EMA benefit/risk revision of fusafungine-containing medicines

Following emerging concerns about increased reported cases of rare but serious allergic reactions with fusafungine by independent French drugmaker Servier and other sources, the European Medicines Agency initiated in September 2015 a review process.

On February 12, considering the benefit/risk ratio as negative, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended that the marketing authorization be revoked to the Coordination Group for Mutual Recognition and Decentralized 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.