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Old 11-02-2009, 05:37 PM
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Default Vetsulin Sales Prohibited - FDA Warning - Dogs Changing to NPH

http://www.fda.gov/AnimalVeterinary/.../ucm188752.htm
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Old 11-02-2009, 06:06 PM
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Default Re: Vetsulin - FDA Warning

Quote:
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.
Yikes! No lot numbers or dates offered as to when this seems to have occurred.

Thank you Ann for posting this!

Anyone here using Vetsulin seeing any problems?

Natalie
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Old 11-03-2009, 04:51 AM
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Default Re: Vetsulin - FDA Warning

Bailey is still in the process of getting regulated and I just purchased 6 bottles of Vetsulin to get the best price with the shipping included. If this ends up being a true issue, they better end up recalling the problem batches because I'm going to be really upset if I am out $200.
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Bailey - 5 yo Schnoodle - diagnosed 9/09
24 lbs. - Currently on 10 units Vetsulin twice a day and still in the process of getting regulated.
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Old 11-03-2009, 05:07 AM
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Default Re: Vetsulin - FDA Warning

I have not seen anything yet
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Old 11-03-2009, 06:13 AM
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Default Re: Vetsulin - FDA Warning

I see no indication whether the problem mentioned in the notice might also apply to Caninsulin. Anybody know?

Ann - how did you learn of this? Did you receive a notice?

Though I'm in Canada (where the same stuff as Vetsulin is sold as Caninsulin), I sent a copy of the notice, along with a link to the page, to my vet. She has some patients on Caninsulin.

Tue, 3 Nov 2009 06:12:10 (PST)
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Old 11-03-2009, 07:38 AM
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Default Re: Vetsulin - FDA Warning

the FDA issued the notice yesterday. I called Schering Plough. They are going to have a vet call me back. I called my vet and she is calling me when she was a moment. It appears this has been going on for awhile, YIKES, and the FDA, given its approved the drug, is going to force them to stabilize their specification. If they have any real information when I'm called back, I'll post it. I would expect they are going to put out one statement for all to dictate to us that call so I don't expect anything new quite frankly. I'll ask about Canininsulin. I would expect it's got the same problem, however, given the FDA does not have jurisdiction in Canada, you probably won't hear anything unles Schering Plough puts something out. Just my opinion, not a fact.
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Old 11-03-2009, 08:19 AM
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Default Re: Vetsulin - FDA Warning

I think that Intervet will be highly motivated to resolve this problem. Any dog who switches to NPH in the interim and does well is unlikely to switch back so there is potential to lose a fair number of customers and, worse still, the vet who had been prescribing it if they don't.
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Old 11-03-2009, 09:05 AM
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Default Re: Vetsulin - FDA Warning

Thank you for getting this info out to us! I wonder if this is limiting supply already and that's why the last bottle I got was $51, a $10 increase. My vet
doesn't use NPH at all. I think they only use meds that you must purchase at their clinic. If the price and availability becomes a problem I may need to switch vets and find one that uses NPH. So far my vets were not aware of the warning and didn't seem too concerned.

Linda and Daygo
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Old 11-03-2009, 01:28 PM
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Default Re: Vetsulin - FDA Warning

Quote:
Originally Posted by k9diabetes View Post
I think that Intervet will be highly motivated to resolve this problem. Any dog who switches to NPH in the interim and does well is unlikely to switch back so there is potential to lose a fair number of customers and, worse still, the vet who had been prescribing it if they don't.
Natalie,

I have been out most of the day but got your e-mail when I came in.

I contacted the vet practice at tea time tonight, and Anna one of the vets called me back. I had explained on the phone what I was calling about and they said they would get someone to phone me, and it was Anna I told her where I had got the information she knew I was on a forum.

I explained that you did not know if it was the UK as well.

She said she had phoned Intervet who said they would get back to her and she would let me know what they say.

I think it must affect caninsulin also as they are the same type of insulin.

I explained the FDA had put a notice out.

I am in a funny situation as I won't be able to tell if it is the insulin or the pred drops that are making Lucy's numbers jump about.

I will be following this thread with great interest.

Thanks Natalie
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Old 11-03-2009, 07:55 PM
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Default Re: Vetsulin - FDA Warning

In checking your dog while still on Vetsulin and deciding what to do, it's probably worth pointing out that the problem should be variance between bottles, not between various injections from one bottle.

Let's say just for argument's sake that one bottle has 75% ultralente and another bottle has 65%. All of the injections from the first bottle would deliver 75% ultralente crystals so any variations you see while using a single bottle of insulin most likely come from other factors. All of the injections from the next bottle would deliver less, 65% ultralente.

If you see a change in the insulin response when you start another bottle, that could very well be the issue that FDA is warning about. For those starting to see hypoglycemia after starting a new bottle of insulin, it's conceivable that there is extra ultralente or that there is relatively more shorter-acting insulin.

At least that's what I can deduce from the announcement... not that there is a flaw with the crystals themselves but that there is a variance in the amount of crystals in each bottle.

So in theory you could use a stockpile recently purchased but would have to be very careful when starting a new bottle and perhaps even drop the dose slightly until you have a chance to see how the new bottle seems to work for your dog.

Each time a new bottle is opened, you would have to consider that it might be different than the last one.

The lack of supply is almost the bigger issue. I don't know how much vets have stockpiled the insulin... it has seemed in the past when there were some brief supply shortages that they don't necessarily keep a lot of it around. Folks with only one bottle could have a serious problem.

I think it's worth talking to the vet now about obtaining a few months worth of insulin if you plan to stay on Vetsulin or even just want some time to think it over... and especially if, like Soaphie, NPH is not an option.

Tami, I think Soaphie can stay on Vetsulin if you can obtain some bottles of it. I know you would test and adjust as needed.

I'm not so worried about folks who home test blood sugar, more about the ones who don't and the ones who don't monitor much of anything. And about the ability to get insulin at all.

Several times over the past four years we have seen bouts of dogs on Caninsulin or Vetsulin who sudden lost regulation and we have speculated that there may be production problems at those times that have altered the makeup of the insulin. The perceived problems were essentially what I would think would happen here - that new bottles of insulin seemed to have a different amount of kick than previous ones.

Natalie
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