To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Tetrabenazine for Treatment of Chorea in Huntington's Disease URL: http://www.pslgroup.com/dg/228C36.htm Doctor's Guide August 15, 2008
ROCKVILLE, Md -- August 15, 2008 -- The US Food and Drug Administration (FDA) has approved tetrabenazine (Xenazine) for the treatment of chorea in people with Huntington's disease. Serious side effects reported with use of tetrabenazine include depression and suicidal thoughts and actions. Tetrabenazine should not be used in patients who are actively suicidal or in patients with untreated depression. Concerns about the risk of suicide are heightened in all patients with Huntington's disease. "[Tetrabenazine] represents hope for patients and families dealing with this difficult disease," said Timothy Coté, MD, Office of Orphan Products Development, FDA, Rockville, Maryland. "For the first time, there is a treatment that can help patients with this disease gain some quality of life." The safety and efficacy of tetrabenazine was established primarily in a randomised, double-blind, placebo-controlled, multicentre clinical trial. Patients treated with tetrabenazine had a significant improvement in chorea compared to patients treated with placebo. Other studies provided additional support for this effect. The most common side effects reported by patients using tetrabenazine in clinical trials include insomnia, depression, drowsiness, restlessness, and nausea. While the drug has been shown to decrease chorea in the short-term, it also showed slight worsening in mood, cognition, rigidity, and functional capacity in clinical trials. Healthcare professionals should pay attention to all facets of the disease. Tetrabenazine has been approved with a required Risk Evaluation and Mitigation Strategy to ensure that the benefits of the drug outweigh its risks, particularly the risks of depression and suicidal thoughts and actions. FDA: Questions and Answers on Risk Evaluation and Mitigation Strategies http://www.fda.gov/cder/regulatory/FDAAA/FR_QA.htm SOURCE: US Food and Drug Administration --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.