Those “adverse event reports” mean that someone reported their dog’s death or injury after taking the drug. The FDA said they do not automatically mean that the drug caused the event and that reviewers from the FDA’s Center for Veterinary Medicine “must assess the report(s) for potential causality.”
Concerns about the drug were first reported in a story by WSB-TV in Atlanta.
WSB-TV reported that Librela was approved for use after producer Zoetis conducted a study of 272 dogs in the U.S. and another 281 dogs in Europe.
Librela was approved to control osteoarthritis pain in dogs in May 2023, according to the FDA.
WSB-TV reported Librela’s label lists side effects including urinary tract infection, anorexia and lameness but not death.
The FDA told WSB-TV that its approval “means the drug is safe and effective when it is used according to the label”, adding that the approval ensures the drug’s strength, quality and purity are consistent and that the labeling is “truthful, complete, and not misleading.”
In a statement, the FDA said that it monitors the safety of new drugs after it approves them, especially in the first three years after approval, “because widespread use of a drug product in a large number of patients may uncover adverse events not observed prior to approval.” The agency added that animal drug companies are required to report all cases where an animal experiences negative effects after taking the drug.
The FDA also confirmed it is reviewing adverse event reports from dogs who received Librela.
In a letter to veterinarians, the FDA gave more information about what some of the “adverse events” were.
Many of the events were neurological signs, the FDA wrote, such as abnormal or uncoordinated movements, seizures, muscle weakness or paralysis and incontinence. In some cases, the FDA said, the reports said that the events led to death.
Zoetis said in a statement that the data the FDA is referencing aligns with its own ongoing monitoring of Librela, and that the company is discussing updating its labeling with the FDA, which would make the label consistent with labels in other countries including Australia, Canada, the European Union, New Zealand, Switzerland and the United Kingdom.
The company said that label changes in pharmaceuticals are common, especially in the first few years after launch.
It said that there have been 21 million doses of the drug distributed worldwide, and that there have been no “individual adverse event sign” reported at a rate higher than “rare” as defined by the European Medicines Agency, or less than 10 occurrences per 10,000 doses given.
“We remain confident in Librela’s safety and effectiveness and are committed to supporting veterinarians and pet owners in helping dogs live with less pain and greater mobility,” the company said.
