What happened to those pain-killing ear drops?

The Pediatric Insider

© 2017 Roy Benaroch, MD

MJ wrote in about her daughter. In the past, she used to use a prescription drop called Auralgan (benzocaine plus antipyrine) for ear pain, but it’s been taken off the market. What happened to it? Was it unsafe? Can she start buying it from Canada? What other options are there?

The FDA got tough on Auralgan and several other similar ear drops – AB Otic, Aurodex, Auroto, and other brands – in 2015. To my knowledge, there wasn’t any specific incident or allegation that these products caused any problems. But they’ve never been shown to be safe, and they’ve never been shown to be effective.

For many years these and other older “grandfathered” drugs were cheerfully sold alongside other prescriptions. But all new drug applications submitted to the FDA must include proof of both safety and effectiveness – that’s been the law since 1938, though what’s passed for “proof” has varied. Many older drugs, like these ear drops, slipped though when things were less stringent. But the FDA has always had the right to ask for more proof from the manufacturers.

I don’t really know why these drops got the FDA’s attention. It is true that there’s never been any proof of effectiveness. A German study cited in the non-discontinued products’ insert showed that children given Auralgan for earache did improve – but they didn’t compare the responses with a placebo, and we know that ear aches get better on their own, anyway. There was also a study from Pittsburgh in 1997 – the authors say they showed that topical Auralgan was “likely to provide additional relief” when given along with acetaminophen. But their study showed no statistical difference in pain scores at 3 of the 4 time periods, meaning that Auralgan was equivalent to their placebo (olive oil drops.)

There’s also no science reason to even think these drops would work. The two ingredients, benzocaine and antipyrine, are not effective when applied to the skin – they only work when injected or swallowed. Benzocaine has some activity when rubbed onto a mucus membrane, like on your tongue or gums, but that’s not what’s inside your ears. And: it makes absolutely no sense to use these to treat middle ear pain (like an ear infection, or the pain you get in an airplane), because drops in your ear canal don’t get into your middle ear. That’s like treating stomach pain by pulling on a finger. OK, bad example (ref: grandpa). Anyway, you get the idea.

Real Drugs are only supposed to be marketed in the USA with FDA approval, which requires proof of safety, effectiveness, and quality control manufacturing standards. For ear pain, if you want to stick with a Real Drug, acetaminophen is a pretty good choice. MJ asked about buying Auralgan from Canada – it looks like it’s still on the market up there. I found one place selling it for $142. That’s one expensive placebo.

Or, MJ could wander outside of the realm of Real Drugs. The 1997 study used olive oil as a placebo, and that’s safe – and you could use the leftovers in a salad. Or you could look in the alt-med, “alternative medicine” section of the drug store – there are ear drops there, but they’re not FDA regulated, so purveyors can sell whatever they’d like. You don’t know what you’re getting in those bottles, and there’s no reason to think they’d work any better than olive oil, pickle brine, or ranch dressing.

 

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12 Comments on “What happened to those pain-killing ear drops?”

  1. Debby Corscadden Says:

    Anecdote alert. As a child of two chain smokers I experienced multiple ear infections and perforations. Auralgan was my only relief other than ASA (it was the late 60s) and I remember that blue bottle fondly. I had my last ear infection in my mid 20s and Tylenol 3 hardly touched it so I sent my husband to find the ear drops in “the blue bottle”. Maybe it was a placebo but it gave me almost instant relief. Would the tympanic membrane be similar to a mucous membrane? Looked at my local pharmacy typically cost is $11.50 CND.

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  2. Debby Corscadden Says:

    I guess there is an study looking at this https://clinicaltrials.gov/ct2/show/NCT03116737

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  3. Dr. Roy Says:

    It looks like they’re still recruiting, though the original description says they’d be done with the study now. It’s also for benzocaine alone, not benzocaine/antipyrine.

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  4. Karen S Denson Says:

    Auralgan and the generic both worked!! I’m 61 years old and have used they on ME in the past, I had Strep Throat with referred ear pain…the warmth these ear drops provided was WONDERFUL!! & eased the pain of my Strep Throat. BRING THEM BACK, PLEASE??

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  5. mka Says:

    I am 56 yrs old currently have a dble ear infection (apparently a bad one) My rt ear is hurting horrible, nothing helping. In the past I too used benzocaine drops with relief. I am shocked they are no longer available. I might add I’m a nurse as well, please bring those gtts back!!

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  6. Jan Stephens Says:

    I am 56 years old and have had ear infections all my life. I few years ago I asked for those ear drops but wasn’t given them was given oral medication instead. A few months ago another ear infection this time I wasn’t given anything for it. It will get a little better but then come back. I have lost some of my hearing because of this. Three days ago along with the ear ache I get a sore throat I went to the doctor yesterday to find out I have strep throat and both my ears are a mess. My new doctor tells me that there isn’t any more ear drops that a antibiotic and a steroid will have to help the ears. Because the FDA thinks they don’t help and have taken them off the market I have lost some of my hearing. They did help. I am on a opioid for back pain and it hardly touches the pain in my right ear. If I had that 120 dollars I would be glad to send it to Canada to get those ear drops. The people out there who have that chronic ear need those drops. Please find a way to bring those back before I go deaf

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  7. Dawn Corra Says:

    They work amazingly well… all if my kids,when quit crying within minutes of using them and even when they were older they said it stopped the pain comepletely.

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  8. Julie Says:

    The tone of this article is offensively skeptical of the effectiveness of these ear drops. Earaches are excruciating! These drops worked so well on me as well as my son. I’m so bummed that they are no longer available. I’m sitting here in horrible pain wanting those drops to help alleviate it and no, Olive oil won’t help!
    For those of you who came looking for the drops, the only thing that has helped me the past two nights with this pain is a super hot compress. The compress cooled too quickly so I filled a CamelBak bladder with super hot water and slept with that draped on my ear and meck. Good luck to you my fellow sufferers.

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  9. Dr. Roy Says:

    “Offensively skeptical”. What a puzzling phrase. I summarized the entirety of the medical literature on this product, all of it. There is no evidence that it works. These are just the facts as they are, with no intention to offend.

    I agree, a warm compress is a very good idea. Maybe be careful, though, with a hot compress on a child. Thanks for your comment.

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  10. A collins Says:

    We use a hot pad on low so it does not get too hot try this it may work for you good luck.

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  11. Dana Atwell Says:

    Are you serious? What about asking the people who used them? Do you think that they are all lying? Tell that to the screaming babies who stop screaming when these are administered. I can tell you that they do work. Almost instantaneously. People used them for years with NO issues but because there wasn’t 9 million dollars spent on studying why there were no issues now no one can have them-even If they don’t care about supposed “risks”. Common sense is dead.

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  12. Justin Says:

    AB otic was a DESI drug. This means it marketed and used before our government required a New Drug Application which does require a proof of safety and efficacy. It does not mean the drug was not safe or not effective. Unfortunately that proof costs a pretty penny with conducting current trials and the like. Older drugs have the opportunity to do studies in today’s market or pull their product altogether. I am a pharmacist and this drug works. It is unfortunate that many other safe and effective drugs fell off in this same manner. This was all driven by money. I agree the tone of this article suggests a bias when knowledge on the topic was limited.

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