WARNING: This medicine can have very serious side effects and has been misused and abused. Do not use with other medicines that slow your breathing or mental activity, or cause sleepiness. XYREM has caused changes in alertness (or consciousness) and trouble breathing (respiratory depression). Call your doctor right away if you have any of these serious side effects. These effects happened even when XYREM was given in recommended doses. In studies, almost all of the patients with narcolepsy who were given XYREM were also taking medicines to help them stay awake during the day. XYREM is a form of gamma hydroxybutyrate (GHB). Abuse of GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), very low levels of alertness (or consciousness), coma, and death.
There were 184 patients in the intent-to-treat analysis. Responders included 28 of 74 patients (%) in the low-dose group, 17 of 52 patients (%) in the high-dose group, and 9 of 58 patients (%) in the placebo group ( P = and P = , respectively, versus placebo). Rescue medication was taken within the first 24 hours by 23 patients (%) in the low-dose group ( P = versus placebo), 18 patients (%) in the high-dose group ( P = versus placebo), and 29 patients (%) in the placebo group. The low-dose group had an adverse event (AE) profile similar to that of the placebo group, with an odds ratio (OR) of (95% confidence interval [95% CI] –). High-dose colchicine was associated with significantly more diarrhea, vomiting, and other AEs compared with low-dose colchicine or placebo. With high-dose colchicine, 40 patients (%) had diarrhea (OR [95% CI –]), 10 (%) had severe diarrhea, and 9 (%) had vomiting. With low-dose colchicine, % of the patients had diarrhea (OR [95% CI –]), none had severe diarrhea, and none had vomiting.
ALABAMA - ALASKA - ARIZONA - ARKANSAS - CALIFORNIA - COLORADO - CONNECTICUT - DELAWARE - FLORIDA - GEORGIA - HAWAII - IDAHO - ILLINOIS - INDIANA - IOWA - KANSAS - KENTUCKY - LOUISIANA - MAINE - MARYLAND - MASSACHUSETTS - MICHIGAN - MINNESOTA - MISSISSIPPI - MONTANA - NEBRASKA - NEW HAMPSHIRE - NEW YORK - NEW JERSEY - NEW MEXICO - NEVADA - NORTH CAROLINA - NORTH DAKOTA - OHIO - OKLAHOMA - OREGON - PENNSYLVANIA - RHODE ISLAND - SOUTH CAROLINA - SOUTH DAKOTA - TENNESSEE - TEXAS - UTAH - VERMONT - VIRGINIA - WASHINGTON - WASHINGTON DC - WEST VIRGINIA - WISCONSIN - WYOMING