FDA sets rules for anti-depressants - WALB.com, Albany News, Weather, Sports

FDA sets rules for anti-depressants

March 22, 2004

The Food and Drug Administration has released advisory and new labeling recommendations on the possible risks associated with prescribing anti-depressants to children.

An FDA review found the use of those drugs may show an increase in suicidal behavior. Michelle Franzen has the story. Ten prescription drugs used to treat depression in children, adolescents and adults, will soon have changes on their warning labels.

The FDA is asking makers of anti-depressant drugs including Prozac, Zoloft and Paxil to highlight warning labels telling parents and doctors to watch for worsening signs of depression and possibly suicide.

The advisory comes after an FDA review of previous studies that showed an increase risk of suicidal thoughts and actions in children and adolescents who were prescribed anti-depressants.

The FDA also says, despite the recent review, there is still no clear evidence linking anti-depressant drugs to an increase in suicidal behavior since the 1980's doctors have increasingly prescribed anti-depressant drugs for children.

It's estimated 11 million prescriptions were written last year to treat children battling depression. Some psychiatrists say the drugs have improved over the past decade.

The FDA says it will continue its investigation to find out more about whether the prescribed drugs are helping or hurting patients coping with depression.

Drugs that will have the new warning statement include: Prozac (Fluoxetine); Zoloft (Sertraline); Paxil (Paroxetine); Luvox (Fluvoxamine); Celexa (Citalopram); Lexapro (Escitalopram); Wellbutrin (Bupropion); Effexor (Venlafaxine); Serzone (Nefazodone); and Remeron (Mirtazapine).

It is estimated 2500 children and adolescents commit suicide each year. Warning signs for suicide include: sleep and appetite difficulties, withdrawal from friends, giving away of possessions, social isolations, problems with falling grades. For more information you can log on to the FDA's website.

posted at 5:20PM by dave.miller@walb.com

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