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Discussion
The PRAC noted the notification letter from the UK Medicines Agency highlighting the more recent
scientific data that had become available on cardiovascular safety of the NSAIDs - including published
results from a large meta-analysis of more than 600 randomised clinical trials from the Coxib and
traditional NSAID Trialists’ (CNT) collaborative group 2 - indicating that the cardiovascular risk
associated with high-dose ibuprofen (2400 mg) may also be similar to that of COX-2 inhibitors.
The PRAC noted that, in addition, there was accumulating evidence that ibuprofen may also inhibit the
antiplatelet action of low-dose aspirin for cardiovascular prophylaxis and agreed that related data
should be further examined.
The PRAC considered that in the majority of individuals ibuprofen is usually taken at lower doses and
for short periods of time and there is no suggestion that such use is associated with an increase in
cardiovascular risk with ibuprofen. However, it was agreed that a review of available clinical trial and
epidemiological data relating to high dose ibuprofen (2400 mg) including published and unpublished
data on the risk of thrombotic events in adults along with new evidence on interaction with low-dose
aspirin should be performed.
The PRAC appointed Dolores Montero Corominas (ES) as Rapporteur and Julie Williams (UK) as Co-
Rapporteur for the procedure.
Summary of recommendation(s)/conclusions
The Committee adopted a list of questions (EMA/PRAC/332909/2014) and a timetable for the
procedure (EMA/PRAC/332908/2014) both published on the EMA website.
3.2. Ongoing Procedures
3.2.1. Bromocriptine (NAP)
Review of the benefit-risk balance following notification by France of a referral under Article 31
of Directive 2001/83/EC, based on pharmacovigilance data
Regulatory details:
PRAC Rapporteur: Sabine Straus (NL)
PRAC Co-Rapporteur: Isabelle Robine (FR)
Administrative details:
Procedure number: EMEA/H/A-31/1379
MAH(s): Sanofi-aventis, Meda Pharma, various
Background
A referral procedure under Article 31 of Directive 2001/83/EC is ongoing for bromocriptine-containing
medicines (see PRAC minutes 3-6 March 2014). The PRAC (Co)-Rapporteurs prepared an assessment
report on the responses received to the list of questions from the MAHs.
Summary of recommendation(s)/conclusions
2 Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual
participant data from randomised trials. Coxib and traditional NSAID Trialists' (CNT) Collaboration. The Lancet - 30 May
2013
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 13/75