EMA kills meprobamate
January 25, 2012
MEPROBAMATE-containing
medicines in the European Union
are facing an uncertain future after
the European Medicines Agency
announced a blanket
suspension of the drugs’ marketing
approval.
Meprobamate is a sedative
medicine used to treat the
symptoms of anxiety and related
conditions, including anxiety
states, alcohol withdrawal,
migraine attacks, digestive
disorders, muscle tension or
cramps, and insomnia.
The recommendation follows a
decision by French authorities in
July last year, to suspend
authorisations for oral
meprobamate-containing
medicines because of serious side
effects seen with these medicines.
The new EMA suspension is the
result of a review of oral
meprobamate-containing
medicines following the French
decision, which found that the
drug’s risks outweighed its
benefits, particularly the risk of
serious side effects affecting the
nervous system.
As part of the EMA review the
Agency’s Committee for Medicinal
Products for Human Use looked at
all available data on the safety and
efficacy of these medicines,
including data from studies, postmarketing
surveillance and the
published literature, as well as
from poison control centres on
cases of poisoning with
meprobamate.
The review found that there was
a risk of serious and potentially
fatal side effects, such as coma, in
patients taking meprobamatecontaining
medicines under
normal conditions of use.
The Committee considered that
these risks were increased due to
the danger of unintentional
overdose because of the small
difference between the treating
dose and the dose that can harm
patients, including elderly people.
Reviewers also noted the drug’s
addictive qualities, and the fact
that these can lead to serious and
sometimes fatal side effects if
treatment is stopped abruptly
after long time usage.
The subsequent EMA suspension
notice covers all marketing
authorisations for oral
meprobamate-containing
medicines in European nations.
Rather than an immediate stop,
the EMA has recommended that
the drugs should be withdrawn
from the market over 15 months.
The above article was sent to subscribers in Pharmacy Daily's issue from 25 Jan 12To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 25 Jan 12
