US authorities list “death” as an adverse side effect of dog drug
For Judy Coleman, beloved dog Dougal was her reason to get up in the morning — he died within months of starting a new arthritis drug and now US authorities are warning of side effects.
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A seemingly wonder drug for treating dogs with osteoarthritis may actually be a killer, with American authorities warning vets that “adverse events” identified include death.
Beransa is a new drug used for treating osteoarthritis in dogs.
The Australian Pesticides and Veterinary Medicines Authority (APVMA) — the independent authority responsible for assessing and registering veterinary chemicals in Australia — registered Beransa in September 2022 for use in dogs and is now scrambling to assess the new evidence.
The US Food and Drug Administration (FDA) approved the drug, marketed as Librela in the US, in May 2023.
However, on December 16 the FDA notified American vets about adverse events reported in dogs treated with Librela.
It followed the FDA’s Center for Veterinary Medicine completing an evaluation of adverse events reported in dogs treated with Librela.
The included ataxia, seizures, other neurological 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,” the letter states.
The FDA advised vets that if a dog under their care experiences an adverse event while receiving Librela, “the FDA encourages you to report it to Zoetis, the drug sponsor … drug sponsors are required to submit reports of adverse drug events to FDA.”
An APVMA spokesman said Beransa was approved for use in Australia only when prescribed and administered by a registered vet.
“The APVMA is aware that international regulators have made public statements regarding alleged adverse experiences associated with Beransa,” he said.
“The APVMA is working with international regulators to assess available evidence.
“The APVMA may take appropriate regulatory action to ensure products continue to meet the strict safety, efficacy, and trade standards required by Australian law.
“This may include amending the conditions for legal use, conducting a formal review, or cancelling product registrations.”
The label for Beransa was updated in August 2024 to include “rarely identified” side effects.
Judy Coleman said her beloved Maltese Shih tzu cross Dougal, aged 15, was put on Beransa in April last year and was dead by July.
“He had three injections and ended up with liver failure,” Ms Coleman, 81, said.
“He was my life, my reason to get up in the morning.
“Dougal could not tolerate the other drug so was put on Beransa but went downhill, he was only a small dog but lost 1.5kg and would not eat or drink.
“I don’t blame the vet, but people need to know about the danger of this drug as more information comes to light.”
The manufacturer Zoetis released a statement to The Advertiser saying it is dedicated to upholding the highest standards for all its products.
“Zoetis stands firmly behind the safety and efficacy of Beransa and its ability to help dogs suffering from osteoarthritis to live with less pain and greater mobility,” it says.
“Beransa has undergone robust testing and has been approved as a safe and effective treatment for controlling osteoarthritis pain in dogs. With over 25 million doses distributed globally, no individual adverse event sign has been reported at a rate higher than 1 occurrence per 10,000 doses. This demonstrates the product’s strong safety profile.
“Label updates, issued in the years following a product launch, are a normal part of a product’s lifecycle. Label updates serve to educate veterinarians and assist their discussions with pet owners.
“Zoetis works with regulators around the world to update product labels as necessary. This includes a label change in Australia in August 2024 and in the US in February 2025.”
Originally published as US authorities list “death” as an adverse side effect of dog drug
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