A 4 YEAR RETROSPECTIVE STUDY OF ANTIBIOTI C-INDUCED SIDE-EFFECTS IN AREGIONAL POSTMARKETING SURVEILLANCE (PHARMACOVIGILANCE) CENTER

The present retrospective study investigates the antibiotic-induced si de effects in a regional French Pharmacovigilance Center between 1989 and 1992. Five-hundred and seventy six side effects were reported, inv olving 611 drugs and accounting for 18 % of the total activity of the pharmacovigilance center. Most of the side effects involved penicillin s and systemic quinolones followed by sulfonamides, cephalosporines an d glycopeptides. When expressed in number of adverse effects in Define d 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 cutaneo us and/or immunologic (54 %) and digestive (24 %) disturbances. Among serious side effects, 3 toxic epidermal necrolysis (2 with cotrimoxazo le), 16 pseudomembranous colitis (11 with beta-lactam antibiotics, 4 w ith macrolides and lincomycines and 1 with vancomycin), 14 neuropsychi atric reactions (seizures, confusions and hallucinations with beta-lac tam antibiotics and fluoroquinolones) were notified. Five antibiotic-i nduced side effects led to the death.