[Adverse effects of antimalarial drugs spontaneously reported to pharmacovigilance national center in Burkina Faso: descriptive study and factors associated].

Aim: To study spontaneous reporting of adverse effects of antimalarial drugs sent to pharmacovigilance national center.

Method: A cross-sectional study was conducted to explore spontaneous reporting of adverse effects of antimalarial drugs sent to pharmacovigilance center from January 1, 2009 to December 31, 2013.

Results: In total 104 spontaneous reporting forms regarding antimalarial drugs were analysed. The sex ratiowas (male/female) 0,8. The majority of patients were aged over 13 years (66,3%). Self-medication and use of concomitant drug (>2) were observed in 22,1% and 46,2% of cases respectively. The artemisinin-based combination therapies (ACTs) were used in 77,8%. Several categories of adverse effects were observed among which skin and annexes disorders(34,6%), disorders of general health conditions, (29,8%), central nervous system disorders(29,8%), gastro-enterological disorders (23,0%). The most part of adverse effects was mild (67,3%).The adverse effects regarding central nervous (p=0,009)and gastro-enterological (p=0,0009) systems were significantly associated to the ACT use compared with use of other antimalarial drugs.

Conclusion: These results show the importance to implement active surveillance of ACTs to have a safety profile in our real conditions of use.