Expert group meeting on the safety profile of injectable artesunate

19 March 2013
Vienna, Austria

This meeting brought together representatives from various organizations to discuss the safety profile of injectable artesunate. The following recommendations were made:

  • The report from this meeting should be shared for review by the WHO Technical Expert Group which is updating the Malaria Treatment Guidelines.
  • Physicians need to be made aware of the possibility of delayed haemolysis after injectable artesunate for severe malaria, and the need for continued monitoring of patients, particularly those with high pre-treatment parasitaemia. However, the high clinical benefits of artesunate should be emphasised compared to quinine to ensure the continued use and further adoption of injectable artesunate as a life-saving treatment in severe malaria.
  • For data to be comparable across clinical studies, a consistent definition of delayed haemolytic anaemia and of severe malaria is required.
  • Mechanistic studies on the effect of artesunate on erythrocyte production, destruction and regeneration should aim to result in measures that improve clinical outcomes.
  • Prospective clinical trials need to be conducted in different patient populations. The objective of clinical studies should be to define the frequency of delayed anaemia, identification of prognostic factors and to examine interventions that may reduce the frequency of delayed anaemia. This includes determining the appropriate ACT dose suitable as follow on therapy following multiple doses of injectable artesunate to assess if there is a dose–response relationship with post-treatment delayed anaemia.
  • Standardisation of methods for safety reporting systems would enable/ improve data collection.

Download the meeting report [PDF: 417Kb, 27 pages]

Attendees:

Dr Peter J de Vries, Academic Medical Center, Amsterdam
Mr Cees KW van Veldhuizen, ACE Pharmaceuticals, Zeewolde
Dr Alan MaGill, Bill & Melinda Gates Foundation, Seattle
Dr Jakob Cramer, Bernhard Nocht Institute for Tropical Medicine, Hamburg
Dr Thierry Rolling, Bernhard Nocht Institute for Tropical Medicine, Hamburg
Dr Paul Arguin, Centers for Disease Control and Prevention (CDC), Atlanta, GA
Dr Hao Cui, State Food and Drug Administration, PR China
Dr Cuili Liu, State Food and Drug Administration, PR China
Dr Akim Adegnika, CERMEL, Lambaréné
Dr Thomas Zoller, Charité – University of Berlin, Berlin
Mr Ding Tao, Chinese Embassy, Vienna
Dr Bruno Moonen, Clinton Health Access Initiative, Nairobi
Dr Eric Pelfrene, European Medicines Agency, London*
Dr Eileen Navarro, US Food and Drug Administration (FDA), Silver Spring*
Dr Elizabeth O'Shaughnessy, FDA, Silver Spring*
Dr Hala Shamsuddin, FDA, Silver Spring*
Dr Jean-Marc Bouchez, Guilin Pharma, Ivory Coast
Dr Linchun Fu, Guilin Pharma, PR China
Ms Lily Su, Guilin Pharma, PR China
Ms Michelle Xiong, Guilin Pharma, PR China
Dr Pierre Buffet, Hôpital de la Pitié-Salpêtrière, Paris
Dr Stéphane Jauréguiberry, Hôpital de la Pitié-Salpêtrière, Paris
Dr Benjamin Mordmüller, Institut für Tropenmedizin, Tübingen
Dr Carsten Köhler, Institut für Tropenmedizin, Tübingen
Prof Arjen Dondorp, Mahidol–Oxford Tropical Medicine Research, Bangkok
Prof Tsiri Agbenyega, School of Medical Sciences, Kumasi
Prof Ogobara Doumbo, Malaria Research and Training Centre, Bamako
Dr Martin De Smet, Médecins Sans Frontières
Dr Mohandas Narla, New York Blood Center, New York
Dr Antonella Bacchieri, Sigma-Tau Pharmaceuticals, Rome
Dr Marco Corsi, Sigma-Tau Pharmaceuticals, Rome
Prof Sanjeev Krishna, St George's University, London
Prof Christoph Hatz, Swiss Tropical and Public Health Institute, Basel
Dr John Cutler, UNITAID, Geneva
Dr Ambachew Yohannes, UNITAID, Geneva
Prof Donatella Taramelli, Università di Milano/WRAIR, Milan
Prof Anne McCarthy, University of Ottawa
Prof Peter Kremsner, University of Tübingen
Dr. Stefanie Bolte, University of Tübingen
Dr Andrea Bosman, WHO-GMP, Geneva
Dr Peter Olumese, WHO-GMP, Geneva
Dr Shanti Pal, WHO-Pharmacovigilance, Geneva*
Dr Matthias Stahl, WHO-Prequalification, Geneva*
Dr Cathy McDermott, USAMMDA, US Army
Col Bryan Smith, USAMMDA, US Army

MMV Participants:

Dr David Reddy, CEO  
Dr Stephan Duparc, Chief Medical Officer  
Ms Heidi Divecha, Personal Assistant to the Chief Scientific Officer  
Mr Pierre Hugo, Associate Director, Product Development  
Dr Wiweka Kaszubska, Vice President, Head of Product Development
Dr Jörg Möhrle, Head of Translational Medicine

 
* By teleconference

David Reddy

MMV's David Reddy participated in this event.

Stephan Duparc

MMV's Stephan Duparc participated in this event.

Pierre Hugo

MMV's Pierre Hugo participated in this event.

Wiweka Kaszubska

MMV's Wiweka Kaszubska participated in this event.

Jörg Möhrle

MMV's Jörg Möhrle participated in this event.