Tejal Somvanshi
The Food and Drug Administration’s Center for Veterinary Medicine has issued an urgent warning about Librela, a widely-used injectable medication for dogs with osteoarthritis, following reports of severe adverse effects including deaths.
Between January 2023 and March 2024, over 3,600 cases of adverse reactions were documented, ranging from neurological complications to fatalities. Most reports were submitted by veterinarians and other healthcare professionals. The FDA’s evaluation revealed concerning side effects such as ataxia (loss of muscle control), seizures, partial paralysis, and urinary problems.
“In some cases, death (including euthanasia) was reported as an outcome of these adverse events,” the FDA stated in its December 16 letter to veterinarians.
Reported Health Impacts
The most frequently reported clinical signs in the Standard Adverse Event Review include:
- Ataxia
- Anorexia
- Lethargy
- Seizures
- Recumbency
- Urinary incontinence
- Polyuria and polydipsia
The drug, manufactured by Zoetis and approved by the FDA on May 5, 2023, is administered monthly via subcutaneous injection. Dosage varies based on the dog’s weight, with available concentrations from 5 to 30 mg/ml.
Real-World Impact
Pet owners have reported devastating outcomes. Phil Jordan’s 12-year-old rescue dog, Daisy, experienced severe complications after receiving Librela. “She began to limp and wobble weeks after her first injection,” Jordan reported. After a second dose, Daisy lost her ability to walk, became lethargic, stopped eating, and developed kidney failure, ultimately requiring euthanasia.
Manufacturer’s Position
Zoetis maintains its stance on the drug’s safety, stating that adverse events represent a minimal percentage of administered doses. “We continue to have the utmost confidence in the safety and efficacy of Librela,” a Zoetis representative said. “With more than 21 million doses distributed globally, no individual adverse event sign is reported at a rate higher than rare.”
Dr. Richard Goldstein, Global Chief Medical Officer at Zoetis, emphasized the importance of proper diagnosis: “We should do our best to diagnose every possible condition prior to prescribing Librela and then have a risk-benefit conversation with the pet owner.”
Regulatory Response
The FDA recommends adding a Post Approval Experience section to Librela’s label to inform pet owners about potential adverse effects. Veterinarians are urged to report adverse reactions to Zoetis (1-888-963-8471) or directly to the FDA at www.fda.gov/reportanimalae.
When reporting incidents, veterinarians should provide the following:
- A full medical history
- Number of Librela treatments received
- Lot number from the used vial
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Market Impact
With approximately 14 million dogs suffering from osteoarthritis in the United States alone, the implications of these findings are substantial. Treatment costs vary based on the amount needed for the dog, with additional fees potentially applying for veterinary consultation and administration.
Expert Recommendations
Veterinarians are advised to:
- Confirm osteoarthritis diagnosis before prescribing
- Avoid use in pregnant or lactating dogs
- Monitor treated dogs closely
- Report any adverse reactions promptly
- Discuss potential risks with pet owners
The FDA continues to monitor the situation and will release additional information as it becomes available. Pet owners with concerns should consult their veterinarians about alternative treatment options.
