Withdrawal of fusafungine-containing medicines from the market

01/04/2016

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) endorsed, on 31 March 2016 by consensus, the Pharmacovigilance Risk Assessment Committee (PRAC) recommendation, dated February 2016, to revoke the marketing authorisations of fusafungine-containing medicines.

Fusafungine is a medicinal product with bacteriostatic and anti-inflammatory properties indicated in the treatment of upper respiratory tract infections (rhinopharyngitis, sinusitis, rhino-sinusitis, rhinitis, tonsillitis and laryngitis). The first marketing authorization was granted in 1963 and fusafungine is marketed in 31 countries worldwide under the following trade names: Bioparox®, Fusaloyos®, Locabiosol® and Locabiotal®.

The PRAC considered that, taking into account the mild and self-limiting nature of upper airway diseases (such as blocked nose, cold), the benefits of fusafungine did not outweigh the risk of rare but serious allergic reactions.

In accordance with the CMDh’s position, Les Laboratoires Servier will proceed with the withdrawal of Bioparox®, Fusaloyos®, Locabiosol® and Locabiotal®. The withdrawal will be implemented in all concerned countries (in Europe and outside Europe). Les Laboratoires Servier will extend this withdrawal measure to Locabiotal® distributed in France, which does not contain fusafungine but peppermint oil.

Les Laboratoires Servier will send detailed information to healthcare professionals specifying the decision of health European authorities and the practical implications for the management of their patients.