New safety warnings added to Metacam veterinary labels, FDA reports

Rockville, Md.

-- The Food and Drug Administration (FDA) says that a boxed warning has been added to the label of two Metacam (meloxicam) products.

The label additions, by its maker Boehringer Ingelheim Vetmedica (BIVI), are for Metacam Solution for Injection and Metacam Oral Suspension.

The warning 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."

FDA says it asked BIVI to add the warning based on "FDA's review of reported adverse drug events for the drug."

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, FDA reports. Metacam Oral Solution is approved for dogs only. "No safe and effective dose of the oral suspension is approved for cats."

The warning on the Metacam labels "helps inform veterinarians of the serious risks associated with extra-label use of meloxicam in cats," FDA says.