During their meeting in April 2014, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicine Agency (EMA) started a review of the benefit/risk balance of medicines containing ambroxol and bromhexine, which are widely used as expectorants. Some formulas are even used to treat respiratory disorders in premature and newborn babies.

The review came at the request of the Belgian Federal Agency for Medicines and Health Products (FAMHP). There was concern about an increased number of reports of allergic reactions, including anaphylactic (severe allergic) reactions with ambroxol. In addition, the FAMHP was concerned about the use of ambroxol as an expectorant in children younger than 6 years and the agency believes that the benefits of ambroxol don’t outweigh its risks in this population. Since bromhexine is mainly converted into ambroxol in the body, the FAMHP believe that the assessment should also extend to medicines containing bromhexine.

Furthermore, during the same meeting of April 2014, the PRAC announced that it wil start a review of all codeine-containing medicines used to treat cough and cold in children (< 18y). This follows on an earlier review of codeïne containing medicines when used for pain relief in children, which was initiated because of concerns about the risk of morphine toxicity.

Share This