The Pharmacy and Poisons Board on Wednesday flagged the floracil 1000 (Fluorouracil 1000mg/2ml injection) drug declaring its immediate censure from the Kenyan market.
Through a notice, the Board revealed that this decision had been arrived at after the conduction of a routine surveillance terming it as unregistered and substandard.
“During routine post-market surveillance (PMS) activities, the Board identified an unregistered and substandard product, Floracil 1000 (Fluorouracil 1000mg/2ml Injection,” the notice read in part. The drug is manufactured by an Indian pharmaceutical company.
In the aftermath of their observation, the board cautioned the public and healthcare professionals against the sale and usage of the drug as it would bring dire consequences for all parties involved.
“In light of this, the Board strongly cautions the public and healthcare professionals against the trade, distribution, wholesale, retail, issuance, dispensing, use, or administration to patients of this product,” the Board noted.
The Board further declared that it would collaborate with the relevant authorities and crack the whip on persons or companies that dared to proceed against their directive.
“Further, in collaboration with Government Investigative Agencies, the Board will take legal and regulatory action against individuals involved in placing this unregistered product in the market, in violation of the Pharmacy and Poisons Act (CAP 244),” it warned.
Floracil 1000 is a medicine that is used in the treatment of gastric cancer, esophageal cancer, small intestine cancer, colorectal cancer, liver cancer, pancreatic cancer, head and neck cancer, lung cancer, breast cancer, cervical cancer, cancer of uterine body and ovarian cancer. It has effects to suppress proliferation of cancer cells by inhibiting synthesis and functions of the cancer cell gene. Depending on the type of cancer, it is used in combination with other medicines or radiation.
On the other hand, the Board has issued a quarantine order for a suspected substandard oral suspension medicine. This is after it was determined that the drug had been contaminated.
“The Board informs the public of a Quarantine Order issued for Mefnac Oral Suspension (Mefenamic Acid 50 Mg/5 MI). This action has been taken due to suspected contamination with Diethylene Glycol (DEG)/Ethylene Glycol (EG) at levels above the acceptable limits,” the Board informed.
“In light of this, the Board advises all pharmaceutical outlets, healthcare facilities, healthcare professionals, and members of the public to immediately quarantine the product and stop the further distribution, sale, issuance, or use until further communication from the Board,” it added.
The Board went on to reiterate its commitment to upholding the safety and standards of the healthcare sector but urged the public to maintain vigilance. They urged Kenyans to report cases of substandard drugs to the Board through its various channels- SMS, email, telephone, and via their website.
