FDA Wants New Warnings for Arthritis Drugs

The agency is requiring Pfizer, Eli Lilly, and AbbVie to include new heart safety and cancer warnings on the drugs.

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According to a recent Reuters article, the FDA has asked three major drug companies to update safety restrictions for their arthritis drugs. The drugs in question belong to the class of treatments known as JAK inhibitors, which treat rheumatoid arthritis. All three drugs: Pfizer’s Xeljanz, AbbVie’s Rinvoq, and Eli Lilly’s Olumiant, currently have boxed warnings about blood clots and lymphoma. With updated warnings, the FDA is essentially pushing back the drugs’ place in the treatment sequence and limiting their use.

The decision came after the FDA considered a large study that linked Xeljanz to an increased risk of side effects on the heart and cancer versus standard TNF blockers. Olumiant and Rinvoq are guilty by association, but haven’t demonstrated the same heart and cancer problems in their own clinical trials. The warning won’t affect JAK inhibitors from Incyte or Bristol Myers Squibb that treat blood disorders, but the FDA is requiring other updates to their labels. 

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