WC500165698

3.2.2. 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 in the inhibition of lactation (see PRAC minutes 2-5 September 2013). The (Co-)Rapporteurs
assessed the data submitted by some of the MAHs on the issue.
Summary of recommendation(s)/conclusions
The PRAC noted further aspects to be addressed during the review and agreed on a list of outstanding
issues and on an updated timetable (EMA/PRAC/493206/2013 rev.1).
3.3. Procedures for finalisation
3.3.1. Domperidone (NAP)
Review of the benefit-risk balance following notification by Belgium of a referral under Article
31 of Directive 2001/83/EC based on pharmacovigilance data
Regulatory details:
PRAC Rapporteur: Isabelle Robine (FR)
PRAC Co-Rapporteur: Jean-Michel Dogné (BE)
Administrative details:
Procedure number: EMEA/H/A-31/1365
EPITT 15994 – Follow up January 2014
MAH(s): Janssen-Cilag, various
Oral Explanation(s): Janssen-Cilag
Background
A referral procedure under Article 31 of Directive 2001/83/EC for domperidone-containing medicines
(see minutes of the PRAC 6-9 January 2014) was to be concluded. A final assessment of the data
submitted was produced by the Rapporteurs according to the agreed timetable.
Discussion
The PRAC discussed the conclusion reached by the Rapporteurs. One oral explanation took place at the
meeting. The review confirmed a small increased risk of serious cardiac adverse drug reactions related
to the use of domperidone. A higher risk was observed in patients older than 60 years, patients taking
daily doses of more than 30 mg, and those taking QT-prolonging drugs or CYP3A4 inhibitors
concomitantly. Therefore the PRAC agreed on a series of risk minimisation measures including a
restriction of the indication to the relief of the symptoms of nausea and vomiting in which benefit risk
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/253432/2014 Page 11/64