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13-07-2020 | Rheumatology | News | Article

Regulatory update

FDA adds hypersensitivity warning to baricitinib label

Claire Barnard

medwireNews: The US FDA has added a precaution to the label for baricitinib advising of a possible risk for reactions including angioedema, urticaria, and rash that may reflect drug hypersensitivity.

This label change follows reports of hypersensitivity reactions in some patients during post-approval use of the Janus kinase inhibitor, but the FDA notes that “[b]ecause these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”

The FDA advises that patients who experience allergic symptoms should contact their healthcare provider immediately, and discontinue baricitinib use until the cause of the reaction is established.

Baricitinib is currently approved by the FDA for the treatment of adults with moderate-to-severe rheumatoid arthritis and an inadequate response to one or more tumor necrosis factor inhibitors.

medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group

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