results of an agency-funded study suggest women who use Yaz, Yasmin and other oral contraceptives made with drospirenone could face a 1.5-fold increase in the risk of blood clots compared to those who take other pills.

In addition to Yaz and Yasmin, drospirenone is found in birth control pills sold under the names Ocella, Safyral, Syeda, Zarah, Beyaz, Gianvi, and Loryna.

In yesterday’s Drug Safety Communication, the FDA said the six epidemiologic studies it evaluated presented conflicting information about the risk of blood clots. Two were postmarketing studies required by the FDA or European regulatory agencies that did not report any difference in blood clot 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 blood clot 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 the FDA-funded epidemiologic study involving 800,000 women that is exploring the association of blood clots with several different hormonal contraceptive products, including levonorgestrel-containing contraceptives, appear consistent with conclusions from the 2009 and 2011 published studies, finding a 1.5-fold increase risk for blood clots among women taking contraceptives with drospirenone.

The FDA did note that the available studies have only examined the risk of blood clots in users of contraceptive pills that contain drospirenone and 0.03 mg of ethinyl estradiol (an estrogen) and not other pills that contain drospirenone combined with a lower dose of estrogen. It is unknown at this time whether the reported increased blood clot risk applies to all drospirenone-containing products.

The FDA said it hasn’t yet reached a final conclusion that any of the products raise the risk of blood clots beyond that of other pills. According to a report from The Wall Street Journal, the FDA will convene an outside panel of medical experts on Dec. 8 to discuss the matter.

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