Xyrem® (sodium oxybate)
December 17, 2012
FDA is reminding healthcare professionals to avoid Xyrem® (sodium oxybate) in combination with other medications that cause central nervous system (CNS) depression. Patients who use sodium oxybate in combination with other CNS depressants are at increased risk of depressed breathing, loss of consciousness, coma, or death. The product label was updated after FDA recently evaluated reports of patients who died while taking sodium oxybate. Many reports did not include enough details for FDA to determine whether use of sodium oxybate contributed to the death. However, because many of the patients who died were taking sodium oxybate in combination with alcohol or other CNS depressants, the product label will now include stronger warnings about these drug interactions.
Sodium oxybate is FDA-approved to treat excessive daytime sleepiness in patients with narcolepsy and to reduce attacks of muscle weakness in patents with cataplexy. Sodium oxybate is a sodium salt of gamma-hydroxybutyrate (GHB) and at normal doses can cause confusion, depression, and other neuropsychiatric events.
The sodium oxybate label was updated to include a new contraindication against drinking alcohol while on sodium oxybate. The product label already includes a contraindication advising against sodium oxybate in combination with sedative hypnotic insomnia medications. The product label was also updated to include specific information about the risks of using sodium oxybate in combination with other medications that affect the CNS. Benzodiazepines, general anesthetics, muscle relaxants, opioid analgesics, sedating antidepressants, and antipsychotics increase the potential for severe breathing problems when used in combination with sodium oxybate. The product label now recommends reducing the dose or discontinuing one or more of these CNS depressant medications (including sodium oxybate) if concomitant therapy cannot be avoided. Another warning statement recommends interruption of sodium oxybate treatment when short-term opioid treatment is required.
Follow sodium oxybate dosing recommendations and updated warnings and contraindications to avoid lethal drug combinations. Use sodium oxybate cautiously in patients with respiratory diseases (eg, sleep apnea, chronic obstructive pulmonary disease). Sodium oxybate is only available through the Xyrem® Success Program, which requires patient and physician registration. Sodium oxybate is only distributed through a central mail-order pharmacy.
Additional information is available at the following links:
- MedWatch Safety Alert:
- Drug Safety Communication:
- Xyrem® (sodium oxybate) updated prescribing information:
December 17, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.