Gsunate Plus Suppository Not Guaranteed – FDA

Sunyani Regional Hospital Receives Medical Equipment

The Food and Drugs Authority (FDA) has re-emphasized its call to the general public to avoid patronizing an anti-malaria medicine for children called Gsunate Plus.

According to the authority, no clinical trial study had been conducted on the product made up of the combination of Artesunate 25mg and Amodiaquine 75mg.

Investigations conducted by the FDA revealed that Gsunate Plus, manufactured in India by BLISS GVS PHARMA LTD, located at 10 Dewan Udyog Nagar, Aliyali Palghar Maharashtra- 401, 404 India, had neither been registered nor approved by the Medicine Regulatory Authority in India for sale or use.

'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,' Dr Stephen K. Opuni, Chief Executive of FDA said.

He said the Gsunate Plus suppository had not been registered by the FDA and therefore the drug cannot be guaranteed for the treatment of malaria in children.

'Hospitals, clinics, pharmacies, licensed chemical sellers and other health facilities having stocks of Gsunate Plus Suppository are reminded to immediately stop dispensing them and handover stocks to the nearest FDA office countrywide for safe disposal,' he said.

 
Meanwhile, the importer, Tobinco Pharmaceutical Ltd, is still assisting the Food and Drugs Authority (FDA) to ensure a total recall of the drug from the market.

  By Jamila Akweley Okertchiri