Highlights
- •First case-control study on Delayed Cutaneous Adverse Reactions (DCADRs)
- •1798 reports: 867 ‘cases’ and 931 ‘non-cases’
- •Antibacterials, antiepileptics and allopurinol are at a high risk in inducing DTCRs.
Abstract
Purpose
To assess delayed-type cutaneous reactions (DTCRs) related to drugs, using a case-control
approach to qualify drug risks.
Methods
The study used the Tunisian pharmacovigilance database of Monastir. The association
between drugs and DTCRs was assessed using a case/non-case method. Drugs were grouped
according to the ATC Classification System. Patients were defined as “cases” if they
have developed DTCRs regardless of the causality assessment. All other reports were
“non-cases”. Association between reactions and drugs was calculated using the reporting
odds ratio (ROR) with 95% confidence intervals (CIs). A p value < 0.05 was considered significant.
Results
The analysis was carried out on 1798 reports, of which 867 concerned DTCRs (cases)
and 931 concerned non-cases. The calculated risk estimates were significant for cefotaxime
(ROR 2.1; 95% CI 1.5 to 3), pristinamycin (ROR 4; 95% CI 2 to 7.9), sulfamethoxazole
(ROR 4.4; 95% CI 1.6 to 11.7), oxacillin (ROR 2.2; 95% CI 1.2 to 3.8), doxycycline
(ROR 10.8; 95% CI 1.4 to 84.9), carbamazepine (ROR 3.3; 95% CI 1.7 to 6.2), phenobarbital
(ROR 2.3; 95% CI 1.03 to 5.1), allopurinol (ROR 3.6; 95% CI 1.8 to 7.2), furosemide
(ROR 2.4; 95% CI 1.3 to 6.3), hydrochlorothiazide(ROR 2.9; 95% CI 1.3 to 6.3) and
candesartan (ROR 4.7; 95% CI 1.3 to 16.6).
Conclusion
Our findings corroborate risks for a number of drugs, such as antibacterials, antiepileptics
and allopurinol in inducing DTCRs. Given the widespread use of these drug classes,
awareness should be raised among patients and prescribers about these risks.
Keywords
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Article info
Publication history
Published online: February 04, 2018
Accepted:
January 31,
2018
Received in revised form:
January 16,
2018
Received:
October 16,
2017
Identification
Copyright
© 2018 Published by Elsevier B.V. on behalf of European Federation of Internal Medicine.
