Warnings -- Columns-Drugs & Supplements -- December 2003

Arava Manufacturer Strengthens Warnings on Liver Damage

Aventis, the manufacturer of the rheumatoid arthritis drug Arava, recently issued a letter to health care professionals informing them that the drug could, in rare cases, cause severe liver damage.

The letter, which was issued to doctors in October, stated that the company was strengthening the warnings in the products package insert to reflect post-marketing surveillance that cases of severe hepatic injury, some resulting in death, had been reported during treatment with Arava.

According to the letter, most of the cases occurred within six months after the initiation of Arava therapy and …