FDA adds strict safety warnings on arthritis drugs from Pfizer, AbbVie and Lilly

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The U.S. health regulator has added its strictest warning to the labels of drugs from Pfizer , Eli Lilly and AbbVie belonging to a class of anti-inflammatory treatments called JAK inhibitors, citing risk of serious health issues and death in patients 50 and over, the drugmakers said on Friday.

Xeljanz, which brought in worldwide sales of $2.44 billion for Pfizer in 2020, is approved in the United States for the treatment of conditions including rheumatoid arthritis, psoriatic arthritis and ulcerative colitis - an inflammatory bowel disease.

The Food and Drug Administration's boxed warnings on the labels of Rinvoq , Xeljanz and Lilly's Olumiant flags the risk of cardiovascular death and stroke in high-risk patients who are aged 50 and above, and are current or past smokers. Additional information about the risk of some types of cancer and death was also added to their labels.

The marketing applications for Rinvoq's expanded use in atopic dermatitis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis remain under review by the FDA, AbbVie said.Reporting by Manojna Maddipatla in Bengaluru; Editing by Anil D'Silva and Krishna Chandra EluriSubscribe for our daily curated newsletter to receive the latest exclusive Reuters coverage delivered to your inbox.

 

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