Ketamine recalls: More brands, more recalls in the pipeline, more questions

December 31, 2009

BSPVetSurgeryThe snowball keeps rolling downhill in the ongoing recall of ketamine, an anesthetic drug used in veterinary practice.

The story began last summer, when the FDA sued Teva Animal Health, the largest manufacturer of generic animal drugs in the United States, after agency inspections turned up adulterated animal drugs.

On Dec. 7, Teva reported to the FDA that it had begun receiving  reports dating back to November that as many as five cats may have died as a result of the affected ketamine. The FDA says it reviewed those reports on Dec. 11, and issued the following announcement on Dec. 21:

Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level. This product had previously been recalled to the distributor level and is being expanded as a result of an increased trend in serious adverse events associated with this product.

Veterinarians who have this product in their possession are instructed to cease using the product immediately and return it to their distributor.

[….] This recall is being conducted as a result of an increased trend in serious adverse events associated with this product, including lack of effect, prolonged effect, and death and involves all lot numbers within expiration.

Teva Animal Health, Inc is voluntarily recalling the aforementioned product. The FDA has been apprised of this action.

The Veterinary Information Network News Service followed up with an in-depth article on Dec. 29, saying that five cats may have died as a result of the compromised drug, and describing a quagmire of unanswered questions, confusing conversations with a Teva representative who refused to identify herself, and conflicting information about just what drugs were or weren’t involved.

From VIN News Service’s Jennifer Fiala:

The expiration dates of the lots range from September 2009 to February 2012, the FDA says. Additionally, the American Veterinary Medical Association (AVMA) warns practitioners not to rely on the Teva brand name to determine whether their ketamine falls under the recall. Rather, the following signs offer a better indication:

* If the lot number is six numeric digits, the product is not part of the recall.
* If the lot number is seven numeric digits, the product should be returned.
* If the lot number starts with 5401, regardless of the number of digits or the presence of letters in the lot code, the product should be returned.

This recall actually began last summer at the distributor level, following the filing of the FDA lawsuit and a subsequent FDA shutdown of Teva’s manufacturing facility in St. Joseph, Missouri.

Fiala’s report also raised the question as to whether Teva was manufacturing ketamine under other labels — a practice reminiscent of the 2007 pet food recall, when surprised pet owners learned that Menu Foods, a company few had ever even heard of, was manufacturing so many foods bearing other manufacturers’ names.

Today, that question was answered: yes, the Teva recall includes other brands, including Fort Dodge, one of the largest names in veterinary drug manufacturing, and that was acquired by Pfizer this fall. (Note: Pfizer is a sponsor of the Pet Connection newspaper feature’s database.)

The FDA’s Center for Veterinary Medicine today told the VIN News Service that affected labels include:

* AmTech Group Inc. Ketamine Hydrochloride Injection, USP, manufactured by IVX Animal Health Inc., St. Joseph, Mo.
* Butler KetaThesia, distributed exclusively by Butler Animal Health Supply, Dublin, Ohio
* Fort Dodge Ketaset, manufactured for Fort Dodge Animal Health, Fort Dodge, Iowa
* VEDCO KetaVed, distributed by Vedco Inc., St. Joseph, Mo.
* Phoenix Ketaject, manufactured for Phoenix Pharmaceutical Inc., St. Joseph, Mo.
* LLOYD Laboratories VetaKet, manufactured for Lloyd Laboratories in Shenandoah, Iowa
* RXV Keta-Sthetic, manufactured for RXVeterinary Products, Westlake, Texas

It’s crucial to note that veterinarians have had as much trouble getting answers about this recall as pet owners have. The problems with ketamine go back several weeks at least, and there’s no estimate how many animal may have been affected, or might be affected in the future — the inevitable outcome of slow, fragmented recalls with partial and often misleading information being dispensed both by industry and government.

It’s not likely there will be more information over the long holiday weekend, but we’ll keep watching the story as it develops. Gina is speaking with Joshua Sharfstein, the FDA Deputy Commissioner leading the agency’s transparency task force, on Monday — hopefully we’ll have more information for you then.

And kudos to Jennifer Fiala at VIN News Service for moving this story today. You can follow them on Twitter, subscribe to their RSS feed, or just plain old check their website to keep up with their coverage. Great work.

Filed under: pets, connected,recalls,veterinary medicine — Christie Keith @ 9:04 pm

31 Comments »

  1. I really worry this will fall through the cracks, coming out as it is on New Year’s Eve. Please help spread the word if you can. :(

    Comment by Christie Keith — December 31, 2009 @ 9:25 pm

  2. I think this is going to get bigger. Thanks so much for posting this, Christie. And happy new year. It’s 2010 now on the east coast. So far, so good!

    Comment by David S. Greene — December 31, 2009 @ 10:06 pm

  3. For anyone whose animal may need a procedure in the immediate future —

    Rather than bringing what may be an inadequate list of lot numbers, etc. to the vet in an effort to avoid the adulterated drug, can anyone make any suggestions for alternatives to ketamine that an owner can request?

    Comment by H. Houlahan — January 1, 2010 @ 7:13 am

  4. Heather … we can get this answered, but maybe not today. Hard to get experts on a holiday. I’ve sent out some requests …

    Comment by Gina Spadafori — January 1, 2010 @ 7:34 am

  5. Am wondering if this was the cause of Fay’s death.

    Comment by Nadine L — January 1, 2010 @ 10:11 am

  6. Not all vets use ketamine or a combination of ketamine and valium, I know that some use a drug called Telazol. I would contact your veterinary hospital and ask if they know about this, and encourage them to make their clients aware that they are aware.

    Comment by Devery — January 1, 2010 @ 12:55 pm

  7. Thanks for being on top of this. It’s timely for me since CJ, my old catgirl, is going in on Monday to have a likely vaccine-induced sarcoma removed. I most definitely will be asking if they are aware of this issue – and what they will be using for her.
    Reminds me of the Peter, Paul and Mary song – Blowin’ in the Wind . . . “how many —– will it take?”
    cm5

    Comment by catmom5 — January 2, 2010 @ 7:14 am

  8. If anyone knows what specifically occurred in the death of the cats who were given ketamine (ie., kidney failure or ??) please post that information or a link. Our very vibrant and healthy two year old cat Zia died during a routine dental last July. He was given ketamine, diazepam, and atropine.

    Comment by Cathy — January 4, 2010 @ 8:43 am

  9. It costs more, but you can always request gas anesthesia on any procedure to stay away from the use of ketamine. It is an option offered at most clinics.

    Comment by Lonnie Blum — January 4, 2010 @ 10:49 am

  10. The two aren’t the same class of drug — ketamine is used in combination with other drugs to INDUCE anesthesia before gas, and gas is used to MAINTAIN anesthesia after induction. You can’t replace ketamine with gas.

    Inducing with gas is VERY dangerous and should never be done:

    http://www.petconnection.com/blog/2007/05/15/the-anesthesia-myth-that-can-kill-your-pet/

    Comment by Christie Keith — January 4, 2010 @ 11:01 am

  11. In response to the question regarding “other drugs to use:” YES, there are. Many Boston breeders have used alternative methods for a very long time. We don’t even allow our dogs to be “pre-sedated” or whatever the heck they call it now. Our dogs are safely “masked-down” using Isoflurine gas; NO I.V. drugs at all… If access is necessary to the animal’s mouth or throat, then Propofol administered I.V. is a great alternative anesthesia, as it is short-acting & clears the system quickly – again, with no pre-sedation. NO DOPEY PET UPON WAKING!
    *I am NOT a vet & my comment should NOT be construed as veterinary advice, simply an opinion.

    Comment by GrayHaven Bostons — January 4, 2010 @ 11:06 am

  12. *We have been inducing our Bostons with Iso for over 10 years, & I know many, many other breeders who insist upon the same protocol for their dogs, & we have NEVER lost a dog, nor have we had a dog experience any adverse reaction.
    On the FLIP-SIDE: the 3 times we’ve had to race to the E.R. for emergency surgeries – where they REFUSE to do anything BUT use the “pre-sedation cocktails,” we have come away EVERY SINGLE TIME with dogs that are too incapacitated to care for their babies, unable to maintain body temp., can’t wake-up for up to 24 hours, no milk, & so on… In one case, we nearly lost a singleton puppy as a result of her being so anesthetized (via her mom)she was too depressed to breathe on her own for almost an hour.
    When implemented correctly by an experienced Vet, inhalation induction – using Isoflurine gas – is VERY SAFE – we have found it to be more safe than any other method. We urge all our new puppy owners to find a vet who will do the same for their puppies/dogs.
    *AGAIN: NOT a vet! Just sharing experience & opinion in the hopes it may help others.

    Comment by GrayHaven Bostons — January 4, 2010 @ 11:19 am

  13. GrayHaven, you are putting your dogs at enormous and unacceptable risk.

    You are believing and spreading a dangerous myth.

    Inducing with gas is MORE hazardous in EVERY WAY than pre-inducing with injectables and maintaining with gas. I linked to my article about this up above, but I’ll quote it now because I’m deeply concerned at the number of people who might find this post down the road and not click on the link.

    Many people think that using only gas to anesthestize their pets is safer than using injectable drugs to induce anesthesia first, then use gas to maintain it. Sadly, some veterinarians even believe this. It turns out that nothing could be further from the truth.

    How can that be? After all, it makes perfect sense that the fewer drugs, the better in any anesthesia procedure. More drugs would mean more risk. It seems logical.

    However logical it might seem, however, it’s not true, and owners who refuse to use multi-drug anesthesia protocols, or veterinarians who opt not to use them, are doing a grave and potentially life-threatening disservice to those animals.

    I’m referring here to the practice known as “masking down” or “gassing down” a pet, where the anesthesia gas, usually isoflurane, is given via face mask to get the cat or dog anesthetized enough to be intubated and then given a maintenance dose of the gas. This procedure was once believed to be easier on the pet, especially older or medically fragile pets, but in fact, the opposite is true.

    There are a number of risks associated with “masking down” a pet, all of which are substantially reduced if a protocol of injectable induction agents is used instead. They include:

    1. While we think we’re using less drug, we actually end up using more. That’s because you have to use a much higher dose to induce with gas than to maintain anesthesia.

    2. Gas anesthetics powerfully dilate the blood vessels, which means that they can send blood pressure plummeting — all the more so with the high doses you have to use to “gas down” or “mask down.” This is very dangerous for any dog or cat, but much more so for pets with kidney or heart problems – the very pets some veterinarians reserve this procedure for.

    3. Gas induction also causes more severe cardiovascular depression, with its obvious risks to the heart.

    4. Whenever you anesthetize an animal, they go through three stages of anesthesia. The second stage is called the stage of “involuntary excitement,” and you have to go through it to get to stage 3, which is “full surgical anesthesia.”

    The problem is that when you “mask down,” stage 2 lasts much longer — which puts a great deal of stress on the heart. The more gas you give (as you have to when you “mask down” or “gas down” to induce), the greater the risk. Arrythmias in particular are more likely to occur, risky for all pets but especially for senior pets or those with heart disease.

    5. When you use gas to “mask down” the animal instead of inducing with injectable drugs, you have no way to get rapid control of the airway during the procedure. A delay in getting control of the airway could be the difference between the animal surviving a bad reaction, and being killed by it.

    6. From the vet/staff’s points of view, gas inductions expose THEM to waste gases and are hazardous. Improper venting and disposal of waste gases is a huge workplace safety issue for veterinary staff and not something that should be taken lightly.

    Please do not use a vet who wants to mask down your pet, nor try to convince your vet to do it instead of using injectable induction. It is outdated, it’s unsafe, it’s bad for the pet AND the vet staff, and it’s bad medicine.

    For more on this, including some references and links to additional information, check out the section at the end of this article I wrote last year on the Vet Techs blog, here:

    http://vettechs.blogspot.com/2005/07/masking-down-safer-way-to-anesthetize.html

    DON’T MASK DOWN! DON’T GO TO VETS WHO USE THIS OUTDATED, DANGEROUS, DISCREDITED PRACTICE!

    Comment by Christie Keith — January 4, 2010 @ 11:32 am

  14. I second Christie’s comment. I’ve written on this subject several times for dogs and cats, and masking is definitely a dangerous and outdated way to go.

    Comment by Kim Thornton — January 4, 2010 @ 11:54 am

  15. I am so glad to know that the oncology vet I took my golden to 3 yrs ago agreed with Christie and Kim…even though Harry only needed to be “down” for his radiation a very short time I know they used an IV first and then a mask…and since he had this for 15 treatments and a CT mapping–I am very glad they did…and I might add that by the time he got out in the car he was wide awake and ready for his picnic breakfast!

    Comment by Carol V — January 4, 2010 @ 12:15 pm

  16. I did read your article… There is not much mention made regarding adverse reactions or deaths resulting from all the pre-op & post-op “cocktails” that are given.
    Speaking from personal experience, I have to say that I have never had a dog “panic” when masked-down – I am with my dogs during procedures, & my dogs bounce-back & are much, much stronger & more functional due to the surgical protocol we employ.
    I don’t know – I read the article, but I just don’t see enough there highlighting the benefits of “pre-ops” to cause me to change my protocol. Some of the negatives you mention about “masking down” I have never seen my dogs experience, so I would encourage you to look further. My dogs sit or lie quietly while masked; no fear or panic involved. They go to sleep very quickly & with no fanfare.
    I personally have seen fear, pain, & stress on both the front & back end of procedures when using the protocol you are urging, PLUS near fatalities… NO induction method is totally “safe,” as we all know.
    Every pet owner must make personal choices for his/her pet & move in the direction s/he feels is safe & appropriate.

    Comment by GrayHaven Bostons — January 4, 2010 @ 12:20 pm

  17. Speaking from personal experience …

    Comment by GrayHaven Bostons — January 4, 2010

    Honestly, your personal experience doesn’t mean anything to me compared to peer-reviewed studies, a/k/a actual, you know, science.

    Every pet owner must make personal choices for his/her pet & move in the direction s/he feels is safe & appropriate.

    Comment by GrayHaven Bostons — January 4, 2010

    Our job here is to make sure people are able to make those personal choices based on proven best practice.

    Comment by Gina Spadafori — January 4, 2010 @ 12:28 pm

  18. GrayHaven, with a h/t to Daniel Moynihan, everyone is indeed entitled to their own opinions, but not their own facts. What you believe is factually incorrect and you do all animals and their owners a disservice by disseminating it as if opinion and fact should carry equal weight.

    It’s irrelevant if induction drugs carry risks when you are comparing them to something that carries GREATER risk. You have no choice but to engage in the risky behavior in most cases; your task as your animal’s caregiver is to choose the least risk and the most benefit. Which in this case is clearly and overwhelmingly to induce with injectables and maintain with gas.

    Last, your perception that your dogs are “calm” is meaningless. The reactions to “masking down” are physiological, not psychological.

    Comment by Christie Keith — January 4, 2010 @ 1:13 pm

  19. Thank you for this my cat crashed while being spayed. Luckily they were able to revive her.

    Comment by Marilu Shah — January 4, 2010 @ 10:02 pm

  20. What are the adverse reactions the FDA is talking about.
    What has this drug done and why are we not being informed of the actual findings and animal deaths.
    I have been searching for some answers for the last 3 days.
    On this subject.
    See my colt was given Ketamine and volume Dec 28th 2009
    and died for no apparent reason 7 days latter.
    All internal organs shut down one at a time.
    He lived for 15 hours and we had to humanely euthanize him.
    And autopsy has been done see they don’t just die not for no reason but there is no apparent reason for his death the vets are studying internal organs and blood at this time.
    But I just found the info on the Recall.
    and would like to find where to get some real answers as to how many animals this drug has killed and what happened .

    If any one has any info on this it would
    be greatly appreciated

    Comment by chris — January 9, 2010 @ 12:18 am

  21. My 6 month old kitten had an adverse reaction to Ketaset in Novemeber and almost died. The side effects included agitation, loss of bladder control, loss of consciousness and seizure. On Jan. 6, 2010 a 2 year old tomcat I rescued died a few hours after an uneventfull neuter. Pfizer is paying for a necropsy at MSU to determine if Ketaset was the cause of death. The Ketaset used in his surgery is NOT a lot# currently involved in the recall. To be safe I would postpone any elective surgeries until this is resolved.

    Comment by Sharon Hancock — January 9, 2010 @ 12:08 pm

  22. I wrote on Jan 4 that our two year old male kitty Zia died during a routine dental procedure last July. He was given ketamine, diazepam, and atropine. We don’t know if the lot# involved in the recall was given to him. Here is more info on what happened — don’t know if ketamine contributed to this or not.

    A necropsy was done. He died of pneumothorax, a collection of air in his chest cavity. His lungs collapsed. According to the vet, the procedure went fine with vitals normal. When he started coming out of the anesthesia, the vet tech noticed swelling under throat and felt subcutaneous emphysema. At that point ISO was off and he was on oxygen only. Vet’s report outlines the steps they took but he went into cardiac arrest within moments.

    Necropsy did not find any lesions or tearing anywhere to explain why this air leakage occurred. Nor did he have any trauma or any symptoms that would have predicted this. Intubation was “non-traumatic.” No organ damage was seen and he was “in good nutritional and good post-mortem condition.”

    So, even after the necropsy, we still have questions on what happened to our sweet boy.

    Comment by Cathy — January 11, 2010 @ 3:49 pm

  23. Is there any information on why butorphanol is being recalled as well? I see it linked in the SFGate article but cannot find anything of it.

    Also, if Telazol is a combo of ketamine and another drug, should Telazol be considered as part of the recall as well?

    Comment by Marlene — January 14, 2010 @ 8:03 am

  24. Cathy, I’m so sorry about your Zia. I know how difficult his loss must be, particularly when he was a healthy boy and it came so unexpectedly.

    As of now the necropsy on the young tomcat hasn’t determined the cause of death. Tests are continuing. I’m not expecting a definitive answer, but it would be helpfull if we could compare the necropsies of all the cats thought to be affected. A common factor might be apparent. So far we have three male cats on this page who may have had an adverse reaction to the drug, but I don’t see how gender could be a contributing factor. I’m grasping at straws like everyone else, looking for any links. I recued the cat who died last week. I can’t help but think that he would still be alive if I hadn’t. He was supposed to go to a barn home after a few days of recuperation.

    Comment by Sharon Hancock — January 15, 2010 @ 10:53 am

  25. Marlene, I don’t know why, of all the products listed as having problems in the initial “observations” by the FDA reported here, the butorphanol and ketamine were named in the Sept. 4 “distributor level” recall.

    I do know that the veterinarian-level recall of Dec. 22 that was expanded on Dec. 29 was initiated, and this whole thing became public, because of reports of five cat deaths that may have been associated with the recalled ketamine. But at this time we don’t know what happened to those cats, either.

    Comment by Christie Keith — January 15, 2010 @ 11:35 am

  26. Sharon, your comment above: “I recued the cat who died last week. I can’t help but think that he would still be alive if I hadn’t. He was supposed to go to a barn home after a few days of recuperation.”

    Certainly understand how you’re feeling. I too am still haunted by “what if” scenarios. If I had taken Zia to a different vet on a different day, etc. Same vet cleaned our other kitty’s teeth and extracted a tooth several months before with no problem. My dear husband has told me repeatedly “you did the best you could; you were trying to take care of him” helps some. We still miss terribly our little Zia, a black rescue kitty with the sunniest and funniest personality you can imagine.

    Comment by Cathy — January 16, 2010 @ 8:30 am

  27. Cathy, I’m glad your Zia had so much love even though it was just for a short time. It’s so difficult lose an animal who has become part of the family, particularly one so young. Zia will be with you always and will be waiting to see you again when it’s time. I know both of us were trying to do the responsible thing. And I take some consolation from knowing the dead kitty had someone who cared about him.

    I did call the FDA and am still playing phone tag with a lady there. I want to see if there is a way to compare the necropsies of some of the animals whose deaths are linked to Teva ketamine. If I can get the FDA to do the comparison and anyone wants to share their info with the gov’t, please email me at savemercycats@gmail.com. There are a lot of “ifs” there, but I’d like to prevent any more losses if possible. I’m not sure what else I can do.

    Comment by Sharon Hancock — January 20, 2010 @ 10:43 am

  28. The necropsy on the rescued black cat came back. The probable cause of death was an idiosyncratic reaction to anesthetic. There is no way to tell if it was the ketamine or if he would have had a reaction to any anesthetic. Pfizer is getting a copy of the report. We’ll see what happens next.

    Comment by Sharon Hancock — January 21, 2010 @ 7:14 pm

  29. Oh my, Sharon, thank you for pursuing this and letting us know. I am so very sorry for your loss. I hope that you are able to find a way to get necropsies compared, like you wrote above. Its all so very sad and my heart goes out to you.

    Comment by Sandi K — January 21, 2010 @ 9:16 pm

  30. Makes me wonder if my healthy sled dog who died while being treated for fight wounds died under anesthesia because of a recalled product.

    Stinky – in Fairbanks, Alaska

    Comment by stinkypup — March 2, 2010 @ 3:33 pm

  31. Hello.
    My Sammy was lightly sedated with ketamine for lab work 3 days ago and since yeterday he is all agitated and I’m worried. He is eating but I’m just not happy with his behaviour. Is ketamine dangerous also in small doses for lab work ???
    joanna.

    Comment by joanna — December 17, 2010 @ 9:48 pm

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