Registration Dossier
Registration Dossier
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EC number: 209-967-5 | CAS number: 599-61-1
Specific investigations: other studies
Administrative data
Link to relevant study record(s)
Description of key information
Dapsone is not only an anti-leprosy and anti-malaria drug but has also some anti-epileptic activity at concentrations used previously for the first two treatments.
Dapsone given at a dose of 100 mg/person/day on a long-term bases to women with malaria, leprosis, and HIV sero-positve condition does not show any severe adverse effects to mother and unborn child. However, confounding factors such as other drugs in combination with dapsone, adverse effects due to the illness itself, and incomplete data recording in most studies cannot exclude an effect on the unborn child and on suckling babies.
The safety results of a Human Phase III study (Africa) based on FDA with an approved study protocol demonstrated that Chlorproguanil-Dapsone-Artesunate (CDA) (as well as Chlorproguanil-Dapsone -CD; LAPDAP™) have an unacceptable safety risk in patients with G6PD deficiency, due to the propensity of the DDS component to cause severe haemolytic anaemia in such patients. Since the prevalence of G6PD deficiency in sub-Saharan Africa is relatively high (approximately 10-20%) and it would be impractical to screen patients for the deficiency prior to treatment, CDA does not fulfil the requirements for a suitable antimalarial treatment in Africa, where the WHO advocates empiric use of antimalarials for treatment of fever. As a result, further development of CDA has been discontinued.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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