WHO Drug Information Vol. 16, No. 2, 2002
(2002; 91 pages) View the PDF document
Table of Contents
Open this folder and view contentsHerbal Medicines
Open this folder and view contentsCurrent Topics
Open this folder and view contentsGood Clinical Practices
Open this folder and view contentsSafety Information
Close this folderRegulatory Action
View the documentAlosetron hydrochloride: restricted marketing
View the documentBaclofen: abrupt discontinuation dangerous
View the documentIrinotecan: prescribing changes
View the documentSodium oxybate/GHB approved for cataplexy
View the documentRofecoxib: new indication and label changes
Open this folder and view contentsEssential Medicines
Open this folder and view contentsRecent Publications and Sources of Information
View the documentProposed International Nonproprietary Names: List 87

Rofecoxib: new indication and label changes

United States of America - The Food and Drug Administration has approved new labelling text and precautions for rofecoxib based on the results of the Vioxx Gastrointestinal Outcomes Research (VIGOR) study.

The VIGOR study, a prospective, randomized, double-blind, one year study, evaluated approximately 4000 patients on rofecoxib 50 mg a day (twice the highest approved dose for chronic use) and approximately 4000 patients on the standard dose of naproxen, 1000 mg a day, a nonsteroidal anti-inflammatory drug (NSAID). Patients who were under treatment with low dose aspirin for heart attack prevention were excluded from the study.

The study demonstrated that rofecoxib was associated with a lower incidence of serious upper gastrointestinal(GI) adverse events of major bleeding, perforation and obstruction compared to naproxen. The reduction in risk was over 50 percent in cumulative rates for rofecoxib (.52%) compared to naproxen (1.22%).

An additional finding in the study, however, was that there was a higher cumulative rate of serious cardiovascular thromboembolic adverse events (such as heart attacks, angina pectoris, and peripheral vascular events) in the rofecoxib group (1.8%) compared to the naproxen group (0.6%). Data from two smaller studies comparing placebo and rofe-coxib 25 mg daily did not show a difference in the rate of serious cardiovascular thromboembolic adverse events. The relationship of the cardiovascular findings in the VIGOR study to use of rofecoxib is not known.

After carefully reviewing the results of the VIGOR Study, FDA agreed with the Arthritis Advisory Committee recommendations of February 8, 2001 that the label for Vioxx® should include gastrointestinal and cardiovascular information. The committee advised that the NSAID-class warning regarding GI adverse events should be modified, but not removed, from the VIOXX® label. This warning advises patients and their doctors about the risks of GI ulcers, bleeding, and perforation.

The committee also advised that the CV findings should be included in the Vioxx® label to provide doctors and patients with the available data on the potential risks and benefits compared to naproxen. The new labelling information approved by FDA will advise doctors to use caution in prescribing rofecoxib for patients with ischemic heart disease and notes that rofecoxib 50 mg is not recommended for chronic use.

In addition, the geriatric section of the label will reinforce information in the existing standard warning section of all NSAIDs indicating that the elderly are at higher risk of serious GI and renal events such as GI bleeding and acute renal failure.

The Food and Drug Administration has approved a supplemental application for the use of rofecoxib (Vioxx ®) for rheumatoid arthritis in addition to the previously approved indications for osteoarthritis and pain. The new label also provides information from studies of patients with rheumatoid arthritis at the chronic dose of 25 mg rofecoxib compared to naproxen.


1. FDA Talk Paper, T02-18, 11 April 2002

2. Letter from Merck & Co. Inc. dated April 2002 http://www.fda.gov


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