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Pfizer’s Xeljanz Could See Narrower Label And New REMS Due To CV And Malignancy Risks

 
• By Sue Sutter

The US FDA will ponder its regulatory options now that final data are in from a long-term postmarketing study showing tofacitinib is associated with a higher rate of major adverse cardiovascular events and malignancies compared with TNF-inhibitors.

x-ray hands, rheumatoid arthritis
A Xeljanz study in high-risk rheumatoid arthritis patients has raised safety concerns. • Source: Shutterstock

The US Food and Drug Administration will weigh its regulatory its options for Pfizer Inc.’s Xeljanz (tofacitinib) in light of cardiovascular and malignancy risks identified in a long-term, postmarketing safety trial of the JAK-inhibitor in rheumatoid arthritis patients.

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More from North America

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• By Cathy Kelly

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