Arthritis Drug Vioxx Pulled Off MarketMerck Pulls Vioxx From Shelves Worldwide

Sept. 30, 2004 -- Merck Pharmaceutical voluntarily pulled its popular anti-inflammatory drug Vioxx from shelves worldwide today after concerns it increases risk of stroke and heart attack.

The move comes after a recent clinical trial linked the arthritis drug to these potentially fatal conditions. The company says trial data show an increased risk of heart attack and other cardiovascular problems began 18 months after patients started taking Vioxx. The study did not show any increased risk of confirmed problems in the first 18 months.

The three-year study of 2,600 people was initially targeted to show that Vioxx at a 25-milligram dose prevents recurrence of polyps in the colon and rectum. But it was stopped early after Merck discovered a higher risk of heart attack and stroke associated with the medication.

"We are taking this action because we believe it best serves the interests of patients," says Raymond V. Gilmartin, Merck's chairman, president, and chief executive officer.

This is not the first time there has been evidence linking Vioxx to heart attack. A study earlier this year showed that patients taking more than 25 milligrams a day had triple the risk for heart problems. Another study showed that Vioxx doubled the risk of heart attack in patients taking blood pressure medication.

Vioxx has been one of Merck's blockbuster drugs in a class of Cox-2 inhibitors, which are used to relieve arthritis and joint pain.

Merck says patients who are currently taking Vioxx should contact their health care provider to discuss discontinuing Vioxx and possible alternative treatments. Patients and health care providers can obtain more information by calling (888) 36-VIOXX (1-888-368-4699).

"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," says acting FDA Commissioner Lester M. Crawford, MD, in a news release.

"Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."

The FDA says it will closely monitor other drugs in this class for similar side effects. "All of the NSAID [non-steroidal anti-inflammatory] drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician," says Crawford.

Worldwide sales of Vioxx in 2003 were $2.5 billion. Merck says it expects a significant drop in its stock price following today’s news. Since the close of business yesterday, Merck’s stock price has fallen by more than 25%.