Sunday, February 6, 2011

ALERT for pets on Vetsulin

On Friday, the FDA dropped a bomb on our family when they announced that Vetsulin will be taken off the market.

Vetsulin is manufactured by Intervet/Schering-Plough Animal Health for diabetic cats and dogs. According to the official Vetsulin website, "Vetsulin (porcine insulin zinc suspension) is an insulin developed specifically for veterinary use in both dogs and cats with diabetes. Vetsulin has been used successfully by veterinarians in over 30 countries worldwide for more than 15 years." still contains the assurance that the product is,"the only veterinary insulin FDA-approved for both dogs and cats." That's surprising because in November 2009, the company announced that a problem had been discovered:

The product has been found to be out of specification in regards to the long term stability of the crystalline, or long acting, component. Specifically, the concentration of the crystalline component is higher than what is outlined in the specifications of the product. Consequently, the amorphous, or short-acting, component may have a lower concentration. This could mean that diabetic patients on VETSULIN may experience a delay in onset of action, a delay in peak activity and an overall extension of the duration of activity. The product is remaining in distribution, but supplies will soon be exhausted. Veterinarians should plan on transitioning their diabetic patients to other insulin products and should not be starting any newly diagnosed diabetic patients on Vetsulin.

At the time, we had a new bottle, and the vet had a good supply available, so we kept using Vetsulin in hopes that the company would sort out the problem.  Here's the big question: Our cat Indy has been on Vetsulin since at least early 2008. It's managed his condition very well. In fact, he had his latest glucose check on Saturday morning, and his blood sugar levels were, as the vet told us, "perfect." Why, after more than 12 years of successful management of small animal diabetes, was the product suddenly found to be of questionable efficacy?

In May of last year, Schering-Plough created the Vetsulin Critical Need Program. If a veterinarian determined that a dog or cat's diabetes could most effectively be controlled with the use of Vetsulin, the pet owner and vet could complete paperwork to join the Critical Need Program. When more Vetsulin is needed, I pay my vet, the vet orders it, and the product is shipped directly to the consumer.

I don't recall if Vetsulin ships via FedEx, UPS or USPS Express.
You know what that leads to? Indy's Vetsulin sitting in a delivery truck all weekend.

We stopped by our vet's office on Monday just before noon and paid for the order. Vetsulin, as with human insulin, is supposed to be kept at a constant temperature. From the client information sheet provided at "Vetsulin should be stored in an upright position under refrigeration (2-8 Degrees Celsius / 36-46 Degrees Fahrenheit). Do not freeze." It's packed with ice, and we have it shipped to my husband's work, so it can be refrigerated instead of left sitting on our front porch all day.

Our vet's office faxed in the order Monday afternoon. We called on Thursday because we hadn't received it yet. The vet's office called Schering-Plough, and notified us that it didn't ship right away because of bad weather, but it was on the way and should arrive on Friday. On Friday at 4:30, my husband called, but the vet's office had not been provided with a tracking number. So, our Vetsulin is sitting on a truck somewhere. Maybe it's outdoors or parked in an unheated warehouse. Maybe it's between 36 and 46 degrees in the truck. Maybe it's below zero with snow packed around it.

We have maybe a week's worth left. It's a very stressful situation for our family all around.

I just visited and found some discussion of other products. The only one our vet had mentioned to us before and today is Humulin. The discussion on the Feline Diabetes Message Boards suggest that Humulin is a lot more difficult to dose and regulate than Vetsulin has been for us. Someone had also posted a link to an article about a lawsuit against the makers of Vetsulin. I think Mr. Friedman is to blame for the product being pulled off the market. I'm truly sorry that his dog died, but I wonder if he can prove that Vetsulin is to blame.

We have been very careful to give Indy his doses on time. He gets injections at 8am with breakfast and 8pm with dinner. The vet said we could be safe giving it to him within an hour of that time. I think maybe once we gave it to him nearly an hour late, and we skipped a dose one night when we went to an event out of town for a special occasion. We were back for his morning dose. On a typical day we might be 15 minutes early or late. We keep the bottle refrigerated. We use the syringes twice, with the vet's blessing, and after first use, we keep it in the fridge, too. We swirl the bottle carefully, mixing it with the least amount of air bubbles as possible. My husband doesn't trust the last couple of doses in the bottle, usually (though in the coming days that may not be an option).

I wonder if Mr. Friedman has been as careful with giving his dog injections on time. I wonder if he stored the bottle upright (in the photo accompanying the article, he's holding the box on its side). I wonder how careful he was mixing up the solution each day. The thing is, these things cannot be proven in court, for either side. If it goes to trial and Mr. Friedman testifies he did everything by the book every time, will the jury believe him?

And again, why this problem with the mix of long-acting and quick acting components not a problem for the first dozen years the product was on the market. Did someone else complain because their pet died? Did the FDA suddenly get stricter, or did the manufacturer stop paying off their government contact?

If you have a pet on Vetsulin, I'd be really curious to hear your thoughts and experiences. If you have a pet on Humulin or another alternative, I'd like to hear about that as well.