Forane (isoflurane) liquid for inhalation
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2010
- Adverse reactions encountered in the administration of Forane (isoflurane, USP) are in general dose dependent extensions of pharmacophysiologic effects and include respiratory depression, hypotension and arrhythmias. Shivering, nausea, vomiting and ileus have been observed in the postoperative period. As with all other general anesthetics, transient elevations in white blood count have been observed even in the absence of surgical stress. See WARNINGS for information regarding malignant hyperthermia and elevated carboxyhemoglobin levels. During marketing, there have been rare reports of mild, moderate and severe (some fatal) postoperative hepatic dysfunction and hepatitis. Forane (isoflurane, USP) has also been associated with perioperative hyperkalemia.
The following adverse events have been identified during post-approval use of Forane (isoflurane, USP). Due to the spontaneous nature of these reports, the actual incidence and relationship of Forane (isoflurane, USP) to these events cannot be established with certainty.
- Cardiac Disorders: Cardiac arrest
- Hepatobiliary Disorders: Hepatic necrosis, Hepatic failure