Vioxx Faq
Sept. 30, 2004 -- Merck has announced a voluntary worldwide withdrawal of Vioxx (rofecoxib), a popular arthritis medication.
What is Vioxx?
Vioxx is a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs are a large group of drugs that include aspirin, ibuprofen, and naproxen, but these drugs are not part of the withdrawal. Vioxx works by reducing substances that cause inflammation, pain, and fever in the body and is used to treat arthritis, acute pain in adults, and painful menstrual cycles.
Why has Vioxx been withdrawn?
New research shows that Vioxx may cause an increased risk of cardiovascular events such as heart attack and stroke if used long-term.
Did the FDA require this action?
No. Merck made this decision independent of input from the FDA. But the FDA agrees with the company that there appears to be significant safety concerns for patients, particularly those taking the drug long-term. The FDA plans to work closely with Merck to coordinate the withdrawal of this product from the U.S. market.
What action did the FDA take today?
The FDA issued a public health advisory concerning the use of Vioxx. This advisory is based on Merck voluntarily withdrawing Vioxx from the market due to safety concerns.
What should I do if I am taking Vioxx?
The risk that an individual patient will suffer a heart attack or stroke related to Vioxx is very small. We encourage people taking Vioxx to contact their doctor to discuss discontinuing the use of Vioxx and finding alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your doctor based on an assessment of your specific treatment needs.
What evidence supports the withdrawal?
Merck's decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe trial. In the APPROVe trial, Vioxx was compared with placebo (sugar pill). The purpose of the trial was to see if the 25 mg dose of Vioxx was effective in preventing the recurrence of colon polyps. This trial was stopped early because there was an increased risk of serious cardiovascular events, such as heart attack and stroke, after 18 months of continuous treatment with Vioxx.
Why wasn't the APPROVe trial stopped earlier?
The APPROVe trial began enrollment in 2000. The trial was being monitored by an independent data safety monitoring board. It was not stopped earlier because the results for the first 18 months of the trial did not show any increased risk of cardiovascular events from taking Vioxx.
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Vioxx Resources
Merck
U.S. Food and Drug Administration
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