Vetsulin Sales Prohibited - FDA Warning - Dogs 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

[baileysmom]

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.

[peggy0]

Re: Vetsulin - FDA Warning

I have not seen anything yet

[CarolW]

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)

[peggy0]

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.

[k9diabetes]

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.

[minpinlover]

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

[k9diabetes]

Re: Vetsulin - FDA Warning

Many vets are unaware, it seems, of how good an insulin NPH is for dogs. I attended a seminar this spring on canine and feline diabetes and when the speaker asked how many in the room use NPH not one hand went up!!

I was shocked!! And made a point of bringing up NPH when someone asked about a dog who was not doing well on Vetsulin. He's a big dog too so it was costing a fortune to keep him going on Vetsulin and he had to have a huge volume of liquid injected.

The speaker brought up the old rumor that NPH will be gone any day now and I countered that I've been hearing that for four years and that it works really really well in dogs so I'm happy to see it used for as long as it is available. The vet asking about the dog had not even considered using NPH.

It seems like many vets settle on one insulin and don't branch out. They probably used Humulin L before Vetsulin came along and switched to Vetsulin when Humulin because both are lente insulins so somewhat similar.

Natalie

[Soaphie & Sydney's Mom]

Re: Vetsulin - FDA Warning

What are the other choices besides NPH? Soaphie had a horrible reaction to NPH and is on Vetsulin.

We haven't seen any issues......yet.....knock on wood!

Tami & Soaphalupagus

[pgcor]

Re: Vetsulin - FDA Warning

Hey Linda - I used Vetsulin for a while when Pip was first diagnosed because that's the only kind of insulin my Vet had. I broke a bottle and was forced to go to an emergency vet clinic when our Vet was closed. That prompted me to change to NPH. I didn't want to be in a position to have to run all over finding a bottle.

NPH is readily available at our all night drug stores.

You don't need a prescription in Illinois, so with the help of the folks on the board I switched to NPH. I started out with reduced amount of NPH insulin and eventually worked my way up to Pip's needs.

It was relatively easy and if you buy NPH at Wal-Mart (it's called Relion) it's only about $25 to $27. Vetsulin at my Vet was running me around $45.00

If you and Daygo can switch, it's worth the savings. I would check with the Vet, although, I must say - I was met with resistance from my Vet as she was really "pushing" the Vetsulin. Good Luck!

Pam

[Margaret Boyle]

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.

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

[k9diabetes]

Re: Vetsulin - FDA Warning

Alternatives are limited beyond NPH. Lantus is one. Levemir is another but a dog that's allergic to NPH is likely to be allergic to Levemir as well - both contain protamine.

Because Chris did not do well on another lente insulin (Humulin L, which is constructed like Vetsulin but uses human insulin), we never tried Vetsulin.

Chris was allergic to NPH and did not do well on Lantus so we were stuck. That's when we went to Regular insulin - we were able to give it four times a day; otherwise that would not have worked either.

It is possible, as I understand it, that only the U.S. product is a problem. Kathy tells me they are made in different plants.

Natalie

[peggy0]

Re: Vetsulin - FDA Warning

All

Heard from my vet. She contacted Schering. She can't speak for them of course but feels this is something that isn't necessarily new. She agreed with Natalie that they will be most anxious to fix it. She does not want to switch Forbin given he is doing so well and she knows I'm vigilant in monitoring him. She said its really up to the comfort level of all of us, but she advises to monitor and hold tight. I have not heard from Schering Plough. She believes it would affect caninsulin as well as the specification is what's off and needs to be changed from her understanding of the issue. I'm sitting tight for now.

[peggy0]

Re: Vetsulin - FDA Warning

Just heard from Schering Plough, they are stopping production until they fix this issue. They have no idea at the moment how long it will take to fix. Supply is definately going to be a problem. She told me it could be months................Not good. There are no specific lots or batches. It's an inconsistent problem. I explained to them that I don't give Forbin his shot until I know he is on his way back up from his typical nadir time. They told me that is the only thing you can do to check it. There will be a panic for sure to switch or hoard. Very upsetting. I guess we are going to have to go with our instincts on this one. I don't know what else to do