FDA warns Pfizer about reporting side effects

The U.S. Food and Drug Administration has issued a warning to drugmaker Pfizer for failing to quickly report serious and unexpected potential side effects from its drugs, according to a Reuters news service report.

In a 12-page warning letter, the FDA cited examples involving some of the company’s best-selling brands, including the impotence drug Viagra, the cholesterol lowering pill Lipitor, and the seizure medicine Lyrica.

According to a Reuters news service report, “… while Viagra and similar medications are known to cause serious visual problems, including blindness, Pfizer failed to report cases related to its drug within the agency’s 15-day deadline ‘by misclassifying and/or downgrading reports to non-serious without reasonable justification.’”


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