FDA concludes drospirenone safety review

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FDA concludes drospirenone safety review The US FDA has completed its review of recent epidemiologic studies investigating the risk of venous thromboembolism (VTE) in women taking drospirenone-containing combined oral contraceptives (COCs).* The agency concluded that these studies did not provide consistent estimates of the comparative risk of VTE between COCs containing drospirenone and those not containing drospirenone. Furthermore, these studies did not account for important patient characteristics that may have influenced prescribing. Revised drug labels will state that some epidemiologic studies reported as much as a three-fold increase in the risk of blood clots with drospirenone-containing products, whereas other epidemiologic studies found that these agents were associated with no additional risk of blood clots. * See also Reactions 1371 p2; 803060977 FDA. FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone. Internet 803069300 Document : 10 Apr 2012. Available from: URL: http://www.fda.gov

0114-9954/10/1398-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Reactions 21 Apr 2012 No. 1398

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