1995 ADVERSE DRUG EXPERIENCE SUMMARY

This issue of the FDA Veterinarian contains a pull-out section of the second half of the 1995 Veterinary Adverse Drug Experience Summary. The first portion was included in the September/October issue.

This summary includes all domestic adverse drug experience reports submitted to the Center for Veterinary Medicine (CVM) for calendar year 1995 which the Center has determined to be at least possibly drug related. It is organized alphabetically by generic drug, and within each drug by species, and within each species by the general route of administration. The percentages represent the number of reports containing a sign divided by the total number of reports. Also, reported signs are truncated at twenty-two characters.

The Center¹s adverse drug reaction review process takes into consideration confounding factors such as dosage, concomitant drug use, the medical and physical condition of the animals at the time of treatment, environmental and management information, product defects, etc. These complex factors, however, cannot be fully addressed in this summary. This summary is intended only as a general reference to the type of reactions that veterinarians, animal owners, and others have voluntarily reported to FDA or the manufacturer after drug use; therefore, it is not by itself a basis for:

• Determining drug association for a particular sign
  
• Determining the safety and efficacy of a given drug
  
• Determining the frequency of occurrence of an adverse reaction
  
• Comparing one drug with another drug.

Nevertheless, the information in the summary can alert readers to suspected drug effects being reported by their colleagues and sensitize them to potential problems. The report may also serve to stimulate readers to share their own experiences for the benefit of their colleagues and ultimately the improvement of veterinary products.

Please note that this summary does not include drug ineffectiveness reports. In addition, it does not include reports of drug product defect reports unless the report also contains adverse reaction information. Also, the report does not include adverse experience reports for biologics and topically applied, externally acting parasiticides. These reports are forwarded to the government agency that regulates the product in question. Finally, the human reports involve human exposure to an animal drug.

An abbreviation table and additional information about the summary may be found on page I-1 of the September/October issue of the FDA Veterinarian.