PRAC Concludes Safety Review of Ambroxol, Bromhexine Meds

Megan Brooks


January 14, 2015

Medicines containing ambroxol or bromhexine carry a small risk for severe skin reactions, which include erythema multiforme and Stevens-Johnson syndrome, and the product labels should be updated to reflect this, the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded.

Ambroxol and bromhexine are used as expectorants and for sore throat. Some are used to treat breathing disorders in premature and newborn babies, as well as to increase lung maturation prenatally. Most ambroxol- and bromhexine-containing medicines are available over the counter, although some are prescription-only. The drugs are authorized in 29 European countries.

In April 2014, the PRAC started a safety review of ambroxol- and bromhexine-containing medicines at the request of the Belgian medicines agency after they received reports of allergic reactions and severe skin reactions associated with ambroxol and bromhexine.

The PRAC reviewed all available data and reports of severe allergic and skin reactions with ambroxol and bromhexine and "confirmed the already known risk of allergic reactions, which remains small," the EMA said in a statement released January 12.

The PRAC also identified a "small risk" for severe skin reactions with these medicines.

Therefore, they have recommended adding a new warning about the risk for severe skin reactions to the production information, together with advice to discontinue treatment immediately if symptoms of allergy or severe skin reactions occur.

The PRAC recommendation will be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures–Human, which will adopt a final position.


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