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FDA News

FOR IMMEDIATE RELEASE
P04-50
May 4, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA


FDA Approves First Insulin Drug for Diabetic Dogs

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 lowblood 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.

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