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Oral Contraceptive Update
For years, package inserts for oral contraceptive products containing progestin and estrogen have included the warning that these products increase a woman’s risk of developing blood clots (venous thrombosis and cardiovascular events). On April 10, 2012, the FDA announced in a drug safety communication that all oral contraceptives containing the drug drospirenone may be linked to a higher risk of venous thrombosis than products containing other types of progestins.1
This announcement was based on an FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenonecontaining products compared with users of other hormonal contraceptives. The list of approved oral contraceptives with drospirenone includes brand name products such as Yaz, Yasmin, Safyral, and Beyaz (all manufactured by Bayer). Generic oral contraceptive products that contain drospirenone will also carry this warning.
1. Food and Drug Administration website. FDA drug safety communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone. April 10, 2012. www.fda.gov/Drugs/DrugSafety/ucm299305. Accessed May 1, 2012.
2. Hart RG, Diener HC, Yang S, et al. Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with warfarin or dabigatran: The RE-LY trial. Stroke 2012: DOI:10.1161/?STROKEAHA.112.650614.3.
3. Turpie AG, Jamal W, Schmidt A, et al. XAMOS: A non-interventional study comparing oral rivaroxaban with conventional regimens for thromboprophylaxis after major orthopaedic surgery of the hip and knee. British Society of Hematology 2012 Scientific Meeting; April 16-18, 2012; Glasgow, Scotland
4. The EINSTEIN-PE investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012; 366:1287-1297.
5. Pradaxa (dabigatran etexilate) package insert. Boehringer Ingleheim, Inc. 2010.
6. Rivoraxaban (Xarelto) package insert. Bayer