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Dr. Coates is a veterinarian based in the other “Sunshine State” – that's Colorado to the rest of you – where she lives and plays with a varied range of animals. She shares her professional and personal experiences, Monday through Friday, here on petMD's blog, the Fully Vetted. Log in for your daily dose of her insight and wisdom.

 

Potassium Bromide – Not FDA Approved

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June 04, 2012 / (8) comments


Traditionally, treatment for idiopathic epilepsy in dogs (and in cats, although the disease is much rarer in this species) involves the use of the medication phenobarbital (PB). If seizure control is not adequate and/or side effects are unacceptable with PB use, the drug potassium bromide (KBr) is added and the PB dose is reduced or eliminated over time. This is such a standard protocol that I had stopped giving much thought to the medications themselves. After all, they’ve been used for decades (over a century in the case of KBr) in both human and veterinary medicine.

 

So, when I saw the article "A systematic review of the safety of potassium bromide in dogs" in the Journal of the American Veterinary Medical Association (JAVMA. 2012; 240:705-715), I wondered what the point of the research was — we already know the potential side effects of KBr therapy and how to deal with them if they arise.

It turns out that I was only partially right. Yes, most veterinarians are very familiar with KBr, and scientific studies have been published that support its safety and efficacy. However, potassium bromide is not actually approved by the U.S. Food and Drug Administration (FDA) to treat seizures in either animals or people (neither is phenobarbital, for that matter). These drugs are still legal to use, but no drug company has submitted information about their safety and efficacy or whether they can be consistently manufactured in accordance with the FDA’s quality standards.

In an attempt to determine how safe potassium bromide actually is for dogs, researchers reviewed 111 published studies regarding the drug’s use. To paraphrase the FDA report on the JAVMA article:

 

  • Neurologic — Sedation, ataxia, and behavioral changes were the most common adverse events associated with KBr use. These signs are reversible and usually resolve within several days by lowering the phenobarbital dose (if the dog is on both KBr and PB) or within hours by giving intravenous saline.

  • Gastrointestinal — Vomiting, transient diarrhea, and bloody feces. These adverse gastrointestinal (GI) signs usually resolve without needing to stop KBr therapy. Giving the drug with food may lessen GI irritation.

  • Gastrointestinal — A ravenous appetite (i.e., polyphagia) or loss of appetite. Both signs are commonly reported with KBr and PB. The authors recommend monitoring eating patterns and weight in dogs on potassium bromide, especially "because polyphagia can lead to garbage ingestion and other complications."

  • Pancreatitis — The authors found insufficient evidence to link KBr to a higher risk of pancreatitis. Pancreatitis may be a result of polyphagia and garbage ingestion rather than the drug itself.

  • Reproductive — A variety of reproductive effects have been reported in other species. The authors did not find any studies in the published literature that evaluated the effects of KBr in reproductively active dogs.

  • Endocrine — Although the thyroid gland is a target organ at higher doses of potassium bromide in rats and people, the drug does not seem to affect thyroid function in dogs. However, because of the small number of dog studies that looked at the effect of potassium bromide on thyroid function, the authors recommend monitoring thyroid hormone levels in dogs on KBr therapy.

  • Dermatologic — Skin reactions are rare in dogs on potassium bromide. While uncommon, the skin lesions described areas of white discoloration on the skin, pimple-like lesions, and itchiness.

  • Respiratory — Respiratory disease in dogs from potassium bromide use is unlikely to occur.

 

This is great information. Owners and veterinarians need to remember that current formulations of KBr are not FDA approved and should be on the lookout for (and report) unusual cases of adverse reactions and/or lack of efficacy.

 

 

Dr. Jennifer Coates

 

 

Image: Nancy Clemons / via Shutterstock

 

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COMMENTS (8)
1
Off-Label Use
by TheOldBroad on 06/04/2012 07:12am

"However, potassium bromide is not actually approved by the U.S. Food and Drug Administration (FDA) to treat seizures in either animals or people (neither is phenobarbital, for that matter)."

Might the reason be that these drugs have been used off-label for so long that the drug companies don't see a need to go to the expense of going through the FDA approval procedure?

2
FDA
by hmmm on 06/04/2012 08:07am

There are many drugs we use as veterinarians that we do not have FDA approval on. Why not be straight with your readers and list them all? Bromide has saved lives in my hands - and no drug is without side effects.

3
your opinions please
by Michelle Diamond on 06/04/2012 11:14am

My best friend owns a three year old aussie mix who has been having seizures for approx a year now. Her vet put the dog on Pb also which has mostly controled the seizures, but the side effects of Pb is starting to show. The poor dog is having bladder control issues now. The family took the dog in to the vet to verify that there was not a bladder infection. So now they are waiting on blood work results to see what is going on. In your opinion, do you think this dog should try potassium bromide treatments? Do you think the side effects are less, the same, or worse then Pb? Any information you can give me on this would be greatly appreciated. Thank you :)

by Dr. Jennifer Coates on 06/05/2012 01:35pm

I can't comment on this dog's particular situation, but in my hands, it seems like the side-effects of KBr are milder than those associated with PB. It would certainly be worth asking the vet involved in the dog's care whether he or she feels that KBr would be worth a try.

4
SKIN ALLERGY SIDE EFFECTS
by Erica Alexis Diamond on 06/04/2012 09:37pm

My dog definitely has the skin allergy side effect from potassium bromide but must take it (in fact, he must take phenobarbitol and postassium bromide together, has never been able to transition of the pheno). My question is this, what can be done about the itching and skin lesions besides prednisone shots as he suffers a lot with these symptoms.

5
Opinions Please
by Erica Alexis Diamond on 06/04/2012 09:45pm

Our dog has been taking potassium bromide for some time and I can't remember exactly what we and our vet figured out -- if it's the bromide or the combo of that with the phenobarbitol that makes him extra thirsty, so he drinks like a little camel. More pee = having to go out more often. We had an issue with bladder control issues ourselves for a while and also at first wondered if he had a bladder infection (he actually did once) but for us it mainly turned out that his excessive thirst meant he couldn't hold it as long. Especially if it was warm inside/outside the house which meant he would drink even more! Hope this helps.

P.S. (Also if the seizure is bad enough and his bladder is full he will pee).

by Dr. Jennifer Coates on 06/05/2012 01:42pm

If the itching is truly due to the KBr (I've seen reports of this but it's pretty rare) and not another problem like atopy, you could ask your vet whether trying one of the newer "human" seizure control medications is called for. I wrote a post on these a while back. Here's the link.

http://www.petmd.com/blogs/fullyvetted/2011/nov/new_options_for_seizure_control

6
by telogen effluvium on 06/04/2012 11:16pm

These side effects of KBr have been known for years, given that it has been in use since the 1800's and was the first drug to be produced in a pure form. The drug is not FDA approved because it was grandfathered (so was aspirin).

I think this article is written in a bit of a misleading way, as it can be interpreted that KBr is a new, untested drug, when in fact it has a very long history (over a century) of safe use. There is no reason why a drug company would invest the time and money in drug trials on "current formulations" when today's formulation is the same as it was 1857 - it's a ionic salt of potassium and bromide.

In my opinion, it's important that owners are aware that while giving potassium bromide, the sodium chloride salt content of the food must be kept stable (no sudden changes in diet or drinking seawater at the beach), because that can greatly affect the excretion of the potassium salt. In addition, KBr causes severe respiratory issues in cats and is therefore never used in that species. In dogs, however, it is a safe and generally well-tolerated anti-epileptic, either as a adjunct to other drugs or monotherapy.

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About fully vetted

Jennifer Coates, DVM

Photo of Dr Coates

Image credit: Jim Piraino

...graduated with honors from the Virginia-Maryland Regional College of Veterinary Medicine in 1999. In the years since, she has practiced veterinary medicine in Virginia, Wyoming, and Colorado. She is the author of several books about veterinary medicine and animal care, including the Dictionary of Veterinary Terms: Vet-Speak Deciphered for the Non-Veterinarian. Dr. Coates also writes short stories that focus on the strength and importance of the human-animal bond, and freelance articles relating to a variety of animal care and veterinary topics. Dr. Coates lives in Fort Collins, Colorado with her husband, daughter, and various species of pets.

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