Itchmo Forums for Cats & Dogs Brought to you by Itchmo: Essential news, humor and info for cats, dogs and pet owners.
August 21, 2018, 07:01:55 PM *
Welcome, Guest. Please login or register.

Login with username, password and session length
News:
 
   Home   Help Search Login Register  

Go To Itchmo.com: Read the latest cat, dog and pet news, pet food recall info, product reviews and more — updated daily.


Pages: [1]
  Print  
Author Topic: FDA Warning to Vets re Vetsulin  (Read 3685 times)
0 Members and 1 Guest are viewing this topic.
Carol
Hero Member
*****
Posts: 3200


« on: November 02, 2009, 03:47:42 PM »

Not sure where this should be...

http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm188752.htm

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.
   
 
Contact Us

    * 240-276-9300
    * 240-276-9115 FAX
    *

      Issued by: FDA, Center for Veterinary Medicine

      Communications Staff, HFV-12

      7519 Standish Place

      Rockville, MD 20855
Page Last Updated: 11/02/2009
Logged

“Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.” — Margaret Mead

United we stand     Divided we fall....
bug
Hero Member
*****
Posts: 4905

RIP little angel Katey


« Reply #1 on: November 03, 2009, 09:00:12 AM »

Carol, thanks very much for this. I left a message with the Canadian branch of Intervet/Schering_Plough as I am wondering if Caninsulin (Canadian name for Vetsulin) is also affected. I'm surprised they're not reporting lot numbers. Will post once I have more information for our Canadian members.
Logged

My little babies, you'll always be in my heart. Mom will see you later. Look after each other, ok?
bug
Hero Member
*****
Posts: 4905

RIP little angel Katey


« Reply #2 on: November 03, 2009, 12:18:52 PM »

Spoke with someone "higher up" at Intervet/Schering-Plough Canada who could not confirm at this time that Caninsulin is also affected. He is in touch with the US counterpart to find out if the product is manufactured in the same facility and if it is also affected (again, Vetsulin and Caninsulin are the same product, just a different trade name/mark). I think, just to be on the safe side, anyone using either product should keep an eye on their diabetic pets.

ETA: The problem with the product, in case it isn't clear in the communication, is that they have included too much lente (long-acting) insulin in the two-component product. The short acting component's effects are between 2-4 hours and the long-acting component's effects are between 8-10. Too much of the lente component can cause hypoglycemia because of dose overlap in pets that get two or more injections per day. Hyperglycemia could result because lente also takes longer to kick in after injection.

I am awaiting telephone confirmation on whether or not Caninsulin in Canada is affected. My vet has also been in contact with Schering-Plough and is awaiting a written statement.

My vets had no idea there was even a potential problem as there is no central dissemination agency. Surprise, surprise.
« Last Edit: November 03, 2009, 01:15:03 PM by bug » Logged

My little babies, you'll always be in my heart. Mom will see you later. Look after each other, ok?
5CatMom
Sr. Member
****
Posts: 454


« Reply #3 on: November 03, 2009, 12:56:04 PM »

Carol, thanks.

Sent emails to local clinics and also to AVMA.  For some reason, I don't see the notice on their website.

Surely, the AVMA recognizes that this is a serious issue.

5CM
Logged

What is man without the beasts? If the beasts were gone, men would die from a great loneliness of spirit. For whatever happens to the beasts, soon happens to man. All things are connected - - - Chief Seattle

We are the caretakers of our creatures . . . the peacekeepers of our planet
menusux
Hero Member
*****
Posts: 4456



« Reply #4 on: November 06, 2009, 11:51:21 AM »

http://www.vetsulin.com/vet/Vet_ProductAlert.aspx

"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"
Logged
bug
Hero Member
*****
Posts: 4905

RIP little angel Katey


« Reply #5 on: November 06, 2009, 12:14:25 PM »

I received a call back from the individual (DVM) I spoke with at Intervet and he confirmed that Caninsulin is made at the same plant as Vetsulin (same insulin) in Germany and this is where all of North America gets this product from. So, anyone using the corresponding Canadian product should also be on the lookout for any adverse effects of hypo or hyperglycemia. My vet hasn't forwarded me anything thus far.
Logged

My little babies, you'll always be in my heart. Mom will see you later. Look after each other, ok?
shadowmice
Hero Member
*****
Posts: 549



WWW
« Reply #6 on: November 24, 2009, 12:41:50 PM »

Just stumbled across this while looking for the latest crib recall info.  Took 'em only what? - two weeks after Bug found out the same info. I'm just curious, how many other Canadians would have thought to look at Health Canada for veterinary issues?

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_187-eng.php

Health Canada Advises Canadians About Problems with Insulin Product for Dogs and Cats
Advisory
2009-187
November 19, 2009
For immediate release

OTTAWA - Health Canada is alerting veterinarians and pet owners about a possible manufacturing problem with Caninsulin, a drug used to treat diabetes in dogs and cats.
Logged
bug
Hero Member
*****
Posts: 4905

RIP little angel Katey


« Reply #7 on: November 24, 2009, 06:40:49 PM »

I think most people with diabetic pets would get this info from their vet, but who knows if they are even aware of it.
Logged

My little babies, you'll always be in my heart. Mom will see you later. Look after each other, ok?
lesliek
Hero Member
*****
Posts: 11050


Trooper,Remy & Fragile


« Reply #8 on: November 24, 2009, 08:13:20 PM »

2 people I know with recently diagnosed diabetic dogs were warned by their vets,so hopefully most vets know.
Logged

"the world's most inept extortionist"
JJ
Hero Member
*****
Posts: 8531


« Reply #9 on: November 24, 2009, 08:23:36 PM »

Glad to see vets are keeping their clients informed about their fur babies.
Logged

May your troubles be less,
Your blessings be more,
And nothing but happiness
Come through your door
Pages: [1]
  Print  
 
Jump to:  

Copyright 2007 Itchmo.com: Read the latest cat, dog and pet news, pet food recall info, product reviews and more — updated daily.
Powered by SMF 1.1.21 | SMF © 2015, Simple Machines | Sitemap