Novartis temporarily suspends production of Interceptor, Sentinel

[Trudy Harlow]

This may be old news to some, but I just saw it.

http://news.vin.com/vinnews.aspx?articleId=20998

Novartis temporarily suspends production of Interceptor, Sentinel
December 29, 2011
By: Jennifer Fiala
For The VIN News Service

Dr. Steven Hornstein's supply of Interceptor is limited to what's seen here, plus a 10-pack for small dogs. He uses the product daily in his practice in Monroe Township, N.J.

Click here for larger view

Novartis Animal Health has ceased production of Interceptor, Sentinel and several other drugs manufactured in its plant in Lincoln, Neb., while the facility undergoes "process and compliance improvement activities," a spokesman for the company confirmed today. 

Mickey McDermott, head of communications for Novartis Animal Health in North America, could not immediately identify what other products are being impacted by the plant's temporary shutdown aside from Interceptor and Sentinel, both pet parasitides. He did not specify the type of modifications underway or whether they were prompted by the U.S. Food and Drug Administration (FDA), which regulates facilities that manufacture and process livestock feeds, pet foods and veterinary drugs and devices. 

Officials with the FDA's Center for Veterinary Medicine did not respond today to a query about whether the agency is involved in Novartis's process and compliance upgrades. 

McDermott noted that the changes are being made "voluntarily." The company hopes to resume its regular production schedule sometime in January. 

"We're hoping this will be very temporary," he said. 

So is Dr. Steven Hornstein. As a solo practitioner in Monroe Township, N.J., he dispenses 40 or 50 boxes of Interceptor, a broad-spectrum antiparasitic that contains milbemycin oxime, on a monthly basis.

"It's the main heartworm preventative I use, so this will impact me," Hornstein said. He plans on turning to Elanco's flea killer and heartworm preventative Trifexis, which contains spinosad and milbemycin oxime.

Trifexis is not a direct substitute for Interceptor or Sentinel, which contains milbemycin oxime and lufenuron. According to the label for Trifexis, serious adverse reactions have been reported following concomitant extra-label use of ivermectin, another broad-spectrum antiparasiticide, with spinosad alone, one of the components of Trifexis chewable tablets.

All three antiparasitics act as heartworm preventatives and have similar label claims when it comes to treating common intestinal parasites such as hookworms, roundworms and whipworms. Interceptor, administered via flavored tablets, is not designed to target flea and tick populations. Sentinel, also a flavored tablet, inhibits flea egg development but does not kill adult fleas or ticks. Trifexis targets adult fleas but is not marketed for tick prevention or protection.
Hornstein noted that he's received no communication from Novartis with news of the supply disruption. He found out from a colleague who alerted others via a post on the Veterinary Information Network (VIN), an online community for the profession, after her practice manager attempted to place an order for Interceptor.

Members of VIN have attempted to reach out to Novartis officials in search of clear answers about the supply issues. Thus far, their queries have gone unanswered. 

The most recent news releases featured on the Novartis U.S. website date back to 2009. It's unclear whether Novartis sent a "Dear Doctor" letter — a form of communication that pharmaceutical companies often use to alert medical professionals to changes concerning their products — to veterinarians.

"Would it be nice for the company to warn us? Absolutely," Hornstein said. "I'd like to get this information first, from them."

Editors Note: This article was amended from its original to include additional information about the antiparasitics featured.

[Karen, Jasper and Jackdoodle]

OMG, with all of these dogs having adverse reactions to Trifexis, that's what they're going to use?

I'm so glad I stuck with my tried and true Frontline and Heartgard.

[Jennifer and Jack]

Sigh... so is this a recall on the product or are they saying they are not going to make any more for now, I just won a years supply of Interceptor in October, I only gave one dose because I finished up what I had. Should I return this ?

[AndySharon BoomerShaynaMariner]

 

Jennifer -

My understanding is that they have temporarily stopped making these products while they upgrade the plant.  "The company hopes to resume its regular production schedule sometime in January.  "   If I used these products I would stock up on them to get through this.

[Karen, Jasper and Jackdoodle]

Well, the plot thickens. Novartis has apparently brought out a Frontline type spot on treatment called Parastar. Funny that they're suspending production of one product supposedly because of upgrading the plant, but now here's this new product being marketed.

[F, Calla & Luca]

I don't think it's strange at all. The patent on Frontline must have expired since there are generics out there. So a new product blossoms. I see it all the time with human meds.

[Lynda Kamrath]

Exactly!  You can't make the same profit on products that have become generic - so make something new.  Too bad that it is down to pet meds now also.  It is old news with human meds.

[Elizabeth & Cosmo]

I could be very wrong, but perhaps this suspension of the animal health products is simply a "side-effect" of the voluntary recall of their human products Excedrin, NoDoz, Bufferin, and Gas-X.  From what I can tell, it seems the problems with the human products were mechanical issues: broken pills, pills in the wrong bottle, etc. To me, this is more reassuring than chemical problems with the actual formulation of the meds.

Anyway, here's more info from Novartis and CNN:

http://www.novartis.com/newsroom/media-releases/en/2012/1575836.shtml

http://www.cnn.com/2012/01/08/health/novartis-drug-recall/index.html

I don't see any reason to be concerned about supplies you already have of Sentinel or Interceptor--but those meds could be scarce in the future, if the plant doesn't reopen soon.

[Susan and Sasha]

I just ordered a years supply of Interceptor...online from Drs. Foster and Smith

They said they had it in stock and it would be sent out to me.

Should I be concerned about it??

Sasha has been on Interceptor since she was a puppy...and I don't want to switch her to something else that may have adverse reactions like the Trifexis!

[Karen, Jasper and Jackdoodle]

I used to order my chewable Heartgard and Frontline topical from Foster & Smith to save a little $. Then I got a Heartgard order which was composed of separate odd pieces from several different lots, one from one batch, two from another, etc., all different expiration dates, thrown into a plastic ziploc bag, instead of one sealed box all from the same lot. (None of the reminder stickers that come in the box either.)  Some of them had expiration dates that would arrive before I used them, only one or two months away. I sent it all back and started buying it from my vet. When you break down the cost per month, even if the vet charges $20/per package more than F & S, that still comes out to less than $2 per month. The risk is not worth those savings, IMO.

Check whatever you get from F & S closely, especially the expiration dates.

[Susan and Sasha]

Thanks Karen...

This is the first time I've ordered online and not bought from the Vet..

Sasha's Vet is in N.J...and we just made a permanent move to our other home in S.C...so I have to get her settled in with a new one.

I'll make sure to check everything carefully when it comes in.

Thanks again...

 

[F, Calla & Luca]

Wow, I have never had an experience like this and I buy just about everything on line. Are there even stores out there anymore? One of the places I've had good experiences with is 1-800-Petmeds. Everything I've bought comes in sealed boxes with good expiration dates. I hoped you let F & S know how shabby their product was and that you were going to "out" them. I also buy all sorts of things from Amazon and I try to look up all vendors to see what their ratings are.

[Karen, Jasper and Jackdoodle]

Oh, I called them and complained, you can be sure of that. I had been using them for years with no problem, but after that, I just got gun shy. I've heard too many warnings about counterfeit products on-line.  And the cost per month is really not much more at the vet, plus they often have specials and rebate offers. And, since I'm there every other week (at least) anyway, it's no trouble getting it.