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Adverse drug reactions during treatment of urinary tract infections
Abstract:
Adverse reactions reported to the Swedish Adverse Drug Reaction Committée concerning Sulfapral (a sulphonamide combination for urinary tract infections) and nitrofurantoin were remarkably similar. The commonest hypersensitivity reactions were in skin and lung. During the 10-year period 1966-75 reactions to the sulphonamide were fewer (n=327) than those reported for nitrofurantoin (n=781), but the former appeared to carry a higher mortality rate - 4.6% of reported sulphonamide reactions were fatal as compared to only 1.0% for nitrofurantoin (P less than 0.001). The number of reactions to the sulphonamide tended to remain constant, whereas those to nitrofurantoin increased rapidly, both absolutely as well as relative to sales of the drug.
Insights
Adverse reactions to Sulfapral (a sulphonamide) and nitrofurantoin for urinary tract infections share similarities, particularly skin and lung hypersensitivity. Sulfapral had fewer reactions but a significantly higher fatality rate than nitrofurantoin.
Area of Science:
- Pharmacovigilance
- Clinical Pharmacology
- Infectious Diseases
Background:
- Urinary tract infections (UTIs) are commonly treated with antibiotics.
- Sulfonamides and nitrofurantoin are established UTI treatments.
- Monitoring adverse drug reactions (ADRs) is crucial for patient safety.
Purpose of the Study:
- To compare the types and severity of adverse reactions reported for Sulfapral and nitrofurantoin.
- To analyze trends in ADRs relative to drug usage over a decade.
Main Methods:
- Retrospective analysis of ADR reports submitted to the Swedish Adverse Drug Reaction Committee from 1966-1975.
- Comparison of reaction frequencies, types (hypersensitivity: skin, lung), and mortality rates between the two drugs.
- Correlation of ADR trends with drug sales data.
Main Results:
- Adverse reactions to Sulfapral and nitrofurantoin exhibited similar patterns, predominantly hypersensitivity affecting skin and lungs.
- Fewer ADRs were reported for Sulfapral (n=327) compared to nitrofurantoin (n=781) during the study period.
- Sulfapral ADRs had a significantly higher mortality rate (4.6%) than nitrofurantoin ADRs (1.0%, P < 0.001).
- Sulfonamide ADRs remained constant, while nitrofurantoin ADRs increased disproportionately to sales.
Conclusions:
- While nitrofurantoin generated more adverse event reports, Sulfapral was associated with a higher mortality risk.
- The increasing trend of nitrofurantoin reactions warrants further investigation into its safety profile relative to usage.
- Both drugs require careful consideration regarding risk-benefit assessment in UTI treatment.