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FDA warns Pfizer over adverse reporting

The US FDA has issued Pfizer with a warning letter relating to failures to report adverse events correctly

The US Food and Drug Administration (FDA) has issued Pfizer with a warning letter relating to failures to report adverse events correctly.

The letter, sent to Pfizer on May 26, follows an inspection of the company's New York premises by the US agency, which took place over a period of several weeks almost a year ago.

The inspection was to check Pfizer's procedures for conforming to the FDA's rules that adverse events must be reported to the authority within 15 days.

The letter contained reference to several instances where the pharma giant did not report adverse events relating to Lipitor (atorvastatin calcium) and Lyrica (pregabalin) at all. Further issues included the failure to report issues of visual disturbances as a result of a patient taking Viagra (sildenafil citrate) within the specified 15 day time period.

The US regulator also accused Pfizer of downgrading the classification of some reported events without justification.

In April 2010, the FDA warned Pfizer over its Geodon trials.

10th June 2010

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