Even More Vetsulin Supply Problems are Forecast
photo 2007 Erin Stevenson O'Connor | more info (via: Wylio)
Diabetic cats and dogs generally require daily (or twice daily) injections of insulin. Many years ago most diabetic cats and dogs were placed on a specific brand of insulin: Humulin, made by Lilly.
As its name would imply, Humulin was designed for the human market. Although it was the mainstay insulin for veterinary patients, it was supplanted by other forms of insulin in people. Its profitability was in question, and Lilly cancelled the product.
That left huge numbers of veterinary patients in the lurch. Devising a safe and effective dose of insulin is a complicated thing. Switching insulin types places patients a risk of life threatening complications.
When Humulin was cancelled, veterinarians and owners of diabetic animals were forced to switch. Most cats wound up either on glargine insulin (also known as Lantus) or on PZI insulin, both of which remain readily available. Most dogs (but quite a few cats as well) ended up on a new form of insulin designed specifically for the veterinary market: Vetsulin.
The results were stellar. Vetsulin worked incredibly well. Many dogs that previously had suffered from uncontrollable diabetes enjoyed good results. PZI and especially Lantus also worked well; for a time, things were as good as they could be in the world of veterinary diabetes.
Then, in November, 2009, the United States Food and Drug Administration announced concerns about the quality of Vetsulin. Specifically, FDA was worried that issues with the drug could lead to accidental under- or overdoses. The supply of Vetsulin began to dry up, and significant numbers of animals unfortunately were forced to switch insulin yet again.
However, because Vetsulin was the only insulin that worked well or at all for many pets, and because the problems with the product appeared to be more theoretical than real, Vetsulin remained available to a limited number of animals through the "Vetsulin Critical Need Program".
If your dog or cat is in the program, talk to your vet immediately. More trouble is on the way.
The Kansas City Infozine reported last week that FDA has found more issues with Vetsulin, and that disruptive supply shortages of the product are looming.
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.
Vetsulin's manufacturer, Intervet/Schering-Plough Animal Health, will be sending letters discussing the matter to owners of pets enrolled in the Critical Need Program. However, I worry that options may be limited. Many more animals -- the ones at greatest risk of complications -- may soon be forced to switch insulins.
Photo: Humulin from the olden days.