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Clinical and practitioners' reports on adverse effects of co-trimoxazole
E Weber1, T Jacubeit, A Auwärter
1Medizinische Universitätsklinik, Abteilung Klinische Pharmakologie, Heidelberg.
Abstract:
This study concerns the incidence of side effects occurring in connection with the prescription of co-trimoxazole which, according to the observations of medical practitioners, were suspected of being drug related. It is based on reports from 260 doctors in the Nordbaden/Rheinlandpfalz area between 1981 and 1984, as well as on those from hospital doctors concerning 33,300 in-patients at the Department of Internal Medicine at the University Hospital of Heidelberg from 1980 to 1983. General practitioners' reports: Of 3,739 side effects reported over a three and a half year period, 180 were related to drugs containing co-trimoxazole. Side effects were 3.3 times as frequent with the "forte" dosage as compared to the 80 mg trimethoprim/400 mg sulfamethoxazole preparation. The most frequently cited unwanted reactions concerned the skin (n = 63, of which two were Quincke oedema and three were urticarious reactions) and the gastrointestinal tract (n = 52), as well as disturbance of well being (n = 30). Gastro-intestinal disturbances appeared to occur more frequently after a higher than after a lower dosage. Clinicians' reports: During the period of observation an average of 12.6% of all in-patients were treated with drugs containing co-trimoxazole. The total number of cases of side effects due to this drug amounted to 255. Serious reactions included: two anaphylactic reactions; two thrombocytopenias below 80,000/mm3; and two cases of Lyell's syndrome (one of which could not be confirmed beyond all doubt). Side effects occurred more often after i.v. than after oral application.(ABSTRACT TRUNCATED AT 250 WORDS)
Insights
Co-trimoxazole prescriptions led to side effects, particularly skin and gastrointestinal issues, with higher dosages and IV administration increasing risk. General practitioners and hospital clinicians reported these adverse drug reactions between 1980 and 1984.
Area of Science:
- Pharmacovigilance
- Clinical Medicine
- Drug Safety
Background:
- Co-trimoxazole is a widely prescribed antibiotic.
- Monitoring drug-related side effects is crucial for patient safety.
- Previous data on co-trimoxazole adverse events in specific regions were limited.
Purpose of the Study:
- To investigate the incidence and nature of side effects associated with co-trimoxazole.
- To compare side effect frequency between different dosages and administration routes.
- To document drug-related adverse events reported by healthcare professionals.
Main Methods:
- Retrospective analysis of reported side effects from general practitioners (GPs) and hospital clinicians.
- Data collected from 260 GPs (1981-1984) and 33,300 hospital inpatients (1980-1983).
- Categorization of side effects by organ system and severity.
Main Results:
- 180 co-trimoxazole-related side effects reported by GPs out of 3,739 total.
- Side effects were 3.3 times more frequent with "forte" dosage compared to standard 80 mg trimethoprim/400 mg sulfamethoxazole.
- Common reactions included skin (63) and gastrointestinal (52) issues; IV administration showed higher incidence than oral.
Conclusions:
- Co-trimoxazole is associated with a notable incidence of side effects, including serious reactions like anaphylaxis and Lyell's syndrome.
- Higher dosages and intravenous administration increase the risk of adverse events.
- Continued pharmacovigilance is essential for identifying and mitigating co-trimoxazole-related risks.