Bupropion Approved for Seasonal Depressi
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| Fri, 09-22-2006 - 11:53am |
By Anonymous
United States of America - The Food and Drug Administration (FDA) today approved bupropion HCL extended release tablets (Wellbutrin XL) for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD). This is the first drug approved for SAD. Bupropion has been approved for treatment of major depressive disorder.
SAD is characterized by recurrent major depressive episodes that usually coincide with the seasonal decrease of daylight during autumn and winter. Depressive episodes can last up to 6 months. Although patients with SAD may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the non-seasonal episodes during the individual's lifetime.
A major depressive episode is defined as the presence of 5 or more of the 9 core symptoms of major depression for at least 2 weeks. The symptoms include: depressed mood; loss of interest; weight loss (or other weight or appetite changes); insomnia or hypersomnia; agitation or psychomotor retardation; fatigue; feelings of worthlessness or guilt; impaired concentration; suicidal thinking or behaviour. One of the 5 symptoms must be either depressed mood or loss of interest in activities. Another essential feature of major depression is the presence of significant distress or impairment in social, occupational, or other important areas of functioning. A seasonal major depressive episode is defined by the identical features.
Labelling includes a "black box" warning concerning the increased risk of suicidal thoughts and behaviour in paediatric patients treated with antidepressant medications.
Reference: FDA News, P06-79. 12 June 2006.
Copyright World Health Organization 2006
(c) 2006 WHO Drug Information. Provided by ProQuest Information and Learning. All rights Reserved.
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Published: 2006/09/22 06:00:14 CDT


