Annotation of FDA Label for enflurane
PharmGKB ID
Summary
Enflurane (ETHRANE) is an inhalational anesthetic. The FDA-approved label warns that individuals with known or suspected genetic predisposition to malignant hyperthermia, or patients with Duchenne Muscular Dystrophy, are at greater risk of developing malignant hyperthermia, or hyperkaelemia, respectively.
Annotation
The enflurane drug label does not specifically mention genetic testing or genes, the FDA-approved label for enflurane contraindicates it for individuals with known, or suspected, genetic predisposition to malignant hyperthermia. Note that enflurane is no longer commonly used and is no longer listed in the FDA PGx biomarker table.
Excerpts from the enflurane (ETHRANE) drug label:
CONTRAINDICATIONS...Known or suspected genetic susceptibility to malignant hyperthermia.
In susceptible individuals, enflurane anesthesia may trigger a skeletal muscle hypermetabolic state leading to high oxygen demand and the clinical syndrome known as malignant hyperthermia.
Use of inhaled anesthetic agents has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias and death in pediatric patients during the postoperative period. Patients with latent as well as overt neuromuscular disease, particularly Duchenne muscular dystrophy, appear to be most vulnerable. Concomitant use of succinylcholine has been associated with most, but not all, of these cases.
For the complete drug label text with sections containing pharmacogenetic information highlighted, see the enflurane drug label
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Former FDA Biomarker
This label used to be included on the FDA biomarker list(opens in new window) and has since been removed. The PharmGKB curation staff monitors the FDA biomarker list on a regular basis and notes removals. There is no official list of removals supplied by the FDA.
Evidence for Clinical Annotations
This annotation has been used as evidence for the following clinical annotations.
Source
- Has PGxDrug-Drug Interactions 2Marketing Status: Discontinued
History
No history available.