Vetsulin® Product Alert
Important Notice: VETSULIN® Critical-Need Program EndingFebruary 7, 2011
Dear Doctor:
You are receiving this letter because our records indicate you have one or more clients 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. Quality tests showed that 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 and additional batches are not being manufactured at this time. We, therefore, cannot supply the program and it must be discontinued.
While we are still investigating the quality issue, we are aware of no evidence that the VETSULIN® currently on the market and being used under the CNP is affected. No adverse events consistent with potential bacterial contamination in cats and dogs receiving VETSULIN® have been reported under the current program.
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.
We sincerely regret any difficulties this causes and strongly recommend that you make preparations to convert your VETSULIN® CNP patients to an alternative insulin product as soon as possible.
We will provide an educational webinar that will give step-by-step instructions to help you transition your patients. Information on how to participate in this webinar will be sent to you shortly. The webinar will thereafter be posted on the VETSULIN® web site, www.vetsulin.com, under the "Important Product Alert" section.
A letter to your clients advising them of this situation is being mailed the week of February 7, 2011. A copy is enclosed for your reference.
We sincerely apologize for the need to discontinue the VETSULIN® CNP, but wanted to provide you with as much 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
------------------------------------------------------------------------------------------
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
------------------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------------------
FDA’s Center for Veterinary Medicine Alerts Veterinarians About Problems with Vetsulin® to Treat Diabetes in Dogs and Cats
November 2, 2009
The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) and Intervet/Schering-Plough Animal Health are alerting veterinarians and pet owners that Vetsulin®, a porcine insulin zinc suspension used to treat diabetes in animals, may have varying amounts of crystalline zinc insulin in the formulation. Because this Intervet/Schering-Plough Animal Health product is out of specification it could cause a delay in insulin action and an overall longer duration of insulin activity. Products having significant problems with stability can affect the management of chronic diseases. Unstable insulin products can result in unpredictable fluctuations in the glucose levels of diabetic patients. Intervet/Schering-Plough Animal Health is unable to assure FDA that each batch of their product is stable.
FDA and Intervet/Schering-Plough Animal Health request that veterinarians closely monitor their patients receiving Vetsulin® for any changes in onset or duration of activity, or for any signs of hyperglycemia or hypoglycemia. The classic signs of hyperglycemia include increased thirst, increased urination, weight loss and lethargy. The classic signs of hypoglycemia would include disorientation, unsteadiness, weakness, lethargy, and seizures.
While Intervet/Schering-Plough is working with FDA on resolving this issue, supplies may be limited. Therefore, veterinarians should consider transitioning their diabetic patients to other insulin products. In addition, FDA encourages veterinarians to report any adverse events with the Intervet/Schering-Plough Animal Health product to the company through the Technical Services Department at 1-800-224-5318.
------------------------------------------------------------------------------------------
November 6, 2009
Dear Doctor,
Intervet/Schering-Plough Animal Health, as a responsible manufacturer of quality veterinary products, would like to inform you that we have determined that serials of Vetsulin® porcine insulin zinc suspension have stability test results that are above specification on an indicator of the amount of crystalline insulin in the formulation. We want to advise you that we are working diligently with the FDA Center for Veterinary Medicine and our Quality Control and Research Departments to determine the significance of this finding and permanently address this issue.
Vetsulin contains two insulin components: crystalline insulin, the longer-acting component, and amorphous insulin, the short-acting component. This finding regarding the crystalline component could potentially result in your patients experiencing a delay in the onset of action, a delay in peak activity, and an overall extension of the duration of activity, although at this time, this occurrence has not been documented.
We take all out-of-specification results very seriously and deemed it appropriate to notify you of this situation. Accordingly, we request that you continue to closely monitor your patients receiving Vetsulin for any changes in onset or duration of activity, or for any signs of hyperglycemia or hypoglycemia. The classic signs of hyperglycemia would include polyuria, polydipsia, polyphagia, weight loss and lethargy. The classic signs of hypoglycemia would include disorientation, ataxia, weakness, lethargy and seizures. Based on in vivo pharmacodynamic and pharmacokinetic studies respectively evaluating glucose and insulin levels and because Intervet/Schering-Plough Animal Health has not documented an increase in either adverse event rates or efficacy issues with the product, it is our initial assessment that this finding should not adversely affect either the efficacy or the safety of Vetsulin, but we urge you to closely monitor your patients in any event. We request that you report any of the above clinical signs or concerns with efficacy or safety, and direct any questions, to our Technical Services Department at 1-800-224-5318. If any of your clients have any questions, please direct them to the Pet Owner section of the website or to 1-800-224-5318.
During this period of time while we work on this issue, supplies of Vetsulin may be limited and therefore you should consider starting all new diabetic patients on non-Vetsulin insulin products and transitioning existing diabetic patients to other insulins. If you have Vetsulin inventory concerns as result of the transition to alternative insulins, please contact Intervet/Schering-Plough Animal Health Customer Service at 1-800-521-5767 or your distributor.
Thank you for your ongoing confidence in our company to provide you quality products and service.
Sincerely,
Christopher Pappas Jr., DVM, Director of Technical Services
------------------------------------------------------------------------------------------
November 30, 2009
Re: Vetsulin® Alert and Importance of Diabetic Pet Transition
Dear Doctor:
This letter is a follow-up to the Vetsulin Product Alert letter issued on November 6, 2009. In that Product Alert, we informed you that Intervet/Schering Plough Animal Health had determined that serials of Vetsulin porcine insulin zinc suspension have stability test results that are above specification on an indicator of the amount of crystalline insulin in the formulation. Our original letter, the Frequently Asked Questions and other information can be referenced on our website at www.vetsulin.com.
The purpose of this letter is to emphasize the need to begin transitioning dogs and cats from Vetsulin to other insulin products as soon as possible since we can not accurately predict when this situation will be resolved. We believe it is especially prudent to focus on transitioning your feline patients as soon as possible given the recent FDA approval of a new, long-acting protamine zinc insulin for cats. Going forward, we will have very limited supplies of Vetsulin and will have to employ tight product allocations.
It is likely there will not be sufficient product available to meet the needs of the market as soon as early 2010. We strongly encourage you to take action to inform and meet with your clients to set-up an orderly conversion to other insulin products for all your canine and feline diabetic patients.
To assist you with planning the transition of diabetic pets, enclosed is an AAHA letter with some basic guidance from several expert members of the AAHA Diabetes Guidelines Task Force. We would also refer you to a recent AAHA webcast where experts address insulin transitioning and answer some common questions practitioners face when considering alternate insulin choices for their patients. You can link to this webcast on the AAHA website at www.aahanet.org/insulin. It is open to all veterinarians.
In addition, we are enclosing a Vetsulin Product Alert Update that provides further background on the situation. For other technical questions on Vetsulin, please contact our Technical Services Department at 1-800-224-5318.
Thank you.
Sincerely,
Christopher Pappas Jr., DVM, Director of Technical Services
------------------------------------------------------------------------------------------
January 8, 2010
Re: Transition Assistance Via Independent Phone Consultation
Dear Doctor:
We appreciate all your efforts in transitioning your diabetic patients currently on Vetsulin® (porcine insulin zinc suspension) to other insulin products. As discussed in our letter dated November 30, 2009, it is imperative that you transition all of your diabetic patients off of Vetsulin as future supplies of Vetsulin will be very limited in early 2010, and then exhausted.
Intervet/Schering-Plough Animal Health has worked with expert members of the AAHA Diabetes Guidelines Task Force and provided information on transitioning dogs and cats from Vetsulin to other insulin products (see links to these documents below). However, we have received calls from some concerned veterinarians who are still encountering difficulties despite having followed these recommendations. Therefore, we would like to offer assistance to two specific categories:
- Where there are still difficulties in re-regulating patients on other insulin products;
- Where a veterinarian had initially prescribed Vetsulin because other insulin products had been ineffective in regulating their patient.
In order to assist with these specific patient categories, Intervet/Schering-Plough Animal Health has contracted with Thomas K.Graves, DVM, PhD, DACVIM and his staff at the University of Illinois, College of Veterinary Medicine, to provide independent telephone consultations on these difficult cases.
Please note that Intervet/Schering-Plough Animal Health is making this service available as a patient courtesy. Dr. Graves will be acting as an independent consulting veterinarian, and Intervet/Schering-Plough Animal Health does not guarantee or warrant that the consultation will lead to a successful resolution of these cases. Intervet/Schering-Plough Animal Health will not bear any responsibility for the outcomes of these cases.
If you have a patient that falls into either of the two categories mentioned above, please contact Intervet/Schering-Plough Animal Health technical services at 1-800-224-5318 to discuss if the case qualifies for a telephone consultation with either Dr. Graves or one of his board certified internists.
The costs associated with the telephone consultations organized by our technical services veterinarians will be covered by Intervet/Schering-Plough Animal Health. Any cost incurred as a result of the consultation, including, but not limited to, additional veterinary fees, recommended additional diagnostic tests or additional medications, will not be covered by this program.
Thank you for your cooperation and efforts to transition diabetic patients off of Vetsulin and onto other insulin products.
Sincerely,
Christopher Pappas, Jr., DVM
Director, Companion Animal Technical Services
Intervet/Schering-Plough Animal Health
------------------------------------------------------------------------------------------
February 22, 2010
Re: Vetsulin® Alert Update
Dear Doctor,
This letter is a follow-up to the “Vetsulin Alert/Importance of Diabetic Pet Transition” letter issued on November 30, 2009. In that communication, we emphasized the need to begin transitioning dogs and cats from Vetsulin to other insulin products as soon as possible. This need is driven by a limited supply that will deplete shortly, and an unknown date for replenishment of this product.
We want to remind you that Vetsulin supplies are continuing to deplete, and expediting the transition of your diabetic patients on Vetsulin to other insulin products is extremely important. With the FDA approval of protamine zinc insulin for cats, a new treatment option for your feline patients is available. For both your canine and feline patients, our Technical Services department is available to work with you on difficult-to-transition patients. This may include a telephone consultation with an outside expert for further assistance. Our Technical Services department can be reached at 1-800-224-5318 between the hours of 8:30am-5:00pm EST.
Additional support is available through AAHA. They have posted a letter with some basic guidance from several expert members of the AAHA Diabetes Task Force. Additionally, AAHA provides a web cast on insulin transition hosted by experts who answer common questions practitioners face when considering alternate insulin choices for their patients. The archive of the web cast is on the AAHA website at www.aahanet.org/insulin and is open to all veterinarians.
We also encourage visiting our website at www.vetsulin.com to view current information on Vetsulin. For additional technical questions on Vetsulin, please call our Technical Services department on 1-800-224-5318. Thank you.
Sincerely,
Christopher Pappas, Jr., DVM
Director, Companion Animal Technical Services
Intervet/Schering-Plough Animal Health
------------------------------------------------------------------------------------------
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
------------------------------------------------------------------------------------------
May 5, 2010
Re: Vetsulin® Critical-Need Program Available
Dear Doctor:
In response to the Vetsulin® product alert issued in November 2009, Intervet/Schering-Plough Animal Health (“Intervet”) has been working with the FDA to address an issue identified with our Vetsulin® (porcine insulin zinc suspension) product. Since that time, we have recommended that pets be transitioned to other insulin products as we anticipated a limitation on supply and eventual supply depletion. During the process of transitioning pets to other insulin products, we heard from a number of veterinarians and pet owners who expressed significant concerns that specific dogs and cats cannot be effectively managed on an insulin product other than Vetsulin.
After working with the FDA on this situation, Intervet can now offer a limited supply of Vetsulin to specific, critical-need pets, when in the veterinarian’s medical judgment these pets cannot be effectively managed on another insulin product. The availability of this supply will mean that truly critical-need patients can be maintained on Vetsulin. This Vetsulin® Critical-Need Program, which will be made available the week of May 24, 2010, is intended to apply only to a limited number of pets and includes only pets that currently are being treated with Vetsulin and those that veterinarians have tried to transition from Vetsulin. The program will require veterinarians to contact Intervet and request that their patients be enrolled in this program. The specifics of the program are:
- Veterinarians having potentially qualified patients will need to telephone Intervet’s Technical Services Department at 800-224-5318 and request that their patients be enrolled in the Vetsulin Critical-Need Program. Veterinarians will need to provide the patient’s name, species, breed, age, owner’s name, address and telephone number and the reason they conclude, in their medical judgment, that the particular patient cannot be effectively managed on any veterinary and human insulin products commonly used for dogs or cats.
- Veterinarians will then be faxed or emailed a form they will be asked to sign certifying that in their medical judgment, the named patient cannot be effectively managed on any insulin other than Vetsulin. An owner informed consent form will also be provided and will need to be completed and sent back along with the veterinarian’s certification statement.
- Once Intervet receives the two signed forms and a patient is enrolled in the program, supply of the product will be made through a designated third-party pre-selected to perform this specific activity. Due to the fact that supplies will have to be controlled and are subject to audit, we unfortunately cannot work through additional distribution channels.
- The designated distributor will set-up the Vetsulin order for direct delivery to the pet owner. The company will invoice the veterinarian for the product and delivery fee and, in turn, the veterinarian should invoice the pet owner at the retail price plus the home delivery fee. This procedure has been put into place to ensure that distribution of the product for these critical cases is done in a timely and efficient manner and that the product goes only to pets veterinarians have pre-qualified for the Critical Need Program.
- Veterinarians will need to advise the dog and cat owners of the potential for variability in vial-to-vial potency and instruct dog and cat owners to monitor carefully their pet after starting a new vial of Vetsulin and report any adverse events, including those related to effectiveness. This information will also be included in the owner consent form.
We have been working diligently to address the issues with this product and hope that the Vetsulin Critical-Need Program will only be a temporary measure. Our top priority is the health, safety and welfare of pets and we believe this program will help assist those pets most in need of Vetsulin in the coming months. We remind you that the Vetsulin Critical-Need Program is intended for use only with those patients that you as the treating veterinarian judge cannot be effectively managed on any other insulin product.
If you have any questions, please call Intervet Technical Services at 800-224-5318.
Sincerely,
Christopher Pappas, Jr., DVM, Director of Technical Services
Download PDF of letter – February 7, 2011
Download PDF of pet owner letter – February 7, 2011
Download Vetsulin Critical Need Program FAQ
Download PDF of joint announcement – November 2, 2009
Download PDF of letter – November 6, 2009
Download PDF of letter – November 30, 2009
Download PDF of letter – January 8, 2010
Download PDF of letter – February 22, 2010
Download PDF of CVM Update – May 5, 2010
Download PDF of letter – May 5, 2010
AAHA Vetsulin Notification and Transition InformationAAHA Web Conference — Vetsulin Update: Insulin Transitioning for Diabetic Patients