The Food and Drugs Monitoring Agency on Monday said it may pursue criminal action against two pharmaceutical firms that made products linked to acute kidney injury (AKI), amid a spike in cases and deaths among children this year.

Health authorities have temporarily banned sales of some syrup-based medications and identified the presence in some products of ethylene glycol and diethylene glycol as possible factors in the deaths of 141 children, most of which were under five.

BPOM chief Penny K. Lukito said the agency would work with police to investigate the two firms with a view to criminal proceedings over the composition of their products. Penny did not identify the two companies.

"There are indications in their products ... (of concentrations) that are highly excessive, highly toxic, and suspected to cause the kidney injury," she said, quoted by Reuters.

Indonesia is looking into its rise in AKI cases in consultation with paediatric experts and the World Health Organization (WHO), following a similar pattern in Gambia, which has seen at least 70 child AKI deaths related to syrup medications.

BPOM recently named three medications that contained high levels of ethylene glycol and diethylene glycol and ordered those be taken out of circulation.

The World Health Organization said this month that it found an "unacceptable amount" of diethylene glycol and ethylene glycol in four Indian-made cough syrups that were linked to the deaths of nearly 70 children in The Gambia due to AKI.

Health authorities in Indonesia found traces of similar substances in 102 syrup medicines in the homes of affected children, Health Minister Budi Gunadi Sadikin said last week.

Budi said the ban on all syrup and liquid medicine prescriptions and over-the-counter sales -- announced Wednesday -- will be narrowed to those 102 products.

Most AKI cases reported in Indonesia this year involved children under five years old, according to the ministry's data.

Before the recent rise, the ministry typically saw two or five cases of AKI a month.

Budi said some AKI patients improved after health authorities trialled an antidote imported from Singapore, adding more will be procured for distribution across Indonesia.

Source:
courtesy of THE JAKARTA POST

by Agencies

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