Merck & Co., Inc, a research-based pharmaceutical company, launched Vioxx in the United States in 1999. Vioxx was designed to reduce the signs and symptoms of osteoarthritis, relieve acute pain in adults, and treat primary dysmenorrhea (painful menstrual periods). Eventually it was also approved for juvenile rheumatoid arthritis. Vioxx was marketed extensively and aggressively in the US and in over 80 countries as a stronger, safer alternative to over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs). In 2004, Merck estimated that over 100 million prescriptions were filled for approximately 20 million people.

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The main Vioxx claim was that it provided the relief of other types of pain medications, but without gastrointestinal (GI) side effects like bleeding that sometimes came with other types of medicines, e.g. – naproxen. This was a major improvement on other NSAIDs that were approved by the FDA. Vioxx passed initial mandatory safety testing, and went on the shelves after it was proven to have fewer GI side effects in FDA testing.

Despite its short-term approval, some users who took the drug consistently began having side effects soon after the drug was released. Through testing, Vioxx was found to be associated with a doubled risk in heart attack and stroke. The drug appeared to damage certain compounds in the blood that increased the risk of blood clots and thus, heart attacks, strokes, and other cardiovascular problems. These drug side effects rendered insignificant the main Vioxx claim of reduced GI problems.

Many users later discovered that Merck Pharmaceuticals had either conducted or was aware of testing in addition to the pre-marketing approval tests mandated by the FDA. Merck was aware of test results showing an increased risk of cardiovascular (CV) events such as heart attacks and strokes soon after putting the product on the shelves. More tests were done later to confirm that these Vioxx drug side effects were significant - at least doubled the risk for CV events after 18 months. The FDA gave out numerous warnings/advisories to Merck, including first a warning to stop advertising the drug as safe, then a warning requiring that Merck notify health professionals of the increased CV events risk, then by requiring that the packaging and labeling of Vioxx carry information about the risk, and finally by advising Merck to pull the product off the market. Merck pulled the product in late September 2004. On November 3, 2005, Merck, in a press release, announced that a state court in New Jersey had returned a defense verdict in Humeston v. Merck, rejecting the claims of an Idaho resident who alleged he suffered a heart attack in 2001, at the age of 56, as a result of intermittent use of VIOXX over a two-month period.

For more information, see Why was Vioxx prescribed? Was Vioxx approved by the FDA? What are the adverse
side effects of taking Vioxx? Why was it recalled?.

Suffered harm from Vioxx? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.