BPOM Finds 6,001 Drug Sales Links That Risk Kidney Damage

DOK/Kepala BPOM Penny K Lukito (tengah) didampingi Deputi Bidang Penindakan Irjen Agus Nugroho (kiri) dan Direktur Tindak Pidana Tertentu Bareskrim Polri Brigjen Pipit Rismanto (kanan)/ANTARA/Andi Firdaus

JAKARTA - The Food and Drug Supervisory Agency (BPOM) found 6,001 links identified as selling drug syrup contaminated with kidney-damaging substances on websites, social media, and e-commerce platforms in Indonesia.

"It turns out that many of these products are sold online. We carry out cyber patrols for products that do not meet the provisions", said the Head of BPOM, Penny K. Lukito, in a working meeting with Commission IX DPR reported by ANTARA, Wednesday, November 2.

He said BPOM had coordinated with the Ministry of Communication and Information (Kemenkominfo) and the Indonesian E-Commerce Association (idEA) to take down the content of the 6,001 links since October 24, 2022.

The drug on the link is considered unsafe for consumption because it is suspected to contain hazardous chemical compounds Ethylene Glycol and Diethylene Glycol (DEG) which are associated with the incidence of acute kidney disorders in Indonesia.

The results of the sampling and testing of five of the 38 samples (13 percent) of the syrup, said Penny, was proven to contain EG/DEG contamination exceeding the safe limit of 0.1 mg/ml, namely Termorex Syrup (Bets AUG22A06), Flurin DMP Syrup, Unibebi Cough Syrup, Unibebi Fever Syrup, Unibebi Fever Drops.

"EG and DEG should not be used as additional ingredients in medicinal products taken", he said.

Penny said that there may be EG/DEG contamination in drugs to a certain extent, coming from the solvents Propylene Glycol (PG), Polyethylene Glycol (PEG), sorbitol, and glycerin/glycerol.

In addition, drug ED/DEG contamination is also possible in products that do not have international standards for EG/DEG contamination in medicinal products.

"The BPOM reference is the Indonesian Pharmacopoeia and other standards according to Law 36/2009 on Health", he said.

According to Penny, the safe threshold or Maximum Tolerable Daily Intake (MTDI) of EG and DEG contamination is 0.5 mg/kg BW/per day.

"The results of the EG contamination test found in the product do not meet the requirements, but cannot support the conclusion that the use of the drug syrup has a relationship with the incidence of acute kidney failure", he said.

Several other risk factors, such as viral infection, Leptospira bacteria, and multisystem inflammatory syndrome in children (MIS-C) or post-COVID-19 multisystem inflammatory syndrome.

"Therefore, there must be a causality study whether the incident is related and caused by drugs", he said.