[Adverse effects of quinine in the treatment of leg cramps].

In France, three over-the-counter products containing quinine exist to treat cramps. This study aims to analyse data on spontaneous reports to the French System of Pharmacovigilance of adverse reactions to quinine drug products. From 1985 to 1996, we reviewed 58 adverse reaction reports. Most involved hypersensitivity reactions: rash, pruritus, generalized anaphylaxis, thrombopenia and hepatitis. Cinchonism is rarely observed at the usually low dose of quinine in this indication. No fatal outcome has been notified as described in the USA and Australia. The Food and Drug Administration (FDA) decided that prescription of quinine drug products should not be used any longer in the treatment of muscle cramps. Immuno-allergic reactions are potentially serious and must be avoided by giving clear information to patients and prescribers, and looking into the history of such reactions in patients in respect of the quinine drug and also tonic water.