Why aren't there medicated lollipops available OTC to relieve mouth sores in children with hand, foot, and mouth disease?

[Asher88]

I'm a pharmacist with very little retail experience, so please bear with me. I have a two-year-old who attends daycare, and HFMD is very common, so I'm wondering why there isn't an OTC medicated lollipop. I believe there are compounded products, such as tetracaine lollipops but require RX and compounding. There are OTC throat lozenges but typically not used for the same indication and do not help. Is it because certain ingredients, such as benzocaine, can be harmful to children? Is there a reason why this type of marketed product does not exist? Can someone ELI5?

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[KidPharmD]

Oral anesthetics have historically had a real problem with adverse effects from misuse in children. Oral absorption of anesthetics can be a lot more significant than people think and toxicity can be severe. Baby Orajel no longer contains any benzocaine and even menthol cough drops aren't labeled for under 5 or 6. We still get the occasional case of toxicity from parents using orajel with benzocaine for teething.

 

[Rockinacoustic]

One of the cooler tox cases I've seen was a 70 something year old with Methemoglobinemia from using Hurricaine spray q1h for his sore throat

 

[RXDOC1986]

I was a pediatric ICU pharmacist for over 10 years.
True, oral anesthetics are a serious problem with misuse or over use. Especially with children.

The reason any drug is classified as Legend vs OTC is not due to safety/efficacy but the manufacturers preference. The FDA will go along with whatever the Drug Company decides.

 

[Dred Pirate]

One of the cooler tox cases I've seen was a 70 something year old with Methemoglobinemia from using Hurricaine spray q1h for his sore throat

that is why we removed it from formulary probably a decade ago

 

[panicatthepharmacy]

They still make Actiq?

 

[Rockinacoustic]

that is why we removed it from formulary probably a decade ago

We have the unit dose packs.

Said case was from a SNF where they left the bottle bedside and days later sent him in for fatigue and dyspnea. The giveaway was when we went to draw labs and the tubes were brown.

 

[Dred Pirate]

They still make Actiq?

I was gonna mention this - but didn't want somebody to take my medical advice off the internet -

PS - for anybody reading this - this is NOT a good idea