FDA Issues Warning About "Adverse Events" With Arthritis Drug For Dogs
As dog owners, we want to do all we can to make sure our best friends are comfortable, especially as they get older.
Countless dogs develop osteoarthritis which can make it painful and difficult for them to move around. An injectable drug called Librela hit the market in 2023 to help arthritic dogs, but a few months after launching the "adverse drug events" started coming in.
The U.S. Food and Drug Administration (FDA) has issued a warning after reviewing the 3,637 adverse drug submissions received through March 2024.
88.9% of the submissions were reported by a veterinarian or health care professional.
They looked at the age of the dogs, other medications, and the reported side effects from the drug. According to the review, the three most common signs seen in dogs treated with the drug were ataxia, anorexia, and death.
It states, "Many of the most frequently reported signs for Librela are not currently on the product labeling, including the most frequently reported sign, ataxia, which is reported in 17% of cases so far received. Other frequently reported preferred terms which are unlabeled include polydipsia, death, diarrhea, muscle weakness, convulsion, recumbency, and paresis."
After conducting the review, the FDA's Center for Veterinary Medicine recommends adding a Post Approval Experience (PAE) section to the product's label to warn veterinarians and advise dog owners of the possible "adverse reactions".
Veterinarians and dog owners are advised to report any adverse reactions to the drug to the drug sponsor, Zoetis, at 1-888-963-8471, who must report them to the FDA, or you can report directly to the FDA here.
Zoetis is working with the FDA and released the following statement, "We continue to have the utmost confidence in the safety and efficacy of Librela. Since launching in Europe over three years ago, Librela has been used effectively with millions of dogs suffering from osteoarthritis pain."
You can read the full review here.
Andrea Powell is an animal enthusiast who resides in West Michigan. When not writing, she is exploring the great outdoors with her dogs and horses.