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Fatal adverse drug reactions reported in Denmark 1968-1988
H Kromann-Andersen1, M Andersen, H O Andersen
1Danish Committee on Adverse Drug Reactions, National Board of Health, Brønshøj, Denmark.
The International Journal of Risk & Safety in Medicine
|March 21, 2013
Summary
The risk of fatal adverse drug reactions (ADRs) is extremely low, estimated at 6 per million people annually. Analysis of voluntary reports from 1968-1988 showed consistent annual fatal ADR numbers despite new drug introductions.
Area of Science:
- Pharmacovigilance
- Drug Safety Monitoring
- Public Health
Background:
- Voluntary reporting systems are crucial for monitoring adverse drug reactions (ADRs).
- Denmark's system collected 27,938 ADR reports between 1968-1988, including 713 fatal cases.
Purpose of the Study:
- To analyze trends and identify risk factors for fatal adverse drug reactions (ADRs).
- To assess the overall incidence and specific drug group risks for fatal ADRs.
Main Methods:
- Retrospective analysis of 590 fatal ADR reports (excluding overdosage, congenital malformations, unclassifiable reactions) from Denmark (1968-1988).
- Correction for drug consumption data to evaluate incidence rates by age and gender.
- Identification of frequently reported drug groups and diagnoses associated with fatal ADRs.
Main Results:
- Antirheumatics, cytostatics, antibiotics, and oral contraceptives were the most frequently reported drug groups.
- Bone marrow depression, sudden unexpected death, anaphylactic shock, and malignant disease were common diagnoses.
- Significant reductions in fatal ADRs were observed for oral contraceptives (post-estrogen withdrawal) and halothane-induced hepatic damage.
Conclusions:
- The overall annual incidence of fatal ADRs remained constant, estimated at 6 per million inhabitants.
- Despite new potent drugs, the risk of fatal ADRs is extremely low (1 per 180,000 treatment years).
- Changes in drug formulations and withdrawals have demonstrably reduced specific fatal ADR risks.
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