Dog owners will go to great lengths to keep their beloved pets safe and healthy, including getting them the medicines they need. But just as with human medications, issues can arise with the very products intended to help us feel better. Now, the U.S. Food & Drug Administration (FDA) is warning that a common pain drug for dogs known as Librela has been linked to several serious side effects in canines, including some that have led to death.
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The agency warns that Librela can cause serious neurological symptoms.
On Dec. 16, the agency posted a letter to veterinarians warning that it had received reports of dogs of various ages treated with Librela developing very dire side effects during their course of treatment.
Symptoms included loss of muscle control and coordination; seizures; paresis (weakness or partial paralysis); recumbency (inability to get up from a lying position); urinary incontinence; excessive urination; and polydipsia (excessive thirst). The letter also clarified that some dogs died or were euthanized as a result of these side effects.
The Wall Street Journal reports that the FDA investigated more than 3,600 cases of such symptoms linked to Librela throughout 2023 and up until March 2024. The agency said it approved the monoclonal antibody drug in May of last year for “the control of pain associated with osteoarthritis in dogs,” determining it to be safe when dosed by weight and administered via a monthly shot.
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The drug company maintains that Librela is safe.
On the same day, Librela manufacturer Zoetis released a statement responding to the FDA’s letter, saying the reports were consistent with its own data on the drug. The company said it was in communication with the agency to “ensure the ongoing safety and efficacy” of its products and was working to “contextualize” the data, per Today’s Veterinary Business.
“We continue to have the utmost confidence in the safety and efficacy of Librela,” Zoetis said in its statement. “Since launching in Europe over three years ago, Librela has been used effectively with millions of dogs suffering from osteoarthritis pain. With more than 21 million doses distributed globally, no individual adverse event sign is reported at a rate higher than rare,” which it said was defined by the European Medicines Agency (EMA) as less than 10 per 10,000 treated animals.
The FDA is suggesting the company change the drug’s labels.
In its letter, the FDA says it monitors animal drugs after they are released to look for any adverse effects that may not have arisen before receiving approval. The FDA Center for Veterinary Medicine can then suggest—but not require—specific labeling changes in light of any issues.
In this case, the agency is suggesting that the company should add a “Post Approval Experience” section to Librela’s label to warn about the potentially serious side effects, The Wall Street Journal reports.
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The takeaway.
This week, the FDA warned that Librela, a popular drug used to treat arthritis pain in dogs, could cause serious neurological side effects—and even result in death. Despite the agency’s investigation, parent company Zoetis says the latest reports of adverse health issues in canines are in line with its data collected in Europe. The FDA will now suggest that the company add a “Post Approval Experience” suggestion to the medication’s label.
