Questions re NPH potency

[k9diabetes]

Some questions have been raised recently about NPH purchased in the past 30 days that may be unusually potent or have a more erratic action.

It's not clear yet whether this is a bona fide occurrence or whether heat, disrupted schedules, and/or concurrent diseases are actually behind the erratic responses some dogs on NPH have been experiencing.

Denise's Bogie is one who has been dropping steeply on NPH recently, as well as Judy's Bud. Judy's not a member here but is a friend of mine and I've been in touch with her over the phone in recent days after Bud experienced a pretty severe hypoglycemic episode on Sunday. Since Tuesday, his blood sugar, which is usually fairly flat and stable, has been hitting a high point 7 hours after his injection and then dropping sharply in the afternoon, like from 400 down to 150 in the following five hours - not his usual response. But it will take some time to figure out if it's strictly an insulin problem.

We Hope, can you recommend a web site or sites where human diabetics would report similar experiences?

If it's the insulin, it should be showing up with people too.

We use Regular rather than NPH and I have been decreasing Chris' dose recently along with upping his food some to maintain his current weight. But his activity level is also sharply down. So it's hard to say if more potent insulin is involved.

So NPH users keep a close eye on your dog's blood sugar and alert the pharmacy if you see a distinct change in pattern that can't be easily explained another way.

Natalie

[We Hope]

I'll have a look at some of the places such as Google MSD and AHD newsgroups--this is where many people with diabetes post.

What I'm wondering here is do we have any idea if this is confined to Lilly, to Novo or both? Second question is re: Novo because they produce Novolin and ReliOn/Novolin: If we have reports of problems with Novolin, are they either just re: the ReliOn/Novolin which is sold through WalMart/Sam's Club or are there reports of problems with Novolin NPH, which can be purchased in any pharmacy?

When we normally have an insulin problem, it's due to less potency for one reason or another:

http://petdiabetes.wikia.com/wiki/Regulation_problems#Insulin_problems

If it's mishandled by someone along the supply chain, if it's kept improperly--too warm or possibly frozen, that normally renders it less potent or possibly even destroys it completely.

One problem here is that insulin has not been required to undergo batch testing in the US since 1998-

In the United States, no insulin has been required to undergo batch testing since 1998. As per US Federal Register: "With the repeal of section 506 of the act, and the elimination of the insulin batch certification program, the agency is eliminating these subparts."

According to US law, the potency of any insulin is allowed to vary by 5%. Therefore, it is possible for a batch or lot of insulin to have only 95% potency and still be legally sold by its manufacturer.

I can also tell you that Eli Lilly and Novo Nordisk "arrive" at r-DNA insulin at different starting points.

Lilly uses an e. coli method of culture-

http://pi.lilly.com/us/humulin-r-ppi.pdf

Page 2

Novo uses a special strain of baker's yeast-

http://www.fda.gov/medwatch/SAFETY/2005/Oct_PI/NovoLog_PI.pdf

Page 1

For each company, the human insulin they produce through this process would be their "starting points" for any analogs they also make.

If we can narrow it down to whether this is being seen with only one insulin--from Novo--regardless of whether it's Novolin or ReliOn/Novolin--or from Lilly--it would be helpful as then one could purchase the other brand.

I would urge those who have had problems to report them to FDA--online or by phone:

http://www.fda.gov/opacom/backgrounders/problem.html#medprod

How do I report non-emergencies about medical products: medicines, medical devices, blood products, biologics, special nutritionals?

And I would urge them to report it to the manufacturer of the insulin, and absolutely NOT allow them to tell me they don't need to deal with me because their product has not been approved for use in animals.

I'm posting a portion of an old post I made to another board when we were faced with less than legally potent Lilly Iletin II Lente-

"Lilly was talking about their insulins not being FDA-approved for animals; I talked about paying for their insulin and being entitled to a refund or new insulin. They are asking for the vials to be sent to them and issuing me a refund. We do not need to be treated like second-class people because we use it for our dogs--we pay them FIRST-CLASS money, as do all diabetics. They say they will file an adverse affect report; John and I will ALSO do the same."

When Eli Lilly started saying their insulins were not approved for animals, my answer to them was that I was now calling them as a consumer who had purchased two vials of their flawed product. I received a refund for those two vials without a copy of my pharmacy receipt; repeatedly offered it to them and they kept declining it. They filed an ineffective insulin report in the Green Book (veterinary drugs)--that was the only bad insulin report in it for a long time.

This was where the quest for Caninsulin/Vetsulin for Lucky was born.

Natalie, I am giving my permission to copy this post elsewhere if it will help.

[k9diabetes]

I don't have a definitive answer regarding Novo versus Lilly but I know that Judy and Denise and Johanna are all buying from Wal-mart so are using Novo's product.

[k9diabetes]

Most of what I've seen is definitely Novo.

[We Hope]

The only differences in the Novolin and ReliOn/Novolin insulins would be the labeling for WalMart/Sam's Club and the price. Basically both would come from the same process at Novo.

What I've seen was reports of Novo insulins also.

We'll need to look at the various human diabetes boards with the hope that everyone posting there isn't either pumping or using analog insulins.

We can't speculate here what may be wrong, since there are quite a few things that might be, if it's the insulin.

I surely would switch to the comparable insulin of the competitor for now, even though I know it's going to be more costly, since Novolin outside of WalMart is usually less expensive. Going to a vial of Humulin would let you see if the problems still occur and if they don't, then you know there is a problem with the insulin.

WalMart/Sam's Club claims to have lower prices on meds across the board, so it might be that a vial of Humulin isn't as pricey there as it might be elsewhere.

When we had the problem, we went back to the old Iletin II Lente vial which we knew was not 100% potent any more. But it was more potent than what was in the vials I bought to replace it. The problem with needing pork insulin at that time was that you had to have a pharmacy order it for you, so I couldn't just pop out and get a different vial from a different batch. We got Lucky back in control with the old vial. It took about 2-3 days to do that; we were afraid to change the dose as we had no way to know just how much potency was left in that old vial. This was when we had to put him on the Iletin II NPH which didn't work out well at all for him.

[k9diabetes]

That was my thought as well... the insulin can be tested by purchasing a bottle of Humulin N and comparing the response to that. I've used the two brands interchangeably with no difference in their effect.

I know Walgreens is currently advertising a medication plan that can save money on pet prescriptions.

I too want to emphasize that it's far from certain that there is any problem at all with the insulin.

[We Hope]

If you do a little comparison shopping over the phone, you can often find out who has the best price for what you need. When I was pricing Iletin, I found the lowest price at CVS, then came a local pharmacy who delivered, with one of the large chain/grocery stores, Osco, being the highest. There was quite a big difference in the Osco price for it and the CVS one.

My thought would be to switch over to Humulin now and see if things stabilize. And if I saw that they did, I would not hesitate to make the situation known to Novo if the insulin was either Novolin or ReliOn/Novolin and WalMart, if the insulin one was using was ReliOn/Novolin.

[eyelostit]

usually Niki will go below her normal after a new bottle is opened for a few days, she has had some highs now past 2 wks, but I think thats cause of Chief's passing, She was Ok today, no problems here so far

[We Hope]

Bumping this up.