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Additional Information

What is included in the veterinary ADE database?

• To see if a drug is approved for animals please search the FDA Approved Animal Drug Products Database

• Some, but not all topical flea products are included. If the product is delivered systemically (goes beyond the skin and is distributed throughout the body), FDA regulates it. Otherwise it is regulated by EPA.
  
  Examples of FDA-regulated products include Revolution™ (Pfizer), Dectomax™(Pfizer) or search the above database

• ADE's should be submitted on Form 1932a, available by request:

  • by calling 1-888-FDA-VETS

  • on-line by clicking Form 1932a or

  • by writing to:

ADE Reporting System
Center for Veterinary Medicine
U.S. Food & Drug Administration
7500 Standish Place
Rockville, MD 20855-2773

• Veterinary ADEs appearing in the on-line database represent clinical manifestations that score at least “possibly drug-related”, each scored independently of one another in a single episode.

What is not included in the ADE reporting system?

Veterinary ADE’s are not:

• Complaints regarding human drugs unless administered to animals

  • MedWatch maintains the FDA Safety Information and Adverse Event Reporting Program for human drugs administered to humans

• Accepted via e-mail

• For animal biologics or vaccines

  • Information on animal vaccine adverse events can be found at the USDA Center for Veterinary Biologics

• For topical insecticides.

  • Complaints regarding non-systemic flea products (Frontline, Advantage) should be referred to the Environmental Protection Agency hotline at: 1-800-858-7378.

• Complaints regarding attending veterinary prescribing or dispensing errors.

  • Complaints and questions about prescribing errors should be referred to your State Veterinary Medical Board. See the American Association of Veterinary State Boards (AAVSB) and/or the National Board of Veterinary Medical Examiners (NBVME)

• Complaints regarding company or veterinary reimbursement of costs associated with a pet’s illness.

My vet prescribed a human drug for my dog. Can he do that?

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) allows veterinarians to prescribe extralabel uses of certain approved animal drugs and approved human drugs for animals under certain conditions. Extralabel (or extra-label or off label) use refers to the use of an approved drug in a manner that is not in accordance with the approved label directions. The key constraints of AMDUCA are that any extralabel use must be by, or on the order of, a veterinarian within the context of a veterinarian-client-patient relationship, must not result in violative residues in food-producing animals, and the use must be in conformance with the implementing regulations published at 21 CFR Part 530.

What kind of information should be included in my complaint?

The ADE scoring system uses a modified Kramer scoring system (Keller et al., Vet Clin North Am, Food Anim Pract, March 1999,15(1):13-30). In this system, each sign is separated from the other signs and scored according to previous experience with the drug, alternative etiologic candidates (other causes), timing of the event, whether there was an overdose, whether the reaction continued or subsided with withdrawal of the drug, and whether a reaction recurred on re-introduction of a drug. The scores are most accurate when there is sound clinical information about an animal. This means that the report should include

• a good medical history,

• all Concomitant drugs the animal has been given,

• any recent surgical procedures,

• veterinary exam results,

• clinical chemistries,

• complete blood counts,

• urinalysis,

• fecal exams,

• radiographic results,

• hemodynamic data such as blood pressure, any other pressure measurements in or around the heart,

• and neurologic assessments.

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