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Vioxx Warning

Many argue that Vioxx warning statements should have been heeded much sooner than the recall of this dangerous pain medication. Vioxx was approved by the FDA in 1999 as an effective treatment for chronic pain conditions like rheumatoid and osteoarthritis and menstrual cramps. No Vioxx warning statements were made to the public by the FDA or the drug's maker, Merck, to educate patients about the potential risks associated with this defective drug.

There were several Vioxx warning statements issued prior to the recall of this medication that are now receiving attention from injured consumers, the pharmaceutical industry, the FDA, and others. These groups are asking the question, "Why was nothing done sooner to warn consumers about the grave risks associated with Vioxx?" One reasonably construed conclusion is that Merck purposely downplayed the Vioxx warning claims of serious risks associated with their product and continued to aggressively market Vioxx as a safe and effective pain reliever.

Despite findings gathered in 2001 indicating a serious Vioxx warning, Merck still refused to acknowledge and inform consumers about the serious and fatal risks associated with this COX-2 non-steroidal anti-inflammatory drug (NSAID). The company sponsored a clinical trial called VIGOR designed to compare the gastrointestinal effects of Vioxx and naproxen, a traditional NSAID. The results, published in 2001, showed a significant risk of stroke, heart attack, and other serious side effects among the Vioxx trial participants.

Arguably, this Vioxx warning should have prompted an immediate investigation of the risks associated with Vioxx. Instead of taking the Vioxx warning seriously, Merck decided to downplay the risks and argue that these clinical findings were not worthy of further investigation. In September 2001, two years before the Vioxx recall, a member of the FDA sent a Vioxx warning letter to Merck, expressing concern over their advertising practices and lack of actionable concern in response to the VIGOR study.

In this Vioxx warning letter the FDA representative expressed serious concern about Merck's practices. The letter stated that, after a review of their promotional activities and materials, the FDA, "has concluded that they are false, lacking in fair balance, or otherwise misleading in violation of federal law." The Vioxx warning from the FDA tells Merck that they have "engaged in a campaign that minimizes the potentially serious cardiovascular findings of the VIGOR study." Despite this Vioxx warning letter, Merck took no measures to investigate the dangers of their product or protect the health and lives of millions of consumers.

In 2004, Merck finally recalled their defective product after another study found that Vioxx caused heart attacks and strokes. While consumers are no longer in danger of suffering the effects of Vioxx, many are dealing with the devastating aftermath of serious injury as a result of Vioxx side effects. If you would like to learn more about the Vioxx warning, please contact us to speak with a qualified and experienced attorney who can evaluate your case to determine your legal rights and options.

More Vioxx Resources

MedLine Plus Drug Information - Guide to prescription and over-the-counter medications provided by the United States Pharmacopeia.

Vioxx.com - Official Vioxx Roxecofib site from Merck.

Vioxx Drug Warnings - Vioxx side effects information including lawsuit information and vioxx warnings.

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