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A series of Vioxx alert statements regarding the safety of this non-steroidal anti-inflammatory drug (NSAID) has been issued since this drug was first approved by the FDA in 1999. The biggest Vioxx alert came on September 30, 2004, when Merck announced that they were voluntarily pulling their top selling pain reliever off the shelves for good. This Vioxx alert sparked widespread concern about the overall safety of all NSAIDs and prompted hundreds of lawsuits against Merck for failing to adequately inform consumers about the serious side effects associated with Vioxx use.
Vioxx and other drugs of its class were originally developed in an effort to create a pain reliever without the harmful gastrointestinal side effects associated with original NSAIDs like ibuprofen and naproxen. A study released in 2000, called VIGOR, was designed to measure the gastrointestinal effects of Vioxx compared to naproxen. No major Vioxx alert was issued as a result of this study, as results indicated that Vioxx posed less of a gastrointestinal risk than naproxen.
This study did, however, show some evidence that Vioxx patients had a greater risk of suffering cardiovascular side effects, compared to patients who were taking naproxen. Of the 8,000 Vioxx patients who participated in this study, twice as many suffered heart attacks and strokes as compared to those taking naproxen. Merck did not issue a Vioxx alert about cardiovascular risks at this time, instead arguing that naproxen may somehow prevent adverse cardiovascular events.
In 2004, prompted by Vioxx alert statements concerning this drug's cardiovascular safety, the FDA launched a review of 1.4 million HMO patient's medical records. This investigation revealed that patients taking Vioxx were at a greater risk of suffering cardiovascular side effects than patients taking Celebrex or older painkillers. Doctors, patients, and federal regulators were on high Vioxx alert as concerns mounted over the serious side effects associated with Vioxx use.
A study that was initiated in 2000, called APPROVe, was designed to test Vioxx's effects on colon polyps. Eighteen months into this trial, researchers halted their study after findings revealed that patients who were taking Vioxx were twice as likely to suffer a heart attack or stroke as compared to other trial participants. This Vioxx alert was further heightened when findings indicated that patients taking 25 milligrams of Vioxx or more were three times more likely to suffer serious cardiovascular injury.
This culminating Vioxx alert forced the drug's manufacturer to recall this product in an effort to protect the health of consumers worldwide. Arguably, the cardiovascular risks associated with Vioxx have been clear since before this drug was ever approved for use in the United States. For this reason, Merck has been charged in numerous lawsuits with willfully withholding evidence regarding serious Vioxx side effects. Over 900 plaintiffs were named in about 300 Vioxx lawsuits in the first fifteen days following the Vioxx alert recall.
For more information on the Vioxx alert recall and your legal rights, please contact us.
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.