Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that is approved for cats as a one-time injection given before surgery to control pain and inflammation after spays, neuters, and orthopedic surgeries (like repairing a torn ligament or fixing a broken leg). Injectable meloxicam products are not approved for more than one dose (repeated doses) in cats in the United States. Oral meloxicam products, which come as an oral suspension and a transmucosal spray, are not approved for cats; they are only approved for dogs.
Giving more than one dose of meloxicam to cats or giving the oral products to cats is an extra-label use. Extra-label use, also called “off-label” use, means using an approved drug in a way that isn’t listed on the drug’s label. FDA knows that some veterinarians prescribe meloxicam for extra-label uses in cats. This is legally allowed under certain circumstances. However, after reviewing numerous reports of side effects of meloxicam in cats, FDA identified many cases of kidney failure and death after cats received repeated doses of the drug. Therefore, FDA asked the makers of all meloxicam products to add a boxed warning to the products’ labels regarding the safety risks associated with extra-label use in cats.
A boxed warning on the label of a prescription animal drug highlights important safety information for veterinarians about certain contraindications or potential side effects, especially those that could cause serious harm or death. (A contraindication is a reason for not using the drug in a patient because the risks outweigh any benefits.)
The label for all brand name and generic meloxicam products now includes the boxed warning. The brand name products are marketed under the trade names METACAM® Solution for Injection, METACAM® Oral Suspension, and OroCAM® Transmucosal Spray. The generic products are marketed under the trade names Meloxicam Injection, Meloxidyl®, Loxicom®, and Meloxicam Solution for Injection.
The boxed warning on most of these products states: Repeated use of meloxicam in cats has been associated with acute renal failure and death. Do not administer additional injectable or oral meloxicam to cats. See Contraindications, Warnings, and Precautions for detailed information.
The boxed warning on OroCAM® Transmucosal Spray is very similar and states: Repeated use of meloxicam in cats has been associated with acute renal failure and death. Do not administer meloxicam transmucosal oral spray to cats. See Contraindications for detailed information.
Additional Information About Extra-Label Drug Use in Animals
- Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)
- The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians