NLM It constitutes 40% of the intravenous form of phenytoin. 1985). In fact, between 0.8 and 3.5% of people are estimated to have a skin allergy to propylene glycol (32). Propylene glycol-free melphalan as conditioning regimen for autologous transplantation in myeloma. Propylene glycol is non-toxic when ingested, even in reasonably large amounts. Epub 2018 Oct 22. Epub 2016 May 31. Consuming propylene glycol within the recommended level of the World Health Organization is the best way to prevent the toxicity. The Food and Drug Administration (FDA) has classified propylene glycol as an additive that is “generally recognized as safe” for use in food. It is used, In the general population, propylene glycol exposure occurs primarily through ingestion of food and medications and through dermal contact with cosmetics or topical medications. Metabolic conversion of propylene glycol to lactic and pyruvic acids can contribute to metabolic acidosis and an abnormal anion gap. C. a surfactant or solvent In one case, a woman with epilepsy developed repetitive convulsions and stupor due to propylene glycol poisoning from an unknown source (29). Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. There is no evidence that dietary amounts are cause for concern. Study objectives: Propylene glycol is also used to create artificial smoke or fog used in fire-fighting training and in theatrical productions. People who already have skin conditions or sensitive skin are at particular risk of contact allergy to this additive (6). The amount of propylene glycol found in a normal diet is not associated with any heart problems in children or adults. However, as current intakes are estimated to be above the recommended level, it may be wise to reduce dietary sources where you can, especially as the primary sources are highly processed foods. If a high level of this chemical is ingested, it can lead to symptoms of toxicity [1, 2]. 19. Additionally, 16 patients of a neurology clinic were given 402 mg of propylene glycol per pound (887 mg/kg) three times per day for three days. When consumed in toxic quantities, the buildup of lactic acid can lead to acidosis and kidney failure. About 45% of an absorbed propylene glycol dose is excreted by the kidneys unchanged or as the glucuronide conjugate. [2], Propylene glycol is also used as moisturizer in cosmetic products and as a dispersant in fragrances. Download Printer-Friendly version [PDF - 496 KB], Upon completion of this section, you should be able to. Medically reviewed by Drugs.com. According the FDA, as a food additive, propylene glycol is metabolized in the body and is used as a normal carbohydrate source. Scientists observed that 2–15 ml of propylene glycol caused nausea, vertigo and strange sensations. HHS Propylene glycol is used by the chemical, food, and pharmaceutical industries as an antifreeze when leakage might lead to contact with food. For example, in one study, 19% of critical patients being treated with the drug lorazepam were observed to have signs of propylene glycol toxicity (19). Toxicity, manifested by metabolic acidosis, central nervous system disturbances, and hyperosmolarity, has been reported in patients receiving large amounts of this chemical via IV and topical medications. Large doses and unusual circumstances are necessary for the development of propylene glycol toxicity. Sodium bicarbonate may be administered in order to minimize the metabolic acidosis that may have arose because of this. For more information about this message, please visit this page: Addendum to the Toxicological Profile for Propylene Glycol (December 2008), Agency for Toxic Substances & Disease Registry, Health Effects of Exposure to Substances and Carcinogens, Community Environmental Health Education Presentations, Case Studies in Environmental Medicine (CSEM), Toxicology Curriculum for Communities Trainer's Manual, Compendium of Papers on MRLs and Health Effects, Agency for Toxic Substances and Disease Registry. After ingesting a food containing propylene glycol, about 45% of it will be excreted by the kidneys unchanged. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. It is used as stabilizer for vitamins, and as a water-miscible cosolvent. Twenty-one patients received a benzodiazepine delivered in propylene glycol (lorazepam or diazepam), and 23 patients received a benzodiazepine delivered in an alternative solvent (midazolam). The world health organization has established the maximum amount of propylene glycol that can be ingested in a single day and this is 25mg/kg. Xanthan Gum — Is This Food Additive Healthy or Harmful? Propylene glycol toxicity is a potentially life-threatening iatrogenic complication that is common and preventable. For more information about this message, please visit this page: Agency for Toxic Substances & Disease Registry, Environmental Health and Medicine Education, Ethylene Glycol and Propylene Glycol Toxicity, Download Printer-Friendly version [PDF - 496 KB], Agency for Toxic Substances and Disease Registry, describe the properties and uses of propylene glycol. Aerosolized propylene glycol can provide dense “smoke” without flames. Semin Dial. Accessed March 17, 2012. Propylene glycol is sometimes used as a de-icing agent; however, ethylene glycol is used more often because it costs less. This article examines its benefits and side effects to determine how it affects your health. Eighteen-bed MICU in a 550-bed urban academic hospital. The main sign of toxicity is central nervous system depression. Here's a look at the evidence on…. Experimentally, propylene glycol administration in dogs at 2 g/kg/day has caused no adverse effects. If the patient overdoses on propylene glycol due to the administration of Dilantin, they may also manifest disturbances in the conduction system of the heart, hypotension or decreased blood pressure and abnormal heart rate. Unknown to man, this has several uses and is even useful in the production of food. Propylene glycol used as an excipient EMA/CHMP/334655/2013 Page 5/97 While propylene glycol is generally considered safe as a food additive, concerns have been raised repeatedly with regard to potential toxicity of propylene glycol and its acidic metabolites in … Additionally, because there is no maximum dose limit for propylene glycol used in drugs, it is possible to receive very high doses in some circumstances (9). The rest is broken down in the body into lactic acid (1, 14). Although the safety of its use has been established, there are circumstances which may cause an acute propylene glycol toxicity [1, 2, 3, 4, 5]. While propylene glycol is generally considered safe, you may still choose to avoid it if you are allergic or you simply want to reduce your intake. If you have an allergy to propylene glycol, it is important to let your doctor or pharmacist know about it before taking certain medications. The most common skin reaction, or dermatitis, is the development of a rash on the face or in a generalized scattered pattern over the body (32). Other conditions that may increase the risk are kidney and liver insufficiency and burn patients who requires a long-term therapy of topical products that contains propylene glycol [1, 2, 3, 4, 5]. Most food allergies are caused by just 8 foods. The chemical compound propylene glycol is famous as the main component of antifreeze. Propylene glycol is also used to make polyester compounds, and as a base for deicing solutions. Yahwak JA, Riker RR, Fraser GL, Subak-Sharpe S. Pharmacotherapy. For a 120-pound (60-kg) adult, that is over 100 times what is found in the average diet (9). Fact sheet that answers the most frequently asked questions about a contaminant and its health effects. Toxicity in children may cause hyperosmolarity, agitation, lactic acidosis, arrhythmias, hemolysis and seizures [1, 2, 3, 4, 5]. Osmol gap as a surrogate marker for serum propylene glycol concentrations in patients receiving lorazepam for sedation. Cases of hyperosmolality from absorption of creams applied to burns have been reported. Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more. It is also used in injectable medications, like lorazepam, and in some creams and ointments that are applied to the skin, such as corticosteroids (2, 7). It may exist in air in the vapor form, although propylene glycol must be heated or briskly shaken to produce a vapor. To review relevant content, see Uses in this section. 2005 Sep;128(3):1100-1. doi: 10.1378/chest.128.3.1100. Barnes BJ, Gerst C, Smith JR, Terrell AR, Mullins ME. What Are the Benefits and Risks of Cellulose Gum? A. Propylene glycol is not metabolized in kidneys. 20. However, another study demonstrated that doses of up to 15.4 mg per pound (34 mg/kg) of propylene glycol over 24 hours were tolerated by young babies (24). Close monitoring of all patients receiving IV lorazepam or diazepam for early evidence of propylene glycol toxicity is warranted. This had led to health concerns about possible toxic effects from eating foods that contain it. Healthline Media does not provide medical advice, diagnosis, or treatment. Adverse drug reactions in the ICU: lessons learned. Cellulose gum is used as a thickening agent in many food products. Committee on Drugs Pediatrics 1997;99;268. It has not been found to cause cancer, damage genes or interfere with fertility or reproduction. An alternative can usually be found. Propylene glycol is a synthetic food additive that belongs to the same chemical group as alcohol. On the other hand, in people with kidney disease or liver disease, this process may not be as efficient. B. Propylene glycol is not metabolized to more toxic metabolites to the kidneys. D. Ethanol therapy does not help. Neither metabolic abnormality nor clinical deterioration suggestive of propylene glycol toxicity were identified in subjects receiving IV midazolam. [3] FDA’s SCOGS database; propylene glycol; SCOGS-Report Number: 27; http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASSubstancesSCOGSDatabase/ucm261045.htm. This is the method of choice because of its ability to rapidly reduce the amount of propylene glycol in the system and correct metabolic abnormalities at the same time [1, 2, 3, 4, 5]. For this reason, some items on this page will be unavailable. Note: Javascript is disabled or is not supported by your browser. Propylene glycol is a substance commonly used as a food additive or ingredient in many cosmetic and hygiene products. Propylene glycol poisoning is marked initially by CNS depression and an elevated osmolal gap and, later, by an increased anion gap. J Magn Reson Imaging. Overview of pharmaceutical excipients used in tablets and capsules. Seizures have also been observed in infants who developed toxicity from injectable medications (22). © 2005-2020 Healthline Media a Red Ventures Company. Should You Remove Carrageenan from Your Diet? However, the majority of foods containing it are highly processed junk foods. Here’s what you need to know. No adverse health effects are likely to occur from normal use of these products. Design: In this case, the child received 4.1 grams per pound (9 g/kg) of propylene glycol, which is a very high dose. Patients and methods: COVID-19 is an emerging, rapidly evolving situation. Propylene glycol is also used to make polyester compounds, and as a base for deicing solutions. Self-instructional publication designed to increase primary care provider's knowledge of a hazardous substance in the environment and to aid in the evaluation of potentially exposed patients.

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