OVERVIEW

Merck & Co. withdrew its arthritis drug Vioxx from sales worldwide Thursday because an ongoing trial confirmed the medication increases the risk of heart attack and strokes.

The Whitehouse Station, N.J.-based drugmaker said the immediate withdrawal was based on data from a three-year colon cancer clinical trial that showed a heightened risk of cardiovascular complications began 18 months after patients started taking Vioxx rather than dummy pills.

The colon cancer trial of 2,600 patients began in 2000 and was designed to evaluate the effectiveness of the standard 25-milligram Vioxx dose in preventing recurrence of colon polyp, which can become cancerous.

People who are currently taking Vioxx should consult their healthcare provider about the ongoing treatment using Vioxx and should also obtain information on alternative treatments.

Separately, the Food and Drug Administration (FDA) announced Thursday it will closely watch drugs in the same class as Vioxx for any signs they might raise the risk of serious heart problems. Merck had received FDA approval for Vioxx prior to the commencement of the cancer clinical trial.

Merck launched Vioxx in the United States in 1999 and it has been marketed in more than 80 countries. The drug's worldwide sales in 2003 were $2.5 billion.

The arthritis medicine essentially works on an affected area by decreasing and inhibiting inflammation and pain.

Vioxx sales have suffered in recent years after past clinical test results indicated the medicine increased the risk of blood clots, leading to heart attacks and strokes.

Regarding Vioxx's competing drugs Celebrex and Bextra, Reed advised that people consult their health care provider to see if similar concerns are now valid with respect to those two drugs.

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