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[e-drug] rofecoxib: global withdrawal


  • From: "E-drug" <e-drug@healthnet.org>
  • Date: Thu, 30 Sep 2004 17:37:54 +0200

E-DRUG: rofecoxib: global withdrawal
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[Another blockbuster gone due to ADR... Source: MedWatch - The FDA Safety Information and Adverse Event Reporting Program; copied as fair use. WB]

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