What action did Vioxx manufacturer Merck take? Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib).

What action did FDA take today? FDA issued a public health advisory concerning the use of Vioxx. This advisory is based on Merck & Co., Inc. voluntarily withdrawing Vioxx from the market due to safety concerns.

Why did they do this? Because they found there was an increased risk for serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment with Vioxx compared with placebo.

What should I do if I am currently 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 physician to discuss discontinuing use of Vioxx and alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specific treatment needs.

6. What are the likely long-term health effects, if any, of taking this product? The new study shows that Vioxx may cause an increased risk in cardiovascular events such as heart attack and strokes during chronic use.

7. What evidence supports the Public Health Advisory? Merck's decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe [ Adenomatous Polyp Prevention on VIOXX trial. In the APPROVe trial, Vioxx was compared to placebo (sugar-pill). 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 for serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment with Vioxx compared with placebo.

8. 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 (DSMB). 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.

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