The European Medicines Agency has started a review of medicines containing ambroxol and bromhexine, which are widely used as expectorants (medicines that help clear the airways), as well as to relieve sore throat. Some formulations are used to treat breathing disorders in premature and newborn babies.
The review of ambroxol and bromhexine was requested by the Belgian medicines agency (AFMPS). This follows concerns over an increased number of reports of allergic reactions, including anaphylactic (severe allergic) reactions with ambroxol. Medicines containing ambroxol have also been linked to severe skin adverse reactions. In addition, the AFMPS was concerned about the use of ambroxol as expectorant in children below 6 years of age and considered that the benefits of these medicines did not outweigh the risks in this population.
Since bromhexine gets mainly converted into ambroxol in the body, and there are some reports linking the use of bromhexine with allergic reactions, the AFMPS considered that the review should also cover medicines containing bromhexine.
The European Medicines Agency will now review the available data on the benefits and risks of medicines containing ambroxol and bromhexine, and issue an opinion on the marketing authorisations of these medicines across the European Union (EU).