|
FDA Public Health Advisory:
Safety of Vioxx
Merck & Co., Inc.
today announced a voluntary withdrawal of Vioxx from the U.S. market
due to safety concerns. 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. It is also approved for the
relief of the signs and symptoms of rheumatoid arthritis in adults
and children.
The Agency was
informed by Merck & Co., Inc. on September 27, 2004, that the Data
Safety Monitoring Board for an ongoing long-term study of Vioxx (APPROVe)
had recommended that the study be stopped early for safety reasons.
The study was being conducted in patients at risk for developing
recurrent colon polyps. The study showed an increased risk of
cardiovascular events (including heart attack and stroke) in
patients on Vioxx compared to placebo, particularly those who had
been taking the drug for longer than 18 months. Based on this new
safety information, Merck and FDA officials met the next day,
September 28, 2004, and during that meeting FDA was informed that
Merck was voluntarily withdrawing Vioxx from the market
place.
The risk that an
individual patient taking Vioxx will suffer a heart attack or stroke
related to the drug is very small. Patients who are currently
taking Vioxx should contact their physician for
guidance regarding discontinuation and alternative therapies.
FDA is working
closely with Merck to coordinate the withdrawal of this product from
the U.S. market place. Healthcare professionals are advised to
contact Merck at 1-888-368-4699 or at
www.merck.com or at the FDA’s Drug Information Office at
301-827-4573 or 1-888-463-6332 or go to Vioxx Information on FDA’s
website at:
www.fda.gov/cder/drug/infopage/vioxx/default.gov for
questions about this product.
 Back
to Top 
Back to Vioxx Info
Date created: September 30, 2004 |
