According to a statement released on the agency’s website on Thursday, the BPOM has tested 36 production batches of 26 medicinal syrup products suspected of being contaminated with EG and DEG as of October 19, 2022.
The products tested by the BPOM included those suspected to have been taken by patients with acute kidney failure as well as those produced bymanufacturers who used propylene glycol, polyethylene glycol, sorbitol, and glycerol as solvents in large volumes.
Syrup products made by manufacturers whose compliance in fulfilling quality aspects was low as well as products obtained from low-quality supply chains were also tested.
According to the pharmacopeia and established national standards, the TDI for EG and DEG contamination is 0.5 milligrams per kilogram of a patient’s body weight per day.
The five syrup products found to have higher EG and DEG contamination levels than the TDI include fever medicine Termorex Syrup (distribution permit number DBL7813003537A1) and cough and flu medicine Flurine DMP Syrup (DTL0332708637A1)
They further include cough and flu medicine Unibebi Cough Syrup (DTL7226303037A1), fever medicine Unibebi Fever Syrup (DBL8726301237A1), and fever medicine Unibebi Fever Drops (DBL1926303336A1).
However, BPOM said that the test results of the five products could not conclude that the use of the syrups was related to acute kidney failure.
The agency noted that in addition to taking medication that may cause kidney abnormalities, there are several other factors which can cause acute kidney failure, such as viral infection, leptospirosis, and post-COVID-19 multi-system inflammatory syndrome in children (MIS-C).
BPOM has ordered the manufacturers of the five medicinal syrup products to withdraw their products from markets across Indonesia and destroy all products from the same production batches.
In addition, the agency has asked all pharmaceutical industries manufacturing medicinal syrup products that have the potential to be contaminated by EG and DEG to report self-testing results for EG and DEG levels in their products.
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Translator: Andi Firdaus, Uyu Liman
Editor: Rahmad Nasution
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