Inserm, Institut national de la santé et de la recherche médicale
Faculté de pharmacie, Aix Marseille Université

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Antimalarial ototoxicity : an underdiagnosed complication ? A study of spontaneous reports to the French Pharmacovigilance Network

Jourde-Chiche N, Mancini J, Dagher N, Taugourdeau S, Thomas G, Brunet C, Bornet C, Pastor MJ, Chiche L. Ann Rheum Dis. 2012 Sep ;71(9):1586. doi : 10.1136/annrheumdis-2011-201265. Impact Factor 8.7


Antimalarial drugs have been prescribed for years to treat several connective-tissue diseases. They may play a role in preventing severe complications in systemic lupus erythematosus (SLE). These drugs, especially hydroxychloroquine, are inexpensive and have a good safety profile when systematic monitoring of ophthalmological side-effects is initiated. However, some cases of audiovestibular toxicity have been reported. This study was conducted to evaluate audiovestibular side-effects of antimalarial drugs. All spontaneous reports of audiovestibular adverse events attributed to antimalarial drugs in the French Pharmacovigilance Network database, between January 1986 and December 2010, were reviewed. The French algorithm of Begaud was used to determine imputability. During the study period, 2339 antimalarial drug-associated side effects were reported, including 61 (2.6%) audiovestibular complications, of which 31 (51%) occurred in patient with rheumatologic conditions such as SLE. Time to onset was variable, toxicity was unrelated to overdose, also occurred with hydroxychloroquine, and could be irreversible. Ototoxicity from antimalarial agents seems to be rare but can be irreversible.