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