Substandard (contaminated) paediatric liquid dosage medicines identified in WHO region of South-East Asia
[1] Badan POM Press Release: https://www.pom.go.id/new/view/more/klarifikasi/158/INFORMASI-KEEMPAT-HASIL-PENGAWASAN-BPOM-TERHADAP-SIRUP-OBAT-YANG-DIDUGA-MENGANDUNG-CEMARAN-ETILEN-GLIKOL–EG–DAN-DIETILEN-GLIKOL–DEG-.html and https://www.pom.go.id/new/view/more/pers/664/Tindakan-Tegas-BPOM-dan-Bareskrim-Polri-Terhadap-Industri-Farmasi–Produsen-Sirup-Obat-yang-Tidak-Memenuhi-Standar-dan-atau-Persyaratan-Keamanan–Khasiat–dan-Mutu.html
[2] WHO definitions: https://www.who.int/teams/regulation-prequalification/incidents-and-SF/background/definitions
Risks
Ethylene glycol and diethylene glycol are toxic to humans when consumed and can prove fatal.
The substandard products referenced in the annex of this Alert are unsafe and their use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.
Advice to regulatory authorities and the public
It is important to detect and remove these substandard products from circulation to prevent harm to patients.
WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised. National regulatory/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country.
Manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, polyethylene glycol, sorbitol, and/or glycerin/glycerol, are urged to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.
All medical products must be approved and obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked. Seek advice from a healthcare professional when in doubt.
If you have these substandard products, please DO NOT use them. If you, or someone you know, have used them or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre.
If you have any information concerning the manufacture or supply of these products, please contact WHO via [email protected]
Please see annexes 1 and 2 for details of the substandard products referenced in Alert N°7/2022.
Alert n°7/2022 may be updated if further relevant information becomes available
WHO Global Surveillance and Monitoring System
for Substandard and Falsified Medical Products
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