EMA Benefit/Risk Revision of Fusafungine-Containing Medicines

12/02/2016

Following emerging concerns about increased reported cases of rare but serious allergic reactions with fusafungine by Servier and other sources, the European Medicines Agency (EMA) initiated in September 2015 a review process. On February 12th, considering the benefit/risk ratio as negative, the Pharmacovigilance Risk Assessment Committee (PRAC) recommends that the marketing authorization be revoked to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which will adopt a final position in the coming two months. Servier may request a re-examination within 15 days considering that the benefit/risk ratio could be positive in restricted population with reinforced risk minimization measures. 

Servier is informing all health agencies in countries where Fusafungine is marketed of the pending procedure. As soon as this procedure is finalized, Servier will send detailed information to healthcare professionals specifying the CMDh position and the practical implications for the management of their patients. 

Fusafungine is a medicinal product with bacteriostatic and anti-inflammatory properties indicated in the treatment of upper respiratory tract infections. The first marketing authorization was delivered in 1963 and Fusafungine is marketed in 31 countries worldwide under the following trade names: Bioparox, Fusaloyos, Locabiotal* or Locabiosol. 

PRAC mention that fusafungine-containing medicines remain available while a final decision is still pending; patients who have any questions should speak to their doctor or pharmacist. 

*the formulation of Locabiotal marketed in France does not contain Fusafungine, the active ingredient is peppermint oil; in 2005 all local antibiotics were withdrawn from the French market following the review from the French Health Authority.

For further information, please refer to the EMA communication