As a result, the FDA issued a public health advisory on September 30, 2004 about Merck’s voluntary withdrawal of Vioxx from the market. The FDA will closely monitor other NSAIDs (non-steroidal anti-inflammatory drugs) like Celebrex and Bextra for similar side effects. Typically, NSAIDs like Vioxx have risks when taken long-term, especially the risk of gastrointestinal bleeding, and also kidney and liver toxicity.

Vioxx was approved in 1999 by the FDA for the reduction of pain and inflammation caused by osteoarthritis. Vioxx was also approved for the treatment of menstrual pain and for acute pain in adults. Allegedly, Vioxx is the only NSAID to have a lower rate of gastrointestinal ulcers and bleeding. Vioxx was the second of a new kind of NSAID (Cox-2 selective) approved by the FDA. Later the FDA also approved Vioxx to treat the painful symptoms of rheumatoid arthritis in children and adults.

Can I get a refund on unused Vioxx?
Yes. Merck requires patients to mail back the unused Vioxx in the original container, along with a pharmacy receipt to:
     NNC Group – Merck Returns
     2670 Executive Dr.
     Indianapolis, IN 46241

Include a note with the patient's name, address, and phone number. Merck will reimburse the cost of the full prescription plus regular shipping.

Since 2002, Vioxx had a warning about increased cardiac risks of heart attack and strokes based on the results of Merck’s own post-approval study. Nevertheless, the FDA did nothing to remove it from the pharmaceutical marketplace.

The FDA plans to work closely with Merck to coordinate the withdrawal of Vioxx from the U.S. pharmacies. The FDA also has information available on its web site and via a toll-free call to (888) INFO-FDA.