http://www.fda.gov/AnimalVeterinary/newsEvents/CVMUpdates/ucm188752.htm

FDA's Center for Veterinary Medicine Alerts Veterinarians About Problems
with VetsulinR to Treat Diabetes in Dogs and Cats

November 2, 2009

The Food and Drug Administration's (FDA) Center for Veterinary Medicine
(CVM) and Intervet/Schering-Plough Animal Health are alerting veterinarians
and pet owners that VetsulinR, a porcine insulin zinc

suspension used to treat diabetes in animals, may have varying amounts of
crystalline zinc insulin in the formulation. Because this
Intervet/Schering-Plough Animal Health product is out of specification it
could cause a delay in insulin action and an overall longer duration of
insulin activity. Products having significant problems with stability can
affect the management of chronic diseases. Unstable insulin products can
result in unpredictable fluctuations in the glucose levels of diabetic
patients. Intervet/Schering-Plough Animal Health is unable to assure FDA
that each batch of their product is stable.

FDA and Intervet/Schering-Plough Animal Health request that veterinarians
closely monitor their patients receiving VetsulinR for any changes in onset
or duration of activity, or for any signs of hyperglycemia or hypoglycemia.
The classic signs of hyperglycemia include increased thirst, increased
urination, weight loss and lethargy. The classic signs of hypoglycemia would
include disorientation, unsteadiness, weakness, lethargy, and seizures.

While Intervet/Schering-Plough is working with FDA on resolving this issue,
supplies may be limited. Therefore, veterinarians should consider
transitioning their diabetic patients to other insulin products. In

addition, FDA encourages veterinarians to report any adverse events with the
Intervet/Schering-Plough Animal Health product to the company through the
Technical Services Department at 1-800-224-5318.

Contact Us

* 240-276-9300

* 240-276-9115 FAX

*

Issued by: FDA, Center for Veterinary Medicine Communications Staff,
HFV-12

7519 Standish Place