DRUGMAKERS REVISE LABELING FOR REMICADE, STRATTERA OVER LIVER RISKS

Centocor and Eli Lilly are sending "Dear Healthcare Professional" letters to physicians to alert them about severe liver reactions associated with a rheumatoid arthritis product and an attention-deficit/hyperactivity disorder (ADHD) drug, according to announcements posted at the FDA's Medwatch website.

"Severe hepatic reactions including acute liver failure, jaundice, cholestasis and hepatitis have been reported in postmarketing data in patients receiving Remicade," Centocor said in its letter. According to the company, roughly 576,000 patients have been treated with Remicade [infliximab] since it was approved in 1998. Since then, 38 patients have reported severe hepatic reactions after taking the drug.

Centocor said it has updated the product labeling and patient information sheet for Remicade to include information about hepatotoxicity, and added pneumonia to the drug's existing warnings about risks of infections.

The FDA also asked Lilly to update labeling for the company's ADHD drug Strattera (atomoxetine HCl) to include bolded warnings about potentially serious liver injury after receiving adverse event reports about an adult patient and a pediatric patient who had been treated with the drug for several months. Both patients have since recovered, the FDA noted.

To view the Medwatch alert and Centocor's letter for Remicade, go to http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Remicade2 (http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Remicade2).

To view the FDA's talk paper on Strattera, go to http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01335.html (http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01335.html).