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Sodium Oxybate(Xyrem), Fda Made a Mistake, The Battalion Online:"Orphan Medical said Xyrem is 70 percent effective. Patients can also experience severe side-effects, including depressed breathing, confusion, depression and nausea. Xyrem is a risky drug that has led to dependence, including cravings for medicine and severe withdrawal symptoms, according to The FDA should require more testing of Xyrem to ensure greater safety for patients."


Sodium Oxybate(Xyrem), Possible Side Effects, Dartmouth-Hitchcok:"Side effects associated with Xyrem include confusion, depression, nausea, vomiting, dizziness, headache, bedwetting, and sleepwalking. Abuse of Xyrem could also lead to dependence, i.e, craving for the medicine, and severe withdrawal symptoms."


Sodium Oxybate(Xyrem), Orphan Medical Announces FDA Approval Of Xyrem, July 18, 2002, Doctor's Guide:"Narcolepsy is a chronic neurological disorder affecting approximately 140,000 Americans. An estimated 60-90 percent of narcolepsy patients experience cataplexy. Cataplexy is a debilitating symptom of narcolepsy usually triggered by strong emotions such as laughter, anger, or surprise. In its most severe form, cataplexy can cause a person to collapse during waking hours."


Sodium Oxybate(Xyrem), Xyrem approved for use in narcolepsy and cataplexy, Drug Class Info:"The drug Xyrem, sodium oxybate, has been approved for limited use in the treatment of narcolepsy and cataplexy. Sodium oxybate is also known by the more common name of GHB or gamma hydroxybutyrate. GHB had been added to the Controlled Substances Act under schedule I in February 2000 after having been banned by the FDA in 1990. Xyrem will be listed under schedule III."


Sodium Oxybate(Xyrem), Information on New Narcolepsy Drug,"The Food and Drug Administration approved Xyrem (sodium oxybate or gamma hydroxybutyrate, also known as GHB) for treating a small population of patients with narcolepsy who experience episodes of cataplexy, a condition characterized by weak or paralyzed muscles. Because of safety concerns associated with the use of the drug, the distribution of Xyrem will be tightly restricted."


Sodium Oxybate(Xyrem), Important Information, Ohio Health:"Due to serious concerns and adverse events associated with the use of Xyrem, including some events that resulted in death, FDA has worked with the drug's manufacturer, Orphan Medical Inc., to design a comprehensive risk management program. The program includes limited distribution, physician education, patient education, the creation of a patient and physician registry, and detailed patient surveillance. Under the program, prescribers and patients will be able to obtain the product only through a single centralized pharmacy. The pharmacy will send Xyrem to patients only after their doctors have provided instruction on the safe and effective use of the drug and after the patients have read the information provided about the drug. Doctors will also be urged to see their patients at least every three months."


Sodium Oxybate(Xyrem), Project GHB, Inc. Faces New Challenge After FDA Approves Xyrem (GHB) for Medical Use, Project GHB, Inc:"On July 17th, 2002, the United States Food and Drug Administration announced the approval of a controversial new drug, Xyrem. Headlines across the nation read "FDA Approves Date-Rape Drug." Xyrem (aka sodium oxybate) is GHB, or gamma hydroxybutyrate. Project GHB is a California-based nonprofit organization dedicated to promoting awareness to the dangers of abusing the illegal drug gamma hydroxybutyrate (GHB) and operates the website"


Sodium Oxybate(Xyrem), FDA APPROVES XYREM FOR CATAPLEXY ATTACKS IN PATIENTS WITH NARCOLEPSY, July 17, 2002, United States Food and Drug Administration:"The Food and Drug Administration today approved Xyrem (sodium oxybate or gamma hydroxybutyrate, also known as GHB) for treating a small population of patients with narcolepsy who experience episodes of cataplexy, a condition characterized by weak or paralyzed muscles. Because of safety concerns associated with the use of the drug, the distribution of Xyrem will be tightly restricted. In the early 1990s GHB was marketed purporting to be a dietary supplement for enhancing athletic performance and sexual activity and for inducing sleep. It was also abused as a recreational drug and is well-known for use in date rape. As a result of a number of serious adverse events, including death, FDA intervened to prohibit marketing of GHB."


Sodium Oxybate(Xyrem), Xyrem Approved,"Orphan Medical, Inc. received notice from the US Food and Drug Administration (FDA) that Xyrem has been finally approved for treatment of cataplexy associated with narcolepsy. This is welcome news to most of the estimated 140,000 Americans with Narcolepsy, most of whom experience partial or severe cataplexy. Patients in clinical trials have experienced substantial relief from use from Xyrem."


Sodium Oxybate(Xyrem), Date-Rape drug for Narcolepsy, What you need to know about sleep disorders:"Xyrem, the liquid form of GHB, may become the treatment of choice for people who suffer from narcolepsy. There are, of course, drawbacks. Although Xyrem will help to prevent the hallucinations and will work against cataplexy, it will have no effect when it comes to the daytime sleepiness. However, it is hoped that just getting a full and relaxing night's sleep will be beneficial in this area as well."




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