22 March 2004

by Anai Rhoads

AnaiRhoads.org - The Food and Drug Administration (FDA) announced plans on Monday to add a warning label on ten well-known anti-depressants after reports of suicidal behaviour among children.

The notices will be placed on the newer class of drugs, known as SSRIs. The anti-depressants (generic and brand name) listed of interest include Bupropion, Citalopram, Fluoxetine, Fluvoxamine, Mirtazapine, Nefazodone, Paroxetine, Sertraline, Escitalopram Venlafaxine, Celexa, Effexor, Lexapro, Luvox, Remeron, Paxil, Prozac, Serzone, Wellbutrin, and Zoloft. Luvox is not approved for use as an anti-depressant in America.

The connection is unclear whether or not the pre-existing depression is the source of the suicidal thoughts or if the drug compounds or conjures up the behaviour during the course of treatment.

England rejected the use of SSRIs in 2003, citing that they are inappropriate for children. However, Prozac is still on the list as a recommended therapy for children who exhibit depressive disorders. The FDA also voiced a similar opinion on this problem, but it was not until Monday that the agency decided to further examine the issue after parents expressed concern over their children's behaviour while on anti-depressants.

The FDA urges doctors and family members to monitor any unusual behaviour of the individual, regardless of age, while on these drugs. Supervising the patient when they begin taking the anti-depressant and also during any alteration of dosage, will help catch any usual pattern early. Symptoms to watch out for are agitation, akathisia, anxiety, hostility, hypomania, impulsivity, insomnia, irritability, mania, panic attacks. Those who suffer from bipolar disorders are especially in need of supervision.

The Public Health Advisory containing the new label warnings and cautions is available online here.

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