This article is part of the Arthritis Archives.
Dateline: September 30, 2004
The Recall
Arthritis drug Vioxx (Rofecoxib) has been voluntarily recalled by Merck & Co Inc. worldwide.
The move to pull the COX-2 inhibitor off the market on September 30, 2004 shocked the arthritis world and rocked the stock value of Merck.
The Reason
The decision to recall Vioxx followed a three year trial, known as APPROVe (Adenomatous Polyp Prevention on Vioxx), which was 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 begain 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.
The History
Merck CEO Rymond 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 has been marketed in 80 countries and used by 84 million people worldwide.Vioxx has been scrutinized for a potential heart risk for several years, but until now Merck maintained the drug was safe. As recently as April, 2004 the FDA also 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?
What Should You Do?
Merck is urging people to follow their websites for more information at www.merck.com and www.vioxx.com, plus an information hotline has been set up at 1-888-36-VIOXX. If you have been taking Vioxx, you should call your doctor to discuss discontuing the drug and possible alternatives. All dosages and formulations of Vioxx are involved in the recall. Merck will reimburse patients for their unused Vioxx.
What Lies Ahead?
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 are existing lawsuits filed against Merck because of Vioxx and some analysts predict there will be more provoked by the recall. What will this mean for other COX-2 inhibitors? It is expected to impact them in some way. Will it cause a surge in the popularity and use of Celebrex (Celecoxib) and Bextra (Valdecoxib)? Will Novartis' yet-to-be approved Prexige (Lumiracoxib) be affected? Even Merck has another COX-2 inhibitor, Arcoxia (Etoricoxib) , which has been highly-anticipated and expected to get FDA-approval soon.
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
Related Resources
- Vioxx (rofecoxib)
- COX-2 Selective Inhibitors
- NSAIDs(nonsteroidal anti-inflammatory drugs)
- Arthritis Medications
Sources: Merck.com Newsroom Press Release 09/30/2004, <www.vioxx.com/vioxx/documents/english/information_for_patients.pdf>,Information For Patients Taking Vioxx (pdf),<http://www.vioxx.com/vioxx/documents/english/patient_faq.pdf>Frequently Asked Questions About The Recall For Patients (pdf),<http://www.vioxx.com/vioxx/documents/english/patient_refund_instructions.pdf>Instructions For Patients On How To Receive Refund For Unused Vioxx (pdf
First Published: September 30, 2004
