NAFDAC’s Director General (DG), Moji Adeyeye, in a statement on Tuesday, April 23, 2019, in Abuja, said the drug, Hydrochlorothiazide 50mg (containing Glibenclamide) is currently circulating in Cameroon.
“NAFDAC is alerting the public, especially healthcare providers on the circulation of confirmed falsified Hydrochlorothiazide 50mg tablets in Cameroon,” she said.
“The falsified product has been found to contain Glibenclamide instead of Hydrochlorothiazide.
“In March 2019, the World Health Organisation (WHO) was informed by an NGO in Cameroon that a medicine, presented as Hydrochlorothiazide 50mg tablets, has caused hypoglycaemia in patients.
“Confirmatory laboratory analysis has established that the product did not contain hydrochlorothiazide, the stated active ingredient, glibenclamide was instead identified,” Adeyeye added.
She explained that the genuine version of the drug was for treatment of hypertension.
According to her, the falsified medicine poses grave danger to patients.
“Hydrochlorothiazide is used as an anti-hypertensive and diuretic medicine, whereas Glibenclamide is an anti-diabetic medicine.
“The falsified medicine presents a risk for patients who are taking hydrochlorothiazide for the treatment of hypertension.
“The label on the plastic container of this falsified product states Laboratoires Sterop as the manufacturer, however, this company has confirmed to WHO that it did not manufacture or supply the falsified product.
“The Falsified hydrochlorothiazide 50mg is presented in plastic containers of 1000 tablets each,” she said.
The NAFDAC DG further said the drug which had a batch number of 16G04, also carried 16/2017 as its Manufacture Date and 30/05/2021 as expiry date.
“The batch number, as well as a number of other features shown on the label of the falsified Hydrochlorothiazide 50mg tablets, do not correspond with genuine manufacturing records. The label is English and French languages.”
She advised importers, wholesalers, and retailers to avoid illegal importation and sale of the drug in Nigeria as surveillance had been heightened to prevent such.
“Surveillance has been strengthened by NAFDAC at all ports of entry to prevent importation of the falsified Hydrochlorothiazide 50mg tablets from Cameroon.
“NAGDAC has also heightened surveillance to prevent distribution and sale of the falsified product.
“Healthcare providers and other members of the public are advised to be vigilant and contact the nearest NAFDAC office with any information on the product,” she said.
She further advised those already in possession of the drug to submit it to the nearest NAFDAC office.