Three Drugs Contain Dangerous Impurities

The Food and Drug Monitoring Agency (BPOM) has examined 33 of 102 syrup medicines consumed by patients of a typical progressive acute kidney injury in children that were collected by the Health Ministry.

DOKUMENTASI BPOM

Head of Food and Drug Monitoring Agency (BPOM) Penny K Lukito (doc. picture). In Jakarta, Sunday (23/10/2022), Lukito announced the finding of three syrup medicines contained the substances impurities that exceeded the safety threshold. The examined was related in finding causes of typical progressive acute kidney injury in children.

JAKARTA, KOMPAS — Of the 33 products tested by BPOM, three syrup medicines contained ethylene glycol or EG and diethylene glycol or DEG impurities that exceeded the safety threshold.

Head of the BPOM, Penny K Lukito, announced the finding at a press conference in Jakarta on Sunday (23/10/2022). “The BPOM is still sampling and testing 69 of the 102 products delivered by the Health Ministry,” she said.

The three products containing EG and DEG impurities exceeding the safety threshold are Unibebi Cough Sirup, Unibebi Demam Sirup and Unibebi Demam Drops, produced by Universal Pharmaceutical Industries. These three products belong to the five medicines tainted by EG and DEG beyond the safety threshold from the BPOM’s previous test results.

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The BPOM will later inquire into the causes of EG and DEG exceeding their safety threshold in a number of their drugs. The medicines will be withdrawn from the market by their producers under the BPOM’s supervision.

“This measure will serve to strengthen or change the system of pre- and post-market control. In the future we will improve and intensify supervision by requiring pharmaceutical industries to undertake analyses and ensure the enhancement of quality control,” said Penny.

Based on the BPOM’s medicinal product registration rule, all syrup medicines for children and adults are prohibited from using EG and DEG. The two are found as impurities in polyethylene glycol, propylene glycol, sorbitol and glycerin/glycerol compounds serving as additional solvents in liquid or syrup drugs. The safety threshold for EG and DEG consumption is 0.5 milligram per kilogram (mg/kg) of body weight per day. EG and DEG consumption above the safety threshold causes health hazards.

The BPOM suspects that EG and DEG impurities are present in the four additional materials.

Besides, the BPOM has also found seven products safe for consumption as long as their instructions are followed and 23 products without propylene glycol, polyethylene glycol, sorbitol and/or glycerin/glycerol. The BPOM suspects that EG and DEG impurities are present in the four additional materials.

Data tracking

The BPOM has traced registration data on all medicinal products in syrups and drops. The result covers 133 products using no propylene glycol, polyethylene glycol, sorbitol and glycerin/glycerol so that they are safe, provided that they are used by observing their instructions.

AYU NURFAIZAH UNTUK KOMPAS

A box contain syrup medicines putted off from shelf in a pharmacy, Palmerah, West Jakarta, Friday Jumat (21/10/2022).

According to intensified surveillance based on risks, sampling and testing until 23 October 2022, 13 syrup medicines in 21 different production codes are safe for use as long as their instructions are adhered to.

Syrup drug sample testing applies several criteria; among others, it is believed to have been used by the kidney failure patients before and after suffering from the disease. Producers are also examined in connection with the use of the four solvents in big volumes and their poor track records of quality fulfillment. Also examined are product samples from the supply chain suspected of relying on risky sources.

the EG test result that exceeded the normal threshold did not mean that the use of syrup drugs directly had to do with acute kidney failure.

A professor of pharmaco-chemistry, Bandung Institute of Technology, Rahmana Emran Kartasasmita, explained that the EG test result that exceeded the normal threshold did not mean that the use of syrup drugs directly had to do with acute kidney failure. The assessment of the threshold of consumption is based on the daily use per kg of body weight of the user.

Daily Executive Chairman of the Indonesian Consumer Institute Foundation, Tulus Abadi, urged that this case be investigated from upstream to downstream, covering the supply of drug materials, production and marketing. “This massive case proves that the mechanism of supervision of pre-market and post-market aspects by the BPOM is not effective,” he said.

KOMPAS/PRIYOMBODO (PRI)

Coordinating Human Development and Culture Minister Muhadjir Effendy.

Coordinating Human Development and Culture Minister Muhadjir Effendy in a press release also called for a thorough investigation of this issue, including the likelihood of a criminal element. It is because the EG and DEG impurities in medicines are believed to be related to atypical progressive acute kidney failure in 241 children in Indonesia on 21 October 2022. Of the total, 133 children have died.

The acute kidney failure cases were reported by several regions. Abdul Moeloek Regional General Hospital, Lampung, for instance, is treating two children with acute kidney failure. A medical team monitors their health condition. “The origin of basic materials, their entry into Indonesia, as well as the process of production of the drugs containing both dangerous substances should be tracked down,” said Muhadjir.

Health Ministry is preparing antidotes for atypical progressive acute kidney injury patients.

“The acute kidney failure cases with 55 percent deaths are only based on detected data. In fact, our disease detection capacity is lagging and limited. This is an extraordinary event [KLB],” said Dicky Budiman, an epidemiologist at Griffith University. The declaration of KLB is expected to induce serious treatment efforts, including the mobilization of support for regions.

At present, the Health Ministry is preparing antidotes for atypical progressive acute kidney injury patients. Around 200 vials of antidotes have been ordered from various countries and will soon be distributed. Head of the Health Ministry’s Communication and Public Service Bureau, Siti Nadia Tarmizi, said 26 vials of the total were scheduled to be delivered to Indonesia on Sunday, comprising 16 vials from Australia and 10 vials from Singapore. (SKA/AIK/VIO/Z03/Z14)

This article was translated by Aris Prawira.