Subject:   FDA Advisory on Suicidality and the Use of Anti-depressants with Children
Date:   2003-11-10

Updated Information

The FDA has just issued a public health advisory for anti-depressant use with children, which warns that there may be an increased risk of suicidal ideation and suicide attempts:

Reports of Suicidality in Pediatric Patients Being Treated with Antidepressant Medications for Major Depressive Disorder (MDD). FDA Public Health Advisory. 2003-10-2003. Available from http://www.fda.gov/cder/drug/advisory/mdd.htm

Currently anti-depressants are routinely given to children, in so-called off-label use – without studies verifying their safety or efficacy. Now the FDA after analysis of several studies has found harm – an excess of suicidality (suicide ideation and attempts), although the exact rate of increase was not reported in the FDA bulletin. Such findings, based on clinical study, point to the benefits of ongoing medical research, but much remains to be established.

Many in the public are not aware that their children can be given psychoactive drugs, which have a major impact on their child's developing brain and behavior, without studies establishing safety and efficacy. So far in preliminary studies of antidepressants used on children, the FDA bulletin informs us, effectiveness has been only established for one of seven of the anti-depressants drugs used on children.

As already noted, indications are that suicidality is increased with anti-depressant use on children, although the question of whether there is an increased number of suicides remains open. Some have criticized giving depressed person of any age a drug, which when taken in overdose can enable the person to commit suicide. In the past the FDA has prohibited the claim of drug companies to label anti-depressants as a suicide preventative, due to the paucity of any supportive evidence.

In England the Department of Health has issued similar advisories regarding the use of anti-depressant drugs, warning of anti-depressant drug's addictive nature, and serious adverse effects – including increased hostility and suicidality. In particular warnings against any usage of two anti-depressants for under 18 children have been issued. (URL: http://news.bbc.co.uk/2/hi/health/3122360.htm) *

We at CIRCARE are concerned that powerful drugs are increasingly being given to children without evidence establishing their safety and efficacy. In addition, the public may not be being made aware of the paucity of evidence and the experimental nature of anti-depressant use on children, and so not be truly granting informed consent. Lastly, we are concerned that recent evidence is emerging, leading the FDA to issue an advisory, that many children are being harmed.

Michael A. Susko MS, CIRCARE President
(410) 499-4895

Adil Shamoo Ph.D., CIRCARE Co-Founder
(410) 706-3327

* We apologize for providing incomplete information on the story published by BBC News. The story is no longer available.

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Updated Information

U.S. Food and Drug Administration. Antidepressant Use in Children, Adolescents, and Adults. March, 2004. Available from http://www.fda.gov/cder/drug/antidepressants/default.htm. (Overview with links to more detailed information.)

U.S. Food and Drug Administration. Index of Meeting Information, Psychopharmacologic Drugs Advisory Committee, September 13-14, 2004 Joint meeting with the Pediatric Advisory Committee. Available from http://www.fda.gov/ohrms/dockets/ac/cder04.html#PsychopharmacologicDrugs. (Links to material provided to advisory committee members, meeting transcripts, and Federal Register announcements.)

U.S. Food and Drug Administration. Briefing Information, Psychopharmacologic Drugs Advisory Committee, September 13-14, 2004 Joint meeting with the Pediatric Advisory Committee. Available from http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4065b1.htm. (Detailed information about analyses of published clinical trials conducted by FDA and external consultants.)

So what's the bottom line? Same as always: consult your physician for answers to concerns about these and any other medications prescribed for you.

Link:   To create an HTML link to this InfoMail cut and paste the following:

<a href="http://www.circare.org/im/im10Nov2003.htm">FDA Advisory on Suicidality and the Use of Anti-depressants with Children</a>. CIRCARE InfoMail (2003-11-10)

Last Updated: 2006-04-25

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