"We are collaborating with various related parties in conducting epidemiological investigation to establish the clear cause and risk factors that triggered acute kidney injury that the patients experience," Health Ministry's spokesperson, Mohammad Syahril, remarked.
The case investigation involves the Health Ministry, Indonesian Pediatrician Association (IDI), Food and Drug Supervisory Agency (BPOM), epidemiologists, Jakarta Regional Health Laboratory, professors and National Police's Forensic Laboratory Center, he remarked here, Monday.
According to Syahril, the syrup medicine of Praxion brand purchased from a pharmacy was consumed by victims, who suffered from GGAPA here, Wednesday.
Case investigation is undertaken to establish a link between GGAPA experienced by patients and the amount of Ethylene Glycol/Diethylene Glycol (EG/DEG) that exceeds the safe threshold.
The safe threshold for EG/DEG contamination in raw materials for Propylene Glycol (PG) syrup was set to be less than 0.1 percent.
Meanwhile, the Tolerable Daily Intake (TDI) for EG and DEG contamination in syrup medicine cannot exceed more than 0.5 mg/kg body weight per day.
If the raw materials exceed the safe threshold, this may trigger kidney injury that leads to acute kidney failure.
The advanced step taken by the ministry involves issuing warning letters to all health office, health service facilities, and related professional health organizations.
The letters urge these parties to be wary of the clinical signs of GGAPA and the use of syrup medicine while the investigation is underway.
Meanwhile, the BPOM has issued a temporary production and distribution suspension order for medicines consumed by the patients until the investigation is completed.
The BPOM has ensured that pharmaceutical companies that hold the Praxion drug distribution license have conducted a voluntary recall of the medicine.
The BPOM has undertaken investigation of samples of medicine products and raw materials, both from leftovers of patients' medicine as well as the production location and distribution.
These samples have been tested at the National Drug and Food Testing Development Center (PPPOMN) laboratory.
The BPOM has also carried out good production practice examination at the production facilities.
Earlier, two Jakartans aged one and seven years were reported to experience GGAPA. One was confirmed to have died, while the other was undergoing intensive treatment.
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Translator: Andi Firdaus, Fadhli Ruhman
Editor: Sri Haryati
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