Pharmacovigilance of antibiotics. Evaluation by the Midi-Pyrénées Pharmacovigilance Center between 1989 and 1992

• Published in: Therapie Vol. 49; no. 2; p. 123
• Main Authors: Llau, M E, Damase-Michel, C, Lapeyre-Mestre, M, Vie, M, Rascol, O
• Format: Journal Article
• Language: French
• Published: France 01.03.1994
• Subjects: Adverse Drug Reaction Reporting Systems; Anti-Bacterial Agents - adverse effects; Drug Information Services; France; Humans; Retrospective Studies; France
• ISSN: 0040-5957

The present retrospective study investigates the antibiotic-induced side effects in a regional French Pharmacovigilance Center between 1989 and 1992. Five-hundred and seventy six side effects were reported, involving 611 drugs and accounting for 18% of the total activity of the pharmacovigilance center. Most of the side effects involved penicillins and systemic quinolones followed by sulfonamides, cephalosporines and glycopeptides. When expressed in number of adverse effects in Defined Daily Dose, the maximal frequency of side effects was observed with sulfonamides. In contrast, the frequency of penicillin-induced adverse events was low. The most frequently reported side effects were cutaneous and/or immunologic (54%) and digestive (24%) disturbances. Among serious side effects, 3 toxic epidermal necrolysis (2 with cotrimoxazole), 16 pseudomembranous colitis (11 with beta-lactam antibiotics, 4 with macrolides and lincomycines and 1 with vancomycin), 14 neuropsychiatric reactions (seizures, confusions and hallucinations with beta-lactam antibiotics and fluoroquinolones) were notified. Five antibiotic-induced side effects led to the death.