FDA Approves Vetsulin Critical-Need Program

A limited supply of Vetsulin will be offered through the Vetsulin Critical-Need Program.

Intervet/Schering-Plough Animal Health will begin offering a limited supply of Vetsulin (porcine insulin zinc suspension) through its Vetsulin Critical-Need Program, starting May 24.

The U.S. Food and Drug Administration approved the program after hearing concerns from veterinarians regarding the supply of the product.

In November, the FDA questioned the stability of Vetsulin and recommended that diabetic dogs and cats receiving Vetsulin be switched to other insulin products.

“In response to the Vetsulin product alert issued in November 2009, Intervet/Schering-Plough Animal Health has been working with the FDA to address an issue identified with our Vetsulin product,” Christopher Pappas Jr., DVM, director of technical services, wrote in a letter to veterinarians this week. “Since that time, we have recommended that pets be transitioned to other insulin products as we anticipated a limitation on supply and eventual supply depletion. During the process of transitioning pets to other insulin products, we heard from a number of veterinarians and pet owners who expressed significant concerns that specific dogs and cats cannot be effectively managed on an insulin product other than Vetsulin.

“After working with the FDA on this situation, Intervet can now offer a limited supply of Vetsulin to specific, critical-need pets, when in the veterinarian’s medical judgment these pets cannot be effectively managed on another insulin product. The availability of this supply will mean that truly critical-need patients can be maintained on Vetsulin.”

The FDA is recommending that veterinarians with qualified patients contact Intervet/Schering-Plough’s Technical Services Department at 800-224-5318. To enroll a patient, veterinarians must provide the medical rationale for why the patient cannot be effectively controlled using another insulin product. The specifics of the program can be found at: Vetsulin.com/PDF/Vetsulin_Critical_Need_Program_VetLetter.PDF.

The FDA noted that 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.

“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,” according to the FDA. “Use of this product under the Critical-Need Program will require close monitoring of the patient, all of which is described in an owner consent form.”

Intervet/Schering-Plough Animal Health is working with the FDA to address concerns.

“We have been working diligently to address the issues with this product and hope that the Vetsulin Critical-Need Program will only be a temporary measure,” Dr. Pappas wrote. “Our top priority is the health, safety and welfare of pets, and we believe this program will help assist those pets most in need of Vetsulin in the coming months.”

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