# Diethylene glycol: Unnoticed threat in the landscape of fixed-dose combination medications

## TL;DR

Diethylene glycol contamination in fixed-dose combination medications highlights the need for stronger quality control and regulatory oversight in pharmaceuticals.

## Contribution

The paper identifies a pattern of DEG/EG contamination in irrational FDCs and advocates for regulatory reform.

## Key findings

- Seven DEG/EG contamination incidents were reported in nine countries since September 2022.
- Most contaminated products are irrational FDCs with insufficient evidence of efficacy.
- Regulatory reforms and stricter quality standards are needed to prevent contamination and ensure drug safety.

## Abstract

Diethylene glycol (DEG) and ethylene glycol (EG) are organic compounds often found in various consumer products, including antifreeze and industrial solvents used in pharmaceutical preparations, as well as serving as raw materials for polymer manufacturing. Since September 2022, seven consecutive episodes of DEG and EG contamination have been reported across at least nine countries. A notable commonality among the affected products is that at least 14 of them are fixed-dose combinations (FDCs). However, the evidence supporting the efficacy of most of these combinations is insufficient, which renders their prescription, dispensing, and use irrational. Moreover, these products are not without risk, as they can cause adverse reactions. Several factors contribute to the prevalence of these irrational FDCs, including low production costs, consumer popularity, and a tendency to authorise locally manufactured products. As a result, many countries’ pharmaceutical markets keep marketing authorisation for irrational FDCs. The persistent reports of DEG or EG contamination – especially those involving irrational fixed-dose combinations – present a crucial opportunity to enhance quality control measures. In addition, it is imperative to reevaluate the marketing authorisations of these products that lack evidence of safety and efficacy, adapting the national medicines lists and clinical guidelines to WHO recommendations. Strengthening regulatory frameworks and implementing stringent manufacturing and quality assurance standards are essential to prevent contamination incidents and ensure the safety of pharmaceutical products.