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  5. Should I report a problem with an unapproved animal drug to FDA?
  1. Unapproved Animal Drugs

Should I report a problem with an unapproved animal drug to FDA?

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Yes, FDA encourages you to report problems with any drug, even if it’s unapproved.  Problems include adverse events and product defects.

Adverse events are side effects or a lack of effectiveness—the drug doesn’t do what you expect it to do or the drug isn’t working as well as it did previously.  Adverse events also include reactions in people who handle the drug, such as needle stick injuries, rashes, or other side effects caused by exposure to the drug, and medication errors, such as giving the wrong drug or wrong dose or giving the drug too frequently.

Product defects are problems such as a broken seal, a leaking bottle, or the drug is off-color.  By reporting adverse events and product defects with animal drugs, including unapproved ones, you help FDA more easily identify and correct problems.

More information about How to Report Animal Drug and Device Side Effects and Product Problems.

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