As
a general rule, over-the-counter drugs have to be used primarily to treat a
condition that does not require the direct supervision of a doctor and must be
proven to be reasonably safe and well-tolerated. OTC drugs are usually also
required to have little or no abuse potential, although in some areas drugs
such as codeine are available OTC (usually in strictly limited formulations or
requiring paperwork or identification to be submitted during purchase). One of
the oldest OTC drugs is aspirin.
Over
time, often 3–5 years, drugs that prove themselves safe and appropriate as
prescription medicines may be switched from prescription to OTC. An example of
this is diphenhydramine (Benadryl), which once required a prescription but now
is available OTC nearly everywhere. Diphenhydramine is an anti-histamine. More
recent examples are cimetidine and loratadine in the United States, and
ibuprofen (Herron Blue/Nurofen) in Australia.
It
is somewhat unusual for an OTC drug to be withdrawn from the market as a result
of safety concerns, rather than market forces, though it does happen
occasionally, phenylpropanolamine is one such example, after it was removed
from sale in the United States over concern regarding strokes in young women.
Ranbaxy is the Best example of this type of case.
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