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U.S. Department of Health and Human Services

Animal & Veterinary

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Ask CVM - November/December 2004

Q: I understand that FDA is reviewing the safety of “Cox 2 inhibitors” human drugs used for pain relief. Will FDA also be reviewing Cox 2 inhibitors approved for use in animals?

A: No. At this time, FDA does not plan to review the safety of veterinary Cox 2 inhibitor products.

The Center for Veterinary Medicine considers the approved veterinary nonsteroidal anti-inflammatory drugs (NSAIDS), including drugs classified as Cox 2 inhibitors, to be safe and effective when used according to the label and when dog owners are informed about common NSAID side effects.

CVM is constantly screening new Adverse Drug Event (ADE) reports, including those for cardiac ADEs, to determine if the reports contain any unexpected side effects. We have not seen any unexpected side effects for NSAID products.

The concern in human medicine is that the use of Cox 2 inhibitors can lead to heart ailments or strokes. We do not receive many ADEs involving those signs for veterinary NSAIDs or other drugs. Part of the reason for that is the considerable difference between the diagnostic procedures for pets and for humans and the difference in reporting of ADEs. While it is extremely common for physicians to diagnose heart attacks and strokes in humans, it is extremely uncommon for veterinarians to diagnose them in dogs. Most veterinarians do not order MRIs or CT scans for animals, even though those are common diagnostic tools for humans.

Another reason is that dogs rarely suffer lethal heart attacks. Dogs grow good collateral circulation in the heart, but humans do not.

CVM will continue to monitor these and other veterinary drugs and look for unusual frequency and severity of side effects. If, as in the case of the human drugs, we find new and conflicting scientific data on adverse events associated with an approved drug, we will take appropriate action.