A Heads Up About Novartis Products

Boy, oh boy, am I glad I am not the CEO of Novartis Pharmaceuticals right now. On January 9th of this year the company issued a voluntary recall of some of their over-the-counter human products including Excedrin, NoDoz, Gas-X Prevention Products, and Bufferin. It seems that these medications contained stray tablets, capsules, or caplets from other Novartis drugs including prescription painkillers manufactured at the same facility.

Now veterinarians are involved in the ruckus with the announcement that the following drugs are/soon will be on back order:

Interceptor Flavor Tabs® (heartworm preventive)

Sentinel Flavor Tabs® (flea control product)

Program Tablets and Suspension® (flea control product)

MilbeMite® (medication to treat ear mites)

Deramaxx® (pain relief medication)

The explanation for the backorders is closure of a Novartis manufacturing facility in Lincoln, Nebraska. The details are murky as of yet, but interruption of the manufacture of such top selling drugs typically means one thing and one thing only. I suspect that Novartis has been busted for being sloppy, perhaps as related to the recent recall of some of their big-name over-the-counter human products.

Such sloppiness seems to have spilled over to the Novartis animal health division as evidenced by the following letter recently delivered to veterinarians about Clomicalm®, a medication to treat separation anxiety in dogs:

Dear Doctor:

Novartis Animal Health US, Inc. is committed to delivering safe and efficacious veterinary products, and would like to inform you about a recent development involving CLOMICALM® (clomipramine hydrochloride) tablets.

Due to potential packaging issues at our manufacturing facility, there is a rare possibility that a wrong tablet may be found in bottles of CLOMICALM. Novartis has not received any reports where a patient experienced a product mix-up, nor has Novartis received any adverse events attributable to a product mix-up. However, as a precautionary measure, we would like to extend the following recommendations.

  1. Before dispensing CLOMICALM, open each bottle and examine the contents for tablets that are broken or incorrect in color, shape or size (visual guide included).
  2. Post a copy of the Dear Valued Customer letter issued by Novartis Animal Health in your clinic (copy included).
  3. Distribute copies of the Dear Valued Customer letter to affected pet owners. Novartis Animal Health will send your clinic extra copies upon request. If you publish a clinic newsletter, please consider using the provided notice.
  4. Report any abnormal findings to Novartis Animal Health at 800-637-0281.
  5. Return affected product to Novartis Animal Health; call the aforementioned number for full details.
  6. Inform your clients who have already received CLOMICALM® to examine tablets and refrain from administering any that are questionable in color, shape or size; and to contact Novartis Animal Health to discuss product return of affected bottles.
  7. Keep records of communication with pet owners in patient files.
  8. Ensure that any re-packaged tablet bottles are labeled with the product lot number.

Novartis Animal Health requests that you complete and return the enclosed Response Card reflecting that you have read and understand these points, and have discussed them with your clients.

Canine separation anxiety is a complex disorder that has great bearing on patient quality of life and the human-companion animal bond. Uninterrupted treatment is essential for successful management of this condition. Our veterinarians are prepared to discuss best practices with you in the event patients require alternative therapies, in order to minimize the risk of adverse events and potential relapse of signs.

We thank you for your attention and cooperation regarding this important issue. If you have any further questions, please contact Technical Product Services and Pharmacovigilance at 1-800-637-0281.

My response to a letter like this is, “Oy vey!” although I admit to being excited about adding the word “pharmacovigilance” to my repertoire!

So, what does this mean for you and your pets? If you are treating your dog or cat with a product manufactured by Novartis Animal Health, I strongly encourage you to call or email your veterinarian to plan a course of action. If need be, he or she may recommend an alternative so as to avoid any interruption in your pet’s therapy.

Is your dog or cat currently taking a Novartis product? If so, which one?

Best wishes,

Nancy Kay, DVM

Diplomate, American College of Veterinary Internal Medicine
Author of Speaking for Spot: Be the Advocate Your Dog Needs to Live a Happy, Healthy, Longer Life
Author of Your Dog’s Best Health: A Dozen Reasonable Things to Expect From Your Vet
Recipient, Leo K. Bustad Companion Animal Veterinarian of the Year Award
Recipient, American Animal Hospital Association Animal Welfare and Humane Ethics Award
Recipient, Dog Writers Association of America Award for Best Blog
Recipient, Eukanuba Canine Health Award
Recipient, AKC Club Publication Excellence Award
Become a Fan of Speaking for Spot on Facebook

Please visit http://www.speakingforspot.com to read excerpts from Speaking for Spot and Your Dog’s Best Health.   There you will also find “Advocacy Aids”- helpful health forms you can download and use for your own dog, and a collection of published articles on advocating for your pet’s health. Speaking for Spot and Your Dog’s Best Health are available at www.speakingforspot.com, Amazon.com, local bookstores, and your favorite online book seller.

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14 Responses to “A Heads Up About Novartis Products”

  1. Just wanted to let everyone know that a Vet friend of mine in Oregon just received 4 vials of percorten that she ordered directly from Novartis. There was no delay nor was there a back order. She also asked them it there was a problem because she had heard rumors and they assured her she could order any amount she wanted.

    Karissa I am not sure where your vet is ordering his percorten but you might want to check on this.

    I am very glad to hear this as well because I too own and ADog!

  2. Tyler Tansing says:

    I use Percorten-V for two of my dogs, who have Addison’s Disease. I hope this incident does not affect this medication, too.

  3. Karissa says:

    I received a phone call from my vet’s office last Friday inquiring where I was at with my dog’s Percorten-V supply. He gets 1.1ml per month, so each vile lasts for only 3+ months.

    It was explained to me that their most recent order of Percorten-V was on back order for an undetermined length of time. The clinic only had two vials left and were wondering if I needed them to put a hold on it. Considering I have just under one dose remaining, my answer was a resounding YES. The clinic has one other Addisonian patient that wants the other vial, although apparently he has 4 months remaining at home.

    My vet does not anticipate a problem, but it would be an understatement to say I’m worried about this situation. This medication keeps my dog alive! I understand that it’s not a top priority for Novartis due to the limited production and profit, but what on earth are we supposed to do otherwise??

  4. Len says:

    I’m not heartbroken. My dog has been on Interceptor religiously and continually tests positive for roundworms. I will be switching to something else, regardless of their factory problems.

  5. Arlene G. says:

    I just sent some presciptions for Interceptor to the online supplier that I have been using for years. When I called to fill the order the customer service rep informed me that Interceptor may not be available for a while so did I want to fill more than one order. I ended up placing an order for all of the Rx slips I sent in so that I wouldn’t have to switch to another brand. I sure hope they straighten this out. I have been using Interceptor since it came out and have been very pleased with it.

  6. Kathi T says:

    That MDR-1 test just paid for itself.

    I won’t be switching to combo products either, but knowing my dogs’ MDR1 status, I will be ok on HeartGuard even if i don’t like it

  7. Anna Potter says:

    My vet told me last week that interceptor would not be available and offered a three in one type heartworm, parasite, and flea control. I didn’t like the idea and now I have been trying to find Interceptor and have not been very successful. Hopefully the order I just placed with one online company will come through. Very upsetting.

  8. speakingforspot says:

    Hi Deanna,
    Thusfar, there has been no mention made (that I am aware of) about the Novartis product, Percorten, an injectable drug used to treat Addison’s disease. Given what Novartis is going through, however, I would not be surprised to hear that the cost of this already expensive drug is increasing.

  9. Deanna says:

    Do you know if prescription meds like Percorten-V could be affected since it is not a tablet/pill?

  10. Debra Kelley says:

    Dr. Kay, while not Novartis related specically, this comment is certainly health related for our dogs. And I’m sure I’m not the only dog owner you’ll hear from on this. Do you not think it strange that Animal Planet would accept advertising for Hershey’s Ice Breakers Sugar Free Mints on today’s Puppy Bowl, and not require any note or mention of warning that those mints contain xylitol and that it’s dangerous if ingested by dogs? In fact, Hershey’s web site doesn’t even carry a complete list of ingredients of those mints, and says they don’t contain alcohol sugars. Which if you look at the ingredients list on this Walmart site you find is untrue: http://www.walgreens.com/store/c/ice-breakers-frost-sugar-free-mints/ID=prod6047039-product#descriptionNamedTab

    Thanks Walgreens for printing the ingredients. Animal Planet and Hershey’s, no thanks!

  11. Cindi Harry says:

    Finally, thanks to you we learn what is happening. I have been trying to follow this as all 3 of my dogs are on Interceptor and no vet in my area has any left. My vet or office staff just keep saying the factory is closed due to rebuilding. What!! Why not just tell us what is true. Thank you again Dr. Nancy for being up front with us.

  12. mlg says:

    Well, it is right up there with Pfizer’s mix-up on birth control pills. Since we don’t know which products might be in the mix, it may mean either an adverse drug reaction or treatment failure. But Pfizer – unwanted pregnancies in women? We all need to be careful with all drugs – human and veterinary and increase our vigilance for our own safety and that of our pets.

  13. Jana Rade says:

    Well, I’m sure if you were a CEO this mess would never happen in the first place.

    We’ve been using Interceptor. I’m not happy about this at all. Don’t like introducing new medications to Jasmine and Don’t like the idea that many other HW preventatives contain a soup of all kinds of other things.

  14. Susan Ward says:

    Do you know if this will affect the generic Clomipramine? I know that the price more than doubled in December.