FDA Issues Alert for Vetsulin
Problems may lead to hyper- or hypoglycemia in diabetic dogs.
News item written by Mary Straus, published in the Whole Dog Journal, December 2009
On November 2nd, the FDA’s Center for Veterinary Medicine and Intervet/Schering Plough Animal Health began alerting veterinarians and pet owners to problems found with Vetsulin, a prescription insulin product used to treat diabetic pets.
Stability issues have led to variation in the amount of insulin contained in the product. Specifically, there may be too much crystalline insulin, which is the longer-acting component, and too little of the amorphous, short-acting insulin. This can lead to a delay in the insulin beginning to work, a delay in peak effect, or the insulin working longer than expected. The result may be either hypoglycemia or hyperglycemia.
Hypoglycemia (low blood sugar) is a medical emergency: if not corrected, it can be fatal. Symptoms of hypoglycemia can include disorientation, ataxia (loss of coordination or balance), weakness, lethargy, and seizures. If you suspect your dog is suffering from hypoglycemia, rub Karo syrup or honey on your dog’s gums or under the tongue and contact your veterinarian immediately.
Hyperglycemia is less of a concern, at least in the short term. It produces the same symptoms as are seen in diabetic dogs before beginning treatment, such as excess drinking and urination, increased appetite, and lethargy.
If you use Vetsulin to treat your diabetic pet, please contact your veterinarian right away about switching to a different product until these issues are resolved.
If your dog develops problems that your veterinarian believes could be linked to Vetsulin, they should be reported to the FDA and to Intervet/Shering-Plough Animal Health, the company that makes Vetsulin.
UPDATE 4/17/13: Vetsulin is back! Manufacturing problems led to the FDA having it withdrawn from the U.S. market. These issues have finally been resolved and the FDA has approved the drug for release and it is now available again. Note that the product was not reformulated, but there were label changes involving instructions for use, product description, and shelf life. See the following for more information:
More information:
- Vetsulin’s removal from market could be temporary (Update 2/8/11)
- Even More Vetsulin Supply Problems are Forecast
- FDA Announces Upcoming Shortage of Vetsulin for Dogs and Cats in the Critical Need Program (Update 2/4/11)
- FDA’s Center for Veterinary Medicine Alerts Veterinarians About Problems with Vetsulin® to Treat Diabetes in Dogs and Cats
- Intervet/Shering-Plough Animal Health, 800-224-5318
- Medical Alert for Those Caring for a Diabetic Dog or Cat
- FDA Announces Availability of Vetsulin for Critical Needs Dogs and Cats (5/5/10)
- Animal-Only Insulin Still In Infancy
- Blog Post: one person's search to find Vetsulin for her dog
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