Oti pak E and Deafness

[ranedrops]

Daisy was treated for ear infections on 1/9/18 with Oti pak E. We were told she would lose some of her hearing until the medication dissolved which should be approximately 2 weeks. She became stone deaf. We returned to the vet at 2 weeks and her ear infections were cleared but her hearing had not returned. The vet said she still had about 1/2 of the medication in her canals but she wanted it to continue to dissolve since Daisy was having vestibular (balance) issues (which are a whole other subject), which could have been caused by the ear infections. Another week later she is still completely deaf. Returned to the vet and she had her ears flushed out. We are now at almost a month and her hearing still hasn't returned.

I've read about dogs that have permanent hearing loss after treating the infections and I am really hoping this is not the case.

Has anyone had any problems like this after treating ear infections and has the hearing eventually returned?

[Lovetodream88]

My one girl did not react well to that stuff but neither of my girls that have used have gone deaf that’s scary. What does the vet think?

[ranedrops]

The vet is hoping it will come back. She doesn't know why it hasn't yet.

[pstinard]

I recall this happening to someone else on Yorkietalk, but I can't find the other thread. (Either that, or I read about it happening somewhere else.) I feel really bad about this because we expect vets to make the best decisions for our dogs, and perhaps they are, but then something like this happens. I did some reading about oti-pak e and found out that permanent deafness is a rare, but possible, side effect of antibiotics used to clear up ear infections. For oti-pak, I read that temporary deafness may last up to six weeks. If it doesn't clear up by then, I'm afraid that it might be permanent. Ask your vet to look this up for you and let us know what they say.

Our Bella was treated for an ear yeast infection when she was a puppy, but the vet had us use oily eardrops, not oti pak, and the infection cleared up without any side effects. If she ever gets another ear infection, I'll be extra-cautious about what they put in her ears and I'll ask a lot more questions. And I'll avoid oti pak e like the plague. That's all we can do .

Thanks for telling us about this, and I pray that Daisy gets her hearing back. Keep us posted!

[ranedrops]

Yes, I read too that the usual is 2 weeks to get hearing back but some may take up to 6 weeks. I'm really praying her hearing comes back. She's 13 now and her eyesight isn't that great and to have her hearing taken away is just heartbreaking.

We went with the Otipak because she was having vestibular episodes in which she was walking in circles, her head was twitching, body shaking and her eyes darting back and forth. All of which could be cause by ear infections or in worst case a brain tumor. We were hoping it was the ear infections and wanted to clear them out totally so we went with what was a supposed to be a sure treatment to clear the infection. If I had know that the possibility of was there of her losing her hearing, I never would have done Otipak.

[Lovetodream88]

Was she having any hearing issues before the oti pack?

[ranedrops]

No hearing issues before otipak.

[pstinard]

Here is the thread that I was trying to find. It was Taylor's dog: http://www.yorkietalk.com/forums/sic...ack-issue.html

It wasn't exactly the same as Oti-Pack E, but it's similar. From what I've read, permanent deafness is a rare side effect, but your vet should have at least mentioned it as a possible side effect. Oti-Pack E isn't made by a regular pharmaceutical company--it's compounded by a veterinary pharmacy in Phoenix, Arizona and sold to veterinarians: https://www.roadrunnerpharmacy.com/i...l%20EDITED.pdf

[Lovetodream88]

Originally Posted by ranedrops

No hearing issues before otipak.

I’m praying it comes back

[ladyjane]

I won't allow those packs. The problem is that most ear meds do have that side effect. I had it happen years ago with one of my pups from Mometamax. The Gentamycin is what causes it. I don't like the fact that the pack stays in the ear for so long...seems to me it might be stronger?? I don't know...might be an over reaction. I do know my vet doesn't use it as a first line of treatment...it is saved for the dogs who are difficult to treat or who have really bad ears and keep getting infections.

A friend recently had it happen with her poodle with the BNT . She called me crying one morning and I told her to take him to the vet so they could flush the ear. She did and the vet was insisting this doesn't cause hearing loss because there is no Gentamycin in it.. She told him to take it out anyway. He did regain his hearing but it did take about 2 weeks. I thought someone on here also had it happen as Phil said but I cannot remember who it was. I think I read somewhere that the ketoconazole in the BNT can cause it.

Bottom line though, is there is no treatment for it. I do hope Daisy gets her hearing back.

I wish vets would advise people of the side effects....especially with the Mometamax...I just got lucky and figured it out on day three of treatment. He was acting strange and I said something to him and he didn't look at me...I then looked up Mometamax side effects and bang...there it was. I still use that med as it does work but I monitor their hearing closely.

[ranedrops]

Thank you for the info.

[pstinard]

Originally Posted by ladyjane

I won't allow those packs. The problem is that most ear meds do have that side effect. I had it happen years ago with one of my pups from Mometamax. The Gentamycin is what causes it. I don't like the fact that the pack stays in the ear for so long...seems to me it might be stronger?? I don't know...might be an over reaction. I do know my vet doesn't use it as a first line of treatment...it is saved for the dogs who are difficult to treat or who have really bad ears and keep getting infections.

A friend recently had it happen with her poodle with the BNT . She called me crying one morning and I told her to take him to the vet so they could flush the ear. She did and the vet was insisting this doesn't cause hearing loss because there is no Gentamycin in it.. She told him to take it out anyway. He did regain his hearing but it did take about 2 weeks. I thought someone on here also had it happen as Phil said but I cannot remember who it was. I think I read somewhere that the ketoconazole in the BNT can cause it.

Bottom line though, is there is no treatment for it. I do hope Daisy gets her hearing back.

I wish vets would advise people of the side effects....especially with the Mometamax...I just got lucky and figured it out on day three of treatment. He was acting strange and I said something to him and he didn't look at me...I then looked up Mometamax side effects and bang...there it was. I still use that med as it does work but I monitor their hearing closely.

I looked up BNT, and it contains exactly the same ingredients as Oti-Pack E: enrofloxacin to treat bacterial infection, ketoconazole to help prevent fungal growth, and triamcinolone to reduce inflammation, in a lanolin base. Both BNT and Oti-Pack E are manufactured by compounding pharmacies, so they do not have the same type of regulation as products produced by a pharmaceutical company.

If you google BNT and Oti-Pack E, there are many stories of permanent deafness resulting from the use of these products. That could be because people only write about the bad things that happen as a result of using a medicine, but still, the numbers of adverse reactions are large. And the lack of regulation of compounded products might cause warnings about adverse reactions to fall through the cracks. In addition, even if they gave warnings about each individual ingredient in the compounded medicine, drugs sometimes have reactions when used in combination that are unpredictable or unforeseen. Below is a quote from an article about compounded medications and product liability https://www.ncbi.nlm.nih.gov/pubmed/25276868 (portions highlighted for emphasis):

Risk and liabilities of prescribing compounded medications.

Complications resulting from the use of compounded medications have become a troubling trend nationwide. There is a significant potential for patients to suffer serious harm from the use of substandard medications prepared by compounding pharmacies, and the reality of this problem has been demonstrated in several well-publicized incidences of serious medical complications, including patient deaths, that directly resulted from the use of medications prepared at compounding pharmacies. Unlike US Food and Drug Administration (FDA)-approved drugs, compounded products are not required to meet evidentiary standards for establishing safety and efficacy. Moreover, these products are not held to Good Manufacturing Practices, which require regular inspections, quality control testing, and rejection of material not meeting specifications. Physicians, as well as other prescribers, need to be aware that when a patient suffers harm from using a compounded medication, those injured patients may bring negligence and malpractice claims, not only against the pharmacy and the pharmacist responsible for preparing the medication, but also against the prescribing physician and the physician’s practice. Consequently, the best way for physicians to manage professional risk and avoid both litigation and potential negative patient outcomes related to compounded pharmaceuticals is to not use these products if there is an FDA-approved product available. However, if the use of a compounded medication is medically necessary, then physicians should adhere to the FDA guidance concerning traditional compounding. Moreover, it would be prudent for any physician who intends to either resell or participate in the distribution of compounded products beyond the direct treatment of their patients to consider obtaining the appropriate insurance coverage for this activity.

My mission for today will be to collect articles on ototoxicity (the study of medicines that cause toxic reactions to the ears and hearing) and see if I can find out anything more about the possible side effects of these drugs. If I find anything else, I'll post it below.

[ladyjane]

Originally Posted by pstinard

I looked up BNT, and it contains exactly the same ingredients as Oti-Pack E: enrofloxacin to treat bacterial infection, ketoconazole to help prevent fungal growth, and triamcinolone to reduce inflammation, in a lanolin base. Both BNT and Oti-Pack E are manufactured by compounding pharmacies, so they do not have the same type of regulation as products produced by a pharmaceutical company.

If you google BNT and Oti-Pack E, there are many stories of permanent deafness resulting from the use of these products. That could be because people only write about the bad things that happen as a result of using a medicine, but still, the numbers of adverse reactions are large. And the lack of regulation of compounded products might cause warnings about adverse reactions to fall through the cracks. In addition, even if they gave warnings about each individual ingredient in the compounded medicine, drugs sometimes have reactions when used in combination that are unpredictable or unforeseen. Below is a quote from an article about compounded medications and product liability https://www.ncbi.nlm.nih.gov/pubmed/25276868 (portions highlighted for emphasis):



My mission for today will be to collect articles on ototoxicity (the study of medicines that cause toxic reactions to the ears and hearing) and see if I can find out anything more about the possible side effects of these drugs. If I find anything else, I'll post it below.

Thank you Phil!

As to your highlighted sentence, that is exactly what happened with my friend. She texted me while she was at the vet .. he had left the exam room and she was telling me that he said the deafness was NOT from the BNT. I told her to tell him to flush it out anyway and she did. I bet you are right...there are no reports of this hitting the vets' desks. Maybe in time they will have enough reactions that they will put 2 and 2 together...but it is a shame. People SHOULD be advised by someone. Of course it happens often with the newer things....until a bunch of people or animals get sick or die no one does anything.

[pstinard]

There's not much in the literature about the toxicity of ear packs using the ingredients in Oti-Pak E and BNT. Most of the issues are with the use of gentamicin, which is not in these particular products. However, I did find the following warnings about the use of ear packs in general:

(1) If the ear drum is broken, then drugs that would not normally cause deafness can flow into the middle ear and cause deafness:

The most severe signs of ototoxicity become apparent when the ear drum is damaged and the barrier between the external ear canal and middle and inner ear is breached. This allows topical medication to enter the middle ear which can lead to profound damage. It is thus crucially important when deciding on therapy for ear disease that the clinician is able to examine the ear canal and the ear drum effectively. When it is impossible to visualize the tympanum it is safest to assume it is ruptured. If the tympanic membrane is intact then the risks of causing damage to the ear are reduced.

from https://www.cabdirect.org/cabdirect/...0073120055.pdf (OTOTOXICITY – WHAT TO CHOOSE WHEN YOU HAVE TO USE SOMETHING? by Sue Patterson. North American Veterinary Conference, 2007.)

(2) Ear packs can cause toxic substances released by yeast and bacteria to remain in contact with the lining of the ear, causing damage:

Use ear packings of topical drugs cautiously; they maintain cytopathic enzymes in contact with the ear canal longer.

from https://www.cliniciansbrief.com/site...tisExterna.pdf (Otitis Externa, by Louis Gotthelf, DVM, Montgomery, AL)

[ladyjane]

Originally Posted by pstinard

There's not much in the literature about the toxicity of ear packs using the ingredients in Oti-Pak E and BNT. Most of the issues are with the use of gentamicin, which is not in these particular products. However, I did find the following warnings about the use of ear packs in general:

(1) If the ear drum is broken, then drugs that would not normally cause deafness can flow into the middle ear and cause deafness:

from https://www.cabdirect.org/cabdirect/...0073120055.pdf (OTOTOXICITY – WHAT TO CHOOSE WHEN YOU HAVE TO USE SOMETHING? by Sue Patterson. North American Veterinary Conference, 2007.)

(2) Ear packs can cause toxic substances released by yeast and bacteria to remain in contact with the lining of the ear, causing damage:

from https://www.cliniciansbrief.com/site...tisExterna.pdf (Otitis Externa, by Louis Gotthelf, DVM, Montgomery, AL)

I will not be using them. Thanks for all Phil!