October 15, 2011


 FDA reporting numbers of adverse drug experiences

posted September 28, 2011

The Food and Drug Administration's Center for Veterinary Medicine is now providing information about the numbers of reports it receives regarding various adverse drug experiences in animals.

The CVM previously provided information about ADE types in animals, but not the number of reports.

Dr. Lynne A. White-Shim, an assistant director in the AVMA Scientific Activities Division, cautioned that the numbers can be difficult to put in perspective. The ADE summaries do not include information about underlying conditions or concurrent treatments that could have affected animals that had adverse drug experiences, for example, or information about how the number of ADE reports for a particular drug compares with how frequently that drug is used.

The ADE summaries list drugs by active ingredient. For each active ingredient, separate entries for each species and each route of administration list adverse experiences from the most frequent to the least frequent. The ADE summaries are available at www.fda.gov/AnimalVeterinary/SafetyHealth.

The AVMA provides information about how to report adverse experiences in animals associated with drugs and other products at www.avma.org/animal_health/reporting_adverse_events.asp.