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Drug Makers Warned for Potential Diethylene Glycol Toxin Contamination

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Medications contaminated with DEG from a 1995 investigation
Afebril and Valodon, the two medications (in three formulations) found to be contaminated with DEG in Haiti in 1995.

In January 2020, the U.S. Food and Drug Administration warned three pharmaceutical manufacturers for significant violations of current good manufacturing practices and regulations — particularly when it came to drugs containing glycerin potentially contaminated with the deadly toxin diethylene glycol. 

Diethylene glycol, or DEG, is a chemical that can cause potentially fatal kidney and neurological toxicity. Researchers have implicated the chemical in multiple medication-associated mass poisonings over the years, according to Joshua G. Schier and fellow researchers from the Centers for Disease Control and Prevention

Three companies that received the warnings are Chinese manufacturers Sunstar Guangzhou Ltd. and Huaian Zongheng Bio-Tech Co., Ltd. and German manufacturer Dental-Kosmetik GmbH & Co. The FDA is requiring more detailed information on how the companies plan to correct all violations. 

The FDA’s warning did not specify which drugs or active ingredients were in question, but the agency noted that the two Chinese companies manufacture over-the-counter drug products, including medicines for children. 

In its warning letters, the FDA advised that it issued Import Alert 66-40 for all three companies. Import Alert 66-40 stands for “Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs.” Under this alert, the FDA prevents pharmaceutical products in question from entering the U.S. marketplace. 

“Until you correct all violations completely and we confirm your compliance with CGMP [Current Good Manufacturing Practice], FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer,” the agency said in its letters. 

Offshore drug manufacturers recently came under fire because of contamination with N-nitrosodimethylamine (NDMA) — a known carcinogen — in drugs such as valsartan in 2018 and Zantac in 2019. Both instances led to worldwide recalls. 

The FDA has since pledged to be more vigilant and crack down on poor manufacturing practices. 

What Is Diethylene Glycol (DEG)?

Diethylene glycol is a colorless chemical with a sweet taste that’s toxic when ingested by humans. It’s a solvent for water-insoluble drugs and chemicals, and it’s used to make products such as cigarettes, antifreeze, lubricants, brake fluids, cosmetics and wallpaper strippers. 

Because of its toxicity, it’s not allowed in food or drugs. But because of its solubility, some drug makers have inappropriately substituted it for nontoxic ingredients, such as glycerin, in pharmaceuticals such as cough syrups and acetaminophen. 

Over the years, there have been more than a dozen instances of mass human poisonings with high death rates from consuming tainted medication.

Acute kidney failure is the number one cause of death in poisoning cases, and it starts between 8 to 24 hours after exposure to lethal doses of DEG. If people don’t get treatment, symptoms progress to multi-organ failure in two to seven days, according to an article by William M. Snellings and colleagues in Regulatory Toxicology and Pharmacology

Side Effects of DEG poisoning include:

  • Abdominal pain
  • Acute kidney injury
  • Altered mental state
  • Brain disease and damage 
  • Cardio-respiratory failure
  • Coma
  • Convulsions
  • Death
  • Drowsiness
  • Excessive urination (polyuria) followed by low urine output (oliguria) 
  • Hepatitis
  • Increases in creatinine blood levels
  • Multi-organ failure
  • Nausea
  • Pancreatitis
  • Vomiting 

Historic Cases of DEG Poisoning with Medicines

The first known case of DEG poisoning with medicine occurred in the United States in 1937. Known as the sulfanilamide-Massengil disaster, DEG was used in elixir of sulfanilamide, an antibiotic. 

More than 100 people died, about a third of those victims were children. 

Since then, all recorded mass DEG poisonings have been in other countries. The most recent case occurred in Nigeria in 2008 and was linked to an oral painkiller. 

Three of the mass poisonings originated with products from Chinese manufacturing plants, according to Schier and colleagues.

DEG Mass Poisonings

Year Country Medication Type Type of Dose
1937 USA Elixir of Sulfanilamide oral
1969 South Africa Sedative oral
1986 India Glycerin unknown
1990 Nigeria Acetaminophen oral
1990 Bangladesh Acetaminophen oral
1992 Argentina Propolis syrup oral
1995 Haiti Acetaminophen oral
1998 India Cough expectorant oral
1998 India Acetaminophen oral
2006 Panama Cough syrup oral
2008 Nigeria Analgesic oral

 

Source: Regulatory Toxicology and Pharmacology

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

9 Cited Research Articles

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  1. Minns, A. (2012, December 21). Diethylene Glycol Poisoning. Retrieved from https://calpoison.org/news/diethylene-glycol-poisoning
  2. Schier, J.G. et al. (2011). Diethylene glycol in health products sold over-the-counter and imported from Asian countries. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/20927618
  3. Science Direct. (n.d.). Diethylene Glycol. Retrieved from https://www.sciencedirect.com/topics/medicine-and-dentistry/diethylene-glycol
  4. Snellings, W.M. et al. (2017, April 29). Human health assessment for long-term oral ingestion of diethylene glycol. Retrieved from https://www.sciencedirect.com/science/article/pii/S0273230017300806
  5. U.S. Food and Drug Administration. (2011, August 25). Import Alerts Guard Against Unsafe Products. Retrieved from https://www.fda.gov/consumers/consumer-updates/import-alerts-guard-against-unsafe-products
  6. U.S. Food and Drug Administration. (2020, January 14). Warning Letter: Huaian Zongheng Bio-Tech Co., Ltd. Retrieved from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/huaian-zongheng-bio-tech-co-ltd-590789-01092020
  7. U.S. Food and Drug Administration. (2020, January 28). Warning Letter: Sunstar Guangzhou Ltd. Retrieved from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sunstar-guangzhou-ltd-592906-01222020
  8. U.S. Food and Drug Administration. (2020, January 28). Warning Letter: Dental-Kosmetik GmbH & Co. KG. Retrieved from https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dental-kosmetik-gmbh-co-kg-591351-01162020
  9. U.S. Food and Drug Administration. (2020, March 24). Import Alert 66-40. Retrieved from https://www.accessdata.fda.gov/cms_ia/importalert_189.html
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