FDB takes action on artesunate amodiaquine

Accra, Dec. 16, GNA - The health authorities announced on Friday that single tablets of the new malaria drug, artesunate-amodiaquine, which contain 600 mg of amodiaquine and 200 mg of artesunate formulations, should be withdrawn until additional safety tests are done.

The decision was reached at a meeting convened by the Minister of Health, Major (Rtd) Courage Quashigah on Thursday following concerns expressed by the media and individuals about the safety and efficacy of the new drug combination for the management of uncomplicated malaria. The policy change took off in January this year.


A statement signed by Mr Samuel Owusu-Agyei, Deputy Minister of Health, said representatives of local manufacturers, the Food and Drugs Board (FDB), the Pharmaceutical Society of Ghana, Noguchi Memorial Institute for Medical Research, the Pharmacovigilance Centre of the University of Ghana Medical School, among other bodies attended the meeting.


The statement said the Ministry had taken these concerns seriously and as part of the implementation process instituted an independent pharmacovigilance system to follow-up on all reported adverse reactions. It said the Ministry would continue to monitor the safety, efficacy and quality of the new drug combination in the implementation of its malaria treatment policy.


"The Ministry of Health wishes to emphasise that the efficacy of the artesunate-amodiaquine drug in the treatment of uncomplicated malaria is not in question and local as well as international efficacy studies confirm this."


"We wish to indicate that the adverse reactions reported so far appear to be linked to the formulations containing 600mg amodiaquine and 200mg artesunate as single tablets."


The statement said studies from 10 sites spread across the country over the last year provided further confirmation of the efficacy of the combination therapy over chloroquine.

"The Ministry further wishes to advise all prescribes and dispensers not to prescribe and dispense the single tablet formulations containing 600mg amodiaquine and 200mg artesunate and also to adhere strictly to the guidelines provided by the National Malaria Control Programme in the management of uncomplicated malaria.


"In the meantime, the Food and Drugs Board has initiated the process of withdrawing all the single tablet formulations containing 600mg amodiaquine and 200mg artesunate."


The decision to change the drug in the treatment of malaria started in 2002 when it was noticed that the efficacy of chloroquine had reduced significantly.


A series of multi-sectoral meetings was held to discuss the policy change and it was not until 2004 that the final decision on the new anti-malaria policy change was concluded.


A number of systems, including safety, quality and efficacy monitoring were put in place to support the implementation process. "It must be noted that more than 13 African malaria-endemic countries are already using artesunate-amodiaquine combination following their drug policy change," the statement said. 16 Dec. 05