FDA Drug Safety Podcast: Warning against use of Xyrem (sodium oxybate) with alcohol or drugs causing respiratory depression

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Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s Topic: Warning against use of Xyrem, active ingredient sodium oxybate, with alcohol or drugs causing respiratory depression

US Public Health Service LCDR Stephanie Begansky will provide you with additional information about this communication.

LCDR Begansky: On December 17, 2012, the FDA issued a Drug Safety Communication reminding healthcare professionals and patients that the combined use of Xyrem with alcohol or CNS depressant drugs can markedly impair consciousness and may lead to respiratory depression. The use of alcohol with Xyrem is a new contraindication added to the Xyrem drug 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 pre-existing sleep apnea and/or chronic obstructive lung disease. 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:

  • First, the addition of the statement: “Patients should not drink alcohol when using Xyrem” to the Contraindications section
  • Secondly, the addition of a statement recommending that, when concomitant use of Xyrem with a CNS depressant is required, a reduction in dose or discontinuation of one or more CNS 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. This has been added to the Warnings and Precautions section.
  • Third, the addition of a sentence stating that Xyrem may be dispensed only to patients enrolled in the Xyrem Success Program to the Indications and Usage section.
  • And last, 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. This has been added to the Warnings and Precautions section.  

At this time FDA recommends that Healthcare Professionals be aware of the following:

  • Remind patients not to drink alcohol or take insomnia drugs when taking Xyrem; be mindful of the increased risk of respiratory depression, loss of consciousness, coma, and death with such combined use.  The concurrent use of Xyrem with other CNS depressants may also increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death.  Follow the updated information in Xyrem’s drug label.  
  • Xyrem should be used cautiously, if at all, in patients with respiratory issues such as sleep apnea or COPD because of the risk of respiratory depression.
  • Report adverse events involving Xyrem to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including the complete Data Summary, can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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Page Last Updated: 03/14/2016
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