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BPOM Recalls 3 Praxion Products over Acute Kidney Injury Cases

Translator

Dewi Elvia Muthiariny

Editor

Petir Garda Bhwana

7 February 2023 10:53 WIB

TEMPO.CO, Jakarta - The Food and Drug Supervisory Agency (BPOM) stated that it has temporarily ceased the production and distribution of syrup drugs suspected of being the cause of new cases of atypical progressive acute kidney injury in children. They were Praxion brand drugs registered in the agency.

“BPOM has issued an order to temporarily stop the production and distribution of drugs consumed by patients until the investigation is complete,” said the agency on its official website as quoted on Tuesday, February 7, 2023.

The agency ensured that the company holding the drug distribution permit had conducted a voluntary withdrawal.

Health Ministry Detects 2 New Cases of Acute Kidney Failure

The Health Ministry confirmed reports of two new cases of acute kidney injury at the end of January by the Jakarta Health Agency.

A spokesperson for the ministry M Syahril said a 1-year-old child suffered from the disease and died after taking Praxion liquid drug that the parents bought at the pharmacy. 

The other case was a 7-year-old child who had also consumed a fever medicine and was still undergoing treatment at Cipto Mangunkusumo Hospital (RSCM). Syahril stopped short of mentioning the drug brand. “Further examination is being carried out regarding this patient,” said Syahril in his written statement on Monday.

BPOM Previously Listed Praxion among Drugs That Are Safe to Consume

Based on Tempo's investigation, BPOM had previously included three Praxion brand syrup drugs on the list of safe drugs. Their distribution permits were owned by PT Pharos Indonesia and all of them were referred to as children's fever medicines.

This was listed in the annex to the BPOM’s circular No. HM.01.1.2.12.22.191 dated December 29, 2022, concerning the additional 176 medicinal syrups that meet the requirements based on verification data on the results of raw material testing.

FEBRIYAN

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BPOMPraxionAcute Kidney Injury


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