Warnings -- COLUMNS-Drugs & Supplements -- February 2004

Five Japanese Patients Die after Using Rheumatoid Arthritis Drug

Aventis Pharmaceuticals warned physicians in Japan against prescribing Arava to patients with respiratory problems after five participants involved in a postmarketing study of the rheumatoid arthritis drug died after developing interstitial pneumonitis.

Although the manufacturer contends that there is no causal link between Arava and the deaths, it planned to file a report with the FDA regarding the incidence, a company spokesperson stated.

"We will be communicating with the FDA once we have these data better analyzed," J. David Owens, head of Global Product Communications for Aventis' U.S.-based subsidiary, told …