Merck Animal Health has announced that Vetsulin (porcine insulin zinc suspension), the only federally approved insulin for dogs and cats with diabetes mellitus, is once again available to the U.S. veterinary market.
Vetsulin was initially launched in 2004, but in 2009 the the U.S. Food and Drug Administration (FDA) raised concerns about its stability, stating that the product could have an unpredictable onset and duration of action and recommending that diabetic patients be switched to other products.
In 2010 the agency approved the use of Vetsulin for critical needs patients, or dogs and cats whose diabetes couldn’t be managed on other forms of insulin. However, later that year, sterility concerns prevented the release of a new batch of Vetsulin, and the product was ultimately discontinued in 2011.
Merck says these issues have been fully addressed, and FDA approval has been obtained to reintroduce Vetsulin.
According to a company release, the prevalence of diabetes mellitus in dogs and cats ranges from one in 100 to one in 500, and the number of dogs diagnosed with the disease has tripled during the past 30 years. Vetsulin, known as Caninsulin outside the United States, has been used to treat diabetic dogs and cats overseas for more than 20 years.
The source of insulin is especialy important for diabetic dogs, Merck says. Human and bovine insulin, which are used to formulate nonveterinary insulin products, have amino acid structures that differ from that of canine insulin. And because canine diabetes is often the result of an immune-mediated process, anti-insulin antibodies can potentially be a problem in dogs.
The porcine insulin used in Vetsulin has an amino acid structure identical to canine insulin, which helps minimize this immunological risk, the company says. Diabetes in cats is not thought to be an immune-mediated disorder, so anti-insulin antibodies are not as much of a concern in these patients.
For more information about Vetsulin, Merck suggests visiting vetsulin.com or contacting a Merck representative or authorized distributor.