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PAPERS: Dejan Zurovac, Mickey Ndhlovu, Alexander K Rowe, Davidson H Hamer, Donald M Thea, and Robert W Snow Treatment of paediatric malaria during a period of drug transition to artemether-lumefantrine in Zambia: cross sectional study BMJ 2005; 331: 734 [Abstract] [Full text]

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Artemisinins for paediatric malaria: what still needs to be explored?

Renato Bertini Malgarini M.D., Giuseppe Pimpinella Ph.D. and Nello Martini Pharm. D. - Agenzia Italiana del Farmaco   (7 October 2005)

Artemisinins for paediatric malaria: what still needs to be explored? 7 October 2005
Renato Bertini Malgarini M.D., Pharmacovigilance Unit Agenzia Italiana del Farmaco (AIFA), Giuseppe Pimpinella Ph.D. and Nello Martini Pharm. D. - Agenzia Italiana del Farmaco Send response to journal: Re: Artemisinins for paediatric malaria: what still needs to be explored?	Zurovac et al. in their paper describe the first line use of the combination of artemether-lumefantrine in acute uncomplicated Plasmodium falciparum malaria in children weighing 10 kg or more(1). RiametTM (artemether-lumefantrine) the only artemisinin-based medicinal product authorised in the EU, is not recommended for use in patients of less than 12 years of age and weighing less than 35 kg, due to inadequate data on which to base a dose recommendation in paediatric population (2). The criteria to evaluate the risk/benefit ratio of medicines for countries where malaria accounts for high mortality in paediatric population may be different, but risk minimisation cannot be ignored. For artemether- lumefantrine, further data are needed to assess pharmacokinetics in children. Furthermore, not enough trials have been carried out in humans to clarify the neurotoxic potential of artemether despite its neurotoxicity has been demonstrated in laboratory animals (3). Artemisinin based combination therapies have the potential to be one of the greatest public health interventions for Africa in this decade (4). On the other hand, the International Community has not only the duty to ensure the availability and the affordability of these therapies to patients, but also to require companies to invest in appropriate studies to further investigate their safety and efficacy. 1. Dejan Zurovac, Mickey Ndhlovu, Alexander K Rowe, Davidson H Hamer, Donald M Thea, Robert W Snow. Treatment of paediatric malaria during a period of drug transition to artemether-lumefantrine in Zambia: cross sectional study BMJ 2005;331:734 2. Summary of Product Characteristics for Riamet (Artemether-Lumefantrine) – Novartis – June 2002 3. Toovey S, Jamieson A. Audiometric changes associated with the treatment of uncomplicated falciparum malaria with co-artemether. Trans R Soc Trop Med Hyg. 2004; 98(5):261-9 4. Grace Malenga, Ayo Palmer, Sarah Staedke, Walter Kazadi, Theonest Mutabingwa, Evelyn Ansah et al. Antimalarial treatment with artemisinin combination therapy in Africa BMJ 2005;331:706-707 Competing interests: None declared