JAKARTA - Indonesia’s Food and Drug Monitoring Agency (BPOM) on Thursday halted the sale of five brands of fever, cough and flu syrups after nearly 100 children died due to acute kidney injuries this year.
It ordered the manufacturers to withdraw the five brands from circulation and destroy the stocks.
The suspended medicines are found to contain an ingredient – ethylene glycol – in an amount that “exceeds the safe limit”, the agency said in a statement.
However, it noted that it cannot be concluded that these products are solely responsible for causing the kidney injuries and that other factors, such as viral and bacterial infections, may have contributed to the injuries.
Ethylene glycol, along with diethylene glycol, was found in the four Indian-made cough syrups that caused the deaths of nearly 70 children in Gambia.
The substances are typically added as cheap adulterants in propylene glycol, which is used as a solvent in cough syrups. The metabolism of these compounds causes significant liver and kidney damage.
Although the cough syrups from India are not registered and distributed in Indonesia, BPOM has not ruled out the possibility that the same substances could be found in the syrups distributed in the country.
The five banned products are Termorex Sirup, Flurin DMP Syrup, Unibebi Cough Syrup, Unibebi Fever Syrup and Unibebi Fever Drops.
As at Tuesday, the health ministry had reported 206 cases of kidney injury in 20 provinces linked to the medicines, with 99 deaths.
A day later, authorities imposed a temporary ban on sales of all prescribed and over-the-counter syrups as a precautionary measure while an investigation is underway.
Meanwhile, the state-run Dr Cipto Mangunkusumo General Hospital in Jakarta has given antidotes bought from Singapore to 10 patients under its care in the hope of reducing child deaths from acute kidney injury.
“Based on the literature we read, there are substances in certain medicines that can bind toxins in one’s body. We sought the medicines and Singapore happened to be one of those selling it,” the hospital’s president director, Dr Lies Dina Liastuti, told a press briefing on Thursday.
“It’s been two days since we gave the medicine. We are still waiting for the result. So we cannot be certain about it, although some have shown improvement.”
Dr Lies said past treatments did not “bring satisfying results”, and the hospital is seeking to buy more antidotes overseas, including from Singapore and Australia.
From January to Oct 20, the hospital, which serves as the reference for other smaller health facilities, had treated 49 children with acute kidney injuries, of whom 31 died.
Although it has admitted patients with the symptoms since early this year, the surge in cases only started in early August.
Indonesian Paediatric Society’s (IDAI) Piprim Basarah Yanuarso told The Straits Times that the children first reported symptoms that included fever, cough, runny nose, vomiting and diarrhoea, before being diagnosed later with acute kidney injury.
Those who survived acute kidney injury had experienced “decreasing volume of urine”, he said, adding that “after treatment, they can recover”.
IDAI called for the public to remain calm and alert to symptoms, especially a sudden decline in urination or the absence of it.