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Published on 10 June 2010

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Pfizer warned about non-reporting

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Drugs giant Pfizer has been reprimanded by regulators in the US for not reporting complaints about potentially dangerous drugs quickly enough.

The Food and Drug Administration set out several faults of Pfizer products which the firm did not tell government regulators about within the necessary 15 days.

Sometimes the firm did not report the complaints at all, such as those made about both cholesterol drug Lipitor and anti-seizure drug Lyrica’s serious side-effects.

Pfizer’s New York HQ was subject to a routine inspection by FDA inspectors in summer 2009. The administration sent a letter to the firm on May 26 this year warning it of its obligations and highlighting similar violations which occurred in both 2004 and 2006.

The firm had already told the FDA that its file tracking operations would be upgraded and staff retrained but the administration said these measures were “ineffective”.

Copyright Press Association 2010
Food and Drug Administration



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