A medication meant to help dogs with pain has been found to sicken and even kill them.
Librela, also referred to as the bedinvetmab injection, has been used on pups suffering from osteoarthritis since it was introduced and approved by the US Food and Drug Administration (FDA) in May 2023.
But the FDA has issued a letter to veterinarians after completing an ‘evaluation of adverse events’ from pet owners who have given Librela to their furry friends.
‘The adverse events identified and analyzed include: ataxia, seizures, other neurologic signs, including but not limited to, paresis, recumbency, urinary incontinence; polyuria, and polydipsia,’ stated the FDA in the letter on Monday.
‘In some cases, death (including euthanasia) was reported as an outcome of these adverse events.’
There have been more than 3,600 cases of adverse side effects from Librela from 2023 through March of this year.
It is administered through subcutaneous injection once per month and with dosage based on the dog’s weight.
Veterinarians who see dogs display symptoms after being treated with Librela are urged to report it to the drug sponsor, Zoetis, which is required to inform the FDA. Vets may also report the incidents directly to the federal agency.
The FDA stated that it reviewed available studies on the Librela and determined it to be safe for controlling pain from osteoarthritis, before granting the approval.
Zoetis stated that since Librela was launched in Europe three years ago, it has since been used effectively on millions of dogs.
‘We continue to have the utmost confidence in the safety and efficacy of Librela,’ stated Zoetis, according to the Daily Mail.
Zoetis CEO Kristin Peck in a November earnings call said that Librela was projected to become a $1billion franchise.
The FDA’s letter comes just weeks after a dog food manufacturer recalled 400 bags of treats over possible Salmonella contamination that could spread to humans.
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