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Serum sickness-like reactions to cefaclor.

B H Stricker¹, J G Tijssen

¹Netherlands Center for Monitoring of Adverse Reactions to Drugs, Rijswijk.

Journal of Clinical Epidemiology

|October 1, 1992

Summary

Cefaclor use is associated with a significantly higher risk of serum sickness compared to amoxicillin and cephalexin. This risk was consistently observed across different countries and age groups in a global drug safety study.

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Area of Science:

Pharmacovigilance
Clinical Pharmacology
Drug Safety

Background:

Serum sickness is a serious adverse drug reaction.
Cefaclor has been associated with a high number of serum sickness reports.
The global distribution and risk factors for cefaclor-induced serum sickness require investigation.

Purpose of the Study:

To evaluate the global incidence and risk of serum sickness associated with cefaclor.
To determine if voluntary adverse drug reaction (ADR) reporting data can estimate relative risk.
To compare the risk of serum sickness between cefaclor and other antibiotics like amoxicillin and cephalexin.

Main Methods:

A nested case-control study design was employed.
Data from 1968-1987 on ADRs to cefaclor, amoxicillin, and cephalexin were analyzed from the WHO Collaborating Center for International Drug Monitoring.
The ADR-reporting odds ratio was calculated, adjusting for country, age, gender, report origin, and year of marketing.

Main Results:

The adjusted ADR-reporting odds ratio for cefaclor versus amoxicillin was 12.4, and versus cephalexin was 18.5.
In children, the relative risk of serum sickness with cefaclor versus amoxicillin was 13.9 in the USA and 15.1 in other countries.
In adults, the relative risk was lower but still elevated: 2.9 in the USA and 5.5 in other countries.

Conclusions:

The ADR-reporting odds ratio is a valid method for estimating the relative risk of adverse drug reactions.
Cefaclor is associated with a significantly increased risk of serum sickness compared to amoxicillin and cephalexin.
The risk appears higher in children than in adults, with consistent findings across multiple countries.

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