FDA Did Not Request A Drug Recall Vioxx, This Product Is Being Voluntarily Withdrawn From The Market By Merck

fda.gov, Mar 09, 2005

What did FDA know about the risk of heart attack and stroke when it approved Vioxx?

FDA originally approved Vioxx in May 1999.  The original safety database included approximately 5000 patients on Vioxx and did not show an increased risk of heart attack or stroke.  A later study, VIGOR (VIOXX GI Outcomes Research), was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000.  The study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID, however, the study also showed a greater number of heart attacks in patients taking Vioxx. The VIGOR study was discussed at a February 2001 Arthritis Advisory Committee and the new safety information from this study was added to the labeling for Vioxx in April 2002. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx.

Is FDA’s expedited review process putting riskier drugs on the market? 

No. Vioxx received a six-month priority review because the drug potentially provided a significant therapeutic advantage over existing approved drugs due to fewer gastrointestinal side effects, including bleeding.  A product undergoing a priority review is held to the same rigorous standards for safety, efficacy, and quality that FDA expects from all drugs submitted for approval. 

What other drugs are similar to Vioxx?

Vioxx is a COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID).  Other COX-2 selective NSAIDs on the market at this time are Celebrex (celecoxib) and Bextra (valdecoxib). Vioxx is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. You should consult your physician to determine which treatment is right for you.

Does today’s action suggest that other drugs in the same class are dangerous?

The results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class.  All of the NSAIDs have risks when taken chronically, especially of gastrointestinal (stomach) bleeding, but also liver and kidney toxicity.  Patients using these drugs for a long period of time (longer than two weeks) should be under the care of a physician. 

Will Vioxx be recalled?

FDA did not request a recall of Vioxx.  This product is being voluntarily withdrawn from the market by Merck.

Can my pharmacist continue to fill my prescription for Vioxx?

No, Merck is initiating a market withdrawal in the United States to the pharmacy level. This means Vioxx will no longer be available at pharmacies.