[Psychiatric adverse effects of fluoroquinolone: review of cases from the French pharmacologic surveillance database].
BACKGROUND
Psychiatric adverse effects of fluoroquinolones are known for long, but can sometimes be missed. We analyse cases spontaneously reported to the French pharmacovigilance.


METHODS
Cases of psychiatric adverse effects with fluoroquinolones reported to the French pharmacovigilance system were analysed. The studied period was from January 1985 and June 2002. Data analysed included age, sex, adverse effect, fluoroquinolone, seriousness and evolution.


RESULTS
Five hundred ninety cases have been reported concerning 273 males and 316 females (sex unknown in 1 case). Mean age was 66 years (median: 70, range: 12-102). The most frequently reported psychiatric adverse effects were confusion (51%), hallucinations (27%), agitation (13%), delusion (12%), insomnia (8%), somnolence (4%) (several adverse effects could be associated in a single patient). Serious cases represented 21.7% (resulting in hospitalisation in most cases). Evolution was favourable in most cases (88.5%), and was unknown in 9.5% of cases.


CONCLUSIONS
The number of cases reported during this period is moderate, but under-reporting probably interferes. The eventuality of this kind of adverse effect with fluoroquinolones should be kept in mind. Dose should be adjusted to renal function, especially in older patients.
Centre régional de pharmacovigilance, Inserm U657, université Victor-Segalen, CHU, 33076 Bordeaux cedex, France.
A
A
Doussau de Bazignan
F
F
Thiessard
G
G
Miremont-Salamé
C
C
Conri
F
F
Haramburu
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D003221:Confusion / Q000139:chemically induced; D003702:Delusions / Q000139:chemically induced; D004346:Drug Information Services; D005260:Female; D024841:Fluoroquinolones / Q000009:adverse effects*; D006212:Hallucinations / Q000139:chemically induced; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced*; D008875:Middle Aged; D009422:Nervous System Diseases / Q000139:chemically induced; D011595:Psychomotor Agitation / Q000209:etiology; D012189:Retrospective Studies; D012893:Sleep Wake Disorders / Q000139:chemically induced
D024841:Fluoroquinolones