October 21, 2022
JAKARTA – Consumer groups, lawmakers and pharmacists are calling for more action by the Food and Drug Monitoring Agency (BPOM) following its decision to order several medicinal syrups to be recalled from the market over their possible links to fatal kidney injuries among almost 100 children.
This came after an early investigation by an expert team formed by the Health Ministry detected traces of chemical compounds that might have caused the unusual acute kidney injury (AKI), in medicines that had been consumed by the sick children before they displayed signs of the kidney injury and in the children’s bodies.
The dangerous compounds are ethylene glycol (EG), diethylene glycol (DEG) and ethylene glycol butyl ether (EGBE), according to ministry spokesman Mohammad Syahril. The ministry has since banned the use of all medicinal syrups as a precautionary measure while waiting for the BPOM’s investigation results.
While authorities have not identified the definitive cause of the disease, the World Health Organization (WHO) has found possible links between high levels DEG and EG with the deaths of nearly 70 children in Gambia, West Africa. WHO investigators traced the source of those dangerous compounds to medicinal syrups made by India-based Maiden Pharmaceuticals.
The BPOM said last week that no products from Maiden Pharmaceuticals were ever sold in Indonesia, and has always banned the use of DEG and EG in any medicinal syrup products.
But the agency said on Thursday at least five medicinal syrups were found to contain more than the acceptable level of EG. The five products are Termorex Syrup from PT Konimex, Flurin DMP Syrup from PT Yarindo Farmatama and three variants of Unibebi cough and fever syrups from Universal Pharmaceutical Industries.
While the BPOM found no conclusive evidence between the unacceptable EG levels and the AKI cases, the agency has now ordered those products to be taken off the shelves.
Aside from the five products in question, the BPOM has also called on the pharmaceutical industry to submit reports if they produce any potentially harm
However, member of House of Representatives Commission IX overseeing health care Rahmad Handoyo called on the agency to do more and thoroughly investigate further up the supply chain.
“The BPOM has to audit the pharmaceutical companies behind these products. If they contain those dangerous compounds above the legal limit, the companies have to take responsibility through both arbitration and legal means,” Rahmad told The Jakarta Post.
As no definitive cause of the AKI cases has been found, Rahmad said that the agency had to work together with the Health Ministry and the Indonesian Pediatrician Association (IDAI) and get to the bottom of the issue.
Keri Lestari of the Indonesian Apothecary Association (IAI) also urged the entire pharmaceutical industry to use this moment to clean up its act. “We from the association advised the pharmaceutical industry to take a closer look at how they conduct their business, such as in packaging their medicines,” Keri said.
She further explained that both DEG and EG were considered contaminants from several non-hazardous compounds normally used in medicinal products. These compounds, such as polyethylene glycol, glycerin and propylene glycol are typically harmless, but might result in the creation of the potentially toxic DEG and EG.
These compounds have been long used as solvents by the pharmaceutical industry in medicinal syrups, so the recent outbreak of AKI points to other problems, namely the lack of quality control in several pharmaceutical companies. “We’ve consumed paracetamol syrups since we were kids, so why now?” Keri said.
By Tuesday, the ministry had recorded at least 206 cases of unexplained AKI – mostly in children under six years old – in 20 provinces with 99 fatalities since January. This puts the fatality rate at a staggering 48 percent. The spike in cases, according to the ministry, happened in late August.
Previously, COVID-19 was pointed to as a possible cause as the outbreak of AKI in both Indonesia and Gambia happened after the pandemic. But the Health Ministry has been quick to dismiss the rumors, saying it found “no links [between the AKI] and COVID-19 vaccines or infections, particularly since the disease is found in children younger than six, who cannot yet get vaccinated”.
Indonesian Consumers Foundation (YLKI) chairman Tulus Abadi also pushed the government to act more decisively in solving this problem. “If the Indian-made medicinal syrups weren’t sold in Indonesia, then why are the acute kidney injury cases so high in Indonesia? This is a serious issue,” Tulus said in a written statement.
Aside from pushing for the BPOM to pull the potentially dangerous products off the shelves, he also called on the pharmaceutical industry to take responsibility.