WC500185968

Background
Adalimumab is a selective immunosuppressive agent indicated for the treatment of rheumatoid
arthritis, juvenile idiopathic arthritis, Crohn's disease, axial spondyloarthritis, ankylosing spondylitis,
psoriatic arthritis, psoriasis and ulcerative colitis.
The exposure for Humira a centrally authorised medicine containing adalimumab, is estimated to have
been more than 2.9 million patient-years worldwide in the post-marketing setting, in the period from
first authorisation in 2003 up to December 2013.
During routine signal detection activities, a signal of convulsions was identified by the UK, based on 35
cases from a national review. The Rapporteur confirmed that the signal needed initial analysis and
prioritisation by the PRAC.
Discussion
The PRAC discussed the information on the cases of convulsions and requested a cumulative review of
all reported cases of convulsions (retrieved at the level of the high level group term (HLGT) ‘seizures’),
in association with adalimumab with a view to amend the product information for adalimumabcontaining
medicines.
Summary of recommendation(s)
The MAH for Humira (adalimumab) should submit to the EMA, within 60 days, a cumulative
review of all reported cases of convulsions, in association with adalimumab. The review should
include reports from post-marketing and clinical trials. Cases with known history of epilepsy
should also be provided and medically confirmed convulsions (not necessarily witnessed, but
regarded as at least probable by healthcare professionals, e.g. by observation of post-ictal
confusion or electroencephalogram changes) should be analysed separately. If applicable, the
MAH should make a proposal for a change to the product information and/or to the risk
management plan.
A 60-day timetable was recommended for the assessment of this review leading to a further
PRAC recommendation.
4.2.2. Amiodarone (NAP)
Signal of pancreatitis
Regulatory details:
PRAC Rapporteur: Menno van der Elst (NL)
Administrative details:
EPITT 18216 – New signal
MAH(s): Sanofi
Lead MS: NL
Background
Amiodarone is an antiarrhythmic agent used in the treatment of severe rhythm disorders including
tachyarrhythmia, atrial flutter and fibrillation.
The worldwide exposure for medicines containing amiodarone is estimated to have been very wide,
since the medicine has been extensively prescribed since its first authorisation in the mid-1960s.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 16/89