The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians, including healthcare providers, about Phesgo, a suspected counterfeit cancer treatment drug.

The alert on the circulation of the drug was published on the agency’s website.

NAFDAC said a doctor at the Lagos University Teaching Hospital (LUTH) had raised concerns about the drug after a patient brought it in.

The agency said the product had not been administered, but it matched the characteristics of a previously reported counterfeit batch, C3809C51.

“The National Agency for Food and Drugs Administration and Control (NAFDAC) wishes to inform healthcare providers and the public of a report of a suspected counterfeit Phesgo® 600mg/600mg/10ml, labelled with batch C5290S20,” the statement reads.

“The Marketing Authorisation Holder (MAH) Roche received a complaint from a doctor at Lagos University Teaching Hospital (LUTH-NSIA) reporting a suspected counterfeit Phesgo® 600mg/600mg, labelled with batch C5290S20.

“The product was reported to have been brought in by a patient for administration. It had not been administered at the time of the report, as it matched the previously reported counterfeit batch: C3809C51.

“Although no sample was returned to Roche for investigation, only pictures displaying parts of a Phesgo® 600mg/600mg in a 10ml folding box and a labelled vial.

“Images of the suspected product were examined by Roche and compared to the genuine samples retained for reference.

“Although no physical sample was returned to Roche for investigation, images of parts of the product specifically, a Phesgo 600mg/600mg vial and a 10ml folding box were examined.

“The suspected product’s images were compared to genuine samples retained by Roche.

“Roche’s investigation identified several significant differences between the complaint sample and genuine materials, confirming the counterfeit status of the batch.

“These included: no batch number in the MAH database, discrepancies in language, missing basilisk, incorrect bollino date, and tampered evidence labels that did not match genuine Roche materials.”

NAFDAC added that “since no physical sample was available for chemical analysis”, the investigation was “limited to visual comparisons”.

Vivek Murthy, US surgeon-general, has called for new warning labels on alcoholic drinks that inform consumers of the increased risk of cancer.

The surgeon-general’s advisory is a public statement that calls American people to an urgent public health issue and provides recommendations.

Advisories are reserved for significant public health challenges that require the nation’s immediate awareness and action.

In the advisory published on Friday, the surgeon-general said there is extensive evidence that alcohol causes cancer in many ways.

According to the advisory, alcohol breaks down into acetaldehyde in the body, which causes cancer by binding to DNA and damaging it.

“Alcohol generates reactive oxygen species, which increase inflammation and can damage DNA, proteins, and lipids in the body through a process called oxidation,” the advisory reads.

“Alcohol alters hormone levels (including estrogen), which can play a role in the development of breast cancer.

“Carcinogens from other sources, especially particles of tobacco smoke, can dissolve in alcohol, making it easier for them to be absorbed into the body, increasing the risk for mouth and throat cancers.”

The surgeon-general said to reduce cancer risk, the US should “update the existing surgeon-general’s health warning label on alcohol-containing beverages to include a warning about the risk of cancer associated with alcohol consumption”.

He said the US should also pursue changes to label characteristics to make the warning label “more visible, prominent, and effective” in increasing awareness about cancer risks associated with alcohol consumption.

He also said the country should “reassess recommended limits for alcohol consumption to account for the latest evidence on alcohol consumption and cancer risk”.

“Strengthen and expand education efforts to increase general awareness that alcohol consumption causes cancer. Inform patients in clinical settings about the link between alcohol consumption and increased cancer risk,” he added.

“Promote the use of alcohol screening and provide brief intervention and referral to treatment as needed.”

The National Agency for Food and Drug Administration and Control (NAFDAC) has raised the alarm over the circulation of “counterfeit” Paludex tablets and suspensions in Nigeria.

The agency said the drugs, labelled as Paludex (Artemether/Lumefantrine), are manufactured by Impact Pharmaceutical Ltd, and Ecomed Pharma Ltd, Enugu and marketed by MD Life Sciences Ltd, Enugu.

The statement said laboratory tests conducted by a WHO-prequalified laboratory in Germany and NAFDAC revealed that the products contain zero percent active pharmaceutical ingredient (API), rendering them ineffective and potentially harmful.

NAFDAC warned that the products are not on its registered database and all NAFDAC registration numbers stated on the products are false.

“Genuine Artemether/Lumefantrine tablets or suspension is a combination of the two medications Artemether and Lumefantrine used to treat acute, uncomplicated malaria in adults and children,” the statement reads.

“The illegal marketing of medicines or counterfeit medicines poses a great risk to the health of people; by not complying with the regulatory provisions, the safety, quality, and efficacy of the products are not guaranteed.

“Also, poor-quality pediatric formulations or medicines in general have the potential of causing treatment failure when the API content is below the prescribed dose.

“All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the falsified products within their zones and states.

“NAFDAC implores distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, administration, and use of the products.

“All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.”