Summary

Original source:
http://www.usatoday.com/news/health/2004-09-08-drug-warning-usat_x.htm

Details

• Scientific advisers to the Food and Drug Administration next week are expected to recommend tougher warning labels or other restrictions on antidepressants linked to suicidal behavior in children.
• A re-analysis of studies, released last month, confirmed that those on antidepressants may be nearly twice as likely to become suicidal as kids given sugar pills, and some drugs appear to raise the risk much more than others.
• June 2003: FDA advises doctors not to prescribe Paxil for kids under 18 because of possible rise in suicide risk.
• August 2003: Wyeth tells doctors that studies show hostility and thoughts of suicide increase in children 6 to 17 taking Effexor and Effexor XR.
• October 2003: FDA sends a "Dear Dr." letter saying studies can't rule out increased suicidal thinking and attempts in children on the antidepressants, urges caution in prescribing.
• December 2003: British drug regulators advise doctors to use none of the antidepressants except for Prozac with children, saying it's the only one whose benefits outweigh risks.
• March 2004: FDA tells drug companies to relabel 10 antidepressants, warning that patients should be closely watched for worsening depression, suicidal behavior and anxiety.
• September 13-14, 2004: FDA will get public input at hearings and ask its advisory panel if more labeling changes or other restrictions on the drugs are needed.
• In March, the FDA put stronger warning labels on 10 antidepressants after its expert panel recommended the step.
• But critics derided that move as "too little, too late," considering that, in December, British drug regulators had advised doctors to prescribe only Prozac for depressed kids.
• Since most drugs haven't been studied in children, "pediatricians assume, in the absence of data, the drug just hasn't been studied.
• There's rising concern about kids with undiagnosed bipolar disorder (manic-depression) on antidepressants because doctors think they have ordinary depression.

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