New Contraindication Added for Xyrem
The FDA is reminding healthcare professionals and patients that combined use of Xyrem (sodium oxybate; Jazz) solution with alcohol or central nervous system (CNS) depressant drugs can impair consciousness and may lead to respiratory depression.
The use of alcohol with Xyrem is a new contraindication added to the label, which already includes its use with insomnia drugs. In addition, the use of Xyrem with other CNS depressants (eg, opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, general anesthetics, and muscle relaxants) should generally be avoided. The combination of Xyrem along with these products increases the risk of breathing problems that may lead to loss of consciousness, coma, and death.
Healthcare professionals are urged to follow the dosing recommendations, contraindications, and boxed warning in the updated Xyrem drug label and to avoid combinations that raise the risk of respiratory depression and death.
Xyrem solution is an antinarcoleptic indicated for excessive daytime sleepiness and cataplexy associated with narcolepsy.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332430.htm.