Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2013

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06/09/2013

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2013

PRAC highlights

The Pharmacovigilance Risk Assessment Committee (PRAC) gave recommendations on two medicines and started one new safety review at its September 2013 meeting.

PRAC recommends restriction to the use of short-acting beta-agonists in obstetric indications

The PRAC recommended that medicines called ‘short-acting beta-agonists’ should no longer be used in oral or suppository forms in obstetric indications (for the care of pregnant women), such as for suppressing premature labour or excessive labour contractions. However, injectable forms of these medicines should remain authorised for short-term obstetric use under specific conditions.

More information on this, and all other PRAC recommendations, is included in the table below.

PRAC recommends suspension and reformulation for Numeta G13%E and risk minimisation measures for Numeta G16%E

The PRAC recommended suspending the marketing authorisation of Numeta G13%E, an intravenous nutrition preparation given to premature babies for nutritional support, until a reformulated preparation has been approved.

For Numeta G16%E, another intravenous nutrition preparation used in full-term newborns and children up to two years of age, the PRAC considered the benefit-risk balance to be positive, provided that a number of risk-minimisation measures are implemented.

New review for bromocriptine started

The PRAC started a new review procedure for bromocriptine-containing medicines when used orally for preventing or suppressing lactation (milk production) in women following childbirth. The PRAC will assess whether the benefits of these medicines outweigh the risk of rare but potentially serious (including fatal) cardiovascular, neurological and psychiatric side effects.

For an overview of all information available following the meeting of the PRAC, please see the table below.

Agenda

 
Agenda - PRAC draft agenda of meeting 2-5 September 2013


Start of referral procedures

Oral bromocriptine-containing medicinal products

Article-31 procedure: Oral bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum

 

Start of review of bromocriptine in preventing or suppressing lactation
Notification to the PRAC of a referral under Article 31 of Directive 2001/83/EC
PRAC list of questions
Timetable for the procedure
Annex 1

 

Recommendations by PRAC

Numeta G13%E and Numeta G16%E

Article-107i procedure: Numeta G13%E and Numeta G16%E

 

PRAC recommends suspension and reformulation for Numeta G13%E and risk-minimisation measures for Numeta G16%E

 

Short-acting beta-agonists (SABAs)
Article-31 procedure: Short-acting beta-agonists (SABAs)

 

PRAC recommends restricted use of short-acting beta-agonists in obstetric indications

 

Related information

 

Contact point:

Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu