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Article Excerpt
In September 2003, Aventis SA introduced its drug Arava to patients in Japan. The Franco-German pharmaceutical company's treatment for rheumatoid arthritis (RA) had been available in the United States and Europe for five years, and despite a labeling change and reports of severe infections in patients taking the drug, Japanese health officials approved its use without requiring the manufacturer to conduct a clinical trial in their country. Instead, they required Aventis to monitor the first 3,000 patients who took the drug.
In January, the company announced that 16 people in Japan had developed interstitial pneumonia while taking Arava--and 5 of them had died. It also said that more than 80 people worldwide had developed the chronic lung infection and that doctors should no longer prescribe the medication to patients with respiratory problems.
Arava is only one of several drugs developed to treat rheumatoid arthritis that are attracting the attention of the FDA and plaintiff attorneys because of severe infections in patients taking them. Lawyers and clients across the country are assessing the risks associated with these drugs and questioning whether the drug companies' warnings are adequate.
"Many patients say, look, I had arthritis, but the drug made me worse, and I spent months in the hospital for tuberculosis. Is that enough to make the drug defective?" said Christine Brandt of Birmingham, Alabama, who represents several clients injured by...
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