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Friday, December 2, 2022

FDA reacts to WHO’s caution against 4 paediatric medicines found in The Gambia

Food and Drugs Authority (FDA)

The Food and Drugs Authority (FDA) has confirmed the World Health Organization’s (WHO) identification of four substandard medicinal products in The Gambia.

The four products are; Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

The manufacturer has been identified as Maiden Pharmaceuticals Limited based in Haryana, India.

In a statement, FDA explained laboratory analysis of the products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

But as of October 5, FDA’s statement noted Maiden Pharmaceuticals Limited had still not provided safety and quality guarantee of these products to the WHO.

“The FDA would like to inform you that these products have not been registered by the Authority and are not expected on the Ghanaian market, however, they may have been distributed illegally,” the statement cautioned.

FDA concurs with WHO's caution against four substandard paediatric medicines found in The Gambia
The contaminated paediatric medicines identified by the WHO

The statement added that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.

Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

FDA concurs with WHO's caution against four substandard paediatric medicines found in The Gambia

Meanwhile, FDA has urged all healthcare professionals to report suspected falsified medicinal products to the FDA using the link http://adr.fdaghana.gov.gh or call mobile number 024431 0297.

The Authority further assured it has strengthened post-market surveillance activities at the borders and across the country with the view to identify and withdraw any unregistered products on the Ghanaian market.

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