NAFDAC warns against use of amoxicillin product over safety concerns

The National Agency for Food and Drugs Administration and Control (NAFDAC) has warned against the use of the Deekins Amoxicillin 500mg capsules due to its adverse effects on users.

According to a recent statement by the agency, the Deekins Amoxicillin 500mg capsules with batch number 4C639001 were recalled by its manufacturer, Ecomed Pharma Limited, a Nigerian pharmaceutical company, after multiple reports of severe reactions.

“The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the recall of one batch of Deekins Amoxicillin 500mg Capsule, manufactured by Ecomed Pharma Ltd and marketed by DevineKings Pharmaceutical Ltd, with lot number 4C639001,” it said.

Manufacturer’s decision

NAFDAC said the manufacturer made the decision to recall after an unidentified hospital reported three cases concerning drug reactions linked to the product.

NAFDAC said: “This drug batch is being recalled following reports of severe adverse drug reactions.

“According to Ecomed Pharma Ltd, reports of serious adverse drug reactions were received from a hospital that reported three cases of serious adverse drug reactions from patients administered with the batch of Deekins Amoxicillin 500mg capsule”.

About amoxilling

Amoxicillin is a broad-spectrum antibiotic, effective against various bacterial infections such as respiratory tract infections, ear infections, skin infections, and urinary tract infections.

Amoxicillin is one of the most affordable antibiotics in Nigeria, where bacterial infection is prevalent.

Antibiotics is sold under various generic and branded names including the Deekins Amoxicillin 500mg capsule, making it accessible even in rural areas. The affordability makes it a first-line treatment option for many healthcare providers and individuals.

“Consequences could be life-threatening”

However, NAFDAC said adverse drug reactions to such drugs can have life-threatening consequences, including hospitalisation, significant disability, or even death.

The agency has warned health workers against dispensing the Deekin Amoxicillin capsule and the public against usage.

“An adverse reaction to drugs may be life-threatening, may require hospitalisation or prolongation of existing hospitalisation, result in persistent or significant disability or incapacity, or is a birth defect or death in fatal cases,” it said.

The agency also implored distributors within the supply chain to avoid distributing, administering, or selling the affected product.

It also said: “All medical products must be obtained from licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

“Anyone in possession of the affected lot is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office.

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“If you have used this product, or someone you know, has used it, or suffered any adverse reaction/event after use, are advised to seek immediate medical advice from a qualified healthcare professional.”

The agency has also asked healthcare professionals and patients to report any adverse events or side effects associated with using this medicinal product.

NAFDAC also urged citizens to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office.