Animal & Veterinary
FDA/CVM 1998 ADE Reports -- A Descriptive Overview
by Neal Bataller, ME, D.V.M.
FDA Veterinarian Newsletter November/December 1999 Volume XIV, No VI
In previous years, a summary of these ADE reports was included as an insert in the FDA Veterinarian. This year, copies of the 1998 Veterinary Adverse Drug Experience (ADE) Summary may be obtained from CVM's Internet Home Page or by calling or writing the FDA Veterinarian.
The primary purpose for maintaining the FDA/CVM database is for providing an early warning or signaling system for adverse effects not detected during premarket testing of FDA-approved animal drugs and for monitoring the performance of drugs not approved for use in animals. The FDA/CVM ADE reporting system depends upon the detection of an adverse clinical event by veterinarians and animal owners, the attribution of the clinical event to the use of a particular drug ("suspect" drug), and the reporting of the ADE to the manufacturer of the suspected drug or directly to FDA. Data from these ADE reports are coded and entered into the computerized FDA/CVM ADE database.
The reporting of ADEs by veterinarians and animal owners is voluntary. They may send their reports directly to the FDA/CVM ("Direct" reports), to the drug manufacturer ("Manufacturer" reports), or both. The drug manufacturers of FDA-approved animal drugs are required by law and regulation to submit to the FDA post-market ADE reports received by any means from veterinarians and animal owners.
It is important to remember certain caveats when using data from the FDA/CVM ADE database:
- For any given ADE report, there is no certainty that the suspected drug caused the ADE. This is because veterinarians and animal owners are encouraged to report all suspected ADEs, not just those that are already known to be caused by the drug. The adverse event may have been related primarily to an underlying disease for which the drug was given, to other concomitant drugs, or may have occurred by chance at the same time the suspect drug was administered.
- Accumulated ADE reports should not be used to calculate incidence rates or estimates of drug risk. This is because not all adverse reactions are reported, and the actual number of animals receiving the drug is also unknown.
In this article, various kinds of data and information are presented on the ADE reports computerized into the FDA/CVM ADE database during the calendar year 1998. Due to rounding, the percentages in tables may not total to 100 percent.
II. Report Submission Information
Table 1 shows the number of reports received for the last six full calendar years. The numbers only include original reports involving animal injury; follow-up reports and product defect reports are not included. In general, the annual number of reports has increased. Much of the increase in the latter years is attributable to a few newly approved animal drugs.
Table 1. ADE reports by year
Table 2. 1998 ADE reports ranked by source (n=9,385)
|Mail, Direct to FDA/CVM||54||0.6|
|USP Practitioner Reporting Network||10||0.3|
|Telephone, Direct to FDA/CVM||3||0.1|
III. Animal Zoographic Information
Table 3 lists the species that are most represented in ADE reports. The majority of reports involve companion animals and cattle. Few reports are received that involve poultry. The average number of animals adversely affected in each report is more reflective of the animal management and health care associated with each species.
Table 3. 1998 ADE reports by top 10 ranked species, plus average number of animals adversely affected per report (n=9,385). Product defects and multiple species reports are not included for the specific species.
IV. Suspect Drug Information
Table 4. 1998 "Possible" ADE animal injury reports by Top-10 ranked classes of suspect drugs (n=7,930)
Table 5. 1998 "Possible" ADE animal injury reports ranked by Top-10 ranked active ingredients of suspect drugs (n=7,930)
Table 6. 1998 "Possible" ADE animal injury reports ranked by Top-10 ranked tradenames of suspect products (n=7,930)
V. Drug Usage Information
Table 7. 1998 "Possible" ADE animal injury reports ranked by Top-10 ranked routes of drug administration (n=7,930)
VI. Adverse Event Information
Table 8. 1998 "Possible" ADE animal injury reports ranked by Top-10 ranked adverse clinical manifestations (n=7,930)
|Increased Alkaline Phosphatase||941||11.9|
Additional information concerning this ADE summary will be contained in the next issue of the FDA Veterinarian