Skip to main content

Table 1 ASAQ Winthrop Risk Management Plan: issues to be documented

From: Innovative public-private partnerships to maximize the delivery of anti-malarial medicines: lessons learned from the ASAQ Winthrop experience

1. Identified risks: to be minimized with specific information
     • Intake during first trimester of pregnancy
     • Allergy
2. Potential risks: to be quantified in large-scale studies
     • Hepatotoxicity
     • Neutropenia/agranulocytosis
     • Somnolence
     • Audiometric dysfunction
     • Extra-pyramidal symptoms
     • Decreased efficacy (parasite resistance)
3. Missing information: to be documented in new studies
     • Safety of repeated administrations
     • Specific populations (HIV/AIDS patients...)
     • Second and third trimester of pregnancy
     • Safety profile in non parasitaemic patients
     • Drug interactions & Interactions with traditional drugs and remedies
     • Efficacy in species other than P. falciparum