PRAC News - January 2015


The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing ambroxol or bromhexine. This follows concerns over the risk of allergic reactions with these medicines.

PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small

The PRAC has completed a review of medicines containing ambroxol and bromhexine and considers that the risk of allergic reactions is small, but has recommended that the product information for these medicines should be updated with further information on severe allergic reactions. The PRAC has recommended introduction of a new warning, together with the advice on the need of an immediate discontinuation of the therapy in the case of allergic symptoms or severe skin reactions.

Ambroxol and bromhexine are widely used as expectorans to help mucus from the airways in respiratory diseases.

The review was carried out at the request of the Belgian medicines agency (AFMPS) following reports of allergic reactions and severe skin reactions (SCARS) with ambroxol. The review also covered medicines containing bromhexine, since bromhexine is mainly converted into ambroxol in the body.

The PRAC assessed the available data including those from the literature and confirmed the already known risk of allergic reactions, which remains small. The PRAC also identified a small risk of SCARS associated with these medicines. Based on these conclusions, the PRAC recommended adding the risk of SCARs to the product information, together with advice to discontinue treatment immediately if symptoms of SCARS occur.

The PRAC recommendation will now be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which will adopt a final position.

Here you may read more about the PRAC meeting from January 2015.