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Aventis issues drug warning in Japan

Published on 28/01/2004

PARIS, Jan 28 (AFP) - The Franco-German pharmaceutical group Aventis has issued a warning to Japanese health officials following the death of five patients who used its anti-rheumatism treatment Arava, a company spokesman told AFP.

Aventis recommended that patients suffering from lung illnesses stop using the drug, said David Owens, head of Global Products Communications at Aventis Pharma in the United States.

He denied, however, a German newspaper report that the company had told Japanese hospitals to stop administering Arava, which went on sale there in 2003 after being launched in 1998 in the United States and a year later in Europe.

Warnings about possible side effects from the medication already feature on boxes sold in the US and Europe.

“For recently approved drugs in Japan, it is requested that a post-marketing surveillance should be applied on at least 3,000 patients,” Owens said.

“We followed 3,412 patients. Sixteen of them reported an interstitial pneumonitis; five of them died,” he said.

“We still don’t know if the casualties can be attributed or not to the Arava therapy. We are trying to understand what happened.

“All these patients had active lung diseases, but there is no evidence of an increased risk with the Arava therapy.”

Arava is taken by about 595,000 people a year, Owens said.


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