Vetsulin Sales Prohibited - Summary of Information on Changing to NPH

[forloveofandy]

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

[k9diabetes]

Re: Vetsulin - FDA Warning

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

[k9diabetes]

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

[peggy0]

Re: Vetsulin - FDA Warning

I just spoke to the vet at Schering Plough. First there is no time line developed for a fix. It could be months. It affects Vetsulin and Caninsulin. It's a global issue.

Natalies assumption is correct. It does NOT affect the short acting portion of the insulin. It does affect the longer acting portion where the affect could be STRONGER or LONGER, so its really important to make sure that your dogs lowest point is ok and also that its affect is completed before you give them their next shot if you are going to stay with this insulin.

She agreed that if you are seeing no difference after several injections from a new bottle that it was not affected by this problem. It will be consistent with the vial.

She also emphasized that is very very important to make sure you do a good job suspending/mixing the insuling before drawing, being more cautious than ever.

She didn't say but she was clearly concerned that people understand these points if they weren't switching to a new insulin.

[usfacc]

vetsulin warning/Schering Plough

Just a little more information on this problem:

A few minutes ago I spoke with a vet at Schering Plough. I was told that the warning applies to all unexpired insulin that is currently in circulation.
There is no recall, but the because the product is made in Germany, the FDA is restricting anymore being sent to the US until the problem is corrected and Schering Plough can prove to the FDA that the product is uniformly stable.
Therefore, at some point, the vetsulin will not be available.
The number I called is 800-224-5318 if anyone want to get the information for themselves. This is the technical dept. and they will take your number and have a vet call you.


Charlene & Missy

[k9diabetes]

Re: Vetsulin - FDA Warning - Schering Plough

From the Vetsulin Website: http://www.vetsulin.com:80/vet/Vet_ProductAlert.aspx

Whether this issue affects Caninsulin remains an open question. Apparently this warning has not been posted on Intervet's sites in other countries where Caninsulin is used. We have conflicting reports here about whether Caninsulin is involved.

I also do not know what the consequences would be of hundreds to thousands of people ordering Caninsulin from other countries if Caninsulin is not affected.

My sense from all I'm hearing from Schering Plough is that they are suggesting switching dogs to another insulin not so much because of the quality issue but because they expect significant lack of supply.

Trying to hold out with a handful of bottles could be difficult too... We have had reports of people being unable to extend the use of an opened bottle much more than 30 days so small dogs might need a larger supply of bottles of insulin even if they don't use a lot of units per injection.

For big dogs burning through a bottle of insulin quickly, the supply problem could be a big one.

For big dogs especially, NPH would be well worth trying if you haven't tried it before. With Vetsulin you have to inject a lot of volume of the U40 insulin. The costs savings are substantial too considering how many more units you get from U100 NPH than from U40 Vetsulin. And if it doesn't work as well, you can always go back to Vetsulin after things return to normal.

Natalie

[k9diabetes]

Re: Vetsulin - FDA Warning - Schering Plough

The following somewhat more detailed alert has been posted to the Vetsulin website.

http://www.vetsulin.com:80/dog-owner...ductAlert.aspx

PDF of the document is available there to download.

[k9diabetes]

Re: Vetsulin - FDA Warning - Schering Plough

What I'm gathering from various conversations is that Caninsulin and Vetsulin share the same problematic characteristic regarding the ultralente crystals.

The reason it's a "problem" in the U.S. is that FDA is requiring them to resolve the unstable amount of ultralente insulin before any more can be shipped to the U.S., which means there won't be any to buy in the U.S. And that's what is ultimately seen as the "problem" for dogs, not the insulin instability.

True, in the sense that if you can't buy any, it doesn't matter much how well it works. You will have to switch to something else.

Caninsulin will not be similarly restricted so there won't be a shortage of it. So it's "not a problem." I have not had a chance to look into the logistics of requesting it from Canada and whether it's problematic doing so.

Strictly a feeling but it sounds like this lack of Vetsulin could go on for a very long time. Potentially it could mean capital-intensive adjustments to the production process and then FDA testing before any Vetsulin would move in to the market again. We might be talking six months or longer. If it was a shorter period, I don't think Intervet would be advocating switching pets over to another insulin.

If you have or can obtain a stockpile, you can at least postpone the decision to switch and possibly not have to switch at all but I would prepare for going as long as a year on reserves of Vetsulin.

The choices, it seems to me, are:

- Stockpile Vetsulin and stick with it as long as you can, then try NPH if your reserve and the U.S. supply both dry up.

- Explore the possibility of obtaining Caninsulin.

- Try switching to NPH now to see if it works well and then stockpile Vetsulin or explore buying Caninsulin if it doesn't.

Again, based just on the subtext of various conversations, I think this lack of stability of ultralente insulin has been present in Caninsulin and Vetsulin for some time. So if you're using it, you probably already have been dealing with that instability and continuing to use it won't really be a change.

It's the supply issue that's the major problem.

NPH often works really well and it's easy to buy and highly affordable so for a lot of dogs this could actually be a good thing long-term, especially larger dogs using a lot of units per injection.

The only way to know if it will work for your dog is to try it.

I think a generally accepted method of switching over is to reduce the dose by 25% when you start a new insulin - that's what Intervet recommends when switching to Vetsulin. A reduction is especially important if your dog is pretty well regulated as the new insulin can have a different level of glucose reduction.

If you're just getting started and aren't anywhere near regulated, you can probably switch to the same dose of NPH as you were getting started with on Vetsulin.

And don't forget that you will need U100 syringes, which you can also get at any pharmacy, including Walmart, or online.

Natalie

[Margaret Boyle]

Re: Vetsulin - FDA Warning - Schering Plough

Natalie,

I thought I had better let you know I just got a new vial of insulin.

I happened to read the leaflet to see where it was manufactured.

It has 2 addresses

One in Boxmeer in The Netherlands

The other in Germany.

As far as I knew Boxmeer had stopped producing in 2008.

So whether they are still manufacturing I can't be certain, but there are two places of manufacturing on the leaflet, and as far as I know Vetsulin is manufactured in Germany.

You could perhaps check this out!!!

Hugs Marg

[k9diabetes]

Re: Vetsulin - FDA Warning - Schering Plough

http://www.vetsulin.com/dog-owner/Vet_ProductAlert.aspx

For those who have not yet contacted the vet, please make sure to discuss the following recommendation.

Is VETSULIN being recalled?
No. The product is remaining in distribution, but supplies will be limited. 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 plan on transitioning 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. 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.

The closest I have heard to an estimate of how long the shortage might last is "months." Nothing specific.

I tend to take this concern about a shortage very very very seriously when a manufacturer asks you to stop using their product.

If they thought it was 30 days or even 60 days, they could probably work with the existing supply. That's why I tend to think they think it will be longer.

[ravenecw]

Re: Vetsulin - FDA Warning - Schering Plough

Anyone following my thread will know how I feel....

I say try the NPH... it is working great for Sable as I have never been able to get the Vetsulin to do what the NPH does... and that is keep her numbers tight, I always had extreme highs (and some lows) on Vetsulin.

If the Vetsulin is working for you though I would stockpile (if I had Sable stay on I would stockpiled for sure ).

[Soaphie & Sydney's Mom]

Re: Vetsulin - FDA Warning - Schering Plough

I wish the vets realized that NPH doesn't necessarily work for every dog....Soaphie had a HORRIBLE reaction to it....hence, we are HOARDING vetsulin right now and monitoring her closely.

It's really too bad this is happening.

[k9diabetes]

Re: Vetsulin - FDA Warning - Schering Plough

FYI: I consider this protocol flawed as it lumped cats and dogs together and asked that they all be essentially started over at a very small dose.

Richard Nelson in the Web Seminar listed later in this thread provided very different advice. He suggested cutting the dose "A few units" for dogs changing from Vetsulin to NPH because the actions of the two insulins in dogs are typically so similar.

We have been recommending cutting the dose about 20-25% and after seeing a dozen dogs go through the transition, 10-15% percent might be okay.

Natalie

AAHA Recommended Protocol for Transitioning Dogs Off of Vetsulin
http://www.aahanet.org/resources/gra...n_11-16-09.pdf

Dr. Richard Nelson of the University of California at Davis, and Drs. Deb Zoran and Audrey Cook of Texas A&M University, expert veterinary members of the AAHA Diabetes Guidelines Task Force, have developed and approved the following recommendations on how to transition your diabetic patients:

For dogs, use the human recombinant NPH insulin at an initial dosage of 0.25 IU/kg twice daily, and adjust insulin based on clinical response and glucose measurements. You will be starting over with diabetic regulation when you switch to a new insulin product.

In addition to transitioning from Vetsulin, veterinarians need to be vigilant about using the appropriate syringe for the new insulin for each pet. This is necessary to ensure that patients receive the proper dosage of the new insulin product.

We hope that these recommendations will be useful for you when considering how to approach this situation with your diabetic patients. We encourage you to report any adverse event with the Vetsulin product to Intervet/Schering-Plough Animal Health’s technical services department at 800/224-5318.The American Animal Hospital Association will post updated information about the alert to www.aahanet.org as it becomes available.

Thank you Sophia Yin for the heads-up on this protocol announcement.

Natalie

[k9diabetes]

Re: Vetsulin - FDA Warning - AAHA Protocol to Switch to NPH

I would hold onto any Vetsulin you have until your dog has successfully switched to NPH and you find that it's working well. If it isn't working well, you will be glad you have the Vetsulin vials.

We went through the discontinuation of Humulin L about four years ago. There were a handful of dogs who could stay well regulated only if if they stayed on Humulin L and those folks stockpiled as much Humulin L as they could get their hands on - scoured every local pharmacy and shared what they had with others in the same boat. I know some of those dogs managed to accumulate enough Humulin L to last a couple of years.

I don't know how much supply is out floating around of Vetsulin. Humulin L was still being used by people so it had a larger market. But I'd say it's worth holding onto any that you do have at least until you find out whether NPH is a good match for your dog.

Natalie

[peggy0]

Re: Vetsulin - FDA Warning - Schering Plough

http://www.aahanet.org/education/wc_vetsulinupdate.aspx fyi. a webinar Tuesday the 24th on Vetsulin by AAHA