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Metacam Gets Boxed Warning Label for Use in Cats

Posted: October 27, 2010, 7:40 p.m., EDT

Metacam Gets Boxed Warning Label for Use in CatsBoehringer Ingleheim Vetmedica Inc. has added a boxed warning to the labels of its Metacam Solution for Injection and Metacam Oral Suspension.

The labels now include: “Warning. 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 St. Joseph, Mo.-based company added the boxed warning at the request of the U.S. Food and Drug Administration, which made the request after reviewing reported adverse drug events for the products. The FDA said it had 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, according to the FDA.

Metacam Oral Suspension is not approved for use in cats.

The FDA noted that some veterinarians prescribe or use Metacam in an extra-label manner, also known as off-label use.

“The new boxed warning on the Metacam labels helps inform veterinarians of the serious risks associated with extra-label use of meloxicam in cats,” the FDA said.

Both products are also approved for use in dogs to control pain and inflammation associated with osteoarthritis. <Home>


 

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