[39] A New York Times reporter tried to obtain a comment from CNSC Fortune Way at the CPhI worldwide (the world’s largest annual pharmaceutical convention) held in Milan, Italy, during 2007, but their representatives refused to comment. "Austrian power plant to burn 'bad' wine. Additional Side Effects Of Propylene Glycol. 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. 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, Excessive urination (polyuria) followed by low urine output (oliguria), Testing Positive for COVID-19: It Felt Like I Had a Compression Belt Around My Chest, COVID-19: A Consumer’s Guide to the Coronavirus, JET 7 Xtra Flex Catheters Recalled After Injuries and Deaths, Erika Sward of American Lung Association Reveals the Dangers of Vaping and IQOS, This article contains incorrect information, This article doesn't have the information I'm looking for, https://calpoison.org/news/diethylene-glycol-poisoning, https://www.ncbi.nlm.nih.gov/pubmed/20927618, https://www.sciencedirect.com/topics/medicine-and-dentistry/diethylene-glycol, https://www.sciencedirect.com/science/article/pii/S0273230017300806, https://www.fda.gov/consumers/consumer-updates/import-alerts-guard-against-unsafe-products, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/huaian-zongheng-bio-tech-co-ltd-590789-01092020, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sunstar-guangzhou-ltd-592906-01222020, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dental-kosmetik-gmbh-co-kg-591351-01162020, https://www.accessdata.fda.gov/cms_ia/importalert_189.html, FDA Approves First New Mesothelioma Treatment in 16 Years, FDA Issues Guidance to Control NDMA in Zantac, Other Drugs, FDA Issues Warning on ‘Benadryl Challenge’, Thousands of Infusion Pumps Recalled After Several Injuries and a Death, Minns, A. Drugwatch has a stringent fact-checking process. Ethylene glycol is by far the largest volume of the glycol products in a variety of applications. Wang Guiping discovered how easy it was to enter China’s pharmaceutical supply business and earn extra money. Nearly half of the victims were under the age of two. (2020, March 24). Propylene glycol, which is much less toxic than ethylene glycol, is metabolized to compounds that are normal constituents of the citric acid cycle. Diethylene Glycol is a colorless, low-volatility, low viscosity, hygroscopic liquid. This event caused the death of five patients.[3][21][22]. This is one of the major Electronic Cigarette side effects. Warning Letter: Dental-Kosmetik GmbH & Co. KG. 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. Extremely sensitive explosive if not properly desensitized with a phlegmatizer. [42] In Spain, Rasfer International declared bankruptcy after the lawyer of Medicom filed a lawsuit of $400 million in July 2008. Polyethylene glycol 3350 is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. U.S. Food and Drug Administration Press Release. Some of her qualifications include: Drugwatch.com writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Because patients treated with Lisinopril developed a cough (a common side effect of ACE inhibitors), they were prescribed an expectorant. Soon, patients started to present anuria, acidic breathing, hepatomegaly, and unresponsiveness. More than 100 people died, about a third of those victims were children. 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. Patients who survive but develop kidney failure remain dialysis-dependent. 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. Further investigation revealed all patients were treated with topical silver sulfadiazine ointment that contained 7 g/kg of DEG. If swallowed, DEG can be very dangerous, even fatal, if patients do not receive prompt medical care. The industry generally operates to maximize MEG production. Slightly soluble in alcohol and soluble in ether. They cause deposition of oxalic acid crystals in … Please read our disclaimer for more information about our website. The agency also identified urinary DEG as a biomarker for DEG exposures. Both instances led to worldwide recalls. Polyethylene glycol (PEG; / ˌ p ɒ l i ˈ ɛ θ əl ˌ iː n ˈ ɡ l aɪ ˌ k ɒ l,-ˌ k ɔː l /) is a polyether compound derived from petroleum with many applications, from industrial manufacturing to medicine.PEG is also known as polyethylene oxide (PEO) or polyoxyethylene (POE), depending on its molecular weight.The structure of PEG is commonly expressed as H−(O−CH 2 −CH 2) n −OH. Slightly toxic by ingestion. Diethylene Glycol. Note that both of these chemicals are in antifreeze, but I don’t know if the chemical composition may be different in MiraLAX. These measures quickly ended the advance of the epidemic. [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. The regional drug controller authorities after investigation found out that a faulty batch of the Coldbest PC cough syrup contained 34.97% of diethylene glycol, which resulted in poisoning and subsequent renal failures. Editors carefully fact-check all Drugwatch content for accuracy and quality. However, cheap, mass-market vapes have been found to contain diethylene glycol – an industrial solvent which is definitely poisonous. [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. Doctors prescribed glycerine for its osmotic diuretic effect, but patients started to develop kidney failure. [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. Meanwhile, in Panama, De la Cruz, legal representative of Medicom, remains in jail pending a trial. The Himachal Pradesh government is filing a criminal case against the company and its executives. This website and its content may be deemed attorney advertising. At room temperature, it is a colorless and odorless liquid. [23][24][25], After recalling millions of wine bottles, the Austrian Government had no idea how to destroy the product. During September 1986, the Ministry of Public Works started testing a mixture of wine with salt to melt hazardous ice during winter. A dilute solution of diethylene glycol can also be used as a cryoprotectant; however, ethylene glycol is much more commonly used. Diethylene glycol (DEG) is sweet-tasting, odorless, and colorless. Ethoxydiglycol, also known as diethylene glycol monoethyl ether (DEGEE), is produced by the ethoxylation of ethanol. Diethylene glycol (DEG) is an organic compound with the formula (HOCH2CH2)2O. Retrieved from, U.S. Food and Drug Administration. [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. One of our content team members will be in touch with you soon. [5] DEG is used as a building block in organic synthesis, e.g. Some time later, Wang found a reference to diethylene glycol in a chemical book. It is not a substitute for professional medical advice, diagnosis or treatment. U.S. Federal Regulations TSCA 12(b) Not applicable SARA 313 Not applicable SARA 311/312 Hazard CategoriesSee section 2 for more information CWA (Clean Water Act) Not applicable Clean Air Act Not applicable OSHA Occupational Safety and Health Administration [1][7], The symptoms of poisoning typically occur in three characteristic intervals:[1], Fomepizole or ethanol should be quickly administered to prevent diethylene glycol being metabolized to the compound or compounds that cause the real damage.[1]. Import Alerts Guard Against Unsafe Products. 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. CS1 maint: multiple names: authors list (. Panamanian officials traced the toothpaste to a local company in the Colón Free Trade Zone. Human health assessment for long-term oral ingestion of diethylene glycol. Physical dangers Chemical dangers Reacts violently with strong oxidants. In addition to ethoxydiglycol, there are many different types of compounds that belong to this fa… 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. [70], In the first week of 2020, around 17 children from Ramnagar, in the union territory of Jammu and Kashmir, were hospitalised, more than half of whom died of kidney failure. They react with oxoacids and carboxylic acids to form esters plus water. 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. Any unauthorized or illegal use, copying or dissemination will be prosecuted. In fact, Rasfer received the product from CNSC Fortune Way, which in turn bought it from the Taixing Glycerine Factory. The toothpaste was labeled as “Manufactured in South Africa” and contained misspellings like "isclinically", "SOUTH AFRLCA" and "South African Dental Assoxiation". Electronic Cigarettes are found to contain an anti-freeze component known as Diethylene Glycol. Attacks some forms of plastic. [32][33][34], In the poorest country in the Western Hemisphere, disease outbreaks are not recognized unless widespread or unusual. Diethylene glycol is used in the manufacture of saturated and unsaturated polyester resins, polyurethanes, and plasticizers. Diethylene Glycol Safety Data Sheet according to Federal Register / Vol. [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. Laboratory testing at CDC of samples taken from parents revealed significant contamination with DEG. It is completely miscible with water and many organic liquids.1 See Product Description. They also arrested 12 people in connection with the incident. Because of its toxicity, it’s not allowed in food or drugs. Ethylene glycol ingestion results initially in CNS effects. Known as the sulfanilamide-Massengil disaster, DEG was used in elixir of sulfanilamide, an antibiotic. Diethylene glycol poisoning can also result in hepatic disease, pancreatitis, and neurologic abnormalities, which appear up to a few days after exposure [8,12]. This includes peer-reviewed medical journals, reputable media outlets, government reports, court records and interviews with qualified experts. [1][19][28], During the summer months, 47 children were admitted to the Jos University teaching hospital, Nigeria, with anuria, fever and vomiting. 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. [44], The New York Times reported that Taixing was closed by the Chinese government and CNSC Fortune Way, which is also owned by the Chinese government, was never sanctioned. Feel Like Throwing Up 4. Diethylene Glycol. 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. Fatalities Associated with Ingestion of Diethylene Glycol-Contaminated Glycerin Used to Manufacture Acetaminophen Syrup -- Haiti, November 1995-June 1996 . 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. Over the years, there have been more than a dozen instances of mass human poisonings with high death rates from consuming tainted medication. Because of the danger of ethylene glycol, propylene glycol is often used instead. Unfortunately, Taixing used “TD” for the Chinese word tidai, meaning “substitute”. Warning Letter: Huaian Zongheng Bio-Tech Co., Ltd. Retrieved from, U.S. Food and Drug Administration. They identified Tianhong Fine Chemicals Factory as the manufacturer. 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. It starts with our strict sourcing guidelines. Despite the FDA’s milquetoast evaluation of propylene glycol, there are several other health concerns, including: Infants And Pregnant Women — Propylene glycol enters the body as an alcohol and metabolizes in the body’s enzyme pathways. 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. [71][72], InChI=1S/C4H10O3/c5-1-3-7-4-2-6/h5-6H,1-4H2, InChI=1/C4H10O3/c5-1-3-7-4-2-6/h5-6H,1-4H2, Except where otherwise noted, data are given for materials in their, 1937 – The Massengill Incident (United States). Diethylene glycol is an organic compound having the chemical formula C 4 H 10 O 3. Once he was inside, there was nothing to do: the plant had already been shut down. [29] The United States Food and Drug Administration also issued an Industry Guidance Document “intended to alert pharmaceutical manufacturers, pharmacy compounders, repackers, and suppliers to the potential public health hazard of glycerin contaminated with diethylene glycol (DEG)” and recommended appropriate testing procedures for the use of glycerin. 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. Diethylene glycol is a colorless chemical with a sweet taste that’s toxic when ingested by humans. [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. Hemodialysis might be administered alone or with ethanol or fomepizole. The children later developed kidney failure and died. [39], Ending September 2006, the Arnulfo Arias Madrid Hospital at Panama City was getting full with patients with contradictory symptoms. [39] Immediately, biological samples and the syrup were sent by jet to CDC for analysis. Retrieved from, Science Direct. Internal Medicine Residency Program of the College of Medicine of Wake Forest University, North Caroline, U.S.A. Retrieved from, U.S. Food and Drug Administration. 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. The most common use of ethylene glycol is in antifreezeformulations. In its warning letters, the FDA advised that it issued Import Alert 66-40 for all three companies. [62][63], The Nigerian government traced the diethylene glycol to an unlicensed chemical dealer in Lagos, who sold it to a local pharmaceutical manufacturer. [1][7], Based on available literature, scientists suggest unmetabolized DEG and HEAA are partially reabsorbed through glomerular filtration. [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. Ethoxylation is a chemical reaction in which ethylene oxide is added to a substrate. If you found our resources and information helpful, please take a minute to review us on Facebook and Google. What wasn’t reported was that that traces of DG had only been found in one e-cigarette, belonging to one brand, at levels of 1%, OR that smokers are already exposed to DG in tobacco smoke. 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. [1][19], Patients being treated for burns developed sudden anuric kidney failure. 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. Take … 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. Availability of DEG will depend on demand for derivatives of the primary product, ethylene glycol, rather than on DEG market requirements."[4]. It can be a contaminant in consumer products; this has resulted in numerous epidemics of poisoning since the early 20th century. [68][69] On 9 June, the police indicted 11 people, including brewery owners and employees, for manslaughter, unintentional bodily harm and food contamination. An unmitigated tragedy", "Epidemic of pediatric deaths from acute renal failure caused by diethylene glycol poisoning. Common side effects may include: bloating, gas, upset stomach; dizziness; or increased sweating. The death rate of this mysterious illness was nearly 50%, when hospital management decided to isolate all the patients with the illness in a large room and doctors could compare notes and theories. Industry Circular No. Polyethylene glycol 3350 may also be used for purposes not listed in this medication guide. This site complies with the HONcode standard for trustworthy health information: Verify here. Shortly after, 2-hydroxyethoxyacetaldehyde (C4H8O3) is metabolized by the enzyme aldehyde dehydrogenase (ALDH) into the weak acid 2-hydroxyethoxyacetic acid (HEAA) with chemical formula C4H8O4. Soon thereafter, patients died after receiving the medication. The FDA is requiring more detailed information on how the companies plan to correct all violations. (See The FDA, the MHRA and The Electronic Cigarette for more information.). 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. Most ethylene glycol antifreeze contains a few percent diethylene glycol, present as an byproduct of ethylene glycol production. 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. Records also revealed that to fool buyers, Wang falsified his license and laboratory analysis reports. O’Neil M. The Merck Index. 2 Pharmaceutical in 2005. [16][17][18] This episode was the impetus for the Federal Food, Drug, and Cosmetic Act of 1938. Drugwatch is located at: 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. Soon, patients from other parts of the country started to arrive at hospitals. The fiscal attorney urged affected citizens to approach the Public Ministry to update the official legal file and for further medical analysis. At the time, the food and drug laws did not require toxicological analysis before releasing for sale. It was not until September 1996 that Sinochem provided a name of the manufacturer of the tainted syrup. Other than Diethylene Glycol, e-cigarettes also contain cancer-causing compounds like nitrosamines. Barewa Pharmaceuticals was shut down and the product was pulled off the shelves. Laboratory findings in clinical assessment of diethylene glycol can include an elevated osmolar gap, elevated anion gap, elevated creatinine, and acidosis [8,11,12]. [58], In July 2007, health authorities in the UK detected a counterfeit Sensodyne toothpaste on sale at a car boot sale in Derbyshire. Excessive Thirst 2. Diethylene glycol is one of several glycols derived from ethylene oxide. et al. (2011). Rat models suggest DEG is metabolized in the liver by enzyme NAD-dependent alcohol dehydrogenase (ADH) into a hydrogen ion, NADH and 2-hydroxyethoxyacetaldehyde (C4H8O3). Panama awaits the extradition of Criado for her hearing. 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. This being the second incident involving counterfeit glycerine, it prompted the Nigerian National Agency for Food And Drug Administration and Control (NAFDAC) to adopt zero tolerance for counterfeits. The primary results revealed that the mixture was more effective than using salt alone. The information on this website is proprietary and protected. "Counterfeit Colgate Toothpaste Found", June 14, 2007. 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. Upper Abdominal Pain [3] Because of its adverse effects on humans, diethylene glycol is not allowed for use in food and drugs. The CDC employed modern laboratory equipment to analyze the samples and confirm the results: the samples contained approximately 8% v/v DEG. Brake fluids often contain the toxic alcohol diethylene glycol (DEG), which has a boiling point of about 470°F. skin cream and lotions, deodorants), DEG is often replaced by selected diethylene glycol ethers. [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. (2017, April 29). Prior results do not predict a similar outcome. Diethylene Glycol Poisoning. What began as a local alert revealed a global problem in more than 30 countries and involving more than thirty brands. While the FDA tried to find out Tianhong’s address, Chinese officials were reluctant to become involved. 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. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Whitehouse Station, NJ: Merck & Co; 2006. It is It is able to interfere with the hydrogen bonds in water, making it difficult for the water molecules to bind. After a characteristic latent period, signs of inebriation may be followed by serious illness, and even death, caused by toxic metabolites. Drugwatch.com doesn’t believe in selling customer information. Four years ago the FDA said they had found diethylene glycol (DG) in e-cigarettes. Between November 1995 and June 1996, almost 109 children admitted to the University Hospital in Port-au-Prince, Haiti, presented with acute kidney failure. Calling this number connects you with one of Drugwatch's trusted legal partners. After ingestion, DEG is absorbed through the gastrointestinal tract and distributed by the bloodstream throughout the body, reaching peak blood concentrations within 30 to 120 minutes. Vos records revealed the syrup had been bought from Sinochem International Chemicals Company through a German trader, Metall-Chemie. Ethoxydiglycol can be classified as a glycol. [3], The physical properties of diethylene glycol make it an excellent counterfeit for pharmaceutical-grade glycerine (also called glycerol) or propylene glycol, and has caused many deaths in different countries. 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