From a legal point of view? None. From a moral? Not so simple. A lot of drugs are prescription only in the US for really no reason whatsoever.
Two examples are Nystatin and Mebendazole.
I even emailed the FDA about Nystatin and they said that to become OTC it would need a sponsor, which is a stupid reason to leave them prescription only.
You have to remember that not everyone follows directions or uses medications correctly. I don't blame the FDA for not making a drug OTC unless they can prove it will be used safely.
For Nystatin: Does your baby have a rash that looks like raised red dots?
For Mebendazole: Did you drink or come in contact with potentially infected water?
There are plenty of OTC drugs with far more complicated symptoms. It's really completely arbitrary - or more accurately, it's driven by companies wanting to expand their market into OTC (as soon as it goes off patent) rather than anything actually medical.
Take Nexium for example: It was prescription only (and very expensive) till the patent ended. The day the patent expired it turned OTC.
How does that make any sense?
And what would you use instead of nystatin - a broad spectrum antifungal?
Mebendazole is OTC in almost all countries except the US - it's even given routinely without evidence of infection.
There's also terbinafine which works better than the 3 you listead (but more expensive).
Kind of a severe side effect, no?
Nexium was available OTC right after the patent expired because the company that made it went through the OTC approval pathway. It was actually a sales strategy because plenty of people will buy brand name OTC drugs where if the got an Rx most pharmacies require the generic be provided.
As does Acetaminophen (Paracetamol), Ibuprofen, and Metronidazole and those are OTC.
Plus there are many OTC drugs with far worse potential side effects.
Correct but those are "grandfathered" drugs so they don't count.
>Metronidazole
Doesn't look like its OTC except for cats and dogs.
>far worse potential side effects.
Have you looked at http://en.wikipedia.org/wiki/Stevens%E2%80%93Johnson_syndrom... ?
As I'm sure you know there are tons of other medications that can cause that too not just "grandfathered" ones, but it's extremely rare. It's not why those drugs are not OTC. I even asked the FDA - it's about money, and nothing else (like Nexium).
> Doesn't look like its OTC except for cats and dogs.
My mistake. But there are other azole's that are OTC.
> Have you looked at
I did, it was a poor choice of wording - I meant worse as in likelihood * harm.