WC500185968

During routine signal detection activities, a signal of pancreatitis was identified by Spain, based on 8
cases retrieved in the Spanish safety database. The Netherlands confirmed that the signal needed
initial analysis and prioritisation by the PRAC.
Discussion
The PRAC discussed the information on the cases of pancreatitis and requested a cumulative review of
all cases concerning pancreatitis associated with amiodarone with a view to amend the product
information for amiodarone-containing medicines.
The PRAC appointed Menno van der Elst (NL) as Rapporteur for the signal.
Summary of recommendation(s)
The MAH for the innovator medicinal product containing amiodarone (Sanofi) should submit to
the EMA, within 60 days, a cumulative review of all cases concerning pancreatitis associated
with amiodarone, both from clinical trials and spontaneous sources in order to further evaluate
this signal. Also, the MAH should provide a discussion of relevant non-clinical data and
scientific literature. Based on the review, the MAH should also discuss the need for an update
of the product information and the necessity for any additional pharmacovigilance activities.
A 60-day timetable was recommended for the assessment of this review leading to a further
PRAC recommendation.
4.2.3. Donepezil (NAP)
Signal of rhabdomyolysis
Regulatory details:
PRAC Rapporteur: Julie Williams (UK)
Administrative details:
EPITT 18261 – New signal
MAH(s): Eisai Ltd.
Lead MS: UK
Background
Donepezil is a specific and reversible inhibitor of acetylcholinesterase indicated for the symptomatic
treatment of mild to moderately severe Alzheimer's dementia.
The exposure for donepezil is estimated to have been more than 20,000,000 patient years worldwide,
in the period from first authorisation in 1997 up to the latest PSUR (DLP: 25/11/2011).
During routine signal detection activities and following the issue of a new warning on the risk of
rhabdomyolysis by Health Canada, a signal of rhabdomyolysis was identified by the UK, based on 88
cases retrieved from EudraVigilance. The UK confirmed that the signal needed initial analysis and
prioritisation by the PRAC.
Discussion
The PRAC discussed the information on the cases of rhabdomyolysis and considered that this signal
merited further review. Therefore, the PRAC requested a cumulative review of all cases of
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 17/89