Nivell Rayda, Jakarta – The deaths of more than 150 children in Indonesia have sparked concern among parents over the safety of drugs sold in one of the world's most populous nations.
Last week, the Indonesian Ministry of Health imposed a blanket ban on all syrup medications, suspecting that some had been tainted with diethylene glycol and ethylene glycol.
The two substances, used for antifreeze and other industrial applications, have been blamed for the rise in the number of acute kidney injury (AKI) cases among children.
At least five products have been found to have unsafe levels of ethylene glycol and diethylene glycol, the Indonesian Drug and Food Control Agency (BPOM) announced on Oct 20.
These medicines, which include three fever syrups and two cough syrups, were subsequently recalled by their respective manufacturers.
Although Indonesian officials later declared 133 other syrup products to be safe for consumption, last week's ban has left many parents feeling anxious.
"I immediately threw away all my syrup medicines. I didn't care if they were among the five (which were recalled) or not. I just threw them all away," Lenny Kurniawati, a 35-year-old mother of two, told CNA.
Another mother of two, Citra Dewi, 34 went even further. "I threw away all my medicines – syrups, tablets, everything. How can we absolutely be sure if they are safe or not? I am not taking any chances," she told CNA.
Mdm Dewi said she will not give any medicines to her children, at least for now. Instead, she intends to use a cold compress if a family member has a fever, or resort to herbal remedies if they catch a cold.
"We bought these medicines because the government said they were safe. The fact that the government later admitted that some were not safe really shattered my confidence in how drug safety is assessed and monitored here (in Indonesia)," she said.
"I won't be giving any medication to my children unless they are really ill."
Unlike Mdm Dewi however, Mdm Kurniawati said she still has some confidence in medications prescribed by doctors.
"It is a difficult time to be a parent in Indonesia. On one hand, we are still in a pandemic. We are also entering the rainy season when people are more prone to getting sick. But on the other hand, you cannot be 100 per cent sure what medication is safe to consume," she said.
The Indonesian health ministry said on Thursday (Oct 27) that more than 260 children, some as young as six months old, have been diagnosed with AKI. Out of this group, 157 died from the illness. The majority of those who died were under the age of five.
"Sixty-one per cent of patients were already in the third stage of kidney failure. Their body produced no urine because the kidney has already failed to perform its metabolism function," Health Ministry spokesman Mohammad Syahril told a press conference on Thursday, adding that this was the reason why many have died from the illness.
An expert interviewed by CNA expressed worry that this might be the tip of the iceberg, with more cases going unreported in the vast archipelago.
Contamination process still a mystery
Indonesia began examining syrup medications sold in the country after authorities in Gambia found links between AKI cases in the African nation with four cough syrups manufactured in India. Gambia has reported more than 70 AKI deaths.
Cases in Gambia and Indonesia appeared to be unrelated since the four Indian-manufactured medications are not sold in the Southeast Asian nation. However, traces of ethylene glycol and diethylene glycol were found in AKI patients in both nations.
Ethylene glycol and diethylene glycol are colourless and odourless alcohols that can be deadly even in small amounts. Ingesting them can lead to stomach cramps, nausea and vomiting. It can also damage the kidney, liver and central nervous system.
Both chemicals are commonly used in a variety of industrial applications such as manufacturing paint and ink, or as a component for brake fluid.
According to Indonesian regulations, the two toxic substances should not have been found in medications. This led authorities to suspect that they might have been introduced as contaminants in the solutions used to dilute the medicines.
"There could be impurities in the solvent, among (the impurities) were ethylene glycol and diethylene glycol," BPOM chief Penny Lukito told a press conference on Oct 24.
Mdm Lukito said there were "very very high" concentrations of either substance in the five syrup medication products recalled by their respective manufacturers. The BPOM chief noted that the contaminants were only found in certain production batches.
BPOM has not been able to determine how the toxic chemicals ended up in the medicines.
Mdm Lukito said the agency is considering whether to take criminal action against the pharmaceutical companies responsible for manufacturing the five products.
Mr Windhu Purnomo, a public health expert at Airlangga University criticised the drug and food agency, saying that they should not have allowed such cases of contamination to occur in the first place.
"The BPOM (officials) must tighten their monitoring procedures. Such contamination can come from anywhere. Not only must they ensure that safety requirements are met during the production stage but also during shipment and storage before they are purchased and consumed by the general public," he told CNA.
Mdm Lukito revealed that her agency does not regularly test medicines for contaminants after they leave the factory floor. She added that such tests are conducted only in special circumstances such as the recent spike in AKI cases.
"In the future, we will improve and strengthen our monitoring both pre-market and post-market," she said during the Oct 24 press conference.
Help is on the way
With more than 50 per cent of AKI cases in Indonesia resulting in fatalities, Mr Hermawan Saputra, an adviser at the Indonesian Public Health Expert Association, is urging the government to declare a state of national emergency, just like it did when the COVID-19 pandemic hit the country.
"(Declaring a state of emergency) allows the government to allocate more manpower and resources to mitigate cases of AKI," Mr Saputra told CNA.
"The government can also form a task force to see how widely these contaminated products were distributed and see whether there are any acute kidney injury cases there. Because so far, most of the cases reported were the ones treated at major hospitals, so they may well be the tip of the iceberg."
The Health Ministry said AKI cases have been reported in 27 of the 34 provinces in Indonesia.
Indonesian Health Minister Budi Gunadi Sadikin argued that declaring a state of emergency is not yet necessary.
The minister said on Monday that last week's ban on all syrup medications and the subsequent investigation to determine which might be tainted with the two chemicals had been effective in slowing down the number of AKI cases. Without such measures, he said there might be more than 70 cases a month.
Mr Sadikin said some patients appeared to be responding well to fomepizole, a medication used to treat ethylene glycol and diethylene glycol poisoning.
Since the medication is not readily available in Indonesia, the government had to import 20 fomepizole vials from neighbouring Singapore and 16 more from Australia.
Indonesia is also looking to procure 200 more from the United States and Japan.
"We will foot all expenses for this new medication. We will distribute them to all hospitals which are currently treating acute kidney injury patients," the minister said.
Mother of two Mdm Dewi said the availability of a possible treatment for ethylene glycol and diethylene glycol poisoning has made her feel less uneasy.
"However, it doesn't mean I will be buying syrup medications for my children anytime soon," she said.
"The government still has to determine how (the chemicals) get there, punish those responsible and make sure that it will never happen again." – CNA/ni(aw)