Reporting Bad Drug Reactions

By Jan Grebe

Note: Although this article was originally written for French Bulldog fanciers, it is important to report adverse drug reactions in any breed of dog.

If your Frenchie has a bad reaction to a specific drug, you and/or your vet should report this to the drug company that manufactures the drug and/or to the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) so that a record is established for that drug's effects in French Bulldogs.

If similar Adverse Drug Experience (ADE) reports are submitted that involve an adverse event following administration of a drug from a particular batch or lot, the drug company may recall that lot. If numerous reports involve a specific breed's having a bad reaction to a drug, there might be a change in labeling that includes a new warning or contraindication for use in that breed. Sometimes the CVM will require a drug company to notify vets about an action that results from ADE reports.

For example there have long been anecdotal reports of Frenchies who have had bad and even fatal reactions to the drug Acepromazine ("Ace"). However it is not known how many of these cases have been reported to the CVM or to the drug companies. Acepromazine is given as preoperative drug prior to anesthesia, or as a tranquilizer, and there are breeds (especially Boxers) that are thought to be especially sensitive to it and more likely to have serious side effects such as a drop in blood pressure and slow heart rate.

It is not clear whether the bad events in Frenchies were due to a breed predisposition, to individual variation in response to the drug, or to improper dosage, administration, and/or monitoring. The ADA reporting form asks for detailed information that will help clarify just what happened in a given case. It's a good idea to look at this form so that in the event that you ever need to report a bad event you will have some idea of the type of information requested.

If your dog has a bad reaction to a drug, call or have your vet call the FDA Center for Veterinary Medicine at 1-888-332-8387 (or 1-888-FDA-VETS). You or your vet can also report this using form 1932a, which you can download from the FDA website. DOWNLOAD FORM 1932a

To establish that a drug caused, or was a factor in, a dog's death, you must have a necropsy performed by a veterinarian of your choice. If you've reported the event to the drug manufacturer, you should tell them that this has been done as they are entitled to some (not all) of the tissue samples that are obtained.

Note that this reporting does NOT apply to the following:

  • Petfood problems. These are reported electronically through the FDA Safety Reporting Portal or you can call your state's FDA Consumer Complaint Coordinator.
  • Vaccines: these are regulated by the US Department of Agriculture, and illness or bad reactions related to them should first be reported to the vaccine manufacturer, then to the USDA Center for Veterinary Biologics.
  • Flea/Tick Products: varies with the agency that regulates it. Check the product label to see whether it is regulated by the Environmental Protection Agency (EPA) or the FDA.


  • By providing accurate information about adverse events to the appropriate agencies, you can help protect other Frenchies.

    CREDIT: This article first appeared in the September 2011 issue of the American Kennel Club Gazette, and is reprinted with permission. The Gazette is available online at www.akc.org/pubs