Pfizer Inc. Arthritis Pill Raises Safety Concerns, FDA Staff Says
Published: May 08, 2012
Pfizer Inc. (PFE) (PFE)’s experimental pill to treat rheumatoid arthritis, one of the company’s leading drug candidates, raised “serious safety concerns” in trials, U.S. regulators said today. The pill, tofacitinib, carried increased risks of serious infections and malignancies, in particular a higher chance of lymphoma, Food and Drug Administration staff wrote. The agency released the report ahead of a May 9 meeting of FDA medical advisers who will review tofacitinib’s benefits and risks.