Cougar — Midazolam Hydrochloride

A veterinary adverse event report is a submission to the FDA Center for Veterinary Medicine documenting a harmful or unexpected reaction in an animal following administration of a drug. Reports can be submitted by veterinarians, pet owners, or drug manufacturers. The FDA uses these reports to identify emerging safety signals and, when necessary, require label changes, safety communications, or product withdrawals. Reporting is voluntary for clinicians and owners, but mandatory for manufacturers when they become aware of serious events.

Not necessarily. Adverse event reports document that a drug was given and that the animal later died — but they do not establish causation. The animal may have died from its underlying condition, from concurrent medications, or from unrelated causes. The FDA applies a structured causality assessment to each report to determine whether the drug was likely, possibly, or unlikely responsible. Still, all death reports are reviewed and tracked because they contribute to safety signal detection, even when individual causality is uncertain.

You can report a suspected adverse drug reaction to the FDA Center for Veterinary Medicine through the FDA Safety Reporting Portal at SafetyReporting.hhs.gov or by calling 1-888-FDA-VETS (1-888-332-8387). You can also contact the drug manufacturer directly — they are required to forward serious adverse event reports to the FDA. Include the drug name and dose, the animal's species, breed, age, and weight, the duration of treatment, and a detailed description of the symptoms observed and their timeline.