Analysis of patient information leaflets on Artemisinin-based combination therapy

The objective of this research was to analyze the various patient information leaflets on Artemisinin-based combination therapy (ACTs) sold in Cote-D’Ivoire. A descriptive cross-sectional study was conducted from January 1st to February 20th, 2016, that included all patient information leaflets relating to ACTs registered and marketed in Cote-d’Ivoire. The leaflets were compared to European standards of writing summaries of product characteristics, by focusing particularly on side effects. 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. With regard to 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%), along with hemolytic anaemia (20%). Side effects affecting gastrointestinal system were nauseas, vomiting and diarrhoea (80%), hepatitis (60%) and fatal hepatitis (20%). Side effects affecting the nervous system include peripheral neuropathy (80%) and extrapyramidal syndrome (20%). 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. Key words: Side effects, information leaflets, antimalarial drugs, Artemisinin-based combination therapy.