Intended for healthcare professionals

Rapid response to:

Papers

Treatment of paediatric malaria during a period of drug transition to artemether-lumefantrine in Zambia: cross sectional study

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7519.734 (Published 29 September 2005) Cite this as: BMJ 2005;331:734

Rapid Response:

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

Competing interests: No competing interests

07 October 2005
Renato Bertini Malgarini M.D.
Pharmacovigilance Unit
Giuseppe Pimpinella Ph.D. and Nello Martini Pharm. D. - Agenzia Italiana del Farmaco
Agenzia Italiana del Farmaco (AIFA)