FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
| T02-18 | Media Inquiries: 301-827-6242 |
| April 11, 2002 | Consumer Inquiries: 888-INFO-FDA |
FDA has approved a supplemental application for the use of Vioxx (rofecoxib) for rheumatoid arthritis adding the indication to the previously approved indications for osteoarthritis and pain. FDA has also approved new label text and precautions that are based on the results of the Vioxx Gastrointestinal Outcomes Research (VIGOR).
The VIGOR study, a prospective, randomized, double-blind, one year study, evaluated approximately 4000 patients on Vioxx 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 non-steroidal 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 Vioxx 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 Vioxx (.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 Vioxx group (1.8%) compared to the naproxen group (0.6%). Data from two smaller studies comparing placebo and Vioxx 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 Vioxx 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 the 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 of Vioxx compared to naproxen. The new labeling information approved by FDA will advise doctors to use caution in prescribing Vioxx for patients with ischemic heart disease and notes that Vioxx 50 mg is not recommended for chronic use.
In addition, the new label provides information from studies of patients with rheumatoid arthritis at the chronic dose of 25 mg, showing that Vioxx was associated with a higher incidence of hypertension compared to naproxen 1000 mg.
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.
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