Xyrem (sodium oxybate) — warning against use with alcohol or drugs causing respiratory depression

December 19th, 2012

Xyrem (sodium oxybate) — warning against use with alcohol or drugs causing respiratory depression

The FDA reminded health care professionals and patients that the combined use of Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressants can markedly impair consciousness and may lead 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 such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants should generally be avoided.

Xyrem (sodium oxybate) is FDA-approved to reduce attacks 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 CNS adverse events, including death. Even at recommended doses, Xyrem can cause confusion, depression, and other neuropsychiatric events.

Health care 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.

Health care professionals 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.

December 17, 2012 — >FDA safety alert

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