WHO Pharmaceuticals Newsletter 1998, No. 09&10
(1998; 23 pages)
Table of Contents
Open this folder and view contentsRegulatory decisions
Open this folder and view contentsDrug surveillance
Close this folderNew developments
View the documentFomepizole - approved as an antidote in ethylene glycol poisoning: USA
View the documentInfliximab - approved for Crohn’s disease: USA
View the documentLeflunomide - oral treatment approved for active rheumatoid arthritis: USA
View the documentLepirudin - approved for heparin-associated thrombocytopenia: UK
View the documentOral contraceptives - approved for emergency use: USA
View the documentRotavirus vaccine - approved to help prevent rotaviral disease: USA
View the documentThalidomide - approved for use in leprosy: USA
View the documentNew indications
View the documentNew formulations
View the documentNewly approved products
Open this folder and view contentsMedical devices
Open this folder and view contentsGeneral information
Open this folder and view contentsMedication errors
Open this folder and view contentsVeterinary medicine
 

Fomepizole - approved as an antidote in ethylene glycol poisoning: USA

United States of America. The Food and Drug Administration has approved fomepizole (Antizol: Orphan Medical) as an antidote for ethylene glycol poisoning and in cases of suspected ethylene glycol ingestion.

Ethylene glycol is a sweet-tasting compound that has wide commercial use as a preservative, antifreeze, coolant and glycerol substitute. It is commonly used in attempted suicides and ingestion can be fatal. Ethylene glycol has intoxicating properties similar to those of alcohol, and its metabolites cause central nervous system, renal and cardiopulmonary dysfunction together with severe metabolic acidosis.

The use of fomepizole is recommended if ethylene glycol serum levels are above 20 mg/dl or if ingestion of ethylene glycol is suspected. In cases where ethylene glycol levels are equal to or above 50 mg/dl, or when the patient has renal failure or worsening metabolic acidosis, haemodialysis should also be considered. Haemodialysis removes fomepizole, therefore doses must be given more frequently during haemodialysis.

References: FDA Orphan Products approved for Marketing, December 1997 & April 1998, in: INFORx-MED Vol. 16, No. 7, July 1998, Medicines Information Centre, Cape Town, South Africa.

to previous section to next section
 

Last updated: May 3, 2013