FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product

(Reprinted from http://www.fda.gov/bbs/topics/news/2004/NEW01122.html)

FDA News

FOR IMMEDIATE RELEASE P04-95 September 30, 2004

Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA

The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.

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Additional information about this withdrawal of Vioxx, as well as questions and answers for patients, is available online at http://www.fda.gov/cder/drug/infopage/vioxx/default.htm.