The National Agency for Food and Drugs Administration and Control (NAFDAC) has over the years placed a ban or withdrawn the registration on prior approved drugs due to reported cases of adverse side effects and other health-related risks.
Banned by NAFDAC
Some of these drugs include:
1. Gentamycin 280mg
Drug Name: Gentamycin 280
Brand/Trade Name: Garamycin, Gentak
On October 7, 2010, NAFDAC announced a ban on Gentamycin 280mg, an antibiotic used in the treatment of bacterial infections. The use of high dose (280mg/2ml single unit) Gentamycin injection according to NAFDAC was associated with high risk ototoxicity, nephrotoxicity, and increased incidences of endotoxin reactions. Citing international best practices, NAFDAC deregistered and withdrew the high dose Gentamycin injection from circulation in the Nigerian market but was quick to point out that the lower strengths of Gentamycin injection were not affected by the withdrawal. According to NAFDAC, the duly registered Gentamycin 19mg, 40mg, 80mg, and other approved lower strengths of the injection are available for clinical use in Nigeria.
2. Dipyrone
Drug Name: Dipyrone
Brand/Trade Name: Novalgin, Analgin, Optalgin Drunalgin, Dr. Meyers Novalmin, Akarin etc.
On September 1, 2005, NAFDAC’s ban on all drugs containing dipyrone including Novalgin, Analgin, Optalgin, Drugnalgin, Dr. Meyers Novalmin and Akarin came into effect. The ban followed the discovery of two major cases of severe Adverse Drug Reactions involving two students in Delta State, Nigeria.
3. Nimesulide
Drug Name: Nimesulide
Brand/Trade Name: Nise, Nimulid
Effective November 8, 2007, NAFDAC announced a ban on fever and pain drug Nimesulide due to adverse side effects on the liver and resulting death. Nimesulide has been similarly banned in other countries including Spain, Turkey, and Finland. Interestingly, Nimesulide was never permitted to be sold in some countries including Australia, Britain, Canada and the United States.
4. Cisapride
Drug Name: Cisapride
Brand/Trade Name: Cisa, Syspride, Propulsid and Prepulsid
In Nigeria, Cisapride is currently banned by NAFDAC from being sold in the market due to high risk of death and because the adverse effects of these drugs outweigh the benefits.
In the U.S. Cisapride was voluntarily withdrawn from the market on July 14, 2000, following an assessment by the Food and Drug Administration (FDA) that it was likely to cause serious cardiac arrhythmias. Sale of Cisapride has also been banned in India (2011), Germany (June, 2000), Brunei (September 2000), United Kingdowm (July 2000) and Canada (August 2000) while a number of restrictions on these drugs are imposed in countries like New Zealand and Columbia.
5. Phenylpropanolamine
Drug Name: Phenylpropanolamine
Brand/Trade Names: Coartem (Green Blister Pack)
On September 13, 2007, NAFDAC’s ban on cold remedies and nasal decongestants containing Phenylpropanolamine (PPA) became effective. NAFDAC urged companies to reformulate their products to exclude PPA.
The ban followed earlier notification from the FDA alerting that it was taking steps to remove PPA from all drug products and the FDA’s request to drug companies in the U.S. to discontinue marketing of products containing PPA.
6. Coartem 20/120mg Tablets (Green Pack)
Drug Name: Coartem 20/120mg Tablets (Green Pack)
Brand/Trade Names: PPA, Accutrim
On March 8, 2023, NAFDAC notified the public of falsified green blister packs of Coartem 20/120mg tablets found in the North Central zone, particularly in Jos. Novartis, the manufacturer, had stopped producing authentic green blister packs in October 2021. NAFDAC banned the sale of all green blister packs. Coartem is used to treat uncomplicated malaria.
Stated Product Manufacturer: Novartis Pharmaceutical Corporation, Suffam, New York, USA.
| Batch No. | Manufacturing date | Expiry date |
| F2261 | 09/2019 | 09/2022 |
| F2261 | 05/2020 | 05/2023 |
| F2261 | 6/2021 | 06/2024 |
7. Paracetamol Suspension
Drug Name: Paracetamol Suspension
Brand/Trade Names: Para Clear
NAFDAC banned Para Clear, a substandard paracetamol suspension from Liberia. Lab tests revealed it contained toxic ethylene glycol, which can lead to altered mental states, kidney injury, and death.
8. Original Chest and Lung Tablets
Drug Name: Original Chest and Lung Tablets
Brand/Trade Names: Original Chest and Lung Tablets
On June 21, 2023, NAFDAC notified the public of an unregistered and substandard drug named “Original Chest and Lung Tablets” circulating in Nigeria. The product is not listed in the NAFDAC database and has been banned.
9. Artequin 600/750mg Tablets
Drug Name: Artequin 600/750mg Tablets
Brand/Trade Names: Artequin
NAFDAC issued an alert on counterfeit Artequin 600/750mg tablets found in Onitsha and Kaduna. The alert came from Occulus Pharmacare Ltd on behalf of Acino Pharma AG. The license for this medicine had expired and was formally withdrawn. Artequin is used to treat uncomplicated malaria caused by Plasmodium falciparum.
10. Anthrax Vaccines
Drug Name: Anthrax Vaccines
Brand/Trade Names: Not Registered
On September 1, 2023, NAFDAC discovered counterfeit anthrax vaccines circulating in livestock markets in Nasarawa, Kaduna, Kwara, and Oyo states during a local outbreak. Lab analysis showed the fake vaccines contained only water or sugar water. The authentic vaccine remains unregistered in Nigeria
