Journal of Pharmacovigilance

Abstract

Signal Management of Disproportionate Reporting in Moroccan Pharmacovigilance: The Lower Limb Edema Induced by Anti-Tuberculosis Drugs

Soussi Tanani D, Serragui S, Y. Cherrah, Ait Moussa L, El Bouazzi O, Soulaymani R and A. Soulaymani

Objective: To detect and validate new signals in Pharmacovigilance of a combined anti-TB drug ERIP-K4.

Methods: It was a prospective study (October 2012-December 2013), conducted in majority Moroccan TB Diagnosis Centers (MTDC). All TB patients admitted to these MTDC and presented ADRs were eligible for inclusion in the study during this period. Each ADR notified was handled by the WHO accountability method and sent to the international database (Vigibase). The detection of signals was based on 3 statistical methods measuring disproportionality of reporting of combined anti-TB form (ERIP-K4) induced ADRs: the information component (IC), the proportional reporting ratio (PRR), and the reporting odds ratio (ROR).

Results: 927 ADRs were reported during the study. The average age of patients was 40.7 ± 17.5 years with a sex ratio of 0.8. Adverse drug reactions of skin and appendages disorders predominated (24.2%), followed by ADRs of gastrointestinal system disorders (21%) and ADRs of liver and biliary system disorders (14.5%). From 11 signals, a new signal never described in our database: edema of the lower limbs which disproportionate scores (IC, PRR, ROR) were (2.03, 7.5, 7.9).

Conclusion: Edemas of the lower limbs are a potential signal in Pharmacovigilance requiring more investigations to argue well the relation of cause and effect and to find risk factors to manage and avoid these effects.