Recent updates on the availability of Vetsulin® (porcine insulin zinc suspension)
Vetsulin (known as Caninsulin® outside the US) has been used worldwide by veterinarians for more than 20 years. Due to a manufacturing issue, actions were taken in November 2009 in the US to limit availability of the existing Vetsulin inventory. Once this inventory was exhausted, Vetsulin was unavailable until the issue was resolved. The manufacturing issue has been resolved and Vetsulin was re-introduced to the US market in April 2013.
Please watch this video for more information about the reintroduction of Vetsulin.
We recognize that the period when Vetsulin initially went off the market was a difficult one for veterinarians who had to re-regulate diabetic patients with another insulin. Merck Animal Health regrets the difficulties that veterinarians experienced and appreciates their outstanding efforts to manage their patients’ diabetes.
Below are answers to questions you might have about these developments.
Has the manufacturing issue been resolved?
Yes. The manufacturing issue has been fully addressed. Merck Animal Health has made a significant investment in updating our manufacturing processes and has re-qualified the product for sale. We are committed to upholding the quality of Vetsulin and supporting veterinarians in the ongoing treatment of their patients.
Did the manufacturing update have any impact on Vetsulin?
No. The product has the same characteristics. The ratio of amorphous insulin to crystalline insulin stated on the label has changed from 30:70 to 35:65. This is a more accurate reflection of the average ratio range upon release and throughout its shelf life.
Has there been any change to the safety of Vetsulin?
No. The manufacturing issue stemmed from tests that revealed the amount of crystalline component within batches of Vetsulin had risen above specification at some point in the shelf life. Merck Animal Health was permitted to continue selling inventory of Vetsulin because the safety of the product was not compromised, and the FDA agreed diabetic pets could be safely and effectively managed with Vetsulin.