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provides the best antimicrobial activity and lowest risk of ADRs for skin antisepsis during invasive
procedures in neonates.
The PRAC agreed that it was important to further review the data on the use of chlorhexidine
cutaneous solutions - in preterm and term newborn infants - for disinfection of the skin prior to
invasive medical procedures, including whether the data highlighted particular at risk populations.
Additionally the PRAC agreed that the advice of the Paediatric Committee (PDCO) should be sought on
the matter and a list of questions was adopted to explore with the PDCO the availability of European
guidelines and recommendations regarding skin antisepsis prior to invasive procedure (i.e. central
venous catheterisations) in term and preterm newborn infants.
The PRAC appointed Julie Williams (UK) as Rapporteur for the signal.
Summary of recommendation(s)
The MAHs for chlorhexidine containing products 5 should provide further information on the
signal, within 60 days.
The PDCO should be consulted on the matter by means of the agreed list of questions.
A 60-day timetable was recommended for the assessment of this review leading to a further
PRAC recommendation.
4.2.2. Ipilimumab – YERVOY (CAP)
Signal of posterior reversible encephalopathy syndrome (PRES)
Regulatory details:
PRAC Rapporteur: Sabine Straus (NL)
Administrative details:
EPITT 17955 – New signal
Leading MS: NL
MAH(s): Bristol-Myers Squibb Pharma EEIG
Background
Ipilimumab is a monoclonal antibody used in the treatment advanced (unresectable or metastatic)
melanoma in adults.
The exposure to Yervoy, a centrally authorised medicine containing ipilimumab, is estimated to have
been more than 14 000 patients worldwide, in the period from first authorisation in 2011 to 2014.
A signal of posterior reversible encephalopathy syndrome (PRES) was identified by the UK, following a
review of case reports in the Medicines and Healthcare products Regulatory Agency (MHRA) database
performed as part of routine signal detection activities. The Rapporteur confirmed that the signal
needed initial analysis and prioritisation by the PRAC.
Discussion
Posterior Reversible Encephalopathy Syndrome (PRES) is a sub-acute neurological syndrome, which
can be life-threatening and typically manifests with headache, cortical blindness, and seizures.
The PRAC discussed the information on the four reported cases of suspected PRES, as well as cases of
5 Medlock, Ecolab Ltd, CareFusion UK, Regent Medical Overseas Limited and Engelhard Arzneimittel GmbH
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 17/75