Clinical
FDA drug label updates: Safety-related labeling changes
Since November, 2024, five animal drugs used in the treatment of companion animal species have undergone safety-related updates to their labels based on post-approval experience reported to the FDA. Get the details, including important warnings for both veterinary professionals and pet owners, here.
The U.S. Food and Drug Administration (FDA) recently announced safety-related labeling changes to several animal drugs used in small animal medicine. Currently, FDA drug label updates will impact several commonly prescribed drugs for cats and dogs.
According to the FDA, “When adverse events are reported or safety concerns are identified for an animal drug, the FDA may work with the sponsor to revise the labeling to reflect this information.”
Since November 2024, the following drugs have had changes to their label to add safety warnings about their use in animals:
Synotic (fluocinolone acetonide 0.01% and dimethyl sulfoxide 60%)
This drug is indicated for the relief of pruritus and inflammation associated with acute and chronic otitis in dogs.
Recently, warnings were added to indicate that a small number of dogs experienced hearing loss and/or vestibular dysfunction after administration of this drug, along with instructions for veterinary professionals whose patients experience these adverse effects.
Additionally, the wording on the label was changed from “FOR OTIC USE IN DOGS ONLY” to “FOR USE IN DOG EARS ONLY” to clarify that the drug is not for use in the eye. Further warnings were also added to advise against allowing any of the product to have contact with dog’s eyes or with human bare skin.
Bravecto 1-month (fluralaner) chews for dogs
This drug is indicated for the prevention and treatment of flea and tick infestations in dogs and puppies over 8 weeks of age.
Precautions were added regarding reports of adverse effects of the drug in breeding females, including birth defects (including limb deformities and cleft palate), stillbirth, and abortion.
Galliprant (grapriprant tablets) for dogs
This drug is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Warnings were added to the safety and risk section emphasizing that dogs should be observed for signs of potential drug toxicity and that Galliprant should not be administered in conjunction with any other oral or injectable NSAID or corticosteroid.
Other label updates indicate that patients should have a thorough history, physical exam, and laboratory testing performed prior to administration of Galliprant, and to use caution with concurrent administration of Galliprant and nephrotoxic or protein-bound drugs.
Post-approval experience was added to the list of adverse reactions associated with this drug, including gastrointestinal side effects, anorexia, lethargy, weight loss, panting, hyperactivity, renal and hepatic bloodwork abnormalities, ataxia, seizures, hematologic abnormalities, dermatologic effects, and in some cases death.
Credelio Cat (lotilaner)
This drug is indicated for the treatment and prevention of flea and tick infestations in cats and kittens over 8 weeks of age.
Post-approval adverse events including pruritus, vomiting, lethargy, behavioral changes (including hyperactivity, vocalization, and hiding), tachypnea, anorexia, muscle tremor, dyspnea, hyperthermia, and ataxia were added to the label.
Stelfonta (tigilanol tiglate injection) for dogs
This drug is indicated for the treatment of dogs with non-metastatic cutaneous mast cell tumors or non-metastatic subcutaneous mast cell tumors at or distal to the elbow or hock.
Label changes include updates to dosage and administration instructions emphasizing the importance of required concomitant medications.
Post-approval adverse events such as wound formation, limb amputation, and death were added.
The client information sheet was updated with these safety risks, and a fillable medication schedule was added to aid in the administration of required concomitant medications.
How to ensure you’re up to date
The FDA reports that it can sometimes take a year or more for labeling such as drug cartons or package inserts to be available to veterinary practices and pet owners after a decision is made to update drug safety information due to delays in production and distribution. To find the most up-to-date information on safety-related labeling changes to animal drugs, visit the FDA’s Animal Drug Safety-Related Labeling Changes website. You can also sign up for email updates on animal drugs and devices there.
Photo credit: kristyewing/iStock via Getty Images
Disclaimer: Trends™ content is meant to inform, educate, and inspire by providing an array of diverse viewpoints. Any content published should not be viewed as an official stance, position, or endorsement by the American Animal Hospital Association (AAHA) or its Board of Directors.
