VETSULIN ALERT – Frequently Asked Questions
CONTACT INFORMATION
For Customer Service issues, call 1-800-521-5767
For Technical Service issues, call 1-800-224-5318
For Media Relations, call Sharon Dilling, 1 862 -245 -3390.
IMPORTANT: VETSULIN® Critical-Need Program Ending
February 7, 2011
Dear VETSULIN® Customer,
You are receiving this letter because our records indicate you have one or more pets participating in the VETSULIN® Critical-Need Program (CNP). As you know, we alerted you in late 2009 that the product had not met its stability specifications and may have varying amounts of crystalline zinc insulin in the formulation.
We must advise you that because of a manufacturing issue unrelated to the stability issue referred to above, Intervet/Schering-Plough Animal Health is discontinuing the VETSULIN® CNP as of February 7, 2011. However, we will continue to provide VETSULIN® for the CNP until our current supply in the U.S. is exhausted - we anticipate being able to fulfill orders through February 2011.
This difficult decision is being made because quality tests showed the sterility of the most recent batch of VETSULIN® manufactured for the CNP may be compromised by bacterial contamination. This batch of VETSULIN® has not been released. While the company is still investigating the quality issue, additional batches are not being manufactured at this time. We, therefore, cannot supply the program and it must be discontinued.
We are aware of no evidence that the VETSULIN® currently on the market and being used under the Critical-Need Program is affected. No adverse events consistent with potential bacterial contamination in cats and dogs receiving VETSULIN® have been reported under the current program.
We sincerely regret any difficulties this causes and strongly recommend you contact your veterinarian as soon as possible to transition your pet to another insulin product. Your veterinarian has been made aware of this issue as well.
We sincerely apologize for the need to discontinue the VETSULIN® CNP, but wanted to provide you with as much advance notice as possible.
As always, Intervet/Schering-Plough Animal Health is concerned for the well-being and health of animals of all species and the people who care for them.
Sincerely,
Christopher Pappas, Jr., DVM
Director of Companion Animal Technical Services
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VETSULIN® CRITICAL-NEED PROGRAM DISCONTINUATION
February 11, 2011
GENERAL QUESTIONS
- Why is the Critical-Need Program being discontinued?
The most recent batch of VETSULIN® has not been released because we have a manufacturing issue. Quality tests showed that the sterility of the most recent batch of VETSULIN® manufactured for the Critical-Need Program may be compromised by bacterial contamination. Therefore we are not able to supply the program after February, 2011.
No adverse events consistent with any potential bacterial contamination in cats and dogs receiving VETSULIN® have been reported under the current program.
- How is this different from last year's problem with VETSULIN®?
In late 2009, Intervet/Schering-Plough Animal Health notified Veterinarians and Pet Owners that VETSULIN® had not met its stability specifications and may have varying amounts of crystalline zinc insulin in the formulation. The issue of the most recent batch is unrelated to this.
- What is causing the problem?
Quality tests showed that the sterility of the most recent batch of VETSULIN® manufactured for the Critical-Need Program may be compromised by bacterial contamination. This batch of VETSULIN® has not been released, and additional batches are not being manufactured at this time. We therefore cannot supply the program and it is being discontinued.
What is important is that all pet owners contact their veterinarian immediately to begin transitioning their pets to another insulin product.
- What are you doing to resolve the issue with the most recent VETSULIN® batch for the VETSULIN® Critical-Need Program?
We are working to correct the problem and determine the root cause. We have teams dedicated to identifying the issue and solutions. In the interim, we are communicating with veterinarians to help them transition their diabetic patients to another insulin product. We will also be providing educational webinars to veterinary professionals that will give step-by-step instructions to help veterinarians transition patients to other insulin products. Information on how to participate in these webinars will be sent to veterinarians shortly.
- Is VETSULIN® coming back to the market?
We understand the importance of this product to veterinary medicine and to the diabetic pets who need it. We continue to work to address and correct the original stability issue and this most recent manufacturing issue so that we can make VETSULIN® available to veterinarians again in the future. Further activity is needed before we make the necessary regulatory submissions for reintroduction of VETSULIN®.
Therefore, it is very important that all pets currently on VETSULIN® in the CNP be transitioned as soon as possible to another insulin product.
Current supplies of VETSULIN® are expected to be completely exhausted by the end of February, 2011.
- How are you supporting veterinarians trying to transition difficult cases?
To help transition patients, we will be providing an educational webinar for veterinary professionals that will give step-by-step instructions on the transition process.
- When will my veterinarian be able to prescribe VETSULIN® again?
Our dedicated team has been and still is working diligently to verify and appropriately correct both the original stability issue and this most recent manufacturing issue. Further activity is needed before we make the necessary regulatory submissions. We know that we will no longer be able to fill orders for the VETSULIN® Critical-Need Program by the end of February 2011. While we continue to work to resolve the issues, our inventory will be exhausted. Therefore, we must discontinue the program. Because transitioning diabetics can be a lengthy process, we are urging veterinarians to transition their patients to another insulin product as soon as possible.
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Vetsulin Critical Need Program
May 5, 2010
CVM Update
FDA Announces Availability of Vetsulin for Critical Needs Dogs and Cats
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 it’s 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 FDA’s 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 Vetsulin under the Critical-Need Program will require close monitoring of the patient, all of which will be described in an owner consent form.
For additional information, please see:
http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm188752.htm
General Questions
January 8, 2010
- What is VETSULIN?
VETSULIN is a prescription drug that contains porcine insulin zinc suspension in both amorphous and crystalline forms. It is indicated for the management of hyperglycemia and its associated clinical signs in dogs and cats with diabetes mellitus.
- Why has FDA and Intervet/Schering-Plough Animal Health issued a VETSULIN
Alert?
The product has been found to be out of specification in regards to the long term stability of the crystalline, or long acting, component. Specifically, the concentration of the crystalline component is higher than what is outlined in the specifications of the product. Consequently, the amorphous, or short-acting, component may have a lower concentration. This could mean that diabetic patients on VETSULIN may experience a delay in onset of action, a delay in peak activity and an overall extension of the duration of activity.
- Is VETSULIN being recalled?
No. The product is remaining in distribution, but supplies will soon be exhausted. Veterinarians should plan on transitioning their diabetic patients to other insulin products and should not be starting any newly diagnosed diabetic patients on Vetsulin.
- Why is Intervet/Schering-Plough Animal Health asking veterinarians to transition
diabetic pets from VETSULIN to other insulin products?
In its alert, FDA recommended that veterinarians consider transitioning their patients to other insulins. Due to the fact that we do not know when the situation will be resolved, supply shortages are expected, and the supply of VETSULIN will soon be exhausted. Our primary goal is protecting the health of patients. Therefore, Intervet/Schering-Plough Animal Health is asking veterinarians not to start any newly diagnosed patients on VETSULIN and to begin transitioning current diabetic patients off VETSULIN and on to other insulin products.
- What is Intervet/Schering-Plough Animal Health doing to rectify the issue?
Our company, including our Quality Assurance and Research and Development departments, is working diligently with the FDA to address the issue.
- Are there specific serials that are in question, or are all serials affected?
The FDA Alert pertains to all unexpired serials of Vetsulin currently in the field.
- Should I be concerned about the safety or efficacy of the VETSULIN that my
patients are receiving?
Based on the results of limited in vivo pharmacodynamic and pharmacokinetic studies evaluating glucose and insulin levels, respectively, and on a review of pharmocovigilance data, it is our initial assessment that this finding should not adversely affect either the efficacy or the safety of Vetsulin.
This pharmacovigilance review compared affected serials of VETSULIN versus historical serials of VETSULIN and did not demonstrate a significant difference in adverse events or efficacy issues.
We urge you, however, to continue to monitor your patients closely for a delay in the onset of action, a delay in peak activity and an overall extension of the duration of activity or any signs of hyper or hypoglycemia.
We request that you report any potential concerns with efficacy or safety, and direct any questions, to our technical services department at 1-800-224-5318.
- What are the signs of hypoglycemia (low blood sugar)?
Clinical signs of hypoglycemia include depression, lethargy, disorientation, ataxia (lack of coordination), and seizures.
- What are the signs of hyperglycemia (high blood sugar)?
Clinical signs or hyperglycemia include polyuria (excessive urination), polydipsia (excessive thirst), polyphagia (overeating), and weight loss.
- Are either species (dogs or cats) more affected by this finding?
No, we would not expect any differences between dogs and cats.
- Will VETSULIN be available again in full supply? If so, when?
Intervet/Schering-Plough Animal Health is working diligently with the FDA to rectify the situation. At this time we cannot speculate on how long VETSULIN will be unavailable or in limited supply.
Download Critical Need Program General Questions PDF — February 11, 2011
Download Critical-Need Program Ending PDF
