Public warned over unregistered and substandard cancer drug in the market
By Lucy Mumbi |
In a statement on Wednesday, the PPB expressed concern that the unregistered and substandard version of this critical drug poses significant risks to patients' health.
The government has issued a warning about the presence of an unregistered and substandard drug, Floracil 1000 (Fluorouracil 1000mg/2ml) Injection, manufactured by Bruck Pharma PVT LTD, India.
The Pharmacy and Poisons Board (PPB) flagged the product during routine post-market surveillance, cautioning healthcare professionals and the public against its trade, distribution, or use.
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Fluorouracil, the active ingredient in Floracil 1000, is commonly used to treat certain types of cancer, including adenocarcinoma of the colon and rectum, breast, stomach, and pancreas.
In a statement on Wednesday, the PPB expressed concern that the unregistered and substandard version of this critical drug poses significant risks to patients' health.
It noted that the sale and administration of unregistered health products contravene the Pharmacy and Poisons Act (CAP 244).
"During routine post-market surveillance (PMS) activities, the Board identified an unregistered and substandard product, Floracil 1000 (Fluorouracil 1000mg/2ml) Injection, manufactured by Bruck Pharma PVT LTD, India," the Board said.
"In light of this, the Board strongly cautions the public and healthcare professionals against the trade, distribution, wholesale, retail, issuance, dispensing, use, or administration to patients of this product."
It, however, assured the public that it is working with government investigative agencies to take regulatory and legal action against individuals responsible for introducing the product into the market.
Healthcare professionals and the public have been urged to report any suspected cases of substandard or falsified health products, or adverse drug reactions, through the PPB channels such as their online portal; https://pv.pharmacyboardkenya.org/users/mpublic or USSD code: *271#
Users can also report through the mobile application: mPvERS (available on Android and iOS) or Email: [email protected] or [email protected] or telephone contact 0795743049.
The PPB reiterated its commitment to safeguarding public health, calling for vigilance and cooperation to ensure the safety and quality of health products and technologies in Kenya.
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