Vioxx was approved for pain relief of osteoarthritis, rheumatoid arthritis, short-term pain, menstrual pain, migraine headaches, and juvenile rheumatoid arthritis. The main draw of Vioxx was that it was not perceived as causing gastrointestinal side effects. However, it is worth noting that due to lack of long-term studies on gastrointestinal side effects, Vioxx was required to carry the same warnings as other pain relievers such as aspirin. It is also worth noting that Vioxx did nothing to treat arthritis – it only relieved the pain associated with arthritis.
Vioxx was approved for consumer use by the FDA in 1999. Shortly thereafter, however, the first side effects were noticed and the first lawsuits were filed in 2001. After several warnings from the FDA, Merck Pharmaceutical, the manufacturer of Vioxx, finally pulled Vioxx from the marketplace in 2004.
Merck Pharmaceuticals, the manufacturer of Vioxx, conducted testing before bringing the drug to market; however, while tests indicated that patients taking Vioxx may have an increased risk for heart attack and stroke, Merck chose to ignore the study results. Over the next few years, other studies were done, all of which showed that patients taking Vioxx were, at a minimum, at twice the normal risk for heart attack and stroke. The FDA responded to these studies by first telling Merck to stop advertising the drug as being safe; next by requiring Merck to send letters to prescribing physicians, warning of the dangers associated with the drug; third, by requiring Merck to change packaging and label warnings to emphasize the increased danger of heart attack and stroke; and finally by requiring Merck to pull the drug from the market.
Vioxx has been found to double a patient’s chance of heart attack or stroke. Vioxx appears to damage lipids, the fatty compounds found in blood, so that they more easily form blood clots, leading to heart attack or stroke. Heart attack, stroke, and other cardiovascular problems can lead to either permanent disability or death.