EMA codeine restrictions
June 17, 2013
THE European Medicines Agency
has recommended changes to
address safety concerns about
the use of codeine in children,
including not using the drug at all in
those who undergo surgery for the
removal of tonsils or adenoids.
The EMA’s Pharmacovigilance Risk
Assessment Committee (PRAC) has
also recommended that codeine
should not be used in people of
any age who are known to be
“ultra-rapid metabolisers,” nor in
breastfeeding mothers.
“Having assessed all of the
available data, the PRAC noted
that the pharmacokinetic profile of
codeine has been studied in adults
but very limited information is
available in children.
“In addition the limited data on
the effectiveness of codeine as a
pain relief in children suggest that
the effect of codeine on pain is not
significantly better than non-opioid
painkillers such as paracetamol or
ibuprofen,” a statement said.
The PRAC has recommended
that codeine containing medicines
should not be used at all in children
aged under 12, and in those under
18 should not be used after tonsil
or adenoid surgery because these
patients are more susceptible to
respiratory problems.
MEANWHILE the PRAC meeting
has also recommended a series
of cardiovascular precautions in
relation to diclofenac, similar to
those already in place for selective
COX-2 inhibitors.
Patients who have serious
underlying heart or circulatory
conditions should not use
diclofenac at all, the committee
said, while those with key risk
factors such as high blood pressure
or cholesterol should only use it
after careful consideration.
AND the committee also
recommended restrictions on
oral flurpitine medications and
suppositories, saying they should
only be used to treat acute pain
in adults who cannot use other
painkillers, and that treatment
should not exceed two weeks.
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