Association of adverse cutaneous reactions with drug exposure: A case control analysis of a Tunisian pharmacovigilance database

• Published in: Revue française d'allergologie (2009) Vol. 63; no. 3; p. 103513
• Main Authors: Chaabane, A., Chahed, F., Ben Fadhl, N., Ben Fredj, N., Ben Romdhane, H., Chadli, Z., Aouam, K.
• Format: Journal Article
• Language: English
• Published: Elsevier Masson SAS 01.04.2023
• ISSN: 1877-0320; 1877-0320
• DOI: 10.1016/j.reval.2023.103513

Although case-control studies have been described as an excellent approach for validation and assessment of adverse drug reactions, no studies of this type have been published on adverse cutaneous reactions so far. To assess adverse cutaneous reactions using a case-control approach to qualify drug risks. The study used the Tunisian pharmacovigilance database of Monastir. The association between drugs and cutaneous reactions 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 cutaneous reaction 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. The analysis was carried out on 3752 reports, of which 1908 concerned “cases” and 1768 concerned “non-cases”. The calculated risk estimates were significant for alimentary tract and metabolism group (ROR: 1.3; 95% CI: 1.1 to 1.6), blood and blood forming organs agents (ROR: 1.5; 95% CI: 1.1 to 2.1), cardiovascular system group (ROR: 1.6; 95% CI: 1.3 to 1.9), anti-infectives for systemic use (ROR: 1.3; 95% CI: 1.1 to 1.5), nervous system drugs (ROR: 1.5; 95% CI: 1.2 to 1.7). Delayed cutaneous reactions were associated to alimentary tract and metabolism (P<0.001), blood and blood forming organs (P<0.004), cardiovascular system (P<10−3), anti-infectives for systemic use (P<10−3), nervous system (P<0.001). Immediate cutaneous reactions were associated to musculo-skeletal system (P<0.02) and nervous system (P<0.009). Dealing with sublevels, antibacterials for systemic use, mainly penicillins and cephalosporins were associated to immediate reactions (P<10−3). Our findings corroborate risks for a number of drugs in inducing cutaneous reactions with a particular association between some reactions and specific drugs. Given the widespread use of these drug classes, awareness should be raised among patients and prescribers about these risks.