Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

EMA’s safety committee (PRAC) has started a review of the risk of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances) with fenspiride medicines. Fenspiride is used in children and adults in a number of European Union Member States to relieve cough caused by lung diseases. As a precaution to protect patients, the PRAC has decided to suspend these products while the review is ongoing. Healthcare professionals should advise their patients to stop taking fenspiride medicines.

The PRAC will examine all the available evidence and make recommendations on the action to be taken on marketing authorisations for these treatments across the EU.

More information is provided below.


Start of referral

Article 107i procedure: Fenspiride containing medicinal products

Ongoing referrals




Article-31 procedure: Methotrexate containing medicinal products

Under evaluation

PRAC adopted a second list of outstanding issues

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