EMA warns on beta-agonists
September 9, 2013
THE European Medicines
Agency’s Pharmacovigilance Risk
Assessment Committee (PRAC) has
recommended that short-acting
beta-agonists should no longer be
used in oral or suppository forms in
obstetric indications.
The medications have been used
for suppressing premature labour
or excessive labour contractions,
but the committee says that known
risks of cardiovascular side effects
with high doses outweigh the
benefits.
However injectable forms of
the medicines should remain
authorised for short term obstetric
use under specific conditions, the
Committee concluded.
At its most recent meeting the
PRAC also initiated a new review
procedure for bromocriptinecontaining
medicines when used
orally for preventing or suppressing
lactation in women following
childirth.
“The PRAC will assess whether
the benefits of these medicines
outweigh the risk of rare but
potentially serious (including
fatal) cardiovascular, enurological
and psychiatric side effects,” a
communiqué from the meeting said.
MEANWHILE the Committee also
recommended the suspension of
the marketing authorisation of
Numeta G13%E, an intravenous
nutrition preparation given to
premature babies.
The PRAC said it was making
the move because of a risk of
hypermagnesaemia, with the
product requiring reformulation.
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