P326: Pharmacovigilance study in côte-d’ivoire on artemisinin derivatives
© Daubrey Potey et al; licensee BioMed Central Ltd. 2013
Published: 20 June 2013
Analyze the various package leaflets on Artemisinin-based combination therapy (ACT) marketed in Côte-d’Ivoire.
Comparative study, conducted from June 1 to December 20, 2011 which included all package inserts for all ACT registered and marketed in Côte-d’Ivoire. The inserts’ content was compared to that of European product descriptions; our investigation focused particularly on side effects.
Regarding artemether-lumefantrine, all leaflets described digestive disorders. As far as endocrinal and metabolic systems are concerned, appetite loss and anorexia were described in 28,5% and 42,8% of leaflets. As far as skin and annexes are concerned, we found: rash (100%), pruritus (90%), slate-gray pigmentation (28%) and redness of the face (14%). Finally, only notices of plasmocid® and coartem® reported biological side effects. As regards the artesunate-amodiaquine, blood effects were described: agranulocytosis (60%), blood dyscrasia and leucopenia (40%), hemolytic anemia (20%). At the gastrointestinal level, were found nauseas, vomiting and diarrhea (80%), hepatitis (60%), fatal hepatitis (20%). On the level of the nervous system was mentioned peripheral neuropathy (80%), the extra-pyramidal syndrome (20%). At the general level, it was asthenia only found in the leaflet of camoquin plus®.
Information of the laboratories differing from one specialty to another for the same molecule, it would be recommended that these ones harmonize the contents of the leaflets.
Disclosure of interest
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