WC500169468

Summary of recommendation(s)
The MAH for the nationally authorised leuprorelin containing product 6 Eligard should submit a
proposal of risk minimisation measures with a Direct Healthcare Professional Communication
and a communication plan to inform healthcare professionals (HCPs) about the correct product
reconstitution and administration and about the importance of the different steps. These
measures should be accompanied by a draft study protocol to assess their effectiveness. In
parallel the MAH is asked to consider the development of an improved presentation which
would facilitate fewer and easier handling steps. Further information on population exposure
and usage should be provided.
A 60-day timetable was recommended for the assessment of this review leading to a further
PRAC recommendation.
4.3.5. Paracetamol (NAP)
Drug exposure in pregnancy – publication by Brandlistuen et al.; Int. J. Epidemiol., 2013
Regulatory details:
PRAC Rapporteur: Veerle Verlinden (BE)
Administrative details:
EPITT 17796 – Follow up February 2014
MAH(s): Bayer Pharma AG, various
Background
For background information, see PRAC minutes 3-6 of February 2014.
The Rapporteur performed a review of the study recently published, and of relevant preclinical data, on
the effect of paracetamol on neurodevelopment. The authors of the study that triggered this signal had
also provided further clarification to the Rapporteur.
Discussion
The PRAC discussed the findings of the review of observational data including recently available
studies 7 as well as preclinical data and discussed their strengths and limitations. The PRAC concluded
that a causal relationship between paracetamol exposure during pregnancy and neurodevelopmental
disorders cannot be established. The current guidance that paracetamol can be used during pregnancy
if clinically needed remains valid, however, as with any medicine, it should be used at the lowest
effective dose for the shortest possible time.
Summary of recommendation(s)
Current evidence is insufficient to support the conclusion of an association between
paracetamol exposure in pregnancy and neurodevelopmental effects.
6 In line with Article 16(3) of Regulation No (EU) 726/2004 and Article 23(3) of Directive 2001/83/EC, the marketing
authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge
including the conclusions of the assessment and recommendations made public by means of the European medicines webportal
established in accordance with Article 26 of Regulation (EC) No 726/2004 (EMA website). For nationally authorised
medicines, it is the responsibility of the National Competent Authorities of the Member States to oversee that these
recommendations are adhered to
7 Brandlistuen et al. Int J Epidemiol. 2013;42(6):1702-13, Liew et al. JAMA Pediatr. 2014;168(4):313-20
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 25/73