The Pharmacy and Poisons Board (PPB) has issued a quarantine order for two pharmaceutical products Mefnac Oral Suspension and Floracil 1000 Injection. The order comes amid concerns over contamination and regulatory non-compliance, underscoring the critical importance of stringent drug safety measures.
Mefnac Oral Suspension: A Public Health Risk
Mefnac Oral Suspension, a widely used anti-inflammatory medication containing Mefenamic Acid (50 mg/5 ml), has been flagged due to suspected contamination with toxic substances. The product, manufactured by Efroze Chemical Industries Pvt Ltd in Pakistan, was found to contain Diethylene Glycol (DEG) and Ethylene Glycol (EG) levels exceeding acceptable limits.
These substances, commonly used in industrial applications like antifreeze, are highly toxic when ingested, even in small amounts. Consumption can result in severe health consequences, including kidney failure, nervous system damage, and, in extreme cases, death.
In its statement, the PPB emphasized the urgency of the situation, urging all pharmaceutical outlets, healthcare facilities, and professionals to immediately cease distribution and use of Mefnac Oral Suspension.
“The Pharmacy and Poisons Board (‘the Board’) informs the public of a Quarantine Order issued for Mefnac Oral Suspension (Mefenamic Acid 50 mg/5 ml). This action has been taken due to suspected contamination with Diethylene Glycol (DEG) and Ethylene Glycol (EG) at levels above the acceptable limits,” the Board stated.
Floracil 1000 Injection: Unregistered and Substandard
In a separate but equally critical matter, Floracil 1000 Injection, a product used in cancer treatment, has been identified as unregistered and substandard. Manufactured by Bruck Pharma Pvt Ltd in India, this product was flagged during routine post-market surveillance conducted by the PPB.
The Board confirmed that the injection does not meet Kenya’s regulatory requirements for pharmaceutical products. It cautioned against the sale, use, and administration of the drug, citing potential risks to patients undergoing treatment.
Immediate Actions and Legal Implications
The PPB has vowed to take stern legal action against individuals or entities involved in the distribution of these drugs. By issuing a quarantine order, the Board has taken a proactive step to prevent further exposure and potential harm to patients.
Healthcare professionals have been instructed to halt the use of the affected products, while pharmaceutical distributors have been ordered to withdraw these drugs from their inventories. The public is urged to report any adverse reactions or instances of substandard medicines to healthcare authorities through established reporting channels.
The Larger Context of Drug Safety
This development highlights the critical role of regulatory bodies like the PPB in ensuring the safety and efficacy of medicines available in the market. Contamination with DEG and EG has caused several health crises in the past, including the tragic deaths of dozens of children in The Gambia and Uzbekistan in 2022, linked to contaminated cough syrups.
Similarly, substandard or unregistered drugs pose a significant risk to patients, particularly those with serious conditions like cancer, where timely and effective treatment is crucial. The PPB’s swift action underscores its commitment to preventing such incidents in Kenya.
What the Public Can Do
The PPB has called on the public to remain vigilant and report any adverse reactions or suspicious drugs to healthcare authorities. Patients and healthcare providers are encouraged to verify the authenticity and regulatory compliance of medications before use.
As investigations continue, the PPB reassures Kenyans of its dedication to maintaining high standards in the pharmaceutical sector. This incident serves as a sobering reminder of the importance of robust regulatory oversight to protect public health.
For updates and further instructions, the public is advised to follow announcements from the Pharmacy and Poisons Board.
