Evaluation of the safety of macrolides

The safety of all drugs is established by animal studies, administration to healthy volunteers and the observations during clinical studies to confirm efficacy. During these studies, patients are questioned about side-effects and extensive laboratory testing of blood and urine samples is performed. Despite these extensive studies, new problems may arise during post marketi ng surveillance which is designed to identify any rare side-effects. Today, all studies suggest that macrolides, and especially the more recently deve loped agents, are well tolerated. Some variations in tolerability may be du e to the size of the macrocyclic ring and the presence of different esters. There are very few instances of irreversible organ damage. (C) 2001 Elsevi er Science B.V. and International Society of Chemotherapy. All rights reser ved.