(This Question and Answer sheet was created with information provided by the Food and Drug Administration at http://www.fda.gov/cder/drug/infopage/vioxx/vioxxQA.htm)
Q: What is Vioxx?
A: Vioxx is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) used, primarily, for arthritis and acute pain relief. Vioxx is also related to over-the-counter NSAIDs, such as ibuprofen and naproxen. Vioxx was available only by prescription.
Q: What were the likely long-term health effects of taking Vioxx?
A: Studies showed that Vioxx may cause an increased risk of heart attack and stroke.
Q: When was Vioxx withdrawn from the market?
A: Merck & Co., the drug’s manufacturer, announced that it would voluntarily withdraw Vioxx from the worldwide market on Sept. 30, 2004.
Q: Did the government ban Vioxx?
A: No, Merck made the decision to withdraw the drug.
Q: What evidence supported the withdrawal of Vioxx from the market?
A: Merck’s based its decision to withdraw Vioxx from the market on data from a trial called APPROVe (Adenomatous Polyp Prevention on VIOXX). In the APPROVe trial, Vioxx was compared to a placebo. The purpose of the trial was to see if Vioxx 25 mg 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 attacks and strokes, first observed after 18 months of continuous treatment with Vioxx compared with placebo.
Q: Why wasn’t the APPROVe trial stopped earlier?
A: 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 confirmed cardiovascular events on Vioxx.
Q: Did the FDA know about the risk of heart attack and stroke when it approved Vioxx?
A: The FDA originally approved Vioxx in May 1999. The original safety database included approximately 5,000 patients on Vioxx and did not show an increased risk of heart attack or stroke. A later study, called 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.
Q: Can my pharmacist continue to fill prescriptions for Vioxx?
A: No. Merck withdrew the drug from the market, which also meant that it would no longer be available at pharmacies.
Q: What other drugs are similar to Vioxx?
A: Vioxx is a COX-2 selective NSAID. The only other COX-2 selective NSAID on the market in the U.S. at this time is Celebrex (celecoxib), marketed by Pfizer. It is only available by prescription. Patients who have had allergic reactions to either aspirin or sulfa should not take Celebrex.
Bextra (valdecoxib) was removed from the market by its manufacturer, Pfizer, on April 7, 2005 because it too was linked to increased risk of heart attack and stroke.
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.
Q: Are other drugs in this class dangerous too?
A: 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.
Q: Where can I get more information on Vioxx?
A: Visit the Merck Web site at www.merck.com and www.vioxx.com or call 1-888-36VIOXX (1-888-368-4699). The FDA has more information on its Drug Information web page at: www.fda.gov/cder and by calling 888-INFO-FDA (888-463-6332).