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Antidepressant Drug Use In Children

Following reports of suicidal thoughts and suicide attempts, the FDA issued a public health advisory in October 2003 concerning children with major depressive disorder (MDD) who have taken various antidepressant drugs.

The FDA has completed a preliminary review of reports for eight antidepressant drugs:

* Celexa (citalopram)

* Prozac (fluoxetine)

* Luvox (fluvoxamine)

* Remeron (mirtazapine)

* Serzone (nefazodone)

* Paxil (paroxetine)

* Zoloft (sertraline)

* Effexor (venlafaxine)

Although Luvox was reviewed, the drug is not approved as an antidepressant in the United States.

According to the FDA, the data don't clearly establish an association between the use of these drugs and increased suicidal thoughts or actions in children. But at this point, it is not possible to rule out an increased risk of these adverse events for these drugs. In June 2003, the FDA recommended that Paxil not be used in children and adolescents for the treatment of MDD.

The FDA recognizes that MDD is a serious condition for which there are few treatment options. In addition to using non-medication treatment approaches, doctors must often make choices among drugs that are available for treating adult MDD. Prozac is the only drug labeled for use in pediatric MDD.

The FDA has scheduled a meeting on Feb. 2, 2004, of its Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee to discuss data and regulatory actions on this topic.

Antidepressants in adults and children should be used with caution, and antidepressants should not be discontinued before consulting with a physician. The public health advisory can be found at www.fda.gov/cder/drug/advisory/mdd.htm.

COPYRIGHT 2004 U.S. Government Printing Office
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