FDA Announces Upcoming Shortage of Vetsulin for Dogs and Cats in the Critical Need Program
February 4, 2011
The Food and Drug Administration (FDA) announced today an anticipated shortage of Vetsulin (porcine insulin zinc suspension), a product used to treat diabetes mellitus in dogs and cats. Vetsulin is manufactured by Intervet/Schering-Plough Animal Health and is only available to animals currently enrolled in the Vetsulin Critical Need Program.
In November 2009, FDA announced its concerns about the stability of Vetsulin, which may cause the product to have unpredictable onset and duration of action in dogs and cats treated with Vetsulin. At that time, FDA recommended that diabetic dogs and cats currently receiving Vetsulin be switched to other insulin products. In May 2010, Intervet/Schering-Plough Animal Health initiated the Vetsulin Critical Need Program, intended 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.
In November 2010, Vetsulin intended for use in the Critical Need Program, failed critical manufacturing tests which are routinely conducted to assure consistency and quality of the drug. The tests showed that the sterility of the most recently manufactured batches of Vetsulin may be compromised by bacterial contamination. This batch of Vetsulin has not been released.
FDA has no evidence that Vetsulin currently on the market and being used under the Critical Need Program is affected. No adverse events consistent with bacterial infection in cats and dogs receiving Vetsulin have been reported to CVM under the current program.
Intervet/Schering-Plough Animal Health has indicated that it will be sending letters to owners of the pets enrolled in the Vetsulin Critical Need Program and their veterinarians. In those letters, the firm will be notifying veterinarians and pet owners of the upcoming shortage of Vetsulin and consequent discontinuation of the Vetsulin Critical Need Program. Owners of diabetic cats and dogs are encouraged to consult their veterinarian as soon as possible about transitioning their pets to other insulin products. Intervet/Schering-Plough Animal Health is planning to provide detailed instructions to veterinarians on how to manage the transition.