Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013

The Pharmacovigilance Risk Assessment Committee (PRAC) made recommendations on four safety referrals at its June 2013 meeting.

PRAC recommends restricting use of codeine when used for pain relief in children

The PRAC has recommended a series of measures to address safety concerns with codeine-containing medicines when used for the management of pain in children.

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

PRAC recommendation on diclofenac

The Committee concluded that the effects of the pain killer diclofenac on the heart and circulation when given systemically are similar to those of selective COX-2 inhibitors, another group of painkillers. This applies particularly when diclofenac is used at a high dose (150 mg daily) and for long-term treatment.

PRAC recommends suspension of hydroxyethyl-starch-containing solutions for infusion

The Committee concluded that the benefits of infusion solutions containing hydroxyethyl starch no longer outweigh their risks and therefore recommended that the marketing authorisations for these medicines be suspended.

PRAC recommendation on flupirtine-containing medicines

The PRAC recommended that oral flupirtine medicines and suppositories should only be used to treat acute (short-term) pain in adults who cannot use other painkillers (such as non-steroidal anti-inflammatory drugs (NSAIDs) and weak opioids) and that treatment should not exceed two weeks because of the risk of damage to the liver.

As these four PRAC recommendations cover nationally authorised medicines, they will now be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position. The CMDh is a medicines regulatory body representing the European Union (EU) Member States.

If the CMDh position is agreed by consensus, the agreement will be directly implemented by the Member States where the medicines are authorised. Should the CMDh position be adopted by majority vote, the CMDh position will be sent to the European Commission, for the adoption of an EU-wide legally binding decision.

New referral procedure for Numeta G13%E and G16%E

The PRAC started a review of the intravenous nutrition preparations Numeta G13%E and Numeta G16%E following reports of hypermagnesaemia (high blood levels of magnesium) in premature babies.

Other updates

The review of third- and fourth-generation combined hormonal contraceptives continues. An update from the Committee is expected in July 2013.

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


Agenda - PRAC draft agenda of meeting 10-13 June 2013

Start of referral procedure

Numeta G13%E and Numeta G16%E emulsion for infusion

Article-107i procedure: Numeta


Referral notification

Rationale for triggering

PRAC list of questions

PRAC list of questions to be addressed by the stakeholders

Stakeholders' submission form

Timetable for the procedure

Annex I


Recommendations by PRAC

Flupirtine-containing medicines

Article-107i procedure: Flupiritine


Summary of PRAC recommendation


Codeine-containing medicines

Article-31 referral: Codeine


Summary of PRAC recommendation


Hydroxyethyl starch solutions for infusion

Article-31 referral: Hydroxyethyl starch solutions for infusion


Summary of PRAC recommendation


Diclofenac-containing medicines

Article-31 referral: Diclofenac


Summary of PRAC recommendation


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Contact point:

Monika Benstetter
Tel. +44 (0)20 7418 8427