They also arrested 12 people in connection with the incident. It was assumed that DEG was used as a substitute of propylene glycol, and this incident encouraged the Nigerian government to develop pharmaceutical quality control guidelines. Most ethylene glycol antifreeze contains a few percent diethylene glycol, present as an byproduct of ethylene glycol production. The FDA has since pledged to be more vigilant and crack down on poor manufacturing practices. Any unauthorized or illegal use, copying or dissemination will be prosecuted. Suspecting something wrong with Lisinopril, the medicine was removed from the pharmacies[39] while the U.S. Food and Drug Administration conducted lab analyses, revealing the blood pressure drug was safe; CDC epidemiologists were then invited to participate. Tracked Poisoned Drugs, but Trail Went Cold in China", "From China to Panama, a trail of Poisoned Medicine", "Aumentan Envenenados con Dietilene Glycol", "Outbreak of acute renal failure in Panama in 2006: a case-control study", "Caso dietilene glycol puede viciarse: Troitiño", "24 Niños afectados por utilización de tóxico", "Rasfer Internacional se declara en bancarrota", "Panamá bloquea el proceso español por el caso del jarabe asesino", Guidance for Industry – Testing of Glycerin for Diethylene Glycol, "China investigating toothpaste containing potentially deadly chemical", "U.S. checking all toothpaste imports from China", " Toothpaste recall expands 6/18/07", "The Everyman Who Exposed Tainted Toothpaste", Nigeria child deaths from tainted syrup rise to 84, Nigeria child deaths from tainted syrup rise to 84, "84 Children Are Killed by Medicine in Nigeria", NAFDAC Negotiates State of the art Anti Counterfeiting Equipment, "Laudo da Polícia Civil aponta que cerveja adulterada causou doença misteriosa em BH", "Polícia confirma 3ª morte por síndrome nefroneural", "Ministério da Agricultura identifica contaminação em oito rótulos de cervejas da Backer", "Morre 10ª vítima por intoxicação de cerveja da Backer", "Behind killer cough syrup Coldbest: Glaring gaps in regulation and its manufacture", "J&K children deaths: Kids consumed cough syrup with poisonous chemical, probe reveals",, Articles with dead external links from July 2019, Articles with permanently dead external links, Pages using collapsible list with both background and text-align in titlestyle, Articles containing unverified chemical infoboxes, Articles containing Chinese-language text, Creative Commons Attribution-ShareAlike License, 244 to 245 °C (471 to 473 °F; 517 to 518 K), This page was last edited on 20 November 2020, at 22:09. According to the results of its assessment, this substance is not a PBT or a vPvB. Patients who survive but develop kidney failure remain dialysis-dependent. Incidents include its use in China as a component of cheap toothpaste, and by winemakers in Europe as an adulterant to create a "sweet" wine. [5] DEG is used as a building block in organic synthesis, e.g. CS1 maint: multiple names: authors list (. The fiscal attorney urged affected citizens to approach the Public Ministry to update the official legal file and for further medical analysis. [64][65][66], In December 2019, some people in the city of Belo Horizonte, initially all from the same neighbourhood, started having symptoms such as nausea, vomiting, abdominal pain, acute kidney failure, facial nerve paralysis, blurred vision, temporary blindness and sensory changes. The FDA is requiring more detailed information on how the companies plan to correct all violations. It can be a contaminant in consumer products; this has resulted in numerous epidemics of poisoning since the early 20th century. If experienced, these tend to have a Less Severe expression 1. Diethylene Glycol Safety Data Sheet according to Federal Register / Vol. Fourteen patients received hemodialysis, but the treatment failed. "FDA Advises Consumers to Avoid Toothpaste From China Containing Harmful Chemical. It is completely miscible with water and many organic liquids.1 See Product Description. It is able to interfere with the hydrogen bonds in water, making it difficult for the water molecules to bind. [52], On June 1, 2007, the FDA warned consumers to avoid toothpaste from China, although there was no information if these toothpastes had already entered the US, and started testing any imported Chinese toothpaste. After a characteristic latent period, signs of inebriation may be followed by serious illness, and even death, caused by toxic metabolites. [53][54] Days later, Colgate-Palmolive found counterfeit toothpaste with its name, which was contaminated with DEG and found at dollar-type discount stores in New York, New Jersey, Pennsylvania and Maryland. Human health assessment for long-term oral ingestion of diethylene glycol. Electronic Cigarettes are found to contain an anti-freeze component known as Diethylene Glycol. About half were receiving Lisinopril (a blood pressure medicine), and many did not remember clearly if they had been taking other drugs. [60] The world outcry made Chinese officials ban the practice of using diethylene glycol in toothpaste. (2020, March 24). Trial Attorney and Pharmaceutical Litigation Expert, Drug Makers Warned for Potential Diethylene Glycol Toxin Contamination, Diethylene glycol, or DEG, is a chemical that can cause potentially fatal kidney and neurological toxicity. In this case, the substrate is ethanol, otherwise known as alcohol. When 105 people died in 15 states during the months of September and October, the trail led back to the elixir, and the toxic potential of this chemical was revealed. The FDA Detains One Contaminated Shipment, Issues Import Alert", June 1, 2007. [31], A propolis syrup manufactured by Huilen Laboratories in Buenos Aires, Argentina, contained between 24 and 66.5% DEG, and caused the death of 29 people. Acute Renal Failure Investigation Team", "Fatal renal failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic", "Identification and Quantification of Diethylene Glycol in Pharmaceuticals Implicated in Poisoning Epidemics: An Historical Laboratory Perspective", "F.D.A. More than 100 people died, about a third of those victims were children. Because patients treated with Lisinopril developed a cough (a common side effect of ACE inhibitors), they were prescribed an expectorant. Ethylene glycol ingestion results initially in CNS effects. Diethylene Glycol (Reagent) Revision Date 17-Jan-2018 that comprises one of the eligibility criteria for the exemption rule. Soon, patients from other parts of the country started to arrive at hospitals. Polyethylene glycol 3350 is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. Some authors suggest the minimum toxic dose is estimated at 0.14 mg/kg of body weight and the lethal dose is between 1.0 and 1.63 g/kg of body weight,[7] while some suggest the LD50 in adults is of ~1 mL/kg,[1] and others suggest this is the LD30. hexylene glycol 1. identification product name: hexylene glycol cas #: 107-41-5 synonym: 2-methyl-2,4-pentanediol; 2,4-dihydroxy-2-methylpentane; dionlane; alpha, alpha, alpha'-trimethyltrimthylene glycol chemical description: aliphatic polyhydric alcohol 2. hazards identification emergency overview: clear, colorless viscous liquid with no odor [16][17][18] This episode was the impetus for the Federal Food, Drug, and Cosmetic Act of 1938. O’Neil M. The Merck Index. [58], In July 2007, health authorities in the UK detected a counterfeit Sensodyne toothpaste on sale at a car boot sale in Derbyshire. This site complies with the HONcode standard for trustworthy health information: Verify here. Pain in abdomen, vomiting and nausea are symptoms observed when propylene glycol is accidentally ingested in large amount. [29], The Panamanian Government made a nationwide campaign, collecting around 6,000 bottles of cough syrup and three other products with the tainted glycerin manufactured by Social Security Laboratories. It is a colorless, practically odorless, poisonous, and hygroscopic liquid with a sweetish taste. This website and its content may be deemed attorney advertising. “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. It is 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. Authorities warn against using some toothpastes, Taste of Raspberries, Taste of Death – The 1937 Elixir Sulfanilamide Incident, "Wallace Reveals How Federal Agents Traced Elixir to Halt Fatalities", "Medication-associated diethylene glycol mass poisoning: A review and discussion on the origin of contamination", "Popular Wines found to hold toxic chemical. The most common use of ethylene glycol is in antifreezeformulations. If you found our resources and information helpful, please take a minute to review us on Facebook and Google. Review our editorial policy to learn more about our process for producing accurate, current and balanced content. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. When urine analyses for a series of metals, pesticides or their metabolites resulted negative, CDC scientists recalled the Nigeria and Haiti incidents. Special danger of slipping by leaking/spilling product. All patients are likely to suffer significant morbidity. Three of the mass poisonings originated with products from Chinese manufacturing plants, according to Schier and colleagues. Between November 1995 and June 1996, almost 109 children admitted to the University Hospital in Port-au-Prince, Haiti, presented with acute kidney failure. 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, Offshore drug manufacturers recently came under fire because of contamination with, 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. [20], In Cape Town, South Africa, seven children developed vomiting, diarrhea, and dehydration, and died of kidney failure after administration of over-the-counter sedatives. [40] Two months later, findings revealed that 145 were proven to die by DEG intoxication, but the DA still has to investigate 953 demands. The primary results revealed that the mixture was more effective than using salt alone. Throwing Up 8. Once verifying that he was fine, he shipped it to Qiquihar No. [29], When a patient admitted for a heart attack developed the mysterious illness at the hospital, Dr. Nestor Sosa, an infectious disease specialist, analyzed the medical record. [70] On 18 July, the 10th victim died in a Belo Horizonte hospital, a 65-year-old man who had been hospitalized since December 2019 due to the poisoning. However, as required by the new California Consumer Privacy Act (CCPA), you may record your preference to view or remove your personal information by completing the form below. [43] The following month, the Toxicology Department of the Institute of Legal Medicine and Forensic Science published a list of 1,155 names whose medicine bottles tested positive for DEG. skin cream and lotions, deodorants), DEG is often replaced by selected diethylene glycol ethers. This prevents the formation of ice crystals and in turn lowers the freezing point of water. Later on, HEAA leaves the liver through the bloodstream, being partially filtered in the kidneys for elimination. Diethylene Glycol is a colorless, low-volatility, low viscosity, hygroscopic liquid. Industry Circular No. Depending on the conditions, varying amounts of DEG and related glycols are produced. The toxic metabolic by-products of ethylene glycol metabolism cause a build-up of acid in the blood (metabolic acidosis). Ethylene glycol is considered a poison, and ingestion requires serious medical attention. [70] The investigation revealed that DEG had been used as a coolant for the brewery equipment, in what should have been a closed circuit, but an undetected leak in the system contaminated some batches of beer. Retrieved from, U.S. Food and Drug Administration. Take … Remove victim out of the danger area. Further investigation revealed all patients were treated with topical silver sulfadiazine ointment that contained 7 g/kg of DEG. Retrieved from, Snellings, W.M. [11] In the case of DEG, observations demonstrated there were no calcium oxalate crystal deposits in the kidneys, implying ethylene glycol is not on the DEG metabolic pathway. (It’s the reason why spilled antifreeze should be cleaned up immediately, since its sweet taste will attract pets and make them sick.) Diethylene glycol, or DEG, is a chemical that can cause potentially fatal kidney and neurological toxicity. The symptoms seemed to match with Guillain–Barré syndrome, but these patients were also losing their ability to urinate, a symptom not related to Guillain–Barré. Flammable and/or toxic gases are generated by the combination of alcohols with alkali metals, nitrides, and strong reducing agents. From November 1995 through June 1996, acute anuric renal failure was diagnosed in 86 children (aged 3 months-13 years) in Haiti; most (85%) children were aged less than or equal to 5 years. Only 88 children deaths were recalled by doctors or had medical records. An unmitigated tragedy", "Epidemic of pediatric deaths from acute renal failure caused by diethylene glycol poisoning. In July 1996, the American Embassy in China contacted Sinochem and requested a list of Chinese glycerin makers, but the company refused to reveal the names. During the month of July 1985, Austrian wines were found to contain up to 1,000 parts per million of DEG, giving them a desirable sweetness. Other than Diethylene Glycol, e-cigarettes also contain cancer-causing compounds like nitrosamines. Import Alerts Guard Against Unsafe Products. The product was recalled and after an investigation, the Drug Controller General of India, VG Somani, said at India Pharma 2020, that the GMP was not followed, and negligence was found during the production process itself. (2020, January 28). © 2020 Privacy Policy/ Doctors had no idea what was happening: the mysterious illness was attacking elderly citizens with hypertension and diabetes history. Diethylene glycol is almost entirely used for industrial and commercial applications. [67] On 9 January 2020, a police report indicated quantities of diethylene glycol in one brand of beer from a small upscale brewery that could have poisoned 18 people in Belo Horizonte and other cities in Minas Gerais state. (2020, January 28). [49][50][51] For the end of the month, the Chinese government committed to investigate the “supposedly” tainted toothpaste that had been recalled in Panama and Dominican Republic, but stated that, as per an essay written in 2000, a toothpaste containing 15.6% was not dangerous. It is completely miscible with water and many organic liquids. Meanwhile, in Panama, De la Cruz, legal representative of Medicom, remains in jail pending a trial. [27], At a hospital in Bombay, India, patients were admitted to be treated for diverse health problems. Lead CDC investigator Dr. Katherine O'Brien conducted a case-control investigation, looking for potential clues to the epidemic. Testing of medication samples taken from the factory samples by both CDC and by an independent commercial lab located in Miami, revealed contamination by DEG of 16.4% and higher. Not Feeling Well 6. 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. [55][56] Although there were no reports of anyone harmed, several people in the eastern US reported experiencing headaches and pain after using the product. [35] By June 1996, with no idea what was causing the epidemic, the Pan American Health Organization (PAHO) Haiti representative contacted the World Health Organization (WHO, the parent agency of PAHO), and WHO requested that the Centers for Disease Control and Prevention investigate.[36][29][37]. [3] Internal Medicine Residency Program of the College of Medicine of Wake Forest University, North Caroline, U.S.A. Slightly soluble in alcohol and soluble in ether. [38], Ending June 1996, the FDA had discovered counterfeit glycerin traced back to Chemical Trading and Consulting (a German broker), which bought 72 barrels of the syrup from Vos B.V., a Dutch company. Because of its toxicity, it’s not allowed in food or drugs. [1][7], At first, scientists thought that DEG metabolized into ethylene glycol, which is poisonous due to the metabolic production of glycolic acid, glyoxylic acid, and ultimately oxalic acid. [37] As a result of the case-control findings, and subsequent investigation at the factory, public warnings were issued by the Ministry of Health and bottles of the two medications were taken from pharmacy shelves and destroyed. Panama awaits the extradition of Criado for her hearing. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. Packaging 1, 4 L in poly bottle 18 L in steel drum Legal Information Product of Dow Chemical At the request of the United States, the State Food and Drug Administration of China investigated Taixing Glycerine Factory and CNSC Fortune Way, but the agency concluded it is not under their jurisdiction because the factory is not certified to make medicine. "Austrian power plant to burn 'bad' wine. Brake fluids often contain the toxic alcohol diethylene glycol (DEG), which has a boiling point of about 470°F. (2011). Because of the danger of ethylene glycol, propylene glycol is often used instead. The agency also identified urinary DEG as a biomarker for DEG exposures. Ethoxydiglycol can be classified as a glycol. Please read our disclaimer for more information about our website. For late diagnosis where ethanol or fomepizole is ineffective, because DEG has already been metabolized, hemodialysis becomes the only treatment available. (2017, April 29). Massengill Co. (a Tennessee drug company), manufactured sulfanilamide dissolved with diethylene glycol, to create a liquid alternative of this drug. The factory of the medication manufacturer, Pharval, was subsequently investigated by Dr. Joel Selanikio (also of CDC, and an Epidemic Intelligence Service classmate of Katherine O'Brien). Diethylene glycol butyl ether is a high boiling solvent, which can be used in coating industry. [39], Ending September 2006, the Arnulfo Arias Madrid Hospital at Panama City was getting full with patients with contradictory symptoms. In November, The New York Times published a wine recall that the Federal Government released after the Bureau of Alcohol, Tobacco and Firearms tested 1,000 bottles. Later, raw glycerin was analyzed and results revealed 22.2% v/v DEG. DIETHYLENE GLYCOL MONOBUTYL ETHER is a ether-alcohol derivative. In fact, the company bought the product in China and had already re-exported toothpaste to Costa Rica, Dominican Republic and Haiti, making Panama kick off a local warning. Once physicians identified a suspect paracetamol syrup, samples were shipped to the Centers for Disease Control and Prevention (CDC) in the U.S., which identified DEG. Autism Speaks reports that the FDA found trace amounts of ethylene glycol and diethylene glycol when studying these laxatives while the FDA claims these are toxic only in large amounts. [32][33][34], In the poorest country in the Western Hemisphere, disease outbreaks are not recognized unless widespread or unusual. The LD50 for small mammals has been tested at between 2 and 25 g/kg, less toxic than its relative ethylene glycol, but still capable of causing toxicity in humans. Note that both of these chemicals are in antifreeze, but I don’t know if the chemical composition may be different in MiraLAX. Diethylene glycol is a colorless chemical with a sweet taste that’s toxic when ingested by humans. Ethoxylation is a chemical reaction in which ethylene oxide is added to a substrate. The counterfeit syrup ended in ampules of Amillarisin A, a medication for gall bladder problems; special pediatric enema fluid; blood vessel disease injections; intravenous pain reliever; and an arthritis medication. [11] The major cause of ethylene glycol toxicity is the accumulation of glycolic acid in the body,[12] but the accumulation of calcium oxalate crystals in the kidneys can also lead to acute kidney failure. Diethylene glycol dinitrate appears as a liquid. Under normal conditions, diethylene glycol has no detectable odor; however, under high vapor concentrations, a slightly sweet odor may be detected. [45] Spanish authorities are prosecuting Asunción Criado, general manager of Rasfer Internacional, S.A., and await Panamanian citizens, René Luciani (former Social Security Director) and Jéssica Rodríguez (former Purchase National Director) for their hearings. We appreciate your feedback. It is a colorless, practically odorless, poisonous, and hygroscopic liquid with a sweetish taste. At the time, the food and drug laws did not require toxicological analysis before releasing for sale. Diethylene glycol is an organic compound having the chemical formula C 4 H 10 O 3. Diethylene glycol (DEG) is a colorless, low volatility, low viscosity, hygroscopic (picks up water from the air) liquid. The resulting product is two ethylene glycol molecules joined by an ether bond. The CDC employed modern laboratory equipment to analyze the samples and confirm the results: the samples contained approximately 8% v/v DEG. Keep people safe from potentially harmful drugs, medical devices and procedures by informing them of medical conditions, severe side effects and ways to take action. [3], "Diethylene glycol is derived as a co-product with ethylene glycol (MEG) and triethylene glycol. The information on this website is proprietary and protected. The company tested the new product, Elixir Sulfanilamide, for viscosity, appearance and fragrance. The outbreak forced the government to ban the sale of paracetamol elixirs in December 1992, causing a decline of 53% in the admission of patients with kidney failure and an 84% decline in admissions by unexplained kidney failure. partners with law firms. Soon, patients started to present anuria, acidic breathing, hepatomegaly, and unresponsiveness. Warning Letter: Huaian Zongheng Bio-Tech Co., Ltd. Retrieved from, U.S. Food and Drug Administration. Mr. Wang was caught and Qiquihar was shut down by the authorities. After manufacturing a second batch of syrup containing diethylene glycol for Qiquhar Pharmaceutical, no taste-test was performed. We only gather information from credible sources. Hemodialysis might be administered alone or with ethanol or fomepizole. Although there is limited information about toxicokinetics in humans, observations in mass poisonings and experimental studies suggest the following information: The principal method of absorption is through oral ingestion. Bureau of Alcohol, Tobacco, and Firearms. [14][15], In 1937, S.E. [2] It can be a contaminant in consumer products; this has resulted in numerous epidemics of poisoning since the early 20th century. [62][63], The Nigerian government traced the diethylene glycol to an unlicensed chemical dealer in Lagos, who sold it to a local pharmaceutical manufacturer. Four years ago the FDA said they had found diethylene glycol (DG) in e-cigarettes. Diethylene glycol (DEG) is an organic compound with the formula (HOCH2CH2)2O. Drugwatch's trusted legal partners support the organization’s mission to keep people safe from dangerous drugs and medical devices. [67] On 17 January, the police confirmed the fourth death from symptoms matching DEG poisoning, and DEG contamination had been found in eight brands of beer from the same brewery. Glycols related to and coproduced with diethylene glycol and have the formula HOCH2CH2(OCH2CH2)nOH are: These compounds are all hydrophilic, more so than most diols, by virtue of the ether functionality. Editors carefully fact-check all Drugwatch content for accuracy and quality. In fact, Rasfer received the product from CNSC Fortune Way, which in turn bought it from the Taixing Glycerine Factory. And Valodon ) and triethylene glycol is accidentally ingested in large amount ) is an organic compound having the formula! Instead of propylene glycol is an organic compound with the incident is sweet-tasting, odorless poisonous! 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