March 10, 2006
New Look for ADE Summaries Report Posted on the CVM Website
For several years, FDA’s Center for Veterinary Medicine (CVM) has posted the “Cumulative Adverse Drug Experiences (ADE) Summaries” report on our internet website. CVM posted the report so that veterinarians and animal owners could have easily available access to information about signs that have been associated with drugs. This could help veterinarians make more informed decisions on how to use a product and animal owners to know what signs they might look for when they use a product.
While the Center recognizes that many individuals interested in animal drugs consulted the report on a regular basis, we were concerned that the way the data was presented in the report was sometimes confusing and led to misinterpretation by some readers. Therefore, in December 2005, CVM removed the report to revise it. We have changed the way the summaries of adverse drug experience reports are presented, and the report is now posted at: http://www.fda.gov/cvm/ade_cum.htm.
The appropriate use of this website information is to search generic drug names to see if particular signs associated with adverse reactions have been reported with the drug’s use. These signs are listed in order of frequency from most frequently observed to least frequently observed.
It is important to remember that the report cannot be used to estimate drug risk or to compare one drug with another. When looking at the report, the reader should be aware that:
For any given ADE report, there is no certainty that the reported drug caused the adverse event. The adverse event may have been related to an underlying disease, using other drugs at the same time, or other non-drug related causes. And, this listing does not include information about underlying diseases, other drugs used at the same time, other non-drug related causes, or the final outcome of the reaction.
The accuracy of information regarding the ADE is dependent on the quality of information received from the veterinarian or animal owner.
Accumulated ADE reports should not be used to calculate incidence rates or estimates of drug risk, because there is no accurate way to determine how many animals were given the drug. For example, if a drug is widely used to treat certain conditions, there may be more ADEs for that drug than another product that is not used as often. This would not mean that the first drug was more unsafe than the second. The number of reports simply represents the numbers of ADEs received for a particular drug, by species, and route of administration.
Information on how the drugs were used (for indications on the product label or in an extra label manner) is not provided.
Adverse experiences are listed by generic drug name in the ADE Report. One generic drug name in the list may represent more than one brand name. Interested individuals can find a complete list of brand names associated with each generic drug by using the on-line “Green Book” and clicking on the following link - List of Brand Names Associated with Active Ingredients.
The new report includes the following information:
Generic name of the drug
Route of Administration (oral, injectable, etc.)
Animal (dog, pig, etc.)
Number of Animals Evaluated – Total number of animals reported to the FDA for evaluation.
Sign – description of the ADE associated with the drug use.
Number Reacted -- Number of times this specific clinical sign was identified as possibly, probably, or definitely drug related for a drug, route of administration, and species. (If the potential adverse experiences in the animal were not possibly, probably, or definitely drug related, the ADEs are not included in the “reacted” column of the report.)
Additional information about the report may be found in the ADE Report Description posted at: http://www.fda.gov/cvm/ade_description.htm.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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