NAFDAC Expresses Concern About the Spread False Herceptin 600mg In Nigeria

The public and medical professionals have received a warning from the National Agency for Food and Drug Administration and Control (NAFDAC) regarding the distribution of a verified fake batch of Herceptin 600 mg in Nigeria.

In a statement, the agency revealed that the alarm came after formal correspondence from Roche Nigeria, which verified the existence of a counterfeit batch of the cancer medication with batch number A8519B34 in Lagos State.

The public and medical professionals are being informed by the National Agency for Food and Drug Administration and Control (NAFDAC) about a proven counterfeit batch of Herceptin 600 mg that is in circulation in Nigeria.

According to the statement, “This alert comes after official communications from Roche Nigeria confirming a counterfeit case of Herceptin 600 mg with batch number A8519B34 reported in Lagos State, Nigeria.”

A prescription drug called Herceptin, sometimes referred to as trastuzumab, is used to treat some forms of stomach and breast cancer. It is often administered by injection or infusion, frequently in conjunction with chemotherapy, and functions by reducing or preventing the proliferation of cancer cells.

The problem was discovered, according to NAFDAC, following a customer’s complaint that a chemist in Lagos was selling the allegedly fraudulent product for N50,000 less than the going rate.

The Marketing Authorisation Holder (MAH) reports that a client complained about a fake batch of Herceptin 600 mg. According to the statement, a chemist in Lagos allegedly provided a customer the fake batch of the pharmaceutical for N50,000 less than the going amount.

According to the agency, pictures of the suspected counterfeit medicine and the authentic Herceptin 600 mg packaging were compared by Roche Nigeria, the Marketing Authorisation Holder (MAH). The results revealed distinct variations.

Following an inquiry, the MAH (Roche Nigeria) contrasted the images of the fake Herceptin 600 mg that the complaint had supplied with the actual Herceptin 600 mg box. According to the statement, “the comparison revealed significant differences from genuine packaging material, including wrong artwork, wrong expiration date, and incorrect 2D matrix code.”

NAFDAC added that since the number on the fake product did not appear in the manufacturer’s official records, it was impossible to track down the batch.

The batch number A8519B34 is not a valid Roche batch number for Herceptin, hence lot tracing is not feasible. The physical sample was not accessible for return, thus chemical analysis was not possible, according to the statement. The organization cautioned that patients using fake cancer medications run a significant risk of treatment failure and perhaps death.

“Incorrect or nonexistent active ingredients, dangerous impurities, or inappropriate dosage strengths can all be present in counterfeit cancer medications. The statement cautioned that this could lead to treatment failure, the advancement of the disease, severe adverse events, or even death.

To aid in identification, NAFDAC supplied information on the fake product. The maker of the counterfeit medication is identified as F. Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland, and it is branded as Herceptin 600 mg. It has the manufacturing date of January 2024, the expiration date of November 2026, and the batch number A8519B34.

The organization explained that F. Hoffmann-La Roche Ltd. in Basel, at the Kaiseraugst location in Switzerland, produces the authentic Herceptin 600 mg.

NAFDAC has instructed all of its state coordinators and zonal directors to step up surveillance and make sure the counterfeit product is taken out of circulation in the wake of the finding. According to the statement, “all NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the counterfeit product within the zones and states.”

Additionally, the FDA advised importers, distributors, merchants, healthcare professionals, and carers to exercise caution and refrain from dealing with counterfeit medical goods.

In order to prevent the importation, distribution, sale, and use of counterfeit goods, importers, distributors, retailers, healthcare providers, and carers are urged to exhibit caution and vigilance along the supply chain. Every medical product needs to be purchased from approved or licensed vendors. The statement further stated that the products’ physical condition and legitimacy should be thoroughly examined. The public and medical professionals were urged to report any suspected instances of phoney or inferior medications to the closest NAFDAC office or via official channels.

Additionally, the FDA requested that any negative reactions associated with medications or medical devices be reported via its proper channels.

According to the statement, “healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office or through the use of the e-reporting platforms available on the NAFDAC website.” The agency’s Reforms Unit is another channel for the public to file complaints.

In order to bolster international monitoring efforts, NAFDAC further stated that the notice will also be disseminated on the World Health Organization’s Global Surveillance and Monitoring System (GSMS). The message added, “Please take note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).”