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1995 ADVERSE DRUG EXPERIENCE SUMMARY

This issue of the FDA Veterinarian contains a pull-out section of the first installment of the 1995 Veterinary Adverse Drug Experience Summary. This summary includes all domestic adverse drug reaction reports submitted to CVM for calendar year 1995 that the Center has determined to be at least possibly drug related. It should be noted that the human reports are almost always associated with accidental exposure.

This report indicates when products are used in an extra-label manner, i.e., in a species for which they are not approved, at the wrong dosage levels, etc. Readers can note extra-label use by the abbreviation ELU along with the specific type of extra-label use involved. Thus, if an individual report indicates that the drug was used for a species not included in the labeling directions, the listing will indicate ELU-species.

 

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Source: September/October 1996 FDA Veterinarian Newsletter
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