Vetsulin to become available in limited supply
A popular product used to treat diabetes in dogs and cats will be made available to critical patients, despite ongoing concerns about the drugs stability.
The U.S. Food and Drug Administration (FDA) said May 5 that Intervet/Schering Plough Animal Healths Vetsulin (porcine insulin zinc suspension) will be offered to certain dogs and cats in limited supply through the companys new Vetsulin Critical-Need Program.
“The supply is only to be used for a critical-need dog or cat that, in the medical judgment of the pets veterinarian, cannot be effectively managed on another insulin product,” the FDA said.
Intervet has been working with the FDA since last fall to address concerns with Vetsulins stability. In November, the FDA issued a product alert on Vetsulin when amounts of crystalline insulin in the formulation were found to be out of specification in some batches of the product. Intervet sent a letter to veterinarians shortly after that urging them to begin transitioning diabetic patients off Vetsulin due to predicted shortages in product availability.
However, Intervet says it has heard from a significant number of veterinarians and pet owners who were concerned that their patients or pets could not be safely transitioned off Vetsulin.
Intervet sent a letter to veterinarians on May 5 announcing the Vetsulin Critical-Need Program, which officially begins the week of May 24.
“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 veterinarians medical judgment these pets cannot be effectively managed on another insulin product,” the letter says. “The availability of this supply will mean that truly critical-need patients can be maintained on Vetsulin.”
In order to qualify for the program, a veterinarian will need to contact Intervet and request enrollment in the program for specific patients. In addition, the veterinarian must also:
- Provide patient and owner information, and the reason the veterinarian thinks that patient cannot be managed with another product.
- Sign and submit a form certifying that in the doctors medical judgment, the patient cannot use other products besides Vetsulin, and send in a signed owner consent form.
Intervet says the Vetsulin will be delivered directly to the pet owner through a third party designated by Intervet. The veterinarian will be charged for the product and delivery fees, and the veterinarian must then bill the client. Doctors must also advise clients of the potential problems with Vetsulin and make sure they report any adverse effects.
To request enrollment in the program, call Intervets technical services department at (800) 224-5318.
For information on transitioning pets off Vetsulin, click here to see the AAHA Diabetes Guidelines Task Force recommendations