FDA Issues Alert On Expired Malaria Test Kits

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Delese Mimi Darko – FDA Boss

Dailyguide Africa  July 17, 2018

The Food & Drugs Authority (FDA) has issued a warning to healthcare professionals to cease using an expired malaria rapid diagnostic test (RDT) kit called SD Bio Line Malaria, which it says is being sold on the market.

A statement issued in Accra and signed by FDA Chief Executive Officer Delese A. Darko said that although the kit was registered by the authority, its investigations have shown that the product has been “re-labeled” after expiration and was being sold.

According to the FDA, persons who use the kit may suffer inaccurate diagnosis, which may lead to severe health implications.

“The Food and Drugs Authority wishes to alert the general public of an expired malaria Rapid Diagnostic Test (RDT) kit being offered for sale on the Ghanaian market. The FDA has investigated a complaint and established the fact that persons have tampered with the product information on the said expired kit,” the statement said.

“It is, therefore, a dangerous situation to have a test for malaria using the RDT kit, which would certainly produce a false result and may lead to inaccurate diagnosis,” it added.

The FDA also asked the public to furnish it with information should they see the said product anywhere on the Ghanaian market.

The 2012 Auditor General’s report before the Public Accounts Committee (PAC) of Parliament disclosed that a lot of unregistered drugs were imported into Ghana without the prior approval of the FDA.

Among the unregistered medicines which got unto the Ghanaian market between 2012 and 2013 per the Auditor General’s report are popular malaria drug Coartem and dewormer Zentel.

Others include Tres-Orix, Procold, Lofnac-50 tablet, Atenolol, Lofnac Eyedrops, Quine Syrup, among others.

In all, a total of 72 unregistered drugs were imported during that period. The report also revealed that seven drugs were brought into the country “before the importers applied for permit from the FDA.”

Mrs Darko subsequently assured her outfit is on top of issues to ensure citizens are safe.

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