FDA issues warning to vets over pet pain drug Librela after deaths reported

Librela, a relatively new injectable pet medicine, erases pain for so many dogs. But after thousands of complaints about complications, the FDA has issued an open letter to veterinarians to be alert to symptoms like paralysis, or even death.

The Symptoms

According to the FDA's letter, "The adverse events identified and analyzed include: ataxia, seizures, other neurologic signs, including, but not limited to, paresis, recumbency, urinary incontinence, polyuria, and polydipsia. In some cases, death (including euthanasia) was reported as an outcome of these adverse events." 

Revisions to the drug's current label are recommended.

Animals Affected 

The FDA reports that 3,674 pet owner complaints were studied. Ninety-nine percent were dogs. It's unclear how many pets have died, but estimates from the research are as many as 800. Because many elderly or already unwell pets were affected, the exact cause of death can muddy the data. 

Approval Process 

Librela has been used in Europe since February 2021. The FDA approved its use in the U.S. on May 5, 2023. The first adverse effect was reported on Sept. 8, 2023. It's not unusual to update warning labels as a product is more widely used. 

More Information 

The drug sponsor, according to the government report, is concerned there is "overreporting" of possible Librela-related symptoms due to social media activity. The Center for Veterinary Medicine countered that under-reporting is more likely an issue.