FYI --
Aventis: 5 Japanese die after taking drug
The Associated Press
1/27/2004, 12:30 p.m. ET
TOKYO (AP) — Franco-German pharmaceutical company Aventis SA said Tuesday that five Japanese have died after taking its arthritis drug and said it has warned doctors against prescribing it to patients with respiratory problems.
It has not been confirmed whether the drug, Arava, caused the deaths, but doctors in two cases believe the medication may have been responsible, said Yota Kikuchi, a spokesman at the company's Tokyo-based subsidiary, Aventis Pharma Japan.
Sixteen people developed interstitial pneumonia, a debilitating lung condition, after taking Arava. Five of them, aged between 57 and 71, subsequently died, Kikuchi said.
The company has warned doctors not to prescribe the drug to patients with respiratory problems, a history of interstitial pneumonia or lung problems. It also advised that x-rays be conducted on any patient who is to receive the drug for the first time, Kikuchi said.
"We were aware of the side effects ... but we did not imagine such a frequency. We will promptly investigate whether the drug was responsible," Aventis Pharma Japan's Vice President Masaki Noguchi said.
Since its launch in Japan last September, some 3,400 people have taken the drug, which is generically known as leflunomide and is used to treat rheumatoid arthritis — a chronic illness that can result in inflammation of the joints, stiffness, loss of movement and sometimes deformity.
The drug has been administered to some 400,000 people worldwide, of which 80 people have developed interstitial pneumonia, Kikuchi said.
Arava first went on sale in 1998 in the United States and has since been made available in 72 countries. In 2002, worldwide sales of Arava were worth 31.9 billion yen ($300 million), according to a company statement.
