View Full Version : What makes some Rx drugs become OTC?
I was wondering why some drugs, like Claritin, eventually become ok by the FDA to be over the counter (OTC) drugs. Yet, will we ever see an anti-biotic, like penicillin, become OTC? - Jinx
12-22-2002, 05:12 PM
OTC drugs are those that have been determined to have a benign enough side-effect profile, little enough risk of addiction, and a great enough difference between the effective amount and the toxic amount, that there is little or no danger to the individual or to the public in allowing it to be sold directly to patients. The manufacturer usually submits an application containing studies showing these things, and the regulatory agency (FDA in the U.S.) approves it, rejects it, or asks for further study.
Claritin is unusual in that the manufacturer didn't want it to go OTC, but FDA decided that the policy reasons for going OTC were great enough that they did it over the mfr's objections. The danger from drowsiness caused by OTC antihistamines was greater than anything seen from Claritin.
Antibiotics are dangerous enough in the hands of doctors; there's no way they'll ever go OTC. There'd be poisoned infants and resistant bacteria everywhere.
12-22-2002, 07:05 PM
It also doesn't hurt if you bribe . . . excuse me . . contribute to the campaign or the right people.
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