October 01, 2004

Merck recalls blockbuster arthritis drug

TRENTON, N.J. -- Pharmaceutical giant Merck & Co. is pulling its blockbuster arthritis drug Vioxx from the market worldwide because new data from a clinical trial found an increased risk of heart attack and stroke. Whitehouse Station-based Merck said Thursday that data from the trial showed the increased risk of heart attack and other cardiovascular complications began 18 months after patients started taking Vioxx.

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

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.

Posted by Editor at October 1, 2004 12:06 PM

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