WASHINGTON (AFX) - The Food and Drug Administration and GlaxoSmithKline PLC announced on Friday that a new analysis seems to point towards increased risk of suicide in young adult patients on the anti-depressant drug Paxil.
'Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo,' the FDA said in a statement. 'However as the absolute number and incidence of events are small, these data should be interpreted with caution.'
GSK said that a meta-analysis conducted on 8,958 patients taking Paxil and 5,953 on a placebo showed an increased risk of suicidal tendencies in the former, particularly in the 18-30 age group.
In a letter to doctors, GSK warned that patients on Paxil need careful monitoring, 'It is therefore important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated,' the company's letter said.
However, the letter added that the company 'continues to believe that the overall risk: benefit of paroxetine (Paxil) in the treatment of adult patients with MDD (major depressive disorder) and other non-depressive psychiatric disorders remains positive.'
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'Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo,' the FDA said in a statement. 'However as the absolute number and incidence of events are small, these data should be interpreted with caution.'
GSK said that a meta-analysis conducted on 8,958 patients taking Paxil and 5,953 on a placebo showed an increased risk of suicidal tendencies in the former, particularly in the 18-30 age group.
In a letter to doctors, GSK warned that patients on Paxil need careful monitoring, 'It is therefore important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated,' the company's letter said.
However, the letter added that the company 'continues to believe that the overall risk: benefit of paroxetine (Paxil) in the treatment of adult patients with MDD (major depressive disorder) and other non-depressive psychiatric disorders remains positive.'
newsdesk@afxnews.com afp/jlw COPYRIGHT Copyright AFX News Limited 2005. All rights reserved. The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News. AFX News and AFX Financial News Logo are registered trademarks of AFX News Limited