A Quick Look at Some Drugs Banned by NAFDAC (Issue 4)

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Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has over the years placed a ban or withdrawn the registration of prior approved drugs due to reported cases of adverse side effects and other health-related risks. Some of these drugs include:

1. Chlorproguanil-Dapsone

Drug name: Chlorproguanil-Dapsone
Brand name: Lapdap

On October 2, 2003, GlaxoSmithKline (GSK) announced that NAFDAC had approved the sale of its drug consisting of chlorproguanil hydrochloride and Dapsone (Lapdap) for the treatment of malaria, a drug developed specifically for use in sub-saharan Africa. In 2005, Lapdap was voluntarily withdrawn from the Nigerian market by NAFDAC and GSK as a result of increasing evidence of cardiovascular risk.

2. Potassium Bromate as Dough Improvers/Ingredients in Flour and Bread Improvers

Drug name: Potassium Bromate

In 1993, NAFDAC by virtue of the powers conferred on it by Decree No. 15, made it a crime for local manufacturers in Nigeria to employ potassium bromate in preparation of food and consumables. NAFDAC began the enforcement of this directive on June 4, 2004.

Other countries like Canada, Greece, Japan and the United States have also banned the use of potassium bromate for its implication in cancer, kidney failure, loss of hearing and breakdown of vitamins. In 1992, at the thirty-ninth meeting of the WHO Expert Committee on Food Addictives, the Committee banned the use of potassium bromate as bread improvers and removed it from the list of improvers generally regarded as safe.

3. Phenylbutazone

Drug name: Phenylbutazone
Brand name: Butazolidine

Since 2001, NAFDAC banned the use of phenylbutazone (often referred to as ‘bute’) in relation to any animal intended for human consumption in Nigeria because phenylbutazone is known to induce blood dyscrasias, including agranulocytosis, aplastic anemia, leukopenia, thrombocytopenia and deaths.

4. My Pikin (Teething Mixture)

Drug name: My Pikin Baby Teething Mixture
Contaminated Substance: Engine coolant, diethylene glycol

In 2009, NAFDAC banned Barewa Pharmaceutical Ltd, the manufacturer of “My Pikin Baby Teething Mixture” from selling their paracetamol-based syrup that killed 80 babies in Nigeria. This syrup was contaminated with engine coolant diethylene glycol. On May 17, 2013, a Federal High Court in Lagos convicted and sentenced two official of Barewa Pharmaceutical Ltd to seven years imprisonment.

This article is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances.

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About Bob Aroture 555 Articles
Bob is a Senior Editor and Content Development Manager at Nigerian Law Intellectual Property Watch. He holds a BS degree, with a major in biochemistry. He works directly with the Newsroom Team. His focus areas are technology and innovation, and pharmaceutical technology. Email: editorial@nlipw.com