Withdrawal of oral artemisinin-based monotherapies
The continued use of oral artemisinin-based monotherapies is considered to be a major contributing factor to the development of resistance to artemisinin derivatives. WHO urges regulatory authorities in malaria-endemic countries to take measures to halt the production and marketing of these oral monotherapies, and promote access to quality-assured artemisinin-based combination therapies (ACTs).
For oral artemisinin-based monotherapies to be effective in eliminating malaria parasites, they need to be taken as a full seven-day treatment course. However, due to the rapid clinical response – i.e. clearance of signs and symptoms within 2-3 days – most patients do not complete the full regimen. On day three, the cure rates of all artemisinin derivatives are as low as 52%, leaving the parasite exposed to sub-therapeutic blood levels.
Artemisinin-based therapies are the mainstay of recommended malaria treatments today, and their efficacy must be preserved, as no new class of antimalarial medicines is expected to enter the market within the next few years.
World Health Assembly mandate
In 2007, WHO Member States adopted World Health Assembly resolution WHA60.18 which calls for a progressive removal of oral artemisinin-based monotherapies from markets. Oral monotherapies need to be withdrawn from all pharmacies and health clinics around the world; only rectal formulations for pre-referral treatment and injectable formulations for the management of severe malaria should remain available as monotherapies. Combination treatments do not yet exist for the management of severe malaria.
The WHO Global Malaria Programme has been monitoring the positions of manufacturing companies and national regulatory authorities in relation to the production and marketing of monotherapies.
A strengthening of pharmaceutical regulation and the enforcement of existing regulations is needed to ensure complete withdrawal of oral artemisinin-based monotherapies from all countries. The latest information on the positions of countries and manufacturers regarding the marketing of these products is available in the below documents.
Marketing of oral artemisinin-based monotherapy medicines at country level
Marketing of oral artemisinin-based monotherapy medicines: positions expressed by manufacturers
- Emergence and spread of artemisinin resistance calls for intensified efforts to withdraw oral artemisinin-based monotherapy from the market (2014)
Intensified efforts required to withdraw oral artemisinin-based monotherapies
Regulatory action needed to stop the sale of oral artemisinin-based monotherapy
World Health Assembly Resolution60.18 (2007)