#17,604
For the 6th time in less than a year the World Health Organization has issued a medical product alert on liquid OTC medicines - manufactured primarily in India - containing dangerous (even fatal) amounts of diethylene glycol (DEG) and /or ethylene glycol (EG) as contaminants.
Starting in 2022 we began to see clusters of deaths around the world - usually in children - which were eventually linked to the consumption of adulterated pediatric cough syrups.
A guidance document, released by the US FDA earlier this year describes the recent surge in cases.
In 2022 and 2023, numerous countries reported incidents of oral liquid drug products, primarily indicated for children, with confirmed or suspected contamination with high levels of DEG and EG.6 The cases of contamination, spanning at least seven different countries, were associated with more than 300 fatalities—mostly in children under the age of 5.7 In October 2022, and as part of the investigation into these cases, the Indonesian health authorities identified the presence of DEG and EG in a propylene glycol excipient used in manufacturing oral liquid drug products.8 At the time of issuance of this guidance, FDA had no indication that any contaminated products connected to the recent international incidents have entered the U.S. drug supply chain.The 2022 outbreak resembles previous ones, as manufacturers of oral liquid drug products relied upon COAs provided by suppliers where the chain of custody or distribution history of the highrisk drug component was also not readily known or apparent from the COA. For example, in one instance, the appearance of the label and COA of propylene glycol, used as a component of a drug product, suggested the component container’s content might differ from what the container label and COA stated. As a result of these practices, DEG- and EG-contaminated components, such as propylene glycol, entered the pharmaceutical raw material supply chain.
First the latest WHO Alert, then we'll have more on the plethora of adulterated and counterfeit drugs being sold around the world.
Substandard (contaminated) syrup medicines identified in WHO Region of the Eastern Mediterranean
7 August 2023 Medical product alert Geneva
Alert Summary
This WHO Medical Product Alert refers to one batch of substandard (contaminated) COLD OUT syrup (Paracetamol and Chlorpheniramine Maleate) identified in the Republic of Iraq and reported to the World Health Organization (WHO) on 10 July 2023 by a third party. Please refer to the Annex of this Alert for full details of the affected batch of the product.
Paracetamol and chlorpheniramine combination syrups are used to treat and relieve symptoms of the common cold and allergy symptoms.
A sample of the COLD OUT Syrup was obtained from one location in Iraq and submitted for laboratory analysis. The sample was found to contain unacceptable amounts of diethylene glycol (0.25%) and ethylene glycol (2.1%) as contaminants. The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%.
The stated manufacturer of the affected batch of the product is FOURRTS (INDIA) LABORATORIES PVT. LTD, and the product is stated to be manufactured for DABILIFE PHARMA PVT. LTD. - INDIA. To date, the stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product.
The product referenced in this Alert may have marketing authorizations in other countries or regions. It may also have been distributed, through informal markets, to other countries.
Please refer to the Annex of this Alert for full details of the affected products.
WHO has previously published five Alerts on other contaminated liquid dosage medicines. Please see Medical Product Alert N°6/2022, Medical Product Alert N°7/2022, Medical Product Alert N°1/2023, Medical Product Alert N°4/2023 and Medical Product Alert N°5/2023.
Risks
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
The substandard batch of the product referenced in this Alert is unsafe and its use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.
Advice to regulatory authorities and the public
If you have the affected product, WHO recommends that you do not use it. If you, or someone you know, has, or may have used the affected product, or suffered an adverse reaction or unexpected side-effects after use, you are advised to seek immediate medical advice from a healthcare professional.
While this Medical Product Alert relates to only one batch of the product (as set forth in the Annex hereto), out of an abundance of caution, WHO recommends increased vigilance and testing in respect of the product in general.
Despite the efforts of watchdog and police agencies around the globe, the world remains awash in substandard, contaminated, or otherwise dubious pharmaceuticals.
While many are OTC (over-the-counter) medicines, we've seen reports of adulterated prescription medicines as well.
In 2012 we looked at a Lancet Report: 1/3rd Of Malaria Drugs Fake Or Sub-Standard, followed in 2013 by a study on Substandard & Falsified TB Drugs. In 2015 the AJTMH (The American Journal of Tropical Medicine and Hygiene) and NIH released a series of reports on The Threat From Fake & Substandard Pharmaceuticals.
Also in 2015, we saw a report in The Lancet: WHO Estimates That 50% Of Drugs For Sale Online Are Fake.
In 2017, Changchun Changsheng Life Sciences Limited allegedly sold 500K doses of defective diphtheria, pertussis, and tetanus (DPT) vaccine, while the following year we saw an avian influenza vaccine scandal in Taiwan (see Taiwan's Counterfeit AI Vaccine Trade).
In 2018, we saw Media Reports: Scores Of `Counterfeit' Drugs Removed From Punjab Hospitals, while more recently our own government has repeatedly warned of substandard and unsafe PPEs and hand sanitizers flooding the market during the pandemic (see NIOSH & FDA Updates On Counterfeit N95 Respirators & Hand Sanitizers).
These products aren't just ripping off billions of dollars from consumers each year, in some cases they are contributing to rising antimicrobial resistance (AMR), they may leave some people inadequately treated for potentially serious diseases - and as described above - may be lethal in their own right.
Every summer for the past 15 years Interpol has conducted a global special operation to clamp down on these fake, and often dangerous drugs, in Operation Pangea (see 2020's Interpol Warning On Fake/Counterfeit COVID Vaccines).
For an overview of their operations, you can visit Interpol's Pharmaceutical crime operations website:
