Drug-induced gastrointestinal disorders in surgical patients admitted to the University Hospital, Jena, Germany.
The use of drugs is always accompanied by the risk of adverse drug reactions (ADRs). Particularly important among these are serious ADRs that require hospital admission. Such cases often include patients with gastrointestinal ADRs and many reports have been published on drug-induced gastrointestinal bleeding and ulcers. The objective of the project described here was to detect gastrointestinal ADRs by systematic screening of all medical files in three university departments of surgery, i.e. visceral surgery, vascular surgery and traumatic surgery in the University Hospital of Jena, Germany. The study was retrospective involving the analysis of patients records for the period January 1, 2000 to June 30, 2001. The evaluation concerned all the medical files of individual patients in surgery and in particular those with gastrointestinal disorders due to adverse drug reactions. Side effects were classified according to their severity, duration, symptomatology and pathogenesis and assessed according to frequency, age and sex of the patient and the surgical unit in which the side effect was being treated. Out of a total of 7,715 patients evaluated in the university surgical departments, 471 (6.1%) had gastrointestinal disorders, in 144 (1.9%) of these patients 202 adverse drug reactions were diagnosed and in 70 patients (49.3%) the adverse drug reactions affecting the gastrointestinal tract were classified as serious. Gastric ulcers were present in 86 patients (42.6%) and intestinal ulcerations in 62 patients (30.7%) with intestinal bleeding occurring in 21 (10.4%). In 33 patients (16.3%) the etiology of the gastrointestinal bleeding was uncertain. The average age of patients with gastrointestinal ADRs was 66.1 years in men and 74.4 years in women. Only 1.7% of our patients were aged below 40 years. In approximately 20% of patients analgetic drugs had been withdrawn because of side effects. It is known that there is a correlation between polypharmacy, multiple morbidity and advancing age. The relationship however is complex and the extent to which age is a causative factor in ADRs is difficult to determine. In addition, it is often difficult to obtain clear documentation on the drug history prior to admission to hospital. Physicians are usually unable to devote enough time for a thorough analysis of adverse drug effects and there is a need to correct this deficiency.
Hippius
M
M
Institute of Clinical Pharmacology, Friedrich Schiller University, Jena, Germany. Marion.Hippius@med.uni-jena.de
Hegenbart
U
U
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000368:Aged; D004358:Drug Therapy / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000453:epidemiology*; D005858:Germany; D006785:Hospitals, University / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D012189:Retrospective Studies; D013503:Surgery Department, Hospital / Q000706:statistics & numerical data