VIOXX WITHDRAWN

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MedWatch - The FDA Safety Information and Adverse Event Reporting

Program

 

Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib)

from

the U.S. and worldwide market due to safety concerns of an increased

risk of

cardiovascular events (including heart attack and stroke) in patients

on

Vioxx. Vioxx is a prescription COX-2 selective, non-steroidal

anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for

the

relief of the signs and symptoms of osteoarthritis, for the management

of

acute pain in adults, and for the treatment of menstrual symptoms, and

was

later approved for the relief of the signs and symptoms of rheumatoid

arthritis in adults and children.

 

Read the 2004 MedWatch safety summary, including links to the Public

Health

Advisory, press release, and Q & As, at:

 

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#vioxx