Withdrawal of oral artemisinin-based monotherapies

Last update: 18 March 2016

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).

Likewise, in view of the latest development of resistance, it is essential that neither artemisinin-based injectables nor artesunate suppositories (which are both utilized in the treatment of severe malaria), be used as monotherapies. The initial treatment of severe malaria with these medicines needs to be completed with a full 3-day course of ACT.

ACTs are the mainstay of recommended antimalaria 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 Oral monotherapies need to be withdrawn from all pharmacies and health clinics around the world.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, once the patient can tolerate oral therapy, the treatment needs to be completed with a 3-day administration of an ACT. Combination treatments do not yet exist for the management of severe malaria.

Tracking progress

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 oral artemisinin-based 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.

Key documents