FDA Requires Black Box Warning for Pfizer Drug

Pfizer will be required to add a black box warning for Xeljanz, stating that patients who take it could experience a higher risk of blood clots or death.

Xeljanz Box / Image: Pfizer
Xeljanz Box / Image: Pfizer

A recent Journal Sentinel article discussed a new addition to the packaging of Pfizer’s Xeljanz. The FDA is requiring its most severe warning for the higher-dose version of the drug used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. The change comes five months after a clinical trial demonstrated a link to blood clots in the lungs and deaths. The FDA failed to take action on the drug and Pfizer under the leadership of former Commission Scott Gottlieb, who later took a job on the company’s board of directors.

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