Vetsulin Sales Prohibited - FDA Warning - Dogs Changing to NPH

[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

[peggy0]

Re: Vetsulin - FDA Warning - Schering Plough

If you call Schering they will tell you its both. I think they are only discussing Vetsulin because of the FDA.

[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.

[John F]

Re: Vetsulin - FDA Warning - Schering Plough

October 29, 2009 my dog was diagnosed with diabetes and began taking 9u of VETSULIN twice a day - at this time his BG was 374.

November 4, 2009 my dog had an episode where he could not stand up for several minutes.

November 5, 2009, after taking VETSULIN for 6 days my dogs BG had increased from 374 to 475.

November 6, 2009, after taking VETSULIN for 7 days my dogs BG increased again to over 500. I reviewed the FDA/VETSULIN alert with my Vet and we agreed to continue VETSULIN injections over the weekend at 10u twice a day and retest him again on Monday.

Does anyone have experience where his or her pet's BG actually increased while taking VETSULIN?

[ravenecw]

Re: Vetsulin - FDA Warning - Schering Plough

October 29, 2009 my dog was diagnosed with diabetes and began taking 9u of VETSULIN twice a day - at this time his BG was 374.

November 4, 2009 my dog had an episode where he could not stand up for several minutes.

November 5, 2009, after taking VETSULIN for 6 days my dogs BG had increased from 374 to 475.

November 6, 2009, after taking VETSULIN for 7 days my dogs BG increased again to over 500. I reviewed the FDA/VETSULIN alert with my Vet and we agreed to continue VETSULIN injections over the weekend at 10u twice a day and retest him again on Monday.

Does anyone have experience where his or her pet's BG actually increased while taking VETSULIN?

The experts will chime in here however it almost sounds like maybe it's not working to me.

When you say your dog's bg has increased what exactly do you mean? Do you do curves (meaning checking the bg's every 2 hours for example thru the day)? That way you could tell if the insulin is actually working.

You will get answers but i'm thinking you might need to provide more information, this forum has been so good and helpful, you are in the right place to find out what might be going on.

[peggy0]

Re: Vetsulin - FDA Warning - Schering Plough

Only if the bottle of insulin was bad which occasionally you could get one. I always have my current bottle and a backup or at least 1 shot from the previous bottle that worked to make sure its effective. also, have you done a curve on your dog? there could be times of the day where its very low and its rising continously because of too much insulin. We need more info to help you out. how much does your dog weight and what dosage is it getting

[k9diabetes]

Re: Vetsulin - FDA Warning - Schering Plough

Hi John,

I made a copy of your post and Eric and Peggy's replies in a new thread so you can carry on the discussion there.

Natalie

[Edie]

Re: Vetsulin - FDA Warning - Schering Plough

Thought you all might get a kick of the current post on my blog: November is Pet Diabetes Month. Oh, the irony!

http://www.willmydoghateme.com/2009/...-oh-the-irony/

[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

[peggy0]

Re: Vetsulin - FDA Warning - Schering Plough

Talked to my vet again today. We're staying on Vetsulin until he notices or is notified of a supply issue then we will move to NPH. I also beleive that it could be a capital investment that will take time to correct in production so planning ahead.

[labblab]

Re: Vetsulin - FDA Warning - Schering Plough

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):

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

[Margaret Boyle]

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

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

[peggy0]

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

[k9diabetes]

Re: Vetsulin - FDA Warning - Schering Plough

I'm anxious to hear what she has learned.

Natalie

[Margaret Boyle]

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

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.