Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 February 2015

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13/02/2015

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 February 2015

PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines

The PRAC has completed a review of hydroxyzine-containing medicines following concerns over possible effects on heart rhythm with these medicines.

The PRAC considered that hydroxyzine is associated with a small but definite risk of QT prolongation and torsade de pointes (alterations in the electrical activity of the heart that can lead to abnormal heart rhythms and cardiac arrest).

The PRAC recommended a number of measures, including changes to the product information for these medicines, to minimise the risks.

More information is included in the table below.

Agenda

 
Agenda - PRAC draft agenda of meeting 9-12 February 2015

  

Recommendation by PRAC

Hydroxyzine

Article-31 referral: Hydroxyzine

 

Summary of PRAC recommendation

 

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Related information

Contact point:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu