This is the second indication granted by the FDA for Antizol and follows a 1997 approval for the treatment of confirmed or suspected ethylene glycol poisoning. Methanol is a common toxic chemical found in many household substances such as windshield wiper fluid and cleaning solutions. Methanol poisoning may cause blindness or death. According to the 2000 Annual Report of the American Association of Poison Control Centers Toxic Exposure Surveillance System, over 1,000 patients in the United States were treated for methanol poisoning in 1999. Fomepizole was first approved as an antidote for suspected or confirmed cases of ethylene glycol poisoning in December of 1997.
Ethylene glycol is the primary ingredient in antifreeze and other coolants.
Ethylene glycol poisoning is characterized by central nervous system depression, metabolic acidosis, acute renal system failure, seizures, and severe cardiopulmonary dysfunction. Left untreated, it will result in kidney failure. Fomepizole both prevents and reverses accumulation of acids in the body and renal failure by stopping the accumulation of toxic waste products. Ethylene glycol poisoning accounted for more than 6,000 exposures and at least 27 deaths in the US in 1998. Hemodialysis and ethanol were previous benchmark methods of clinical treatment in confirmed ethylene glycol poisoning cases, but the availability of fomepizole has fundamentally changed this.