FDA OKs critical need program for Vetsulin

FDA OKs critical need program for Vetsulin

May 06, 2010
Rockville, Md. --The Food and Drug Administration (FDA) is allowing Vetsulin maker Intervet/Schering Plough to offer a limited supply of the porcine insulin zinc suspension as part of a new Critical-Need Program.

In a statement released in early May, FDA reports the plan was created to address concerns regarding the supply of this popular diabetes treatment.

“The supply is only to be used for a critical-need dog or cat that, in the medical judgment of the pet’s veterinarian, cannot be effectively managed on another insulin product,” FDA reports.

In November 2009, FDA announced its concerns about the stability of Vetsulin and recommended that diabetic dogs and cats currently receiving the drug be switched to other insulin products.

Veterinarians and pet owners expressed significant concerns to FDA and Intervet/Schering Plough about this decision and treatment options for diabetic patients.

As a result, FDA is recommending veterinarians with qualified patients contact Intervet/Schering Plough’s Technical Services Department at (800) 224-5318. Veterinarians will be required to provide the medical rationale about why the patient cannot be effectively controlled using another insulin product.

“Intervet continues to work with FDA to address concerns associated with the manufacture of Vetsulin,” the agency adds. “Because Vetsulin may have varying amounts of crystalline zinc insulin in the formulation, it could cause a delay in insulin action and an overall longer duration of insulin activity,” FDA says. Insulin products that do not remain within specification throughout the entire shelf life could potentially result in unpredictable fluctuations in the glucose levels of diabetic patients. Use of the product under the Critical-Need Program will require close monitoring of the patient, FDA adds.