The Food and Drugs Authority (FDA), has advised against the patronage of an anti-malaria medicine for children called GSUNATE Plus, a suppository drug made up of combination of Artesunate 25mg and Amodiaquine 75mg.
The medicine, which was manufactured in India by a company called BLISS GVS PHARMA LTD is imported and distributed by a Ghanaian company called Tobinco.
A press statement issued in Accra yesterday by the Chief Executive of the FDA, Dr. Stephen K. Opuni, warned “no Clinical Trial study has been conducted on this combination product”.
“The efficacy of the combination of artesunate and amodiaquine through the rectal route has not been established, therefore, treatment of malaria in children with this drug could lead to therapeutic failures with complications,” it said.
Dr. Opuni’s statement also revealed that “GSUNATE Plus suppository is not registered by the FDA and the drug cannot be guaranteed for the treatment of malaria in children”.
The FDA directed “hospitals, clinics, pharmacies, licensed chemical sellers and other health facilities having stocks of GSUNATE Plus Suppository, to immediately stop dispensing them and handover stocks to the nearest FDA office countrywide for safe disposal”.
Meanwhile, the importer, Tobinco Pharmaceutical Ltd is assisting the FDA to recall this drug from the market.
Additionally, information from the general public on persons in any practice possible of endangering public health and safety with respect to FDA’s mandate is most welcome through any of the following contact numbers; 0244337235, 0544863418, 0244571563 or0244337250.