EMA Rienso review
July 14, 2014
THE European Medicines
Agency’s Pharmacovigilance Risk
Assessment Committee (PRAC)
has finished its review of Rienso
(fermoxytol), used to treat anaemia
in patients with long term kidney
disease, concluding that the
benefits outweighed the risks.
PRAC said it looked at recent
reports of serious hypersensitivity
reactions with the medicine and
that to better manage the risks of
such reactions, it recommended
that it be given by infusion over
at least 15 minutes, instead of by
injection, and that it should be
contraindicated in patients with any
known history of drug allergy.
The Committee also completed
an European Union-wide review
of bromocriptine-containing
medicines for preventing or
suppressing lactation.
The Committee recommended
that the medicines only be used
for this purpose when there are
compelling reasons for stopping
lactation, since an association
with rare but potentially serious
cardiovascular, neurological and
psychiatric side effects could not be
ruled out.
To read the other PRAC review
conclusions, CLICK HERE.
MEANWHILE the European
Medicines Agency has
recommended 39 medicines
for human use for marketing
authorisation in the first half of this
year, compared with 44 in the first
half of 2013 and 33 in 2012.
CLICK HERE for more.
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