European Commission approves continued use of ambroxol, bromhexine products
This decision followed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC), which is part of the European Medicines Agency (EMA). The legally binding decision is effective throughout the European Union.
As part of the EC's decision, the labels on products containing these active ingredients will be updated to include the rare risk of reactions due to hypersensitivity. The updated labels will also include a precautionary warning regarding severe skin reactions.
“We are very happy with this final decision of the European Commission," Boehringer Ingelheim Global CHC Head David Wright said. “The well-being of patients taking our medicines is the top priority for Boehringer Ingelheim, which is why we continuously monitor the safety profile of all our products. Decades of use in the marketplace, as well as numerous clinical studies, confirm that they are safe, effective and well tolerated.”
Ambroxol and bromhexine are used in over-the-counter medications to help manage productive coughing in respiratory diseases. Ambroxol has been on the market for more than 30 years -- bromhexine, for more than 50.