Vetsulin® Product Alert
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
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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
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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
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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
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
AAHA Vetsulin Notification and Transition InformationAAHA Web Conference – Vetsulin Update: Insulin Transitioning for Diabetic Patients