FDA alerts veterinarians to problems with Vetsulin
posted December 1, 2009
The Food and Drug Administration's Center for Veterinary Medicine and Vetsulin manufacturer Intervet/Schering-Plough Animal Health are warning veterinarians that recent formulations may contain varying amounts of crystalline zinc insulin.
An FDA alert warned that because Vetsulin is out of specification, use of the drug could cause a delay in insulin action and an overall longer duration of insulin activity. Unstable insulin products can result in unpredictable fluctuations in blood glucose concentrations in diabetic patients. According to the FDA alert, Intervet/Schering-Plough is unable to assure the agency that each batch of Vetsulin is stable.
The FDA and Intervet/Schering-Plough request that veterinarians closely monitor patients receiving Vetsulin for any changes in onset or duration of activity and for any signs of hyperglycemia or hypoglycemia.
Vetsulin supplies may become limited while Intervet/Schering-Plough is working with the FDA on resolving problems with the product. According to the FDA, veterinarians should consider transitioning diabetic patients to other insulin products. Also, the FDA encourages veterinarians to report any adverse events with Vetsulin to Intervet/Schering-Plough through the Technical Services Department at (800) 224-5318.
2014 American Veterinary Medical Association