The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a public advisory regarding the voluntary nationwide recall of two lots of Brexafemme (ibrexafungerp tablets) 150 mg in the US market.
This action is being undertaken by Scynexis, Inc., following notification from the United States Food and Drug Administration (FDA).
The recall is prompted by the potential cross-contamination of the active ingredient used in the manufacturing process of Brexafemme tablets with a non-antibacterial ß-lactam drug substance.
Scynexis identified this risk during a review of manufacturing equipment and cleaning activities at one of its suppliers.
Why it matters
Brexafemme is an anti-fungal product prescribed for the treatment of vulvovaginal candidiasis (VVC) and the reduction of the incidence of recurrent vulvovaginal candidiasis (RVVC).
The potential risk associated with this recall is the cross-contamination with a non-antibacterial ß-lactam drug substance, which may lead to hypersensitivity reactions including swelling, rash, urticaria, and anaphylaxis—a potentially life-threatening adverse reaction.
Scynexis has not received any reports of adverse events linked to the possible beta-lactam cross-contamination to date.
Products details
NAFDAC noted that Brexafemme (ibrexafungerp tablets) 150 mg is not registered by NAFDAC. While the product is not found in the NAFDAC database, there is a possibility that it may have entered the country through informal markets.
NAFDAC urges importers, distributors, retailers, healthcare providers, and patients to exercise utmost caution and vigilance within the supply chain to prevent the importation, distribution, sale, or administration of falsified or substandard medicinal products.
All medical products should be sourced from authorized and licensed suppliers, with careful verification of authenticity and physical condition.
The agency strongly advises anyone in possession of the recalled product to not use it. Individuals who have used the product or experienced adverse reactions are urged to seek immediate medical advice from qualified healthcare professionals.
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