Objective: Analyse the various patient information leaflets on Artemisinin-based combination therapy (ACTs) sold in Côte-D’Ivoire.
Methods : A descriptive cross-sectional study, conducted from January 1st to February 20th, 2016 which included all patient information leaflets relating to ACTs registered and marketed in Côte-d’Ivoire. The leaflets were compared to European standards of writing summaries of product characteristics, by focusing particularly on side effects.
Results : Regarding artemether-lumefantrine, all leaflets mentioned digestive disorders. As far as endocrine and metabolic systems are concerned, appetite loss and anorexia were outlined in 28,5% and 42,8% of leaflets examined. Concerning skin and annexes, we noticed: rash (100%), pruritus (90%), slate-gray pigmentation (28%) and redness of the face (14%). Finally, only plasmocid® and coartem® leaflet reported biological side effects. Regarding artesunate-amodiaquine, side effects involving blood were outlined: agranulocytosis (60%), blood dyscrasia and leucopenia (40%), hemolytic anaemia (20%). Side effects affecting gastrointestinal were nauseas, vomiting and diarrhoea (80%), hepatitis (60%), fatal hepatitis (20%). Concerning side effects affecting the nervous system, peripheral neuropathy (80%), extrapyramidal syndrome (20%).
Conclusion: Regarding information from pharmaceutical companies differing from one specialty to another for the same molecule, it would be desirable that they harmonize the patient information leaflets contents.
Keywords : side effects, Information leaflets, antimalarial drugs, Artemisinin-based Combination Therapy