Editor note: On 09/30/2004, Merck the maker of Vioxx, issued a worldwide recall, halting sales of the drug. On 04/07/2005, Following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. See: Questions & Answers: FDA Actions On COX-2 Inhibitors & NSAIDs Fallout from the Vioxx recall will continue for years to come.
Dateline: August 26, 2004
More red flags
In the past few years, study results have raised red flags about an association between the arthritis drug Vioxx (rofecoxib) and side effects involving potential heart problems. The link has caused sales of the drug to sag, arthritis patients to be concerned, and doctors to be cautious.
Based on a large study financed by the Food and Drug Administration (FDA) and reported at an epidemiology conference in France on August 25, 2004, one of the largest U.S. health maintenance organization's, Kaiser Permanente, is reconsidering its use of Vioxx.
About the study
In the study:
- Medical records of 1.4 million people insured by Kaiser Permanente were analyzed.
- The outcomes of 40,405 patients who took Celebrex (Pfizer's arthritis drug) and 26,748 patients who took Vioxx (Merck's arthritis drug) were compared.
- Patients taking the typical starting dose of Vioxx had a 50 percent greater chance of heart attacks and sudden cardiac death than patients taking Celebrex.
- Patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as patients not taking standard painkillers.
Most users of Vioxx take daily doses of 12.5 or 25 mg. for arthritis. A 50 mg. dose has been FDA-approved for the treatment of pain for no longer than five days.
Merck responds
Merck representatives questioned the accuracy of "observational" studies which differ from randomized, controlled clinical trials. In their own 8,000 patient pre-market trial of Vioxx, more than two times the number of patients taking Vioxx had heart attacks and strokes than patients taking naproxen (one of the older NSAIDS). Merck claimed Vioxx did not cause the heart attacks but that naproxen prevented them. Other subsequent smaller trials by Merck did not conclude there was greater risk of heart attack versus rival drug Celebrex.
The FDA will review the most recent data and decide if any recommendations need to be made or actions taken. To emphasize their strong disagreement with the conclusions of the observational analysis, Merck issued a press release to explain its position.
Related Resouces
Source: Product Press Release, Merck Newsroom, 08/26/2004
First published: 8/26/2004
