Despite rigorous clinical trials required by the Food and Drug Administration’s Center for Veterinary Medicine (CVM) to prove an animal drug’s safety and effectiveness, potential side effects of drugs may not be obvious until after the drug has been approved and widely used, according to the CVM.
Pet owners are encouraged to report suspected Adverse Drug Events (ADEs) to the CVM, where the information is processed. The CVM has a hotline to report ADEs at 1-888-FDA-VETS (1-888-332-8387).
The Division of Surveillance is responsible for consolidating all ADE reports, necessary referrals, consultations, and preparation of summary reports, according to Linda Grassie, communications director at the FDA.
Pet owners can also report ADEs by obtaining a 1932a “Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report,” from the CVM, a pre-addressed, prepaid postage form which can be completed and dropped in the mail. To obtain the form, write to ADE Reporting System, Center for Veterinary Medicine, U.S. Food & Drug Administration, 7500 Standish Place, Rockville, MD 20855-2773.
The division, said Grassie, uses a modified Kramer scoring system to “score” ADEs. In the CVM system, each sign is separated from other signs and scored according to previous experiences with a drug, other causes, timing of the event, whether there was an overdose, whether the reaction continued or subsided with withdrawal of the drug, and whether a reaction recurred on re-introduction of the drug.
“Vets in the Division of Surveillance analyze the data provided to classify the suspected report as remotely drug related, or as possibly, probably or definitely related to the drug,” she said.
To help the agency accurately analyze information, pet owners should provide “sound clinical information” about the animal, according to the CVM.
“This means that the report should preferably include a good medical history, all other drugs the animal has been given, any recent surgical procedures, and as much in the way of clinical findings as possible,” according to the CVM.
The agency will also contact the veterinarian to get as much information as possible from medical records.
Pet owners can get a copy of the summary report after experts at the CVM have analyzed the information to determine whether the pet had an ADE. To get a copy of the report, pet owners can submit a Freedom of Information (FOI) request to the CVM at: FDA, FOI staff, HFI-3556000 Fishers Lane, Rockville, Maryland.
ADE reports have increased from 1,011 in 1992 to 9,731 in 1999, according to the FDA. Most ADEs are underreported, estimated at only one percent of actual drug reactions. And most are reported by pet owners, not veterinarians.
Questions regarding ADE reporting can be addressed to: Center for Veterinary Medicine, Division of Surveillance, HFV-210, 7519 Standish Place, Rockville, MD 20855, or call 1-888-FDA-VETS (332-8387). For more information, visit the CVM’s website at www.fda.gov/cvm.
Veterinarians are not required to report ADEs to the CVM, though drug manufacturers are. To report an ADE to Pfizer Animal Health, which manufactures Rimady (carprofen), call 1-800-366-5288; Boehringer Ingelheim Vetmedica, Inc., which manufactures Metacam (Meloxican), call 1-800-821-7467, or 1-800-325-9167; Novartis Animal Health, manufacturer of Deramaxx (Deracoxib), call 1-800-332-2761; Wyeth-Fort Dodge Animal Health, maker of EtoGesic (Etodolac), call 1-800-477-1365; Merial, maker of Previcox (Firocoxib), call 1-888-637-4251; and Schering-Plough, maker of Zubrin (Tepoxalin), 1-800-224-5318.