This issue of the FDA Veterinarian contains a pull-out section of the second half of the 1994 Veterinary Adverse Drug Experience Summary. The first portion was included in the September/October issue.

[Editor's note: this electronic version of the FDA Veterinarian does not include the ADE summary. ADE information is available as a section in the On-Line Library elsewhere on this site. (Be warned that there is no link back to here)] This summary includes all domestic adverse drug experience reports submitted to the Center for Veterinary Medicine (CVM) for calendar year 1994 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 Center's 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.

This summary does not include product failure or adverse experience reports for biologics and topically applied, externally acting parasiticides. Such reports received by CVM are forwarded to the government agency that regulates the product in question. In addition, it does not include reports of drug product defect reports unless the report also contains adverse reaction information. 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.