Medical Product Warning no. 6/2019 (English version)

Counterfeit hydrochlorothiazide (containing glibenclamide) in Cameroon

This medicinal product alert applies to confirmed counterfeit hydrochlorothiazide found to contain glibenclamide instead of hydrochlorothiazide circulating in the WHO African Region. The adverse effects attributed to these products have been reported. True hydrochlorothiazide is used as an antihypertensive and diuretic drug, while glibenclamide is an antidiabetic drug.

In March 2019, a non-governmental organization in Cameroon was notified by the WHO that a drug representing 50 mg of hydrochlorothiazide caused hypoglycemia in patients. Preliminary studies showed that the product did not contain any of the above active ingredients, instead hydrochlorothiazide and glibenclamide were identified. Verification from this manufacturer confirmed that this product was false. Local health authorities were notified of this incident.

Table 1: Counterfeit product data hydrochlorothiazide 50 mg, subject to WHO medical device alert No. 6/2019

This product is presented in plastic containers of 1000 tablets each. The mark is in French and English.

Further confirmatory laboratory analysis revealed that the product:

• does not contain any expected active ingredient, hydrochlorothiazide, but
• contains approximately 5 mg of glibenclamide.

This poses a risk to patients taking hydrochlorothiazide for the treatment of hypertension. It should
it should be noted that hypoglycemia in Cameroon patients is attributed to the use of the above
hydrochlorothiazide with batch number 16G04.

The sticker on the plastic container of this product lists Sterop as a manufacturer. However, this company has
confirmed by WHO that:

• did not manufacture or supply the above product, i
• the batch number, as well as a number of other features shown on the label, do not match the original
  production records.

The WHO is demanding greater vigilance in the supply chains of the countries that these counterfeiters could influence
medical product. Increased alertness should include hospitals, clinics, health centers, wholesalers, distributors,
pharmacies and any other suppliers of medical products.

If you own the above specific product, do not use it. If you took this fake doctor
product, or if you have a harmful event or unexpected lack of performance, seek advice immediately
qualified health care provider and ensure that they report the incident to the local Ministry of Health / National
Medicines Regulatory Authorities / National Pharmacovigilance Center.

All medical products must be obtained from credible and reliable sources. Their authenticity and condition
should be carefully checked. If in doubt, seek the advice of a healthcare professional.

The national health authorities ask you to notify WHO immediately if this counterfeit medical device is discovered
in their country. If you have any information on the production, distribution or supply of this medicine
contact the product [email protected]

WHO Global Surveillance and Surveillance System
for substandard and counterfeit medical products

For more information, visit: http://www.who.int/medicines/regulation/ssffc/en/

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