title: Gender differences in adverse drug reactions: analysis of spontaneous reports to a Regional Pharmacovigilance Centre in France.
abstract: The aim of this study was to investigate putative gender-related differences in adverse drug reactions (ADRs). Data were ADRs recorded in the database of the French Midi-Pyrénées Pharmacovigilance Centre in 1998. A total of 927 ADRs were spontaneously reported to the Centre in 1998, of which 53.1% were in females (difference vs. males not statistically significant). There was no statistically significant difference in the incidence of reported ADRs in males (3.6/10,000 inhabitants) vs. females (3.9/10,000 inhabitants) for the total population of the Midi-Pyrénées area. The number of reported ADRs was similar across different age groups (10-year age ranges). However, 'serious' ADRs were more frequently reported in males in the 0-9 and 60-69 age groups (and in females between 20 and 29 years old). There were significantly more neuropsychiatric (69 vs. 43, P = 0.05) and fewer cardiovascular (8 vs. 2, P = 0.05) ADRs reported in females than in males. ADRs were more frequently reported in females for some classes of drugs (such as genito-urinary, sex hormone, antineoplastic, antiparasitic and respiratory drugs). These results confirm that female gender is a risk factor for the development of ADRs.
authors.affiliation: Service de Pharmacologie Clinique, Unité de Pharmacoépidémiologie, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Centre Hospitalier Universitaire, 31073 Toulouse, France. montastruc@cict.fr
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Montastruc
authors.forename: Maryse
authors.initials: M
authors.lastname: Lapeyre-Mestre
authors.forename: Haleh
authors.initials: H
authors.lastname: Bagheri
authors.forename: Atoussa
authors.initials: A
authors.lastname: Fooladi
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005602:France; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D004364:Pharmaceutical Preparations / Q000145:classification; D012307:Risk Factors; D012737:Sex Factors
chemical_list: D004364:Pharmaceutical Preparations