FDA and WHO investigate contaminated cough syrup from India linked to 300 deaths

By Lisa Marie Basile | Fact-checked by Jessica Wrubel
Published March 28, 2023

Key Takeaways

  • The World Health Organization (WHO) and The Food and Drug Administration (FDA) are investigating the source of cough syrup products contaminated with diethylene glycol (DEG) and ethylene glycol (EG). This investigation comes after more than 300 people died in The Gambia, Indonesia, and Uzbekistan. 

  • Diethylene glycol (DEG) and ethylene glycol (EG) can cause severe toxicity, including organ failure, coma, and death. 

  • There is no evidence that these DEG and EG-contaminated products have found their way into the United States.

Earlier this year, the World Health Organization (WHO) released a call to action demanding an investigation into contaminated over-the-counter cough syrups responsible for more than 300 deaths in The Gambia, Indonesia, Uzbekistan, and other countries. The vast majority were children under the age of five. The Food and Drug Administration (FDA) has since joined the investigation.[]

Reports of contaminated cough syrup products first surfaced in October 2022, when the WHO found “unacceptable amounts of diethylene glycol (DEG) and ethylene glycol (EG) as contaminants” in several products, including Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup. The products were manufactured by Maiden Pharmaceuticals Limited, based in Haryana, India, which denied the allegations.[] 

These medications were responsible for the deaths of 70 children from The Gambia in 2022. In a special report by Reuters, these first 70 deaths in The Gambia were said to be the “deadliest total poisoning on record from toxins that have been known to scientists for decades.” Delays in testing—after doctors spent weeks sounding the alarms to health officials—reveal the limitations and dire consequences of a poorly resourced country.[] 

But the issue continued. The WHO also released two other medical alerts regarding substandard fatal products found in Indonesia (listed here) and Uzbekistan (listed here). 

These weren’t the first instances of death due to EG and similar compounds, either. In 2007, a string of deaths in Panama occurred after people ingested cough syrup made with DEG.[] 

A closer look at diethylene glycol and ethylene glycol

“Ethylene glycol is a chemical commonly found in radiator antifreeze. It is odorless, colorless, and sweet tasting, and it is also highly poisonous when consumed by humans and pets,” says Kelly Johnson-Arbor, MD, FACEP, FUHM, FACMT, medical toxicologist, co-medical director, and interim executive director at the National Capital Poison Center.

“Diethylene glycol (formed when two ethylene glycol molecules are bound together) is found in some antifreeze formulations as well as artificial fog products, brake fluids, and chafing dish fuel. Like ethylene glycol, diethylene glycol is highly poisonous,” she adds. 

In fact, she says, as little as a swallow of concentrated ethylene glycol can be poisonous, while it only takes small amounts of diethylene glycol to lead to toxicity. When ingested, EG takes just a few hours to absorb through the stomach—with 80 percent of it converting into toxic compounds. EG affects the central nervous system (CNS), the heart, and the kidneys, and DEG causes renal insufficiency and failure, encephalopathy, peripheral neuropathy, coma, and death.[][] 

Spotting DEG and EG poisoning

The signs and symptoms of diethylene glycol and ethylene glycol intoxication include:[]

  • Confusion

  • Stupor

  • Change in urine output

  • Metabolic acidosis

  • Abdominal pain

  • Nausea

  • Vomiting

  • Coma

MedlinePlus recommends physicians consider ethylene glycol toxicity in patients who become “severely ill after drinking an unknown substance, especially if they at first appear drunk and you can't smell alcohol on their breath.” Blood and urine tests, as well as other tests, can confirm high levels of ethylene glycol, signs of organ failure or damage, and blood chemical disturbances.[] 

Johnson-Arbor says physicians should know there are antidotes—which include both fomepizole and ethanol—for EG poisoning and that these can also be used for patients with diethylene glycol poisoning. “For maximum effectiveness, these antidotes must be administered within a short period of time after the poisoning has occurred,” Johnson-Arbor says. “In a mass poisoning scenario like the outbreaks [in Gambia], the hospitals may not have enough of the antidote available to treat large numbers of affected patients.”[] 

How do DEG and EG contamination occur?

Contamination risks boil down to the preparation and quality control of pharmaceutical products, Johnson-Arbor says. In many countries, such as India, “Inadequate regulation of manufacturing processes, or use of substandard quality control procedures, may result in drug companies using alternative ingredients or solvents during the manufacture of pharmaceutical products. Both ethylene glycol and diethylene glycol dissolve well in water as well as alcohols, making them effective for use as solvents,” Johnson-Arbor says.[] 

Using DEG may also be cheaper, Johnson-Arbor adds: “[It] is less expensive than many traditional pharmaceutical solvents, [so] some drug manufacturers in developing nations may use it in lieu of other solvent products to save money during the manufacturing process.”

Here in the United States, Johnson-Arbor says, “Pharmaceuticals, such as cough syrups, are regulated by the Food and Drug Administration (FDA), and contamination with diethylene glycol is unlikely to occur.” 

However, they said, “we are investigating the potential impact on FDA-regulated drug products. We are making every effort to prevent contaminated drug products from entering the US market.” Additionally, they’re reminding drug product manufacturers and foreign regulatory counterparts to remind that any products “intended for sale within the US must meet Current Good Manufacturing Practice (CGMP)  requirements and appropriate quality specifications.”

In the end, you may want to tell your patients—especially those who travel to affected countries—to be mindful of where their medications come from. Still, Johnson-Arbor says, “Some medications sold in the United States may be illegally imported from other countries, so people should read package labels carefully to ensure that the product is manufactured within the United States.”

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