Ministry orders the withdrawal of new malaria drug

The Ministry of Health (MOH) says it has authorized the Food and Drugs Board (FDB) to start the processes of withdrawing the much- publicised new malaria drug, Artesunate-Amodiaquine from the market.

This was contained in a press statement released on Friday December 16, 2005 in an apparent reaction to Public Agenda?s publication of a story that touched on the side effects of the drug that has caused one death so far. According to the statement, all the single formulations containing 600mg amodiaquine and 200mg artesunate are to be withdrawn. The ministry therefore cautioned all prescribers and dispensers to desist from prescribing and dispensing the said drug and also to ?adhere strictly to the guidelines provided by the National Malaria Control Programme in the management of uncomplicated malaria.?

The statement indicates that the decision is necessitated by reports the link the adverse reactions to the formulations containing the 600mg Amodiaquine and 200mg Artesunate as single tablets. The Ministry, meanwhile, admits that there is the need for additional safety tests to be conducted after meeting stakeholders including representatives of local manufacturers, the FDB, the Pharmaceutical Society of Ghana, the Noguchi Memorial Institute and the Pharmacovigilance Centre of the University of Ghana Medical School on Thursday December 15, 2005. The MOH however, justifies the decision to resort to the new drug by stating that the drug policy change became necessary due to the fact that the efficacy of chloroquine had reduced significantly.

The statement emphasized that the efficacy of the drug in treating uncomplicated malaria is not in question both locally and internationally, citing, the case study of more than 13 African malaria-endemic countries which are already using Artesunate-Amodiaquine combination following their drug policy change.

?Additional studies from 10 sites spread across the country over the last year provide further conformation of the efficacy of the combination therapy over chloroquine?, it added. The Ministry assured the public that it would continue to monitor the safety, efficacy and quality of the new drug combination in the implementation of the policy.