"The result of the testing shows that Praxion syrup met the requirements and standards set by the Indonesian pharmacopeia," acting deputy for supervision of drugs, narcotics, psychotropics, precursors, and addictive substances of BPOM Togi Junice Hutadjulu stated in Jakarta, Wednesday.
Hutadjulu remarked that the seven samples tested were those of the medicinal syrup and raw materials, which comprised samples of leftover drug syrup from patients, syrup on the market, samples at the production site with the same batch, syrup samples from a batch adjacent to the patient's drug syrup, samples of sorbitol raw material, and two other syrup products that use raw materials with the same batch number.
She noted that the sample testing conducted on February 2-3, 2023, at the BPOM National Food and Drug Testing Development Center (PPPOMN) laboratory had met the standards of the World Health Organization (WHO), due to which the accuracy could be ensured.
"The validity of the test results can be trusted to support the results of BPOM supervision," she affirmed.
She also noted that the BPOM had ordered temporary suspension of the production and distribution of drugs consumed by patients, who were confirmed to have died due to Atypical Progressive Acute Kidney Disease (GGAPA) on February 4, 2023.
One of these cases was a toddler, who died after consuming the Praxion brand syrup in Jakarta.
"In order to be careful and anticipate further downfall, BPOM has issued an order to temporarily stop the production and distribution of drugs consumed by patients," she stated.
Moreover, the BPOM continues to coordinate with related parties, such as the Ministry of Health, Jakarta Health Service, Jakarta Regional Health Laboratory, the Indonesian Pediatrician Association, epidemiologists, and pharmacologists, to investigate the cause of the toddler's death.
The BPOM also reminded the public to be vigilant and continue to exercise caution while purchasing and consuming drugs.
"This step was taken to ensure the causes and risk factors of GGAPA," she remarked.
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Translator: Adimas Raditya F P, Resinta S
Editor: Azis Kurmala
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