WASHINGTON -- The FDA is warning healthcare professionals that patients taking the muscle weakness and narcolepsy drug sodium oxybate (Xyrem) should not consume alcohol or use central nervous system depressants.
Sodium oxybate is indicted for the reduction of muscle weakness attacks -- cataplexy -- and as a treatment for daytime sleepiness in patients with narcolepsy.
Mixing alcohol or central nervous system depressants with sodium oxybate can cause "markedly" impaired consciousness and respiratory depression, which can lead to loss of consciousness, coma, and death, the agency said in a statement Monday.
Patients taking sodium oxybate should not drink alcohol or take opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, muscle relaxants, or insomnia drugs, the FDA said.
A new boxed warning for sodium oxybate notes that the drug can only be dispensed to patients enrolled in the Xyrem Success Program -- a program that informs pharmacists and patients about correct drug use and drug risks and benefits. Xyrem's label also lists website and contact information for the drug's manufacturer, Jazz Pharmaceuticals.
The drug's main ingredient can cause adverse events related to central nervous system damage, including death, if abused, the agency noted. Sodium oxybate also can cause confusion, depression, and other neuropsychiatric events even if used as prescribed.