[AF] Retirada Mundial de Vioxx (rofecoxib) debido a incremento de riesgo de efectos cardiovasculares

Mariano Madurga mmadurga en agemed.es
Jue Sep 30 16:58:45 CEST 2004


Os remitimos mensaje recibido de la FDA sobre retirada mundial de Vioxx. En
breve esta Agencia informará al respecto.
Un saludo,
Mariano Madurga

-----Mensaje original-----
De: CDER MEDWATCH LISTSERV [mailto:MEDWATCHLIST en CDER.FDA.GOV] 
Enviado el: jueves, 30 de septiembre de 2004 15:30
Para: MEDWATCH en LIST.NIH.GOV
Asunto: FDA MedWatch - Market withdrawal of Vioxx (rofecoxib) due to
incr eased risk of cardiovascular events


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

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