FDA Adds More Warnings To Certain Oral Contraceptives

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FDA Adds More Warnings To Certain Oral Contraceptives.

The Wall Street Journal (4/11, B9, Dooren, Subscription Publication) reports on Tuesday, the US Food and Drug Administration announced that some birth-control medications may have a higher risk of blood clots compared to other oral contraceptives.

        The AP (4/11) explains the agency is "adding labeling to drospirenone and ethinyl estradiol [Yaz] and other newer birth control" medications. "The labeling will apply to Bayer's Yaz, its predecessor drospirenone and ethinyl estradiol [Yasmin] and similar drugs containing the manmade hormone called drospirenone, which mimics the naturally occurring female hormone progesterone."

        Bloomberg News (4/11, Edney) reports oral contraceptives "containing drospirenone, a synthetic version of the hormone progesterone, will carry new labels about a review that showed as much as triple the risk for blood clots," the agency said. "The research compared the drugs with low-dose estrogen" tablets and "some studies found no increased risk." Last December, "advisers to the FDA voted...that the benefits of the drospirenone-containing class of birth-control" tablets "outweigh the risks and suggested a label change to better reflect the potential for blood clots."

        HealthDay (4/11, Reinberg) reports, "The decision follows recommendations made in December by an FDA-appointed panel that several drospirenone-containing contraceptives carry revised labels warning about an increased risk of potentially fatal blood clots." The agency's "advisers had voted 21-5 in favor of new labels for the oral contraceptives."

        Medscape (4/11, Lowes) reports, "In addition to not offering consistent estimates of the comparative risks for VTE between birth control pills that contain drospirenone and those that do not, the studies did not 'account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots,' the FDA stated in a safety communication."

        MedPage Today (4/11, Gever) reports, "The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control" tablets, "according to the statement." In addition, "the FDA noted, the risk of clotting while using these products still appears to be lower than thrombosis risk during pregnancy and in the immediate postpartum period." Also covering the story are Reuters (4/11, Yukhananov) and Heartwire (4/11, Lowes).

 http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/32123?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&eun=g376694d0r&userid=376694&email=jlong@i-review.com&mu_id=5369993

FDA Warns of Clot Risk with Yaz, Other OCs