National agency for food and drug administration and control (NAFDAC) has again warned against the continued distribution, sale and use of banned products by some unscrupulous healthcare providers, patent medicine vendors and other pharmaceutical outlets. Some of the banned products ( active substance) and grounds for decision are listed as follows
- NAFDAC directed marketing authorization holder in Nigeria to vouluntrly withdraw product from circulation in Nigeria within 6 months. Total recall to be effected by june 2012. Agency to carryout mop up of products remaining in circulation by june 2012. Risk of congestive heart failure
2) GENTAMYCIN 280mg
- Deregistration of 280mg and mop up from circulation. Public alert on action taken due to increased risk of ototoxicity, impaired hearing, deafness, nephrotoxicity and increased risk of endotoxin reactions with some recorded deaths
3) TEETHING MIXTURE
- Deregistration and ban o all teething mixture in circulation in Nigeria. Low benefit/risk ration
- Restriction of registration of product due to report on liver toxicity. Product had no obbbious advantage over extisting NSAID that are already in the market.
- Ban due o serious ADR’s reported e.g toxic epidermal necrolysis (TEN) and recorded death
6) CHLORPROGUANIL- DAPSONE
- voluntary withdrawal by NAFDAC and GSK. cardiovascular risk
- ban of cough and cold remaedies containing this active, directives from the agency for replacement of acties wih the sympathomimetic agents
8) MERCURY CONTAINING CREAMS AND SOAP
- ban on creams and soap conaining mercury cause dermatitiss, cumulative toxicity causes damage to kidneys which could manifest as hypertension and fatal kidney failure
9) COSMETIC PRODUCTS CONTAINING CORTICOSTERIODS
- ban on cosmetic products containing corticosteroids. prolonged use on the skin causes recalcitrant acne, red straie, excessive hairiness, proneness o infections. absorption through the skin could manifest as severe hypertension, diabetes and cataract.
10) CREAMS CONTAINING HYDROQUINONE > 2%
- Ban on creams containing hydroquinone >2%. exogenous ochronosis which manifests as a dirty brown pigmentation on sun exposed areas, loss of skin elasticity
11) POTASSIUM BROMATE AS DOUGH IMPROVERS/INGREDIENTS IN FLOUR AND BREAD IMPROVERS
- banned and removed from the list of permitted food additives. decomposes vit A, B, B2 AND E. implicated in kidney failure and hearin loss
- ban on use in human due to agranulocytosis
in order to guarantee public safety, NAFDAC hereby directs as follows
- all pharmacies, patent medicine vendors, healthcare facilities and other sales outlet that have these products in stock should submit them to the nearest NAFDAC office fo destruction
- NAFDAC hereby advises the general public to desist from the use of these offensive products and report to the nearest NAFDAC office anyone suspected to be stocking, distributing o selling them by sending sms to these hotlines
08133630600, 08058741647 fo immediate action
NAFDAC: safeguarding & protecting the health of the nation.
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