Intervet/Schering-Plough Animal Health reported today that it is discontinuing the Vetsulin Critical Need Program and will no longer provide Vetsulin (porcine insulin zinc suspension) after the current supply is exhausted, which is expected to be the end of February.
The discontinuation is being initiated based on quality tests that showed that the sterility of the most recent batch of Vetsulin, a product used to treat diabetes mellitus in dogs and cats, may be compromised by bacterial contamination. The batch has not been released from the manufacturing facility, according to Intervet/Schering-Plough Animal Health, a subsidiary of Merck & Co. Inc. of Whitehouse Station, N.J.
The company further noted that they are aware of no evidence that the Vetsulin currently on the market and being used under the program is affected.
The U.S. Food and Drug Administration, which sent out a notice late Friday announcing the anticipated shortage, confirmed that statement. No adverse events consistent with bacterial infection in dogs and cats receiving Vetsulin under the current program have been reported, according to the agency.
The Vetsulin Critical Need Program was launched in May 2010, intended for a critical need dog or cat that, in the medical judgment of the pet’s veterinarian, could not be effectively managed by another insulin product.
The program was initiated about six months after the FDA announced concerns about the drug’s stability. The FDA was concerned that the product could have unpredictable onset and duration of action. Consequently, the FDA recommended that diabetic dogs and cats receiving Vetsulin be switched to other insulin products.
Intervet/Schering-Plough Animal Health continues to investigate this issue, according to Sharon Dilling, global communications of U.S. Animal Health at Merck.
The company is also looking into the recent quality issue.
The FDA is encouraging owners of diabetic dogs and cats to consult their veterinarian as soon as possible about transitioning their pets to other insulin products.
Intervet/Schering-Plough Animal Health will be providing detailed instructions to veterinarians later today on how to manage the transition, Dilling said. The letters are being e-mailed and faxed to veterinarians for whom they have contact information for. Veterinarians with patients in the program will also be getting hard copies mailed to them via U.S. Mail, she said. The letters will also be posted at Vetsulin.com.
In the meantime, veterinarians can contact their sales representative if they have questions. They can also call Intervet/Schering-Plough Animal Health’s Technical Services with any medical questions at 800-224-5318.