International Journal of Risk & Safety in Medicine - Volume 2, issue 6 - Journals

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Article Type: Other

DOI: 10.3233/JRS-1991-2601

Citation: International Journal of Risk and Safety in Medicine, vol. 2, no. 6, pp. iii-iv, 1991

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Editorial

Article Type: Other

DOI: 10.3233/JRS-1991-2602

Citation: International Journal of Risk and Safety in Medicine, vol. 2, no. 6, pp. 303-304, 1991

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Fatal adverse drug reactions reported in Denmark 1968–1988

Authors: Kromann-Andersen, Hans | Andersen, Morten | Andersen, Hans Otto | Juul, Per

Article Type: Research Article

Abstract: During the period 1968–88 a total of 27,938 reports on adverse drug reactions (ADR) were received through the voluntary reporting system in Denmark, of which 713 concerned fatal reactions. Excluding cases of overdosage, congenital malformations and unclassifiable reactions, 590 reports were selected for analysis. Of 215 drugs involved, 41% were marketed before 1968. When corrected for drug consumption figures no significant differences in incidence were found with age and gender. The most frequently reported drug groups were antirheumatics (92), cytostatics (54), antibiotics (53) and oral contraceptives (50). Over-the-counter drugs were involved in 13 reports. Fatal drug interactions were reported in …17 cases. In general the duration of treatment was longer in cases of fatal ADR than the average for ADR as a whole. The diagnoses most frequently reported were bone marrow depression (105), “sudden unexpected death” (57), anaphylactic shock (30) and malignant disease (23). The incidence of fatal thromboembolism involving oral contraceptives was halved following the withdrawal of high-estrogen preparations resulting in an incidence over the period 1983–88 of 1 per 141, 000 user years. The corresponding figure concerning non-steroidal antiinflammatory agents was 1 fatal ADR per 26,000 treatment years. Halothane-induced hepatic damage was reported in 33 cases during 1968–83, but only in 2 cases over the period 1983–88. The number of fatal ADR following use of inhaled adrenergic antiasthmatics was 19 during 1968–83, but 0 during 1983–88 despite a sale corresponding to 360,000 treatment years. Lactate acidosis following oral antidiabetics was reported in 18 cases during 1968–78, but only in 1 during 1978–88 following the withdrawal of phenformin. The annual number of reported fatal ADR remained fairly constant throughout the period despite the introduction of numerous potent drugs. Subject to reservations reflecting the shortcomings inherent in a retrospective analysis of data from a voluntary ADR reporting system, the risk of a fatal ADR is considered extremely low, being estimated at 6 per million inhabitants per year and 1 per 180,000 treatment years. Show more

Keywords: Fatal adverse drug reactions, Voluntary reporting

DOI: 10.3233/JRS-1991-2603

Citation: International Journal of Risk and Safety in Medicine, vol. 2, no. 6, pp. 305-319, 1991

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Risk evaluation and estrogens

Authors: Palmlund, Ingar

Article Type: Research Article

Abstract: The risks of estrogens are a matter of concern both within the the medical community and in society at large. Estrogen products are a technology in manu medici. They have been prescribed and used in medical practice for over 180 bodily conditions. Experimentation with estrogens has from the 1930s been accompanied with warnings of the risks of cancer and other disease. Successively evidence of iatrogenic disease due to estrogens has accumulated but total consensus has not yet been reached. The social interaction over the risks of estrogens within the medical community as well as in society at large is described. …The societal evaluation of the risks of estrogens reveals that not only factual data but also values and culture influence the evaluation of medical technology. Show more

Keywords: Estrogen, Risk evaluation, Iatrogenic disease

DOI: 10.3233/JRS-1991-2604

Citation: International Journal of Risk and Safety in Medicine, vol. 2, no. 6, pp. 321-342, 1991

Price: EUR 27.50