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Stop buying GSUNATE Plus antimalarial medicine - FDA warns public

The drug— GSUNATE PlusThe Food and Drugs Authority (FDA) has reiterated its call on the general public not to patronise an antimalarial medicine for children called GSUNATE Plus.

It said the drug, a suppository composed of Artesunate 25mg and Amodiaquine 75mg, is manufactured in India by a company called Bliss GVS Pharma Ltd.

A statement signed by its chief executive, Dr Stephen K. Opuni and issued by the FDA said no “Clinical trial study has been conducted on this combination product.”

It said investigations conducted by the FDA had revealed that GSUNATE Plus suppository had not been registered by the Medicine Regulatory Authority in India (i.e. approved for sale or use in India) although malaria was one of the major killer diseases in that country.

The statement said the efficacy of the combination of artesunate and amodiaquine through the rectal route had not been established and, therefore, cautioned that the treatment of malaria in children with the drug, could lead to therapeutic failures with complications.

“GSUNATE Plus suppository is not registered by the FDA and the drug cannot be guaranteed for the treatment of malaria in children,” it said.

The statement directed hospitals, clinics, pharmacies, licensed chemical sellers and other health facilities keeping stocks of GSUNATE Plus suppositories, “to immediately stop dispensing them and hand over stocks to the nearest FDA office countrywide for safe disposal.”

It said the importer, Tobinco Pharmaceutical Ltd was assisting the FDA to ensure a total recall of the drug from the market.

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