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.
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:
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[masked]-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[masked]-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?