FDA Announces Addition of Boxed Warning to METACAM® (meloxicam) Labels
October 27, 2010
The Food and Drug Administration (FDA) announced today the addition of a boxed warning to the label of two METACAM® (meloxicam) products. The drug’s manufacturer, Boehringer Ingelheim Vetmedica, Inc. (B.I.V.I.), changed the label to include:
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 label change affects:
- METACAM® Solution for Injection, under New Animal Drug Application (NADA) 141-219; and
- METACAM® Oral Suspension, under NADA 141-213.
Boxed warnings on prescription drug labels highlight for prescribers certain contraindications or adverse drug events, especially those that may cause death or serious harm. A contraindication occurs when the risk of using the drug in a patient outweighs any benefit. An adverse drug event, also called an adverse drug experience, occurs when there is an undesired side effect associated with the drug, or when there is a lack of effect (the drug does not do what it is supposed to do).
FDA asked B.I.V.I. to add the boxed warning based on FDA’s review of reported adverse drug events for METACAM®. FDA identified many cases of kidney failure and death in cats associated with repeated use of METACAM®.
METACAM® Solution for Injection is approved for one-time use in cats before surgery to control postoperative pain and inflammation associated with orthopedic surgeries, spays, and neuters. In the United States, the safety and effectiveness of more than one dose of METACAM® Solution for Injection has not been shown in cats for any condition.
METACAM® Solution for Injection and METACAM® Oral Suspension are approved in dogs to control pain and inflammation associated with osteoarthritis. METACAM® Oral Suspension is approved for dogs only. No safe and effective dose of the oral suspension is approved for cats.
FDA is aware that some veterinarians prescribe or use METACAM® in an extra-label manner. When an approved drug is used in a manner other than what is stated on the label, it is an extra-label (or “off-label”) use. Under certain circumstances, veterinarians are allowed to use a drug in an extra-label manner. The new boxed warning on the METACAM® labels helps inform veterinarians of the serious risks associated with extra-label use of meloxicam in cats.