Counterfeit cancer drug found on Kenyan market: Pharmacy and Poisons Board warns
The Pharmacy and Poisons Board (PPB) has asked Kenyans to be on alert for a batch of falsified Herceptin 440 mg (Trastumuzab 440 mg), which is said to have flooded the market.
Herceptin is a drug that is currently approved by the US drugs regulatory agency, the Food and Drug Administration (FDA), to treat metastatic HER2-positive breast cancer and stop the cancer from growing.
It does so either as part of a regimen with chemotherapy or alone after a chemotherapy regimen that includes an anthracycline( a type of antibiotic that comes from certain types of bacteria) to reduce the risk of the breast cancer coming back (recurrence).
Herceptin can also be used in combination with Perjeta and Taxotere before surgery to treat HER2-positive, early-stage cancer which must be larger than two cm or cancer that is in the lymph nodes, inflammatory, or locally advanced-stage breast cancer with a high risk of metastasizing or becoming fatal, the FDA says.
“In combination with Perjeta and chemotherapy after surgery to treat HER2-positive, early-stage breast cancer with a high risk of recurrence,” FDA states.
According to PPB, the product batch in the country is claimed to be manufactured in Germany by Roche Products Limited.
“It bears batch number C5830083. Mfg. Date 12/2021, Exp. Date 11/2024. The public is notified that this specific product is a confirmed counterfeit and is not authorized to be sold in the market,” PPB said in an official statement on Saturday.
“It is a falsified product in view of the falsified contents, packaging, labelling, aspects which have been confirmed by the brand owner,” PPB CEO Dr Fred Siyoi warned.
The CEO further cautioned the public, urging Kenyans to keep of the counterfeit drug.
“PPB cautions the public against the use, supply, sale or distribution of the product batch number C5830083 as their safety, quality and efficacy CANNOT be assured,” he said.
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For this reason, the PPB in collaboration with government investigative agencies has put in place legal and regulatory actions against individuals perpetrating illegal activities in contravention of PPB Act( Cap 244).
Dr Siyoi said PPB has also initiated a rapid response and heightened surveillance of the market to ensure public health is protected.
“We would like to assure the public that PPB has established robust market surveillance and control system that continuously monitors the quality and safety of medical products in the Kenyan market,” the CEO said while urging Kenyans to report and volunteer information on suspicious activities that may be related to such acts of falsification as well as all suspicious, substandard and falsified medical products to PPB via pv@ppb.go.ke or +254795743049.
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