Quote:
Originally posted by Undertoad
I think some new drugs don't go over the counter early in their lifetime because they are bigger money-makers if Medicare and insurance companies are paying for them.
Plus, I think if something is over the counter it has to have really low toxicity and stuff... you have to be able to survive a huge overdose, in order to be OTC.
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Correct on the first part, not correct on the second. In fact, one HMO is now petitioning the FDA to make Claritin (AND Clarinex, just for good measure) OTC -- usually, the manufacturers have to petition for that. And there's some possibility that the FDA will approve Claritin for OTC use for treating hives. Of course, that means all us allergy sufferers will be able to buy it OTC and use it in a manner contrary to the package directions. Once Claritin goes OTC, the other manufacturers will have to get off their butts and get their protects OTC too, or lose market share big time.
On the second part: Acetominophen (Tylenol), for instance, is pretty deadly in small overdose. Deadly in a nasty way, too -- shuts down your liver and you die a slow and painful death. The difference between lethal overdose and theraputic dose is considered by the FDA, but it isn't an overriding factor.