On September 30, 2004 the manufacturer of Vioxx withdrew the drug from the market because of safety concerns.

Vioxx, a once-popular prescription painkiller, was removed from the market because of concerns it increased the risk of heart attacks and stroke among patients.

Vioxx is a rofecoxib-based drug that is administered orally. Vioxx was used as treatment for osteoarthritis, rheumatoid arthritis, acute pain and dysmenorrhea.

People who took Vioxx may have experienced a heightened risk of conditions including heart attacks and sudden cardiac death.

These side effects may result in death or serious long-term complications. Click on Warnings and Side Effects for more information on Vioxx side effects.

Vioxx was removed from the market after a long-term study found an increased risk of serious cardiovascular events – including heart attacks and stroke– among patients who took the medication.

The voluntary removal of the drug from the market by Merck & Co. was announced Sept. 30, 2004 by the U.S. Food and Drug administration. (See FDA news release below.) The study of the drug, conducted by Merck using patients who took Vioxx (chemical name rofecoxib) and others given a placebo, suggested that some Vioxx users face twice the risk of suffering a heart attack.

Kline & Specter, PC, with more than 40 experienced attorneys (five of whom are also highly regarded doctors), is one of the nation's leading law firms involved in pharmaceutical injury litigation. At this time we are no longer accepting cases involving Vioxx side effects.

Background: Vioxx was approved in the late 1990s and immediately surged toward the top of the drug sales charts as the latest and greatest in pain medication. “Wonder drugs,” some called the new class of pain medication. Vioxx, which can be taken just once in a 24-hour period, was considered more effective than traditional pain killers and to cause fewer gastrointestinal side effects.

But as Vioxx became widely used, problems began to arise, including serious heart ailments. One source of the information was the study sponsored by Merck.

The company had set out in its study to confirm the relative gastrointestinal benefits of Vioxx when compared to another pain medicine, naproxen. And the company’s study did show that patients who took Vioxx had fewer ulcers and other stomach ailments. But there was also an unexpected and alarming finding: those who took Vioxx had a greater tendency to experience serious cardiovascular events.

In Vioxx and naproxen test groups with more than 4,000 patients in each, Vioxx users suffered 101 “serious cardiovascular events” and 20 myocardial infarctions. That compared to 46 naproxen users who had cardiovascular events and only four who suffered heart attacks.

Subsequent articles published in medical journals also stated that Vioxx – a Cox-2 inhibitor – may increase the risk not only of heart attack but also stroke and kidney failure. (Less importantly, questions also have been raised about whether the drug is actually more effective in treating pain.)

In 2001, the U.S. Food and Drug Administration took action. While not removing Vioxx from the market at that time, the federal agency issued a “Warning Letter” about the medication. It told Merck that its review of the company’s promotional activities and materials for Vioxx were “false, lacking in fair balance or otherwise misleading.” The FDA also blasted Merck for minimizing and omitting important risk information about using Vioxx in tandem with other drugs.

FDA News Release
September 30, 2004
FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily
Recalls the Product

The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.

"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," said Acting FDA Commissioner Dr. Lester M. Crawford. "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."

Dr. Crawford added that FDA will closely monitor other drugs in this class for similar side effects. "All of the NSAID 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."

FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of NSAID (Cox-2 selective) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.

At the time that Vioxx and other Cox-2 selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects.

Merck contacted FDA on September 27, 2004, to request a meeting and to advise the agency that the long-term study of Vioxx in patients at increased risk of colon polyps had been halted. Merck and FDA officials met the next day, September 28, and during that meeting the company informed FDA of its decision to remove Vioxx from the market voluntarily.

In June 2000, Merck submitted to FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. After reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new safety information. In April 2002, FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke.

Recently other studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. FDA was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market.


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