Drug-associated acute pancreatitis: Twenty-one years of spontaneous reporting in the Netherlands

OBJECTIVE: Drugs are considered a rare cause of acute pancreatitis. We cond ucted a descriptive study to assess which drugs have been associated with a cute pancreatitis in spontaneous adverse drug reaction reports in the Nethe rlands. METHODS: Our study is based on reports of drug-associated acute pancreatiti s reported to the Netherlands Center for Monitoring of Adverse Reactions to Drugs and the Netherlands Pharmacovigilance Foundation LAREB between 1 Jan uary 1977 and 1 January 1998. We used an algorithm to validate the diagnosi s and to assess the causal relationship between acute pancreatitis and use of the suspected drug. RESULTS: A total of 55 cases were available for review. We excluded 11 (20. 0%) reports, as we could not confirm the diagnosis of acute pancreatitis. A nother 10 (18%) cases were excluded, as the causal relationship with the su spected drug was unlikely. In the remaining 34 reports, acute pancreatitis was labeled as definite in 11 (32%) and as probable in 23 (68%); The age of the patients ranged from 17 to 84 yr with a median of 41; 24 (71%) patient s were female. Of the 34 cases, 27 (79%) recovered, five (15%) died, and in two (6%) the outcome is unknown. Azathioprine, cimetidine, interferon-alph a, methyldopa, metronidazole, olsalazine, and oxyphenbutazon all had a defi nite causal relationship with acute pancreatitis. Doxycycline, enalapril, f amotidine, ibuprofen, maprotiline, mesalazine, and sulindac had a probable causal relationship with acute pancreatitis. CONCLUSIONS: :A variety of drugs was associated with acute pancreatitis in Dutch adverse drug reaction reports. Quantitative information about drug-in duced pancreatitis is scanty. Epidemiological studies to assess the risk of drug-induced acute pancreas, therefore, are needed. (Am J Gastroenterol 19 99,94:2417-2422. (C) 1999 by Am. Coll. of Gastroenterology).