posted June 1, 2010
The Food and Drug Administration is allowing Intervet/Schering-Plough Animal Health to offer Vetsulin for critical-need dogs and cats with diabetes mellitus that cannot be effectively managed with another insulin product.
In November 2009, the FDA announced concerns about the stability of Vetsulin and recommended that veterinarians switch diabetic dogs and cats receiving Vetsulin to other insulin products. Afterward, the agency and Intervet/Schering-Plough heard from many veterinarians and pet owners who expressed concerns that Vetsulin was the only product that could control diabetes in certain dogs and cats.
The FDA is recommending that veterinarians with such patients contact the Intervet/Schering-Plough Technical Services Department at (800) 224-5318 to request enrollment of the patients in the Vetsulin Critical-Need Program. Veterinarians must provide the medical rationale for why another insulin product cannot control diabetes effectively in these patients.
Intervet/Schering-Plough continues to work with FDA to address concerns with the manufacture of Vetsulin. Use of the product under the Critical-Need Program will require close monitoring of patients.
Additional information about the Vetsulin situation is available at www.avma.org/issues under "Drugs."