FDA Issues Alert On Pet Insulin Product Due To Formulation Problems

Veterinarians are closely watching pets on Vetsulin due to a potential danger in the formulation.

Veterinarians are being warned to closely monitor dogs and cats receiving Vetsulin because the product may have varying amounts of crystalline zinc insulin in the formulation, according to an alert sent out Nov. 2 by the U.S. Food and Drug Administration’s Center for Veterinary Medicine.

Vetsulin, which is manufactured by Intervet/Schering-Plough Animal Health, is a porcine insulin zinc suspension used to treat diabetes in animals.

Because the product is out of specification, there could be a delay in insulin action and overall longer duration of insulin activity, according to the FDA. Products having significant problems with stability can affect the management of chronic diseases. Unstable insulin products can result in unpredictable fluctuations in the glucose levels of diabetic patients, the FDA noted in its alert.

Veterinarians are urged to monitor patients for any changes in onset or duration of activity, or for any signs of hyperglycemia or hypoglycemia. The classic signs of hyperglycemia include increased thirst, increased urination, weight loss and lethargy. The classic signs of hypoglycemia include disorientation, unsteadiness, weakness, lethargy and seizures.

The FDA said that while Intervet/Schering-Plough Animal Health is working with them to resolve the issue, supplies may be limited. Therefore, the FDA is suggesting that veterinarians consider transitioning their diabetic patients to other insulin products.

The FDA is also encouraging veterinarians to report any adverse events with Intervet/Schering-Plough Animal Health at 800-224-5318.

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