The objective of this survey is to evaluate the safety and efficacy of fomepizole intravenous infusion in Japanese patients with ethylene glycol and methanol poisonings in daily medical practice.

Start Date27 Jan 2015

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT00661141 / CompletedPhase 2

A Phase IIa, Prospective, Randomized, Blinded, Intra-Subject Controlled, Single Dose, Dose Escalation Study of Antizol® for Mitigation of Acetaldehyde Related Toxicity in Human Subjects With Symptoms of Inborn Altered Ethanol Metabolism With Concomitant Ethanol Exposure

This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol. Long-term, serious health risks have been associated with repeated exposure to acetaldehyde, a carcinogen, among ALDH2-deficient individuals.

Start Date01 Apr 2008

Sponsor / Collaborator

Horizon Therapeutics USA, Inc.

100 Clinical Results associated with Fomepizole

100 Translational Medicine associated with Fomepizole

100 Patents (Medical) associated with Fomepizole

1,029

Literatures (Medical) associated with Fomepizole

01 Dec 2024·AMERICAN JOURNAL OF FORENSIC MEDICINE AND PATHOLOGY

When Vaping Isn't Actually Safer

Article

Author: Chaudhry, Irfan ; Ogburn, Timothy ; Knight, Laura D

Abstract:

Vape juice is a diluent for e-cigarette active ingredients, nicotine or tetrahydrocannabinol (THC). Lack of strict regulation in vape juice production is a concern as ingredients and their concentrations may vary widely from the labeling.A 43-year-old woman was transported via ambulance to the hospital after ingesting homemade vape juice, presenting unresponsive with decerebrate posturing. She reportedly made a tincture combining a vape juice purchased online (containing “ethylene glycol”) and THC for “endometriosis-related pain relief.” Laboratory evaluation revealed anion gap metabolic acidosis, elevated serum lactate, and high serum osmolality. Urine fluoresced under Wood's lamp, and fomepizole was administered as an ethylene glycol antidote, but she expired the following afternoon. Clinical serum toxicology results returned after death revealed 235 mg/dL of methanol, and no ethylene glycol.Autopsy findings included ischemic changes of the gastrointestinal tract and cerebral edema with herniation. Postmortem toxicology performed on hospital admission blood revealed methanol (220 mg/dL), propylene glycol (59 mg/dL), Δ-9 THC and metabolites, and medications administered during hospitalization. The medical examiner determined the cause of death to be methanol and propylene glycol toxicity.To our knowledge, this is the first report of accidental death from ingestion of vape juice contaminated with toxic alcohol.

01 Nov 2024·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Acute kidney failure from ingestion of “wood bleach” beekeeping miticide

Article

Author: Cole, Jon B ; Oakland, Carrie L ; Douglas, Stephen ; Olives, Travis D

Wood bleach is >95 % oxalic acid formulation used off-label as a miticide for Varroa mites by hobbyist beekeepers. Wood bleach (oxalic acid) ingestions are poorly documented in the medical literature. A 46-year-old man presented to the emergency department nauseated and vomiting after accidentally ingesting "bleach and grain ethanol intended for use in beekeeping." Initial evaluation was reported to the regional Poison Center as a creatinine concentration of 2.46 mg/dL (217 μmol/L); he was otherwise well. He was volume resuscitated and discharged home without further evaluation. Four days later, he returned with worsening nausea and vomiting, endorsing ongoing intentional use of the mixture as an intoxicant. He was fully oriented, in no distress, with normal vital signs but for blood pressure of 175/110 mmHg. Investigations revealed a serum creatinine of 16.8 mg/dL (1485 μmol/L) and a high anion gap metabolic acidosis (pH 7.3, bicarbonate 15 mmol/L, anion gap 29). Crystalluria testing was deferred due to anuria. Fomepizole, supplementary thiamine and pyridoxine were administered for suspected occult toxic alcohol poisoning; hemodialysis was initiated the same evening. Ethylene glycol resulted undetectable. Renal biopsy revealed oxalate nephropathy. It was revealed the mixture contained 'wood bleach,' or > 95 % oxalic acid, rather than reported sodium hypochlorite. Hemodialysis continued at 2-week follow-up. Presentations of anion gap metabolic acidosis in those who practice beekeeping should prompt consideration of oxalic acid toxicity. Early nephrology consultation may be needed to facilitate hemodialysis to prevent or treat metabolic acidosis and renal failure.

02 Oct 2024·CLINICAL TOXICOLOGY

Elevated osmol gaps in patients with alcoholic ketoacidosis

Article

Author: Hayman, Chelsea V. ; Hoffman, Robert S. ; Su, Mark K. ; Cohen, Emily T. ; Pires, Kyle D. ; Biary, Rana

INTRODUCTION:

The use of the osmol gap as a surrogate marker of toxic alcohol poisoning is common. Unfortunately, many patients with alcoholic ketoacidosis have elevated osmol gaps and are misdiagnosed with toxic alcohol poisoning. We aimed to characterize the range of osmol gaps in patients with alcoholic ketoacidosis.

METHODS:

This was a retrospective poison center study. Data from 24 years were reviewed using the following case definition of alcoholic ketoacidosis: (1) documented alcohol use disorder; (2) presence of urine or serum ketones or an elevated blood beta-hydroxybutyrate concentration; (3) an anion gap ≥14 mmol/L. Potential cases of alcoholic ketoacidosis that failed to fulfill all three criteria were adjudicated by three toxicologists. Exclusion criteria included (1) detectable toxic alcohol concentration, (2) hemodialysis and/or multiple doses of fomepizole, (3) no osmol gap documented, (4) other diagnoses that lead to a metabolic acidosis. Demographics, pH, anion gap, lactate concentration, and osmol gap were extracted.

RESULTS:

Of 1,493 patients screened, 55 met criteria for alcoholic ketoacidosis. Sixty-four percent were male, and their median age was 52 years. The median osmol gap was 27 [IQR 18-36]. The largest anion gap was 57 mmol/L, and the lowest pH was 6.8. Forty-five (82%) of the patients with alcoholic ketoacidosis had osmol gaps >10; 38 (69%) had osmol gaps >20; 24 (44%) had osmol gaps >30; 11 (20%) had osmol gaps > 40.

DISCUSSION:

The large range of osmol gaps in patients with alcoholic ketoacidosis often reaches values associated with toxic alcohol poisoning. The study is limited by the potential for transcribing errors and the inability to identify the cause of the osmol gap.

CONCLUSIONS:

In this retrospective study, patients with alcoholic ketoacidosis had a median osmol gap of 27. Given that alcoholic ketoacidosis is easily and inexpensively treated, proper identification may prevent costly and invasive treatment directed at toxic alcohol poisoning.

News (Medical) associated with Fomepizole

05 Jun 2023

·www.biospace.com

Waters Takes Targeted, Quantitative Imaging to the Next Level with New DESI Source for the Xevo TQ Absolute System

News Summary: Waters combines the enhanced desorption electrospray ionization (DESI) source with the Xevo TQ Absolute tandem quadrupole mass spectrometer to enable faster and more sensitive targeted pre-clinical MS imaging experiments. 5X more sensitive and 5X faster than discovery-grade quadrupole time-of-flight MS imaging assays.i Enables pharmaceutical development scientists to decide which drug candidates to investigate further and develop into marketable drugs as quickly as possible. HOUSTON, June 5, 2023 /PRNewswire/ -- American Society for Mass Spectrometry (ASMS) -- Waters Corporation (NYSE:WAT) today launched the industry's first targeted imaging mass spectrometer based on its Xevo™ TQ Absolute tandem quadrupole mass spectrometer, the most sensitive and compact mass spectrometer in its class. The new instrument combines the Waters™ DESI XS source with the Xevo TQ Absolute system and is five times more sensitive and five times faster than discovery-based imaging systems at precisely determining whether a particular small molecule drug product – and how much of it - reaches its intended target, such as a brain, liver, or lung, in a test subject. Waters adds DESI XS source to its Xevo TQ Absolute mass spectrometer for fast and sensitive targeted MS imaging. "Customers have successfully applied the Xevo TQ Absolute system to solve a host of problems including PFAS testing at parts-per-quadrillion levels," said Jon Pratt, Senior Vice President, Waters Division. "Now, combining it with the DESI XS source gives drug development scientists a powerful new tool for efficiently evaluating the effects of drugs at the site of action with the statistical power of full studies." Dr. Jephte Akakpo, Post-Doctoral Research Fellow, University of Kansas Medical Center, is part of a team researching an antidote (fomepizole) to drug–induced acute liver and kidney damage caused by an acetaminophen overdose. "The DESI XS source features a high-performance sprayer and that makes the DESI source robust so we can work much more efficiently," said Dr. Akakpo. "Pairing it with the Xevo TQ Absolute system will greatly improve the signal-to-noise ratio and lets us test hypotheses in a way that we couldn't before. The system is taking quantitative MS imaging to the next level." Applications for direct-from-sample DESI/tandem quadrupole mass spectrometry include: Elucidating drug distribution in tissue sectionsii Monitoring relevant biochemical pathways in toxicological studies Classifying tissue and determining tumor margins At this year's ASMS conference, Waters is also showcasing its PFAS analytical workflow based on the ultra-sensitive Xevo TQ Absolute mass spectrometer, chemistries, and software. The end-to-end UPLC-MS workflow allows laboratories worldwide to upgrade their capability and keep current with the latest regulatory requirements for measuring parts-per-quadrillion levels of PFAS in air, water, soil, and food. Additional Resources Learn more about Targeted MS Imaging with the DESI XS and the Xevo TQ Absolute system. Download the DESI XS and Xevo TQ Absolute system brochure. Read the application note Improved Sensitivity for the Detection of PFAS in Environmental Water Samples Using a Direct Injection Approach on the Xevo TQ Absolute. Follow and connect with Waters via LinkedIn, Twitter, and Facebook About Waters Corporation ( ) Waters Corporation (NYSE:WAT), a global leader in analytical instruments and software, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, and food sciences for over 60 years. With more than 8,200 employees worldwide, Waters operates directly in 35 countries, including 14 manufacturing facilities, and with products available in more than 100 countries. Waters and Xevo are trademarks of Waters Corporation. Waters Contact: Brian J. Murphy PR Manager, Corporate Communications Waters Corporation brian_j_murphy@waters.com +1 508-482-2614 i Comparison to Waters high resolution MALDI or DESI-enabled discovery quadrupole time-of-flight MS imaging systems. ii Targeted Desorption Electrospray Ionization Mass Spectrometry Imaging for Drug Distribution, Toxicity, and Tissue Classification Studies doi: 10.3390/metabo13030377 View original content to download multimedia: SOURCE Waters Corporation Company Codes: NYSE:WAT

16 Mar 2023

·www.sciencedaily.com

Fomepizole helps overcome antibiotic-resistant pneumonia in mice, study finds

Pneumococcal disease leads to over three million hospitalizations and hundreds of thousands of deaths annually. A new study suggests that the FDA-approved drug Fomepizole may reduce disease severity in the lungs of mice with some forms of bacterial pneumonia and enhance the efficacy of the antibiotic erythromycin as well. Pneumococcal disease leads to over three million hospitalizations and hundreds of thousands of deaths annually. A study publishing March 16 in the open access journal PLOS Biology by Carlos J. Orihuela at the University of Alabama at Birmingham, Alabama, United States, and colleagues suggests that the FDA-approved drug Fomepizole may reduce disease severity in the lungs of mice with some forms of bacterial pneumonia and enhance the efficacy of the antibiotic erythromycin as well. Streptococcus pneumoniae is the leading cause of community-acquired pneumonia. While vaccines to protect against the bacteria are available, these vaccines are not effective against all strains, with some versions being especially problematic as they are multidrug-resistant. Currently, there are very limited treatment options for combating multidrug-resistant S. pneumoniae infections. In order to test the effects of novel treatments for antibiotic-resistant S. pneumoniae, the researchers conducted a series of experiments with mice. Fomepizole is an FDA-approved drug normally used as an antidote for the ingestion of toxic alcohols (such as methanol or ethylene glycol), and works by inhibiting the enzyme alcohol dehydrogenase. Researchers inoculated mice with a multidrug-resistant S. pneumoniae and tested the effect of fomepizole in a combinatorial treatment with antibiotics. They quantified the bacterial burden in the organs of infected mice, comparing the experimental group with the control group. The researchers found that using Fomepizole blocked normal energy production by S. pneumoniae and enhanced the bacteria's susceptibility to antibiotics and reduced bacterial burden in the lungs of mice with pneumonia. The combination treatment was effective in preventing the development of invasive disease. Future research is needed however, as this novel drug treatment has not been replicated in clinical studies on humans, who may present with complicating factors such as comorbidities, advanced age, or environmental variables that may play a role in disease outcomes. Orihuela adds, "Pharmacological targeting of fermentation pathways is a new way to enhance the susceptibility of some bacteriato antimicrobials. Combination treatment of erythromycin and fomepizole, an alcohol dehydrogenase inhibitor, prevented the in vivo dissemination of antibiotic-resistant Streptococcus pneumoniae."

Vaccine

100 Deals associated with Fomepizole

External Link

KEGG	Wiki	ATC	Drug Bank
D00707	Fomepizole	V03AB34	DB01213

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Ethylene glycol poisoning (disorder)	AU	AFT Pharmaceuticals (AU) Pty Ltd.	01 Dec 2016
Poisoning	FR	SERB SA	16 Oct 2001
Methanol poisoning	US	Par Pharmaceutical, Inc.	04 Dec 1997

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