Update on the availability of Vetsulin® porcine insulin zinc suspension

Updated February 9, 2011

Information we have received from Intervet/Schering-Plough Animal Health has clarified that they expect the U.S. Vetsulin supply to run out in late February or shortly thereafter. They continue to work with the FDA and their manufacturing facility in Germany to resolve the original stability problem and this new manufacturing issue, however further activity is needed before they will be ready to make the necessary FDA submissions. As a result, there will be no additional batches of Vetsulin scheduled to be manufactured at this time. Intervet/Schering-Plough strongly encourages veterinarians to transition all patients currently enrolled in the Critical Need Program to another insulin product. The company is developing resources to help with this process and intends to post these resources on www.Vetsulin.com.

 

In November 2009, The U.S. Food and Drug Administration's Center for Veterinary Medicine, in cooperation with Intervet/Schering-Plough Animal Health, announced that Vetsulin® may have varying amounts of crystalline zinc insulin, one component of the active ingredient in the formula. As a result, use of the product could result in a delay in action of the drug as well as prolonged activity, which could cause difficulty in managing diabetic pets.

The FDA-CVM and Intervet/Schering-Plough Animal Health requested that "veterinarians closely monitor their patients receiving Vetsulin® 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."

On May 2, 2010, the FDA announced they were allowing Intervet/Schering-Plough to offer a limited supply of Vetsulin® through their Vetsulin® Critical-Need Program. The supply was only to be used for a critical-need dog or cat that, in the medical judgment of the pet's veterinarian, could not be effectively managed on another insulin product. To request enrollment of a patient in the Critical-Need Program, veterinarians were instructed to contact Intervet/Schering-Plough's Technical Services Department at 800-224-5318.
Read the FDA press release.

The American Animal Hospital Association (AAHA) offered a free Web conference, "Vetsulin Update: Insulin Transitioning for Diabetic Patients" on November 24, 2009.

On February 4, 2011, the U.S. Food and Drug Administration's Center for Veterinary Medicine issued a statement that Vetsulin intended for use in animals enrolled in the Critical Needs Program had failed critical tests conducted to assure consistency and quality of the drug. The affected batch of Vetsulin was not released from the manufacturing plant. The FDA release also stated that Intervet/Schering-Plough Animal Health will be discontinuing the Vetsulin Critical Need Program.
Read the February 4 FDA press release

Read the FDA-CVM press release about the upcoming shortage of Vetsulin for the Critical Need Program(February 4, 2011)

Read the FDA-CVM press release about the Vetsulin Critical-Need Program(May 5, 2010)

FDA Warning letter to Intervet Schering-Plough about Vetsulin® New Animal Drug Application(March 12, 2010)

American Animal Hospital Association (AAHA) guidance for veterinarians on transitioning diabetic pets(PDF)(November 16, 2009)

Read the FDA-CVM press release(November 2, 2009)

Intervet/Schering-Plough resources

See also www.Vetsulin.com