Xyrem Breathing Problems May Result From Use With Alcohol, Other Drugs

Following a number of reported deaths among Xyrem users who took the nacolepsy medication together with alcohol and other drugs, the FDA is requiring a new label warning about the risk of respiratory depression. 

In a drug safety communication issued on December 17, the FDA noted that a new warning will be added to the label for Xyrem, indicating that patients should not use alcohol with Xyrem. The warning label already contraindicates use of the medication with insomnia drugs, but new information will aldo be added that users should generally avoid central nervous system (CNS) depressants with Xyrem.

The combination of Xyrem and alcohol or CNS depressant drugs can impair consciousness and could lead to severe breathing problems, according to the FDA.

The Xyrem drug label changes came after the FDA reviewed information on patient deaths that were received from the manufacturer, Jazz Pharmaceuticals.

Deaths Caused By Depressed Nervous System

While much of the information was incomplete, preventing the FDA from determining many of the causes of death, the agency said it was clear that some deaths were associated with patients who were using alcohol or taking other drugs with Xyrem that could also depress the central nervous system (CNS).

In addition to alcohol, CNS depressant drugs that should be avoided include neuroleptics, benzodiazepines, and opioids.

The FDA did not say how many deaths it believes occurred due to the potential side effects of Xyrem when used in combination with other drugs or alcohol, but the FDA determined that the drug label should include a strong warning to doctors and patients that there is a risk of CNS depression from the combined use.

Xyrem (sodium oxybate) is approved for the treatment of narcolepsy and cataplexy. It is only available through a Risk Evaluation and Mitigation Strategy (REMS) program called the Xyrem Success Program, which limits its distribution to one central mail order pharmacy. REMS programs are reserved for drugs that the FDA considers high risk but necessary treatments.

Xyrem Off-Label Marketing Case Closely Watched

Xyrem is also at the center of a court case that could change how the pharmaceutical industry advertises medications.

Earlier this month a federal appeals court ruled in a case involving Xyrem that the FDA was interfering with free speech when it told pharmaceutical representatives that they could not promote uses that are not approved by the FDA. The so-called off-label marketing rule currently means that while doctors can prescribe drugs for whatever reason they see fit, companies can only promote their drugs for uses that have been FDA approved.

The federal government has collected billions of dollars over the last several years from pharmaceutical companies who broke the off-label marketing rule.

The FDA advised patients that Xyrem alone can cause respiratory depression, and if they drink alcohol or take other CNS depressants with Xyrem, they are at an increased risk of:

• Depressed breathing
• Loss of consciousness
• Coma
• Death

The agency advised doctors to be mindful of the risk of respiratory depression and other complications when prescribing it to patients taking other drugs. The warning also told doctors to use caution when prescribing Xyrem to patients with chronic obstructive lung disease (COPD) or sleep apnea, due to the respiratory depression risk.