FDA Safety Warning
Xyrem (GHB, sodium oxybate): Drug Safety Communication
Warning Against Use With Alcohol or Drugs Causing Respiratory Depression
Warning Against Use With Alcohol or Drugs Causing Respiratory Depression
v1.0 - Dec 17, 2012
Originally published on FDA.gov
Citation: FDA, Erowid. "Xyrem (sodium oxybate): Drug Safety Communication - Warning Against Use With Alcohol or Drugs Causing Respiratory Depression". Erowid.org, Dec 2012. Online at: Erowid.org/chemicals/ghb/ghb_health3.shtml
Erowid Note: This FDA warning about combining alcohol with GHB (they call it the trademarked product name "Xyrem" and "sodium oxybate") was published December 17, 2012. Erowid first warned about the risks of combining GHB with alcohol in 1996, over 16 years earlier. Although low dose alcohol with low dose GHB can be carefully combined without too much danger, the effects of the two drugs effects are additive and often result in very unpleasant, nauseating vertigo (dizziness). At higher doses effects can include vomiting, respiratory depression, suppression of gag reflex, etc. See GHB Health. Also the slower onset of GHB's effects can be dangerous and potentially fatal if people redose with either alcohol or GHB before the effects of earlier doses of GHB have peaked.
We don't know what prompted the FDA to add the alcohol warning to the Xyrem label now, but it is clearly a good idea. Thanks FDA.
We don't know what prompted the FDA to add the alcohol warning to the Xyrem label now, but it is clearly a good idea. Thanks FDA.
AUDIENCE: Neurology, Internal Medicine, Patient
ISSUE: FDA reminded healthcare professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can markedly impair consciousness and may lead to severe breathing problems (respiratory depression). The use of alcohol with Xyrem is a new contraindication added to the Xyrem label, which already contraindicates its use with insomnia drugs. The use of Xyrem with other CNS depressant drugs (drugs that affect the CNS and may lead to breathing problems) such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants should generally be avoided.
The use of Xyrem along with these products or other CNS depressants increases the risk of breathing problems that may lead to loss of consciousness, coma, and death.
BACKGROUND: Xyrem (sodium oxybate) is FDA-approved to reduce attacks of muscle weakness (cataplexy) and treat daytime sleepiness in patients with narcolepsy. Sodium oxybate, the active ingredient of Xyrem, is also known as gamma-hydroxybutyrate (GHB). GHB is a known drug of abuse that has been associated with central nervous system (CNS) adverse events, including death. Even at recommended doses, Xyrem can cause confusion, depression, and other neuropsychiatric events.
RECOMMENDATION: Healthcare professionals are urged to follow the dosing recommendations, contraindications, and boxed warning in the updated Xyrem drug label and to avoid drug combinations that raise the risk of respiratory depression and death. Patients taking Xyrem should not drink alcohol or take insomnia drugs. See the FDA Drug Safety Communication for a Data Summary.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178