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FDA Warns Against Combining Alcohol, Other CNS Depressants With Xyrem
By News Staff
"Sodium oxybate … also known as gamma-hydroxybutyrate … is a known drug of abuse that has been associated with CNS adverse events, including death," the FDA said in the statement. "Even at recommended doses, Xyrem can cause confusion, depression and other neuropsychiatric events."
Other changes to the Xyrem drug label include the addition of
- a statement recommending that, when concomitant use of Xyrem with a CNS depressant drug is required, a reduction in dose or discontinuation of one or more of these CNS depressants (including Xyrem) should be considered, as well as a further recommendation that, if short-term opioid treatment is required, interruption of Xyrem treatment should be considered;
- an updated summary of risks;
- a sentence stating that Xyrem may be dispensed only to patients enrolled in the Xyrem Success Program, which provides for restricted distribution of the drug through a central mail-order pharmacy;
- 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