Species
FDA Approves First Insulin Drug for Diabetic Dogs
5 April 2004
Announcing, Vetsulin™ (porcine insulin zinc suspension), the first and only FDA approved insulin available in the USA for treating diabetic dogs. See FDA press release below. Vetsulin is a prescription product and will be available through veterinarians.
Vetsulin should not be used in dogs known to have a systemic allergy to pork or pork products. Vetsulin is contraindicated during periods of hypoglycemia. Keep out of the reach of children. Animals presenting with severe ketoacidosis, anorexia, lethargy, and/or vomiting should be stabilized with short-acting insulin and appropriate supportive therapy until their condition is stabilized. As with all insulin products, careful patient monitoring for hypoglycemia and hyperglycemia are essential to attain and maintain adequate glycemic control and associated complications. Overdosage can result in profound hypoglycemia and death.
Vetsulin will be available later this year or ealry in 2005. For more information please visit www.vetsulin.com
FOR IMMEDIATE RELEASE
| P04-50 | Media Inquiries: 301-827-6242 |
| May 4, 2004 | Consumer Inquiries: 888-INFO-FDA |
FDA has approved a porcine insulin zinc suspension product as the first drug for treating diabetic dogs. Prior to the development of this product, the only treatment veterinarians could use on diabetic dogs was human insulin, which is less compatible with a dog’s metabolic system. Estimates are that one in every 200 dogs will develop diabetes. The onset usually occurs in dogs aged 7-9 years, and seems to be twice as prevalent in females as in males.
“This is a very positive development for millions of American dog owners and their pets,” said Acting FDA Commissioner Dr. Lester M. Crawford. “It promises to improve the health and quality of life of dogs who suffer from this debilitating disease.”
The product will be marketed under the trade name “Vetsulin” by its developer Intervet, Inc. of Millsboro, Del., and will be available under a veterinarian’s prescription. The treatment will be used to improve the clinical signs of diabetes in dogs such as excessive thirst, excessive urination, excessive appetite, and weight loss despite good appetite.
Veterinarians will determine the initial treatment dose based on the dog’s weight, and then will use various tests to adjust the dosage to the optimum level. Maintenance administration of the insulin may be done in the home. Dog owners will be provided instructions on how to treat their dogs at home with the insulin. An information sheet that outlines the benefits and risks of the treatment will also be provided.
Among the risks dog owners may face is hypoglycemia (dangerously low blood sugar) if they accidentally inject themselves with the insulin. The product contains warning statements on the label about this risk as well as others such as the need to prevent eye exposure to the insulin. Vetsulin has already been approved in 20 countries, including the United Kingdom, and should be available in the United States in late summer 2004.
