A popular arthritis drug for dogs may be riskier than we realize. This week, the Food and Drug Administration reported serious side effects and deaths associated with the recently approved drug Librela. this
On Monday at the FDA Veterinary Center It's out. A letter to veterinarians detailing the results of the Librela FDA investigation identified several serious side effects linked to use of the drug. Includes seizures and loss of muscle function. Many dogs have been reported to have died or been euthanized due to these complications. The agency recommends that drug manufacturers update their labels to include these potential side effects. and recommend that veterinarians and the public report any adverse events. related to drug use
The active ingredient of Librela Bedinvematab, It is a laboratory-made antibody developed by Zoetis in 2023. FDA that has been approved Used to treat osteoarthritis in dogs. Medicine delivered by injection once a month. It targets and inhibits a protein involved in pain control called canine nerve growth factor (NGF). The drug is designed to reduce levels of NGF, which tend to be higher in dogs with the disease. Osteoarthritis It is the first monoclonal antibody drug approved in dogs. and is the second drug approved for pets.
At the time of approval The most common side effects associated with Librela are certain types of infections (UTIs, bacterial skin infections), rash, vomiting, and weight loss. As is standard with all approved drugs, the FDA has been monitoring Librela-related adverse event reports filed by patients and doctors with the drug. And some dog owners are reporting very serious symptoms in their pets. After starting to take Librela
According to the FDA, there have been 3,674 adverse event reports associated with Librela as of March 2024. These adverse events are more common in older dogs. Which makes sense considering age is a common risk factor for osteoarthritis. The FDA lists several potentially serious adverse events that are currently not included in drug labels as possible side effects. This includes ataxia (poor muscle control), seizures, diarrhea, and paralysis. In some cases, dogs die or are euthanized soon after these serious events occur.
For example, in one case report, a 10-year-old Great Pyrenees girl experienced abnormal symptoms one day after taking Librela. The dog has incontinence and has a deformed leg. This eventually spread to the dog's front legs. Within two days, the dog became paralyzed. After taking the drug for four days The dog died
The FDA is careful to note that these adverse events have not yet been conclusively linked to Librela. The agency dismissed the idea raised by Zoetis that many of the reports related to the drug were due to negative publicity on social media.
“There is no evidence that the reported cases are not actual cases involving Librela,” the agency wrote in its report. review of these reports
Soetis leaves statement According to the FDA book The company criticized some media coverage, claiming that the FDA's communications were mischaracterized as “warnings” rather than “information updates” intended to educate veterinarians and the general public. The company also disputes, based on data from the European Union, that any adverse events Those related to Librela tend to be rare.
“We remain confident in the safety and effectiveness of Librela and are committed to supporting veterinarians and pet owners in helping dogs live lives with less pain and better mobility,” the company said in a statement.
It will take more time and research to confirm these serious side effects. But in the meantime, the FDA has recommended that Zoetis update its Librela labeling to address these potential adverse events. (The Veterinary Center itself cannot issue orders for safety-related labeling changes.)
Meanwhile, Zoetis stands by its medicines. But it said it is discussing possible label changes with the FDA. The FDA also recommends that dog owners and veterinarians continue to report adverse events related to the use of the drug.