Bumisuka.com – 5 Syrup Drugs Containing Ethylene Glycol Contamination Exceeds The Threshold. Cases of atypical progressive acute kidney disease (GgGAPA) are terrorizing the Indonesian people, especially toddlers aged 1 to 5 years. This is because there is no definite single cause.
Seeing a similar case in Gambia, Indonesian people are also afraid of the content of diethylene glycol (DEG) and ethylene glycol (EG) in children’s syrups. While the Indonesian Pediatrician Association (IDAI) has appealed to prohibit prescribing syrups with DEG and EG, the Indonesian Food and Drug Supervisory Agency (BPOM) has finally released the results of its investigation.
1. Derived from four additional solvents
In a circular on Thursday (20/10), BPOM RI reported that the majority of syrup drugs in circulation still meet the safety, efficacy, and quality requirements. This is done through tracking of syrups circulating in Indonesia, sampling, and gradual testing of drugs suspected of being contaminated with DEG and EG.
When testing, BPOM RI uses the Indonesian Pharmacopoeia reference and/or other reference in accordance with Law Number 36 of 2009 concerning Health as the national standard for quality assurance of all circulating drugs. DEG and EG contamination most likely came from four additional solvents, namely:
- Propylene glycol.
- Polyethylene glycol.
BPOM confirms that the four ingredients are not dangerous. According to the Indonesian Pharmacopoeia and national standards, the safe threshold (TDI) for EG and DEG contamination is 0.5 mg/kg body weight per day.
2. Drugs found to contain EG
BPOM also conducted a sampling of 39 batches of 26 syrup drugs suspected of containing EG and DEG. The criteria used include:
- Suspected to be used by patients with acute kidney failure before and during hospital stay.
- Produced by a manufacturer using the previous four solvent feedstocks in large volumes.
- Produced by manufacturers who have a track record of minimal compliance in fulfilling quality aspects.
- Obtained from a supply chain that is thought to come from a quality risky source.
As a result, after testing until October 19, 2022, BPOM RI found five syrup drug products with EG contamination that exceeded the safe limit, namely:
- Termorex Syrup (fever medicine), produced by PT Konimex with distribution license number DBL7813003537A1, box packaging, plastic bottle @60 ml.
- Flurine DMP Syrup (cough and flu medicine), produced by PT Yarindo Farmatama with distribution permit number DTL0332708637A1, box packaging, plastic bottle @60 ml.
- Unibebi Cough Syrup (cough and flu medicine), produced by Universal Pharmaceutical Industries with distribution license number DTL7226303037A1, Box packaging, Plastic Bottle @ 60 ml.
- Unibebi Fever Syrup (fever medicine), produced by Universal Pharmaceutical Industries with distribution license number DBL8726301237A1, Box packaging, Bottle @ 60 ml.
- Unibebi Fever Drops (fever medicine), produced by Universal Pharmaceutical Industries with distribution license number DBL1926303336A1, Box packaging, Bottle @ 15 ml.
For these drug manufacturers, BPOM RI has ordered them to withdraw the syrup drugs from circulation throughout Indonesia (from pharmaceutical wholesalers, government pharmacy installations, pharmacies, hospital pharmacy installations, health centers, clinics, drug stores, and independent practice). ) and destroy entire batches of products.
BPOM RI added that all pharmaceutical industries with syrup drug products potentially containing EG and DEG must report the results of independent testing as a form of responsibility for business actors. If necessary, they can also change the drug formula and/or raw materials.
3. Other BPOM RI appeals
Even so, BPOM said that EG contamination did not support the conclusion that syrups were the cause of GgGAPA. In addition to drugs, BPOM RI has not covered potential causes, such as viral and bacterial infections (especially Leptospira) and multisystem inflammatory syndrome in children (MISC) due to COVID-19.
Then, BPOM cooperates with the Indonesian Ministry of Health, clinical pharmacy and pharmacology experts, IDAI, and other related parties to research GGGAPA, and the results of the monitoring will continue to be updated. As long as there are no conclusive results, BPOM RI urges the public to:
- Purchase and obtain drugs only at official facilities, namely pharmacies, drug stores, health centers or the nearest hospital.
- Buying drugs online can only be done at pharmacies that already have a Pharmacy Electronic System Operator (PSEF) license.
- BPOM continuously carries out cyber patrols on website platforms, social media, and e-commerce to track and prevent the circulation of illegal drugs.
- Apply CLICK Checks, namely Check Packaging in good condition, Check Labels, Distribution Permits, and Expires) before buying or using drugs.
For health workers and the pharmaceutical industry, BPOM RI urges them to actively report drug side effects or unwanted events after using drugs to the National Pharmacovigilance Center/MESO through the e-MESO Mobile application.