Vioxx Lawsuit Help

Vioxx Recall

The 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. Later, Vioxx was also approved to treat the signs and symptoms of rheumatoid arthritis in adults and children.

The multi-billion dollar share of the arthritis and pain relief market Vioxx was able to achieve before the September 30, 2004 Vioxx recall was announced has been widely criticized. Two million Americans were taking the Merck & Co. drug when news of the Vioxx recall broke. Now, both Merck and the FDA have come under heavy attack by critics wondering how Vioxx was able to remain on the market for so many years despite safety questions upon approval that continued to surface until the Vioxx recall.

The Vioxx recall decision was made after a new study found a higher rate of heart attacks and strokes in patients taking the drug than those on a placebo. The study was not the first indicator that Vioxx had major safety concerns. The day of the Vioxx recall, acting director of the FDA’s Center for Drug Evaluation and Research, Steven Galson said the announcement was not a total surprise and the agency had been concerned and aware of cardiovascular safety concerns linked to Vioxx for the previous several years.

Vioxx is part of a fairly new class of NSAIDs (non-steroidal anti-inflammatory drug) called COX-2 inhibitors. The advantages of COX-2 inhibitors are not that they are more effective than traditional NSAIDs, but that the y might have a decreased risk of bleeding and other digestive tract complications. Still, unconvinced they were safer, the FDA approved COX-2 inhibitors, b ut still required that they include the same digestive warning as the NSAIDs had. Merck then attempted to prove Vioxx should not be included with other NSAIDs. Merck launched a trial in hopes of distinguishing Vioxx from traditional NSAIDs. Unexpectedly, this study showed that the drug doubled the risk of cardiovascular problems, which the Merck could no longer ignore.

These cardiovascular events, surfacing just after Vioxx was approved, have been heavily scrutinized in light of the Vioxx recall. Critics have questioned the FDA for failing to take these initial warning signs seriously and requiring further studies be performed, and Merck has been accused of spinning the data. Merck continued to argue Vioxx did not cause cardiovascular problems but that naproxen protected against them, making the trial results appear inconsequential. Even as Merck continued to defend the Vioxx trial results for the next 4.5 years, the company acknowledged in its March 2000 press release that the beneficial naproxen effect had not been previously observed in any other clinical studies.

Safety concerns continued to crop up over the years, requiring Merck to send doctors a letter to clear up “false or misleading impressions and information” in February 2001 and a labeling change noting a possible link to heart attacks and strokes in April 2002. Until a month before the Vioxx recall, Merck continued to minimize findings that questioned the safety of Vioxx. Merck was no longer able to defend Vioxx when its own three-year sponsored randomized trial with 2,600 patients comparing Vioxx to a placebo was stopped early after finding Vioxx increased risk of heart attack and stroke.

Marketed in more than 80 countries with sales totaling $2.5 billion in 2003, the Vioxx recall has affected a high number of people. Merck has said the study results leading to the Vioxx recall will be released at a meeting of specialists in late October 2004.

For more information on the Vioxx recall, please contact us to confer with an attorney.

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