FDA warning letter to Intervet Inc. (division of Merck & Co) states Intervet did not report adverse drug events of Vetsulin as required by law. The FDA warning letter was posted May 4, 2010. Caution to pet owners of diabetic dogs and cats.
Issues with Intervet’s Vetsulin has been surfacing for months. According to the recent FDA warning letters (posted May 4, 2010), it appears Merck’s pet drug subsidiary Intervet did not report to the FDA (in three days as required) known serious adverse drug events. htt“Analytical testing conducted by Intervet Inc., revealed several batches of Vetsulin did not meet stability specifications for non-extractable insulin before the end of the drug’s expiration date. FDA’s approvals are conditioned on approved product specifications, such as stability, and therefore, the safety and effectiveness of products outside approved specifications are unknown. Insulin products with product defects such as nonconformance with stability specifications may result in a serious adverse drug event, and therefore are subject to the FAR requirements in 21 CFR 514.80(b)(1). Although Intervet Inc., was aware that analytical data for batch numbers (b)(4), and (b)(4) of Vetsulin showed out of specification results for non-extractable insulin, you did not submit FARs within three working days of first becoming aware of this information. Failure to submit such required reports is a prohibited act under section 301(e) of the Act, 21 [USC 331(e)].” http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm210578.htm
The FDA warning letter did not provide information if Intervet reported the adverse drug events after the three day response time (or if Intervet did not provide this information at all to the FDA).
On May 5, 2010 the FDA issued the following statement regarding Vetsulin…
“The Food and Drug Administration (FDA) announced today a plan to address concerns regarding the supply of Intervet/Schering Plough Animal Health’s (Intervet) Vetsulin (porcine insulin zinc suspension), a product used to treat diabetes in dogs and cats. 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.
In November 2009, FDA announced its concerns about the stability of Vetsulin and recommended that diabetic dogs and cats currently receiving Vetsulin be switched to other insulin products. After publicizing this recommendation, 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.”
Wishing you and your pet(s) the best,
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