Just when you think you’re heard it all about big drug companies, along comes a FDA warning letter to Pfizer, Inc. that leaves you staggering in shock.
A recently posted FDA Warning Letter on the FDA website, dated May 26, 2010 reports some very startling incidents that Pfizer, Inc. neglected to report to the FDA; adverse drug events. The FDA Warning Letter mentions serious adverse drug events such as “blindness” and “decreased vision” NOT reported in the required 15 day period. Some of the issues FDA addressed with Pfizer, Inc. date back to 2004 requests by FDA for improvements in adverse event reporting.
The FDA Warning letter cites several instances of late/delayed adverse even reporting with several drugs. Lipitor – 1141 and 1102 days late; Azithromycin – 687 and 393 days late; Amlodipine Besilate – 438 days late; Prostin VR – 285 days late; Epirubicin HCI – 728 days late.
Pfizer “agreed to train all pharmacovigilance staff in the worldwide affiliates by February 15, 2009”; yet the FDA warning letter states “only six out of the required sixty-three country offices worldwide were trained”.
The frightening list goes on and on in this FDA Warning Letter to Pfizer. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm215405.htm
If you or your pet takes a drug made by Pfizer, I’d suggest contacting the FDA to see if this drug (the drug you or your pet takes) was involved in their recent inspection concerns. As a consumer/petsumer, you deserve to know in a timely fashion of any adverse drug events related to medicines you or your pet is taking.
Wishing you and your pet(s) the best,
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