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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3 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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