Kenya Regulators Ban Floracil 1000 and Quarantines Mefnac Suspension Over Safety Concerns

The Pharmacy and Poisons Board of Kenya has implemented an immediate ban on the distribution and usage of Floracil 1000 (Fluorouracil 1000mg/2ml injection), following a recent post-market surveillance that identified the drug as unregistered and substandard.

The Board’s announcement raises serious concerns about the safety and efficacy of this cancer treatment, which is manufactured by an Indian pharmaceutical company. Floracil 1000 is commonly utilized in the management of several cancer types, including gastric, esophageal, colorectal, and breast cancer.

Its mechanism involves inhibiting cancer cell gene functions, thus suppressing their proliferation. However, the discovery of its unregistered status prompted swift regulatory measures aimed at safeguarding public health. The Board has strongly cautioned healthcare professionals and the public against the trading, distribution, or administration of Floracil 1000, warning of potential severe health risks for those who flout this directive.

The Board has reiterated its commitment to working alongside governmental investigative agencies to pursue legal actions against any individuals or organizations that violate the ban, in accordance with the Pharmacy and Poisons Act (CAP 244). In a related development, the Board has issued a quarantine order for Mefnac Oral Suspension (Mefenamic Acid 50 Mg/5 ml) amid concerns that the product may be contaminated with Diethylene Glycol (DEG) or Ethylene Glycol (EG) at levels exceeding acceptable limits.

Mefnac is often used for its anti-inflammatory and analgesic properties, and the quarantine aims to mitigate any potential public health threats. Pharmaceutical outlets, healthcare facilities, and professionals have been directed to cease the sale, distribution, and use of Mefnac Oral Suspension until further notice.

The Board has emphasized its unwavering commitment to maintaining rigorous safety standards in the healthcare sector and has encouraged the public to report any instances of substandard drugs through the available communication channels.