Remicade Label to List Risk of Severe Liver Damage, Pneumonia

The manufacturer of Remicade has added a warning to its product labeling to reflect recent data indicating that more than three dozen patients taking the arthritis treatment have suffered liver damage.

In a warning issued Dec. 22, Centocor informed healthcare professionals that it was updating its prescribing information for Remicade to include a new warning on hepatoxicity and additional data on the risk of infections associated with the biological therapeutic.

Centocor said that controlled clinical trials have indicated that three individuals suffered severe hepatic reactions while undergoing treatment with Remicade. The manufacturer also stated that 35 patients have been …