Xyrem manufacturer – Jazz Pharmaceuticals – issues new box warning

Jazz Pharmaceuticals has put a new boxed warning label on Xyrem -a type of Gamma Hydroxbutyrate – GHB – (a drug with sedative hypnotic effects, originally developed as a pre-surgery anaesthetic) used to treat excessive daytime sleepiness and cataplexy, both in patients with narcolepsy.

A new boxed warning for sodium oxybate (Xyrem) 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 Box Warning:

!WARNING:

This medicine has been used illegally and can have very serious side effects. Do not use with alcohol or other medicines that slow your breathing or mental activity, or cause sleepiness. XYREM® is a kind of GHB. Some GHB has been abused or used illegally and not for medical reasons. Illegal use of GHB has caused serious side effects. These effects include sudden fits or convulsions and you may not be able to breathe deeply enough or often enough (respiratory depression). It can also cause very low levels of awareness (or consciousness), with some cases of coma and death. When people have taken GHB for recreational reasons (not for medical use), it wasn’t always clear what kind of GHB they were taking, how much they took or if they were taking other drugs or drinking alcohol along with GHB.

Even when it is given at the usual doses, XYREM has caused confusion, depression and other mental or emotional problems or illnesses. Some patients had times when they could not breathe deeply enough or often enough (respiratory depression). Almost all of the patients with narcolepsy who were given XYREM were also taking medicines to help them stay awake during the day.

To have a prescription for XYREM filled, you have to go through the XYREM Success Program®, which uses one central pharmacy at 1-866-XYREM88® (1-866-997-3688). The Success Program sends information to doctors and patients that explains side effects and the right way to use XYREM safely. It also tells you the steps that you and your doctor will have to take before your medicine is shipped to you. This includes reading the information about XYREM that is given to you and speaking with the pharmacy to be sure you understand the information. You should check in with your doctor about every 3 months while you are taking XYREM. You should report all serious side effects to your doctor. Your doctor should report all serious side effects to the maker of XYREM.