March 15, 2011
Intervet/Schering-Plough Animal Health is discontinuing the Vetsulin Critical-Need Program.
In November 2009, the Food and Drug Administration announced concerns about Vetsulin's stability and recommended that veterinarians transition diabetic dogs and cats receiving Vetsulin to other insulin products. In May 2010, Intervet/Schering-Plough initiated the Vetsulin Critical-Need Program for dogs and cats with diabetes that were difficult to manage with other insulin products.
In November 2010, tests indicated that bacterial contamination might have compromised the sterility of the most recent batch of Vetsulin. Intervet/Schering-Plough did not release this batch of Vetsulin and did not manufacture any additional batches.
The FDA has no evidence that bacterial contamination affects any Vetsulin on the market and has received no reports under the Critical-Need Program of adverse events consistent with bacterial infection.
On Feb. 7, Intervet/Schering-Plough sent letters to veterinarians and pet owners participating in the Critical-Need Program with a notification about the shortage of Vetsulin and consequent discontinuation of the Critical-Need Program.
The letters and additional details are available at www.vetsulin.com in the "Important product alert" section.