FDA reiterates warning against anti-malarial drug

The Food and Drugs Authority (FDA) on Monday reiterated its warning to the public not to patronise GSUNATE Plus, an anti-malarial medicine for children.

Investigations conducted by the FDA have revealed that Gsunate Plus Suppository has not been registered by the Medicine Regulatory Authority in India and has not also been approved for sale or use in India and therefore cannot guarantee its safety.

The anti-malarial, a suppository made up of combination of Artesunate 25mg and Amodiaquine 75mg, which was manufactured in India by a company called BLISS GVS PHARMA Limited, has not undergone any Clinical Trial study on its combination.

A statement issued by Dr Stephen Opuni, Chief Executive of FDA and copied to Ghana News Agency said: “The efficacy of the combination of artesunate and amodiaquine through the rectal route has not been established and therefore treatment of malaria in children with this drug could lead to therapeutic failures with complications,” it said.

It instructed 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.

It said the importer; Tobinco Pharmaceutical Limited is assisting the FDA to recall the drug from the market.

The statement called for any information from the public on persons in any practice possible of endangering public health and safety with respect to FDA’s mandate.

“The…public should call the numbers; 0244337235, 0544863418, 0244571563 or 0244337250 to release any information”.

Source: GNA