EMA: Meeting highlights from the 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.
Posted on the EMA website on 13 February 2015