By Jennifer Calfas
The Food and Drug Administration is warning veterinarians about deaths, debilitating neurological issues and other side effects that followed use of a popular arthritis drug for dogs.
The agency said, in a letter to veterinarians posted on its website, that side effects reported for Zoetis's drug Librela included seizures, lameness and loss of muscle control. The agency said some dogs were euthanized and others died as a result of the side effects.
The agency issued the warning on Monday following a review of more than 3,600 cases of side effects that were reported to the FDA between last year and March 2024.
The Wall Street Journal reported in April that owners were watching their dogs deal with lethargy, paralysis and eventually death after receiving Librela injections.
Zoetis didn't immediately respond to requests for comment Tuesday. Zoetis has said Librela is safe and effective, with reports of side effects representing a fraction of the millions of shots administered in the U.S. and abroad.
Many pet owners have said the drug has relieved painful arthritis for their dogs. The FDA, in approving the drug, found it safe and effective.
The FDA approved Librela in 2023 for control of pain associated with osteoarthritis in dogs. The drug was one of the first antibody treatments cleared for use in pets. Zoetis, the world's largest animal-health company by sales, was counting on it for big sales.
The FDA can recommend animal drugmakers update labels for their product in light of reported side effects, but the agency can't require the companies to do so.
Following its review of Librela side effect reports, the FDA's Center for Veterinary Medicine said it is recommending Zoetis add a "Post Approval Experience" section to its current Librela label that details possible neurologic, urinary and gastrointestinal side effects.
During testing for Librela, common side effects included urinary tract infections, lethargy and increased blood urea nitrogen, a sign of problems with kidney function.
Since its approval, Librela has become the fourth largest pet care product in the U.S., treating one million dogs, Zoetis Chief Executive Kristin Peck said in the company's earnings call in November. The company believes the drug, which had $55 million in sales last quarter, is on track to become a $1 billion franchise.
Write to Jennifer Calfas at jennifer.calfas@wsj.com
(END) Dow Jones Newswires
December 17, 2024 11:12 ET (16:12 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.
Comments