In its letter dated 19 December 2013, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has initiated a written hearing regarding the risk of serious haematological reactions, especially thrombocytopenias, associated with medicinal products containing quinine in the indication "treatment and prevention of nocturnal leg cramps".

To the graduated plan procedure (available in German only)