Invima issues alert for counterfeit batch of cancer drug in Colombia: urges suspension of use
The National Institute for Drug and Food Surveillance (Invima) issued a health alert on Tuesday after detecting the circulation in Colombia of a counterfeit batch of the oncology drug MABTHERA® Vial 500 mg/50 mL. The identified product corresponds to batch N7747, with a manufacturing date of October 2023 and an expiration date of October 2026.
The warning came after the pharmaceutical company F. Hoffmann-La Roche Ltd., the holder of the sanitary registration, reported that the batch is not included in the approved presentations in either Colombia or Mexico, confirming its fraudulent nature.
The institute confirmed the fraudulent circulation of MABTHERA® 500 mg/50 mL, with lot number N7747. Photo: iStock
According to Invima (National Institute of Food and Drug Administration), the counterfeit product's packaging presents multiple irregularities compared to the original. These include variations in the graphic design and typography, spelling errors such as "infusion" instead of "infusion" (in italics) or "public" instead of "publico" (public), alterations to the silver holographic label that doesn't match the dimensions or the QR code , cut edges on the labels, and inconsistencies in the box's barcode.
"This finding alerts us to the serious risks that counterfeit medicines pose to the health of Colombians. The legitimate medicine, MABTHERA® Concentrated Infusion Solution 500 mg/50 mL, has a valid health registration in Colombia and is distributed solely by the registered health authority," said William Saza Londoño, coordinator of the Invima Pharmacovigilance Group.
The fraudulent batch of MABTHERA® has errors in packaging and labels. Photo: Invima
The agency urged patients, caregivers, and healthcare professionals to refrain from purchasing or using the counterfeit batch, verify the authenticity of the medications on the official Invima website , and report any suspicious marketing channels to the authorities. It also recommended immediately suspending consumption of the product if purchased and reporting potential adverse events to [email protected] or through the VigiFlow platform.
The organization also urged territorial health departments, private health insurance providers (IPS), and pharmaceutical establishments to strengthen inspection and control measures to prevent the distribution of the adulterated product. It also urged pharmacovigilance programs to actively search for possible adverse reactions associated with the consumption of the batch in question.
Invima reiterated that the only authorized channel for the sale of MABTHERA® in Colombia is the holder of the health registration and its official importer, and urged citizens to always purchase medications through verified sources.
Environment and Health Journalist
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