Vetsulin Sales Prohibited - FDA Warning - Dogs Changing to NPH

[forloveofandy]

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

[k9diabetes]

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]

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]

I have not seen anything yet

[CarolW]

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]

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]

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]

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]

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]

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