FDA rejects cough medicine restrictions
September 16, 2010
THE US Drug Safety and Risk
Management Advisory Committee
for the US Food and Drug
Administration has voted against
restrictions up for consideration
regarding the common over-thecounter
cough medicine ingredient,
dextromethorphan (DMX).
Tasked with evaluating the
potential for DMX abuse and the
pharmaceutical industry’s ability to
prevent and police such
occurrences, the committee
concluded that there was not
enough risk to warrant that there
was not enough risk to warrant
placing the drug under the
Controlled Substances Act.
For the most part, the FDA will
follow the Committee’s advice,
meaning that the majority of
cough medicines sold in the US
will stay available through
supermarkets.
Had the Committee voted to
reschedule the drug, it would have
fallen under category V (pharmacy
only), meaning Americans would
have had to get the majority of their
cough medicines from pharmacies.
Evidence presented to the
Committee included figures which
showed an increase of 72% in the
last four years of the number of
hospitalisations due to DMX
abuse, with 8000 people having to
seek emergency treatment.
The US Consumer Healthcare
Products Association however
argued that many teenagers
considered DMX a “lousy high”
and that it was using this
impression as part of its own
strategy to discourage abuse.
The Association did however ask
the FDA to introduce tighter
controls on the bulk sale of DMX,
and also to introduce age
restrictions, limiting the sale of
DMX cough products to patients
over 18 years old.
“The greatest potential [for
preventing abuse] is in age
limits,”said one US Drug Safety
and Risk Management Advisory
Committee panelist, Professor
Leslie Hendeles.
The FDA enquiry into the US use
of dextromethorphan heard
evidence that restricting its
availability was likely to burden the
US health system with add an
additional four million visits to
general practitioners a year.
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