REGULATIONS

DEREGISTRATION AND WITHDRAWAL OF GENTAMYCIN 280 MG INJECTION

The National Agency for Food and Drug Administration and Control (NAFDAC) hereby informs healthcare providers and the general public on the deregistration and subsequent withdrawal of Gentamycin 280mg Injection from circulation.

This regulatory action is consequent upon recent safety data associating the use of high dose, single unit Gentamycin Injection with ototoxicity, nephrotoxicity and increase incidence of endotoxin reactions (anaphylactic shock, haemorrhage, fribinolysis, hypotension, inflammation, vascular coagulation etc).

The decision to withdraw Gentamycin 280mg Injection by the Agency is in agreement with International Best Practices which disapproves the use of high dose Gentamycin Injection.

Consequent on the above, NAFDAC hereby advice as follows:

· The prescription and administration of 280mg Gentamycin Injection as single dose should hence forth be discontinued.

· Market Authorization Holders of Gentamycin 280mg Injection in Nigeria are hereby directed to commence the recall of the product from circulation within 3 months of this publication, following which NAFDAC will effect a nationwide mop up.

· The general public is encouraged to report any adverse reaction to medicines to their prescriber/source of the medicine for proper review and appropriate documentation in the Adverse Drug Reaction (Yellow Form) Form.

Please note that the lower strengths of Gentamycin Injection are NOT affected by this withdrawal. Duly registered Gentamycin 10mg, 40mg, 80mg and other approved lower strengths of the Injection are available for clinical use in Nigeria.

NAFDAC is in consultation with the Market Authorization Holders of Gentamycin 280mg Injection in Nigeria to ensure the effective implementation of this directive.

SIGNED: MANAGEMENT

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