NAFDAC warns towards counterfeit Herceptin most cancers drug allegedly sourced from Nigeria, circulating in Ghana
The Nationwide Company for Meals and Drug Administration and Management (NAFDAC) has raised a public well being alert over the circulation of a counterfeit batch of Herceptin® 600mg/5ml (Trastuzumab Resolution for Injection) in Ghana, allegedly bought from Nigeria.
The alert was issued on Thursday and revealed on the official NAFDAC web site.
In line with the company, the counterfeit product, recognized by batch quantity A8519, doesn’t correspond to any genuine batch produced or marketed by Roche, the unique producer of the drug.
“This counterfeit was reportedly offered by a affected person at a hospital in Kumasi, who claimed to have bought it in Nigeria,” NAFDAC said.
Herceptin® 600mg/5ml injection is used to deal with breast most cancers in circumstances the place the tumor exams constructive for HER2.
“It might be administered alone or alongside different therapies for breast most cancers, resembling an aromatase inhibitor for hormone receptor-positive breast most cancers or a taxane, like paclitaxel or docetaxel,” the company defined.
How you can establish the counterfeit Herceptin
NAFDAC said that the faux Herceptin may be recognized via a number of packaging and labeling inconsistencies, together with an invalid batch quantity: A8519, not acknowledged by Roche.
Packaging flaws, resembling Inconsistent font sorts, misplaced label textual content, and variable knowledge, and tamper-evident seals that differ from these used on genuine Roche merchandise.
Dangers of counterfeit medicines
NAFDAC highlighted that the counterfeit product could comprise substandard, falsified, or no lively pharmaceutical ingredient (trastuzumab), rendering remedy ineffective.
“Unknown chemical contents pose a threat of antagonistic drug reactions, together with allergic reactions, systemic toxicity, or different extreme well being outcomes.
“Use of falsified oncology merchandise compromises the integrity of therapeutic regimens, probably resulting in illness development or mortality,” the company said.
The company directed all its zonal administrators and state coordinators to hold out surveillance and mop up the counterfeit Herceptin® 600mg/5ml resolution for injection if discovered throughout the zones and states.
“Distributors, retailers, healthcare professionals, and caregivers are hereby suggested to train warning and vigilance throughout the provide chain to keep away from the distribution, sale, and use of counterfeit merchandise.
“All medical merchandise should be obtained from licensed/licensed suppliers. The merchandise’ authenticity and bodily situation ought to be rigorously checked.
“Healthcare professionals and customers are suggested to report any suspicion of sale of substandard and falsified medicines or medical gadgets to the closest NAFDAC workplace, ” the company suggested.
NAFDAC additionally urged healthcare professionals and sufferers are additionally inspired to report antagonistic occasions or unwanted effects associated to using medicinal merchandise or gadgets to the closest NAFDAC workplace, or via using the E-reporting platforms accessible on the NAFDAC web site www.nafdac.gov.ng.
