Drug-associated acute pancreatitis: twenty-one years of spontaneous reporting in The Netherlands.
OBJECTIVE
Drugs are considered a rare cause of acute pancreatitis. We conducted a descriptive study to assess which drugs have been associated with acute pancreatitis in spontaneous adverse drug reaction reports in The Netherlands.


METHODS
Our study is based on reports of drug-associated acute pancreatitis reported to the Netherlands Center for Monitoring of Adverse Reactions to Drugs and The Netherlands Pharmacovigilance Foundation LAREB between 1 January 1977 and 1 January 1998. We used an algorithm to validate the diagnosis 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. Another 10 (18%) cases were excluded, as the causal relationship with the suspected 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%) patients were female. Of the 34 cases, 27 (79%) recovered, five (15%) died, and in two (6%) the outcome is unknown. Azathioprine, cimetidine, interferon-alpha, methyldopa, metronidazole, olsalazine, and oxyphenbutazon all had a definite causal relationship with acute pancreatitis. Doxycycline, enalapril, famotidine, 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-induced pancreatitis is scanty. Epidemiological studies to assess the risk of drug-induced acute pancreas, therefore, are needed.
Eland
I A
IA
Department of Internal Medicine, Erasmus University Medical School, Rotterdam, The Netherlands.
van Puijenbroek
E P
EP
Sturkenboom
M J
MJ
Wilson
J H
JH
Stricker
B H
BH
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000465:Algorithms; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D010195:Pancreatitis / Q000139:chemically induced* / Q000453:epidemiology*; D013997:Time Factors