Update of product information is recommended
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, which are widely used as expectorants (to help clear mucus from the airways).
The PRAC 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, and that severe skin reactions (SCARs) should be introduced as a side effect. SCARs include conditions such as erythema multiforme and Stevens-Johnson syndrome.
The review of ambroxol and bromhexine was carried out at the request of the Belgian medicines agency (AFMPS) following reports of allergic reactions and SCARs with ambroxol. Several cases of SCARs, possibly linked to ambroxol, were also identified from the medical literature. The review also covered medicines containing bromhexine, since bromhexine is mainly converted into ambroxol in the body. In addition, there were some reports linking the use of bromhexine with allergic reactions.
The PRAC assessed the available data and all reports of severe allergic reactions and SCARs with ambroxol and bromhexine. The PRAC confirmed the already known risk of allergic reactions, which remains small. The Committee 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.