FDA requires box warnings for Pfizer drug Xeljanz

Wall Street Journal

26 July 2019 - Patients taking 10 mg dose twice a day could experience a higher risk of blood clots or death.

The U.S. FDA is requiring that health warnings be added to Pfizer’s drug Xeljanz, advising patients they could experience a higher risk of blood clots or death with a specific dose.

The FDA’s warnings are specifically geared toward patients who take the 10-milligram dose of the medicine, known as tofacitinib, twice a day. The regulatory agency also said it is limiting the use of the treatment for ulcerative colitis so that patients can only take it if they have severe side effects from other medicines or aren’t treated effectively.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Safety