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Pfizer Drug Safety Issues Raised Ahead of FDA Panel


The experimental pill tofacitinib for rheumatoid arthritis increases the risk of cancer and serious infections, according to a government report.

MINYANVILLE ORIGINAL Pfizer's (PFE) experimental pill for rheumatoid arthritis increases the risk of cancer and serious infections, raising the question whether its benefit outweighs the risk, according to a government review of the treatment. The findings by Food and Drug Administration staff are important as Pfizer prepares for a review of the pill by a panel of government expert advisers on Wednesday.

If approved, tofacitinib would compete with blockbuster injected treatments such as Abbott Laboratories' (ABT) Humira. To be fair, Humira and other drugs also carry serious side effects, including the risk of cancer and infections. The debate over the drug's safety on Wednesday may prove to be more important to the drug's warning label than an actual rejection. The vote by the advisers will help the FDA make its decision on whether tofacitinib is ultimately cleared for sale.

Click here for the FDA draft questions for the panel.

(See Pfizer Plan to Buy Stock, Raise Dividends Overshadows Growth Strategy [UPDATE])

Twitter: @brettchase

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