This thread is prompted by the new Prilosec OTC.
So what prompts the manufacturer to move a drug from the prescription side to OTC, besides revenues? What does the manufacturer have to do to justify to the FDA that a drug should now be OTC? After all, if the drug initially required prescription status, say for potential abuse and safety concerns, how are these alleviated once the drug becomes OTC?
Once the company or the FDA can show it IS safe without a prescription. For instance…Having had allergies I can say, short of a steriod, nothing works better than Benedryl. But the side effects (tiredness etc) are worse than the allergy for me. But Claritan, which is now OTC is actully safer. However it is my experience it doesn’t work as well.
Ibuprofin (sp?)[AKA Advil, Motrin] Naproxen[Aleve], Pepcid AC, Orudis, were all at one time prescribed.
Also I don’t know of any prescribed meds that became OTC that are the same does. For instance a prescription does of ibuprofin is FOUR tablets or the bottle says take ONE (or two if one doesn’t work)
Of course this can lead to self medicating. I found ORUDIS to be the best pain reliever BUT only if I take a prescription dose. For me one pill of ORUDIS is worthless.
Claritan was a classic example also of greed. If the manufacturer can keep it prescription he can make more money. I have actually had a dentist prescribe me MOTRIN. Plain old MOTRIN. I asked why can’t I just take 4 generic ibuprofen and save money. He said “Yeah it’s the same.”
It’s also interesting to see what drugs are OTC in Canada versus the U.S., and the other way around.
I’ll spare you all my usual load of registered trademark symbols that I like so much. 
Claritin, Allegra, Reactine (aka Zyrtec) - all OTC here for at least 10 years, if not longer. (But I agree with Markxxx that when it comes right down to it, nothing works better than Benadryl.)
Codeine - available in Canada OTC (but behind the pharmacist’s counter) in a codeine/acetominophen/caffeine combo - essentially Tylenol 1. You just have to ask, and at picky pharmacies, give you name and address. In the U.S., I believe it’s on a state-by-state basis.
Pseudoephedrine - you don’t have to fill out forms to prove you’re not running a crystal meth lab in your basement.
However… we can’t get Aleve OTC here. It’s still prescription-only, as Anaprox. (I had MsRobyn bring me up two big bottles when she came for Doperéal.)
The acid reflux medicines took a while longer to go OTC here; Prilosec is still prescription-only here, as Losec. (I guess the “Pri” prefix was inappropriate for Canadian consumers. )
And some of the wackier prescription drugs approved by the FDA in the U.S. never even make it past Health Canada. I’ll try and dig up some examples and cites.
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