The National Agency for Food and Drug Administration and Control (NAFDAC) has over the years placed a ban or withdrawn the registration on prior approved drugs due to reported cases of adverse side effects and other health-related risks. Some of these drugs include:
Drug Name: Rosiglitazone
Brand/Trade Name: Avandia
In June 2012, diabetes drug Avandia was banned from circulation in the Nigerian market following a directive from NAFDAC. The drug was banned due to fears that it increases the risk of heart attack and strokes in patients.
Avandia was similarly banned in Europe but in the United States, although the Food and Drug Administration (FDA) decided to severely limit the availability of Avandia, it did not issue an outright ban.
2. 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 10mg, 40mg, 80mg and other approved lower strengths of the injection are available for clinical use in Nigeria.
Drug Name: Dipyrone
Brand/Trade Names: 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, Drunalgin, 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.
This articles was originally published as part of NLIPW Patents Law Vol. 1 No. 11, July 7, 2013. The article is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances.