Is it Safe to Use Human Drugs on Animals?

We asked Dr. Stephen Sutherland, Anivive’s Chief Regulatory Affairs Officer, to tell us more about how veterinarians use human drugs for their animal patients.

November 19, 2021
3 min read

Article Highlights

  • Many veterinarians prescribe FDA approved human drugs for extra-label use on pets to satisfy medical needs that cannot be met with FDA approved animal drugs.

  • The Animal Medicinal Drug Use Clarification Act allows extra-label use of FDA approved drugs by veterinarians.

  • Your veterinarian will know what is best for your pet based on knowledge and medical experience.

Is it Legal to Use Human Drugs on Animals?

Human drugs approved by the Food and Drug Administration (FDA) can be legally prescribed for animals by a veterinarian. There are medical needs for animals that cannot be met with FDA approved animal drugs, so oftentimes veterinarians must prescribe drugs approved for human use. Under certain circumstances, the FDA allows veterinarians to utilize human drugs in an extra-label manner to provide prompt relief to animals where there is not an existing animal approved drug suitable for treatment.

What is Extra-Label Use?

The term extra-label (also known as off-label) refers to the use of FDA approved drugs in a manner that is not described in the labeling of the drug, including use in a different species. Only 15% of animal diseases have an FDA approved animal drug. A veterinarian can use drugs in an extra-label manner to address un-met animal medical needs. This extra-label use is permitted under the Animal Medicinal Drug Use Clarification Act. Veterinarians make educated decisions to utilize FDA approved human drugs in pets based on their medical experience and understanding of published medical literature.

What is the Animal Medicinal Drug Use Clarification Act?

The Animal Medicinal Drug Use Clarification Act (AMDUCA), passed by Congress in 1994, provides veterinarians the legal basis to utilize or prescribe human and animal drugs in an extra-label manner. The conditions required for the veterinarian to prescribe a drug extra-label include a valid veterinarian-client-patient relationship and a medical need in a companion animal that cannot be met by an existing FDA approved animal drug.

A drug may only be compounded from approved human or animal drugs and safe ingredients and only when no suitable approved dosage form is available. Extra-label drug use in food-producing animals requires careful provisions to prevent drug residues in food products. There are drugs that are prohibited from extra-label usage. You can visit the FDA website on extra-label drug use in animals and AMDUCA for more information.

Which Drugs are Safe to Give My Pet?

This can only be determined by your veterinarian. Many veterinarians recommend extra-label use of FDA approved human drugs in pets for treatment of disease conditions that are not covered by existing FDA approved animal drugs. This is especially helpful for pets with rare conditions, when it is unlikely there is an FDA approved animal drug. There is a list of drugs that can be used on the FDA website (Animal Drugs @ FDA), and your veterinarian will know what is best for your dog. Never give human drugs to your pet without consulting your veterinarian first.

Why Would I Want to Give My Pet Human Medicine?

If your pet has a disease for which no FDA approved animal drug is available, there may be an FDA approved human or animal drug that can be used in an extra-label manner to effectively treat the disease. The passing of AMDUCA was a huge advancement in veterinary medicine and pet care as it supplies veterinarians the legal basis to utilize FDA approved human and animal drugs in an extra-label manner. The process to achieve approval for an animal drug is extensive, like the process for approval of a human drug, but there are far fewer animal drugs approved and many animal diseases cannot be treated with the animal drugs that are available.

The Bottom Line

Extra-label use of FDA approved drugs provides veterinarians with the tools needed to treat diseases that cannot be met by FDA approved animal drugs. Veterinarians use their keen medical knowledge and understanding of published medical literature to make proper decisions regarding extra-label use of drugs in pets. Human and animal drugs are manufactured to the same FDA standards and safety and effectiveness requirements are similar. Your veterinarian will determine the best therapy available to treat your pet.