FDA Drug Safety Communication

FDA is reminding 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 (FDA warns against combined use) 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.

FDA recently evaluated reports of patients who died while taking Xyrem along with alcohol or other CNS depressants. The cause of these deaths is not clear because the reports contained incomplete information and did not adequately address confounding factors, such as preexisting sleep apnea and/or chronic obstructive lung disease (COPD). Given some of the circumstances noted in the deaths, however, FDA determined that the recommendations in the Xyrem drug label should be strengthened to more strongly remind healthcare professionals and patients of the risks when using Xyrem with CNS depressant drugs or alcohol.

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. 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.

The Xyrem drug label is being revised as follows:

-The addition of the statement: "Patients should not drink alcohol when using Xyrem." (Contraindications section)

-The addition of a statement recommending that, when concomitant use of Xyrem with a central nervous system depressant is required, a reduction in dose or discontinuation of one or more central nervous system depressants (including Xyrem) should be considered; and a further recommendation that, if short-term opioid treatment is required, interruption of Xyrem treatment should be considered (Warnings and Precautions section)

-The addition of a sentence stating that Xyrem may be dispensed only to patients enrolled in the Xyrem Success Program (Indications and Usage section)

-The addition of an updated summary of risks; a description of the components of the Xyrem Success Program; and details of the website and phone number where further information about Xyrem can be obtained (Warnings and Precautions section)

View the full FDA Drug Safety Communication on FDA.gov