European Union
Regulator agency European Medicines Agency’s (EMA) Pharmacovigilance Risk
Assessment Committee (PRAC) has recommended that modified- or prolonged-release form of popular painkiller paracetamol should be removed from market.
The
recommendation was based on results of a literature review that found out that
these medicines behave in a complex way in cases of overdosing, and the amount
of drug release cannot be predicted. The complex pharmacokinetics in cases of
overdosing might result in severe liver damage or death.
The review was conducted
following a request by Swedish medicines authority, the Medical Products
Agency, which had noted problems in managing overdose with such a product since
marketing approval.
"Experience
has shown that in overdose (particularly at high doses), because of the way the
paracetamol in modified-release products is released in the body, the usual
treatment procedures developed for immediate-release products are not
appropriate," the EMA said in the news release.
The matter
is much more complicated if the product also contains Tramadol, because of the
additional effect of overdosing with Tramadol too.
This is of
particular concern in cases when the physician is unaware that modified release
paracetamol has been taken, which affects decisions such as when and for how
long to give an antidote.
The PRAC
committee could not identify means to reduce the harm to patients or design a
standard and feasible protocol to manage overdoing, that could be easily adapted
across whole of European Union. The committee finally concluded that the risk involved
with overdosing outweighs the benefits offered by modified or extended release
preparations.
The Committee
therefore recommended that, “The marketing of modified-release paracetamol
medicines should be suspended. Immediate-release paracetamol products, which
are not affected by this review, will continue to be available as before.”
The PRAC
recommendations will be sent to the Co-ordination Group for Mutual Recognition
and Decentralised Procedures–Human (CMDh), which will review the matter and release
a position statement on the issue.
Full text of
EMA statement.
