The FDA is asking physicians and other health care professionals to highlight key points of the recently updated drug label for sodium oxybate (Xyrem), including the addition of a new warning against consuming alcohol while taking the drug. Patients likely also can benefit from a reminder to not take insomnia drugs while using Xyrem, says a recent FDA drug safety communication(www.fda.gov).
According to the Dec. 17 statement, the FDA recently evaluated reports of patients who died while taking Xyrem -- which is used to reduce instances of cataplexy and to manage other symptoms of narcolepsy -- along with alcohol or other central nervous system (CNS) depressants. Although the precise cause of the deaths remains uncertain -- the reports contained incomplete information and did not adequately address confounding factors, such as pre-existing sleep apnea and/or chronic obstructive pulmonary disease -- given some of the circumstances noted in the deaths, the FDA determined that the recommendations in the Xyrem drug label should be strengthened to highlight the risks of using the drug in conjunction with CNS depressant drugs or alcohol.
"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
Physicians and patients are encouraged to report adverse events associated with Xyrem use to the FDA's MedWatch(www.fda.gov) program.