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  #41  
Old 11-10-2009, 04:43 AM
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Default Re: Vetsulin - FDA Warning - Schering Plough

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Originally Posted by k9diabetes View Post
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.

Natalie
This is purely speculation on my part, but I would suspect that it will be difficult to import Caninsulin from Canada. From a conversation that Kathy and I had earlier about importation issues (http://www.k9diabetes.com/forum/showthread.php?t=1351), it sounds as if, historically, there have been specific problems surrounding the importation of insulin. Here's one piece of what Kathy had to say about her earlier experience (if you visit the link above, you'll find additional comments from Kathy):

Quote:
At the time we were in need of this, there was quite a "heavy hand" policy with regard to certain drugs. Insulin happened to be one of them.

Since Canadian prices were (and still are) cheaper, many people on fixed incomes were taking their chances by ordering from Canadian pharmacies for their own needs. Some of them had their insulin seized. (Quite a bit of this was Lilly insulin made in the US for the Canadian market.) When I needed a back up vial of the discontinued Iletin II Lente (in case there were supply problems), you couldn't buy a vial at all in the US, but you could still obtain them in Canada.

Knowing that the "hammer" was down, I ordered from a Manitoba pharmacy, but asked them not to label the package as insulin, and explained why. It went through without anyone getting "curious".

We were told that there had been only one previous IND-personal use approval for Caninsulin; it was for a dog who'd been a resident of another country. The approval was made to allow the treatment to continue. If we were denied, I considered taking Lucky temporarily to Canada so he could begin treatment with it and then re-applying for the IND under the same conditions, if that was to be the only way he could get what he needed.

With the help of Intervet, Lucky was approved and became the first US patient who was not either part of a previous trial or a previous user of Caninsulin. I can't say enough good things about them; before 24 hours were up after the initial "help!" e-mail to their Netherlands headquarters, we heard from the person in charge of the pending approval (as Vetsulin) in the US. The IND papers were filed that afternoon...
I'm guessing that there are factors at play now that would make importation of Caninsulin difficult again. First, Vetsulin DID end up being FDA approved in the U.S. Once that occurs -- an FDA version becomes available on the U.S. market -- it appears as though the FDA may choose to be much more diligent about barring importation of unapproved versions of a drug from elsewhere in the world (and import waivers of any type, which is what Kathy and I were discussing, become a moot point).

Having said that, it seems as though Vetsulin is in a "Catch-22" situation right now. Technically, it is an approved drug. But production issues are rendering current batches unacceptable. So you might think that the FDA would be willing to exercise a greater degree of "enforcement discretion" right now. But unfortunately, from what you all are saying, Caninsulin suffers from the same production flaws. So, and again this is pure speculation on my part, I am guessing that even if the FDA would otherwise have been more lenient about importation in this situation, they are not going to permit a "competing" unapproved drug into the country that suffers from the same flaws.

Kathy would certainly be more knowledgeable about this than I. But in her absence, I did want to at least mention this conversation that she and I shared earlier...

Marianne
  #42  
Old 11-10-2009, 08:06 AM
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Margaret Boyle Margaret Boyle is offline
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Default Re: Vetsulin - FDA Warning - Schering Plough

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Originally Posted by k9diabetes View Post
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
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
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  #43  
Old 11-10-2009, 05:13 PM
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Default Re: Vetsulin - FDA Warning - Schering Plough

My vet called me today and said she received some more info today. She wants me to call her tomorrow so this should be interesting. I'll post after I talk to her
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  #44  
Old 11-10-2009, 08:56 PM
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Default Re: Vetsulin - FDA Warning - Schering Plough

I'm anxious to hear what she has learned.

Natalie
  #45  
Old 11-11-2009, 06:02 AM
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Margaret Boyle Margaret Boyle is offline
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Default Re: Vetsulin - FDA Warning - Schering Plough

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Originally Posted by peggy0 View Post
My vet called me today and said she received some more info today. She wants me to call her tomorrow so this should be interesting. I'll post after I talk to her

Peggy,

Anna said she would phone if there was a problem, I may find out more at the end of the week as I am going in for another vial of insulin.

I told you I had increased Lucy,s insulin to 10iu on Sun evening.

Well low and behold we have had geat numbers the last few days all in the 100+ and 200+ I have been giving her a wee drop dry food at midday along with her vegts and this seems to be keeping her from going too low in the afternoon

I read Natalie's post advising someone to do this and I thought I would try it with Lucy, and it seems to have worked

This is where the forum is very good as you can pick up some very good tips

It is cold here Peggy I have my heating on all day now very frosty in the mornings, I hate the cold weather

Hugs to you and Forbie.
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  #46  
Old 11-11-2009, 07:48 AM
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Default Re: Vetsulin - FDA Warning - Schering Plough

Wow that is great news about Lucy margaret!!! Just be careful with those new bottles of insulin as I know you will be. Hate it when you have to finally turn that heat on. I do not like being cold at all. the forum is wonderful. I don't know what I would do withouth it and all of our good friends here. I talked to my vet this am and she wants me to curve forbin this weekend on this bottle and next weekend on my next bottle and we are going to discuss whether we should move him to NPH

xo

peggy
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  #47  
Old 11-11-2009, 12:56 PM
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Default Re: Vetsulin - FDA Warning - Schering Plough

A denizen of the Muffin Pet Diabetes list posted today that Merck has merged with Schering-Plough, as of a few days ago. It appears capital investment with respect to Vetsulin may change.

She added that production has been halted, and that supply is limited.

I'm trying to track down further information, but I'm a rotten searcher, and I'm not getting anywhere.

I really want to notify my vets, as they have some patients on Caninsulin, which likely is equally affected (that is, in terms of the contents of individual vials).

Can't reach my vet this afternoon by phone; their office is currently closed. At times, they've had staff meetings on Wednesday afternoons, closing the office, say, from noon to four, so I'll try again in the late afternoon. My vets will be wanting some solid information - if it's available!

If anybody has leads on Vetsulin - or - on Caninsulin - please post them!

Kumbi is on Novolin NPH insulin, has consistently done well on it, so I'm simply thanking our lucky stars, as we appear not to have any particular insulin-concerns, for the moment. But a lot of my friends - you people here, and a few from other forums, have dogs on Vetsulin or Caninsulin, and I feel very deeply concerned about that, and send my LARGE best wishes for relatively easy solutions (any pun intended).

Wed, 11 Nov 2009 12:56:13 (PST)
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  #48  
Old 11-11-2009, 01:54 PM
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Default 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.

Quote:
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.
Quote:
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.
  #49  
Old 11-11-2009, 04:25 PM
AlisonandMia AlisonandMia is offline
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Default Re: Vetsulin - FDA Warning - Schering Plough

Another benefit of changing those that can be changed to NPH early on is that (at least in theory) it should leave more Vetsulin out there for those who really, really need it - ie those allergic to NPH or for whom NPH doesn't work for some other reason.

Alison
  #50  
Old 11-11-2009, 06:41 PM
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Default Re: Vetsulin - FDA Warning - Schering Plough

My vet called me today after receiving more info from Intervet. She shares your concern natalie and wants to move forbin to NPH. She feels that if could be fixed quickly they would have done it immediately to satisfy the FDA and their reputation.
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