EMA's PRAC calls for fenspiride meds withdrawal and Xeljanz restrictions

17 May 2019

The European Medicines Agency’s safety committee has called for the withdrawal of medicines containing fenspiride and temporary restrictions on the use of Xeljanz (tofacitinib) at its monthly meeting over May 13-16.

PRAC recommends withdrawal of marketing authorizations for fenspiride medicines

The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that the marketing authorizations for cough medicines containing fenspiride be revoked, so they can no longer be marketed in the European Union. This follows a review that has confirmed that fenspiride medicines could cause heart rhythm problems.

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