Sunday, September 26, 2010

Update On Merck/Intervet's Vetsulin® -- For Diabetic Companion Animals

The web is a wonderful space. Last Tuesday, I noted that Merck had cleared its November 2009 FDA-issued warning letter. By late Friday night, an anonymous commenter had quite correctly edited my post of Tuesday, in the comment box, to indicate that Vetsulin® remains available only for critical needs -- i.e., may only be given to dogs and cats whose diabetis will not respond to other brands effectively. So the Intervet/Merck product remains restricted to the general market, thus (an FDA update, from May 2010):

. . . .FDA is allowing Intervet to offer a limited supply of Vetsulin through their Vetsulin Critical-Need Program. The supply is only to be used for a critical-need dog or cat that, in the medical judgment of the pet’s veterinarian, cannot be effectively managed on another insulin product. . . .

. . .FDA and Intervet heard from many veterinarians and pet owners who expressed significant concerns about specific diabetic dogs and cats which could only be controlled with Vetsulin.

As a result of these concerns, FDA is recommending veterinarians with qualified patients contact Intervet’s Technical Services Department at 800-224-5318, to request enrollment of the patient in the Vetsulin Critical-Need Program. The veterinarian will need to provide the medical rationale for why the patient cannot be effectively controlled using another insulin product.

Intervet continues to work with FDA to address concerns associated with the manufacture of Vetsulin. Because Vetsulin may have varying amounts of crystalline zinc insulin in the formulation, it could cause a delay in insulin action and an overall longer duration of insulin activity. Insulin products that do not remain within specification throughout the entire shelf life could potentially result in unpredictable fluctuations in the glucose levels of diabetic patients.

Use of this product under the Critical-Need Program will require close monitoring of the patient, all of which is described in an owner consent form. . . .

Again, the web allows sharing of knowledge, and refinements to that knowledge, so rapidly -- it is truly a wonder to live in these times. Thanks to my erstwhile commenters -- and have a great (rest of your) day of rest, one and all.

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