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US FDA Restricts JAK Inhibitors To Second-Line In Rheumatoid Arthritis Amid CV, Cancer, Mortality Risks

 
• By Derrick Gingery

Now that the analysis of Pfizer’s postmarketing trial for Xeljanz is complete, though, application reviews of other products will likely be completed. The Xelijanz study revealed elevated risk of heart-related events, cancer, blood clots and death, resulting in a class-wide indication restriction and a revised boxed warning.

rheumatoid arthritis x-ray image
A postmarket study of the rheumatoid arthritis drug Xeljanz lead the FDA to revise the boxed warning and limit its use. • Source: Alamy

Cardiovascular, cancer and other concerns forced the US Food and Drug Administration to limit the use of several JAK inhibitors to patients who cannot tolerate one or more TNF blockers.

Based on a review of safety data on Pfizer Inc.’s rheumatoid arthritis and ulcerative colitis drugs Xeljanz and Xeljanz...

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