NAFDAC Warns Against Unregistered Menopause Capsules

It warned that some ingredients contained in the circulating Menofix Composition have been linked to rare but serious liver-related adverse effects, including hepatitis, elevated liver enzymes, jaundice and liver failure.

The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians against the sale, distribution, purchase and use of an unregistered menopause support supplement marketed as Menofix Composition, citing potential health risks.

In a public alert issued on Tuesday, the agency said the warning followed a complaint over the marketing and sale of the product, which is promoted as a hormone-free, vegetarian-friendly multivitamin and herbal supplement for women experiencing perimenopause and menopause.

NAFDAC said investigations by its Post-Marketing Surveillance Directorate confirmed that the product is not registered with the agency and differs from similarly named products that have valid approvals.

According to the regulator, the only registered products bearing the Menofix name are Menofix Herbal Capsule (NAFDAC Reg. No. A7-103321L) and Menofix Powder (NAFDAC Reg. No. A7-103342L), both manufactured by Gudugudu Herbal Worldwide Enterprises under the herbal and nutraceutical category.

The agency noted that the unregistered product is being sold over the counter, through online platforms and in open retail outlets.

It warned that some ingredients contained in the circulating Menofix Composition have been linked to rare but serious liver-related adverse effects, including hepatitis, elevated liver enzymes, jaundice and liver failure.

NAFDAC said it has intensified surveillance to trace the product's distribution chain and remove it from circulation.

It added that all zonal directors and state coordinators have been directed to conduct market surveillance and confiscate the unregistered product wherever it is found.

The agency advised retailers, healthcare professionals and consumers to refrain from selling, purchasing or using unregistered medical products, urging Nigerians to obtain medicines only from authorised or licensed suppliers and to verify their authenticity before use.

NAFDAC also encouraged healthcare professionals and members of the public to report suspected cases involving substandard or falsified medicines and medical devices to the nearest NAFDAC office.