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.

Agenda

Agenda - PRAC draft agenda of meeting 11-14 February 2019

Start of referral

Fenspiride containing medicinal products Article-107i referral - Suspension of fenspiride medicines due to potential risk of heart rhythm problems

Ongoing referrals

Procedure

Status

Update

Article-31 procedure: Methotrexate containing medicinal products

Under evaluation

PRAC adopted a second list of outstanding issues

Related documents

Contact point

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