NATIONAL, INTERNATIONAL, DILI, HEALTH

WHO warns the public to avoid eight pediatric drugs produced in Indonesia

WHO warns the public to avoid eight pediatric drugs produced in Indonesia

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DILI, 03 november 2022 (TATOLI)- The World Health Organization (WHO-UK) has officially issued a warning against the use of eight substandard (contaminated) pediatric liquid dosage products identified in the WHO South-East Asia Region (SEARO) ), Indonesia.

These products were identified in Indonesia and publicly reported by the Food and Drug Administration (FDA) on 20 and 30 October 2022. Substandard medical products are products that fail to meet their quality standards or specifications and are, therefore “out of specification”.

“The eight products are Termorex syrup, Flurin DMP syrup, Unibebi Cough Syrup, Unibebi Fever Paracetamol Drops, Unibebi Fever Paracetamol Syrup, Paracetamol Drops, Paracetamol Syrup (mint) and Vipcol Syrup,” WHO’s the statement released on november 3. 

This product contains unacceptable amounts of ethylene glycol and/or diethylene glycol as contaminants, confirmed by laboratory analysis of samples by Indonesian authorities.

Until now, these products have been identified in Indonesia. However, they may have marketing licenses in other countries. These products may have been distributed, through informal markets, to other countries or regions.

“The risks of ethylene glycol and diethylene glycol are toxic to humans when consumed and can be fatal,” it says.

Substandard products referenced annex to this Warning are unsafe and their use, particularly in children, could result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental state, and acute kidney injury that can lead to death.

“WHO advises regulatory authorities and the public that it is important to detect and remove substandard products from circulation to prevent patient harm. WHO also calls for increased oversight and persistence in the supply chains of countries and regions likely to be affected by these products,”

In a released statement, advised the National health/regulatory authorities to immediately notify WHO if products below this standard are found in their respective countries.

Manufacturers of liquid preparations, especially syrups containing excipients such as propylene glycol, polyethylene glycol, sorbitol, and glycerin/glycerol, are encouraged to test for contaminants such as ethylene glycol and diethylene glycol before use in drugs.

According to WHO’s statement, All medical products must be approved and procured from authorized/licensed suppliers. The authenticity and physical condition of the product must be carefully checked. Seek advice from a healthcare professional when in doubt.

“If you have a product below this standard, DO NOT use it. If you, or someone you know, has used it or experienced an adverse reaction/event after use, you are advised to seek medical advice immediately from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre,” the WHO advises.

 

 

Journalist: José Belarmino De Sá 

Editor: Nelia B.

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