US paracetamol alert
August 6, 2013
THE US Food and Drug
Administration has issued a
safety alert about paracetamol
(acetaminophen), after a review
of its Adverse Events Reporting
System database found a risk
relating to some rare skin reactions.
The FDA said a warning will be
added to the labels of prescription
drugs containing acetaminophen,
citing an increased risk of Stevens-
Jonson Syndrome, toxic epidermal
necrolysis, and acute generalised
exanthematous pustulosis.
“It is difficult to determine how
frequently serious skin reactions
occur with acetaminophen, due
to the widespread use of the
drug, differences in usage among
individuals, and the long period of
time that the drug has been on the
market.
“However it is likely that these
events occur rarely,” the FDA said,
noting that NSAIDs also carry the
risk of serious skin reactions which
is already listed on their labels.
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