Adverse events in patients treated with 5-aminosalicyclic acid: 1993-1994 pharmacovigilance report for Pentasa in France.
BACKGROUND: The incidence of the side-effects of 5-aminosalicylic acid (5-ASA) in clinical practice is not known. AIM: To present the safety reports on the use of Pentasa in France. METHODS: Pentasa-related adverse events were recorded from 1 January 1993 to 31 December 1994. Spontaneous reports to Ferring S.A. came from physicians or pharmacovigilance regional centres. RESULTS: In 1993 and 1994, 51 and 79 adverse events were reported; the estimated gross incidence was 6.6 and 9.0 per million days of therapy. Detailed information was obtained 64% of cases in 1993 and 53% in 1994. Adverse events with a high likelihood of causalty included five cases of diarrhoea, 14 cases of pancreatitis, seven cases of liver abnormalities, seven of blood dyscrasias, two cases of renal insufficiency (one of which was in a fetus), and eight of cardiac disorders including three myocarditis. CONCLUSIONS: Pentasa seldom has adverse effects. The majority of the adverse events do not seem to be dose-related. Clinicians should be aware of exceptional but severe adverse events including pancreatitis, cardiac disorders, blood dyscrasias and renal insufficiency.