Me. Llau et al., A 4 YEAR RETROSPECTIVE STUDY OF ANTIBIOTI C-INDUCED SIDE-EFFECTS IN AREGIONAL POSTMARKETING SURVEILLANCE (PHARMACOVIGILANCE) CENTER, Therapie, 49(2), 1994, pp. 123-127
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.