JAKARTA - The government has taken anticipatory actions by stopping the circulation of Praxion branded sirop drug products while conducting an epidemiological investigation related to the exact cause of the two latest cases of Accuracy Accuracy, Atipical Accuracy (GGAPA) that occurred in Jakarta.
"We are working with various related parties to conduct epidemiological searches to ascertain the exact cause and risk factors that cause acute kidney problems experienced by the patient," said Health Ministry spokesman Mohammad Syahril when confirmed in Jakarta, Antara, Monday, February 6.
The investigation of the case involved the Ministry of Health, the Indonesian Pediatrician Association (IDAI), the Food and Drug Supervisory Agency (BPOM), epidemiologists, DKI Labkesda, Pharmacologists, professors, and the National Police Laboratory.
According to Syahril, the type of sirop drug consumed by the victim died due to Atypical Progressive Acute Kidney Disorder (GGAPA) in Jakarta branded Praxion was purchased at a pharmacy.
The case investigation was carried out to ensure the connection between GGAPA experienced by patients with the raw material content of Eten Glikol/Diethilen Glikol (EG/DEG) which exceeded the safe threshold.
Meanwhile, the safe threshold for EG/DEG contamination in the solvent raw materials for the Glikol Propilent (PG) drug circle is set at less than 0.1 percent, while the safe threshold or Tolerable Daily Intake (TDI) for EG and DEG contamination in drug mild does not exceed 0.5 mg/kg of body weight per day.
If the raw material exceeds the provisions of a safe threshold, it risks triggering kidney damage to result in acute kidney failure.
Syahril said the further steps taken by the Ministry of Health were to issue a letter of vigilance to all health offices, health care facilities, and related health professional organizations to be aware of the clinical signs of GGAPA and the use of sirop drugs, during the ongoing investigation process.
Meanwhile, the BPOM has issued an order to temporarily suspend the production and distribution of drugs consumed by patients until the investigation is completed.
BPOM ensures that the pharmaceutical industry holding license for the drug distribution of Praxion has made voluntary recall or withdrawal of drugs from the market.
BPOM has investigated samples of medicinal products and raw materials, both from the remaining patient drugs, samples from distribution and production sites, and has been tested at the National Food and Drug Testing Center (PPPOMN) laboratory.
BPOM has also checked the production facilities related to Good Manufacturing Practices (CPOB).
Previously reported, two DKI Jakarta residents aged 1 and 7 were reported to have experienced GGAPA. One confirmed case died and the other was a suspect and was undergoing intensive treatment.
With the report of additional new cases of GGAPA, as of February 5, 2023, there were 326 GGAPA cases and one suspected spread across 27 provinces in Indonesia.
Of these, 116 cases were declared cured, while six cases are still undergoing treatment at the Jakarta RSCM.
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