KENYA—The Pharmacy and Poisons Board (PPB), a Kenyan drugs regulator, has issued an advisory to the public regarding a suspect batch of Herceptin 440mg (Trastuzumab 440mg).

Trastuzumab, also known as Herceptin, Herzuma, and Ontruzant, is a cancer treatment that inhibits the proliferation of cancer cells in the body.

It specifically targets the human epidermal growth factor 2 (HER2) protein, which allows cancer cells to proliferate and divide, making it an effective treatment for breast cancer, advanced stomach cancer, and advanced gastro oesophageal cancer.

Roche Products Ltd markets Herceptin 440 mg powder as a concentrate for infusion solutions in Kenya under the brand Herceptin.

This notification follows an inquiry by the regulator into a Herceptin 440mg product batch alleged to be manufactured in Germany by Roche Products Ltd for the Kenyan market.

The regulator’s findings indicated that batch number C5830083 of the medicine was created in December 2021, was slated to expire in November 2024, and was proven to be counterfeit.

According to PPB, this product is not approved for sale in the market and is a falsified product due to the false contents, packaging, and labeling characteristics certified by the brand owner.

As a result, the PPB has advised the public not to use, provide, sell, or distribute the product batch number C5830083 since its safety, quality, or efficacy cannot be guaranteed.

Furthermore, the PPB, in partnership with government investigative agencies, has taken legal and regulatory procedures against people suspected of engaging in illicit operations in violation of the Pharmacy and Poisons Act (Cap. 244).

 To preserve the safety and health of the public, the PPB has launched a swift response and increased market surveillance.

This incident is not an isolated case, as the PPB has previously taken action against counterfeit or substandard drugs in the market. 

In November 2023, the regulator issued a warning concerning counterfeit HIV prevention drugs, specifically Truvada, identifying two batches (B4033894D and B425875D) falsely labeled as Truvada.

In another recent incident involving Benylin Pediatric 100ml cough syrup manufactured by Johnson & Johnson {Pty}, South Africa, the PPB initiated a recall of batch No. 329304. 

This action was prompted by a similar recall by the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria, citing quality concerns related to high levels of diethylene glycol detected through laboratory analysis.

In response to these incidents, the PPB has commenced investigations and implemented rapid response measures, including the screening of batches of Benylin Pediatric 100ml syrup for ethylene glycol and diethylene glycol levels. 

With all of these initiatives, the Board is committed to ensuring that only approved health products are utilized, and it urges the general public and healthcare providers to report suspected substandard and false medical items as soon as possible.

These proactive measures are essential for safeguarding public health amidst growing concerns about counterfeit drugs in Kenya, as substandard and falsified medicines pose a significant threat, potentially leading toto fatalities.

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