The decision to recall Vioxx followed a three year trial, known as APPROVe (Adenomatous Polyp Prevention on Vioxx), a multi-center, randomized, placebo-controlled, double-blind study to determine the effect of Vioxx on the recurrence of neoplastic polyps of the large bowel in patients with a history of colorectal adenoma. The trial which began in 2000, involved 2,600 patients and compared Vioxx 25 mg. to placebo. The study revealed that an increased risk of cardiovascular complications began 18 months after patients started taking Vioxx.
Merck CEO Raymond Gilmartin said, "We are taking this action because we believe it best serves the interests of patients." Vioxx, which was launched in the United States in 1999 for the treatment of arthritis, had been marketed in 80 countries and used by 84 million people worldwide.
Vioxx had been scrutinized for a potential heart risk for several years, but until the recall, Merck maintained the drug was safe. Earlier that year, in April 2004, the FDA approved Vioxx for the acute treatment of migraine attacks. In addition, on September 8, 2004, an indication for the treatment of juvenile rheumatoid arthritis was added for Vioxx.
- FDA Advised on Celebrex and Vioxx
- Vioxx: New Evidence Again Links Arthritis Drug to Heart Problems
- COX-2 Inhibitors: Safe for Patients With Heart Disease?
Merck urged people to follow their websites for more information at www.merck.com and www.vioxx.com, plus an information hotline was set up. All dosages and formulations of Vioxx were involved in the recall.
What Lies Ahead?
At the time of the recall, acting FDA Commissioner Dr. Lester M. Crawford stated in a press release that the FDA will closely monitor other drugs in this class for similar side effects. Crawford added, "All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician."
There were many lawsuits filed against Merck because of Vioxx.Note: On April 7, 2005, The U.S. Food and Drug Administration announced actions that were taken regarding the marketing of NSAIDs (non-steroidal anti-inflammatory drugs). These actions included changes for COX-2 inhibitors, as well as prescription and non-prescription (over-the-counter) NSAIDs. See: FDA Announces Changes for All NSAIDs; Bextra Withdrawn From Market
On August 19, 2005, the first Vioxx lawsuit was decided. The jury held Merck liable and awarded $253.4 to the widow of Robert Ernst, a Wal-Mart employee who died of a heart attack while taking Vioxx. See: Jury Holds Merck Liable in Wrongful Death Case
On Nov. 3, 2005, a state court jury in New Jersey returned a defense verdict in Humeston v. Merck by rejecting the claims of an Idaho resident who used Vioxx. See: Jury Finds Merck Not Liable in Second Vioxx Case
On Dec. 8, 2005, NEJM (The New England Journal of Medicine) dropped a bombshell in an editorial alleging that Merck withheld data and information that would affect conclusions drawn in the manuscript about the VIGOR (Vioxx Gastrointestinal Outcomes Research) study which appeared in the NEJM on November 23, 2000. See: Merck Withheld Pertinent Information About Vioxx
On Dec. 12, 2005, a federal court jury in Houston, Texas could not return a verdict in Plunkett v. Merck and is prepared for a retrial, if that becomes necessary. See: Hung Jury in First Federal Vioxx Product Liability Trial
Merck.com Newsroom Press Release 09/30/2004.
First Published: September 30, 2004