NAFDAC Alerts on Revocation of Companies’ Licences after 159 Infant Deaths in Indonesia

The National Agency for Food and Drugs Administration and Control (NAFDAC) has notified Healthcare providers and the public that Indonesian authorities have revoked the licenses of two pharmaceutical companies (PT Yarindo Farmatama and PT Universal Pharmaceutical industries) to prevent them from producing syrup-type medicines following the death of 159 children under-5 years, due to acute kidney injury.

In the alert, posted on the Agency’s website, it explained that the two companies used propylene glycol as a raw material in the production of medicinal syrups.

“The syrups, often used by children, contained excessive amounts of ethylene glycol and diethylene glycol. The findings were based on interviews with employees and an examination of documents, facilities, and products of the companies.

“The two chemicals are often used in industrial applications and in antifreeze and brake fluids. They are used as cheaper alternatives to glycerin (used for thickening cough syrups) in some pharmaceutical products. The ingestion of both chemicals is often toxic and can lead to acute kidney injury (AKI).

Similarly, in November 2022, NAFDAC received a report from WHO and alerted the public on the use of four substandard cough syrups containing unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

“In South Asia, some pediatric medicines were reported by WHO to be containing toxic amounts of ethylene glycol and diethylene glycol. They include Termorex syrup, Flurin DMP syrup, Unibebi Cough syrup, Unibebi Demam Paracetamol syrup (mint), and Vipcol syrup.

“NAFDAC implores importers, distributors, retailers, and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the above-mentioned syrups. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

“Members of the public in possession of the above-listed products are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.

“If you have these substandard products, please DO NOT use them. If you, or someone you know, hasused these products or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.

Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL-FREE from all networks), via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng

January 04, 2023