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More than thirty-five million individuals have taken Prozac since is approval in 1987.   Prozac is an antidepressant drug produced by Eli Lilly & Company and is classified as a selective serotonin reuptake inhibitor or "SSRI."

Nerve cells that carry messages to the brain are not linked to each other; instead, there is a small gap between each nerve cell. This gap is called a synapse. When a message reaches the gap, a chemical called serotonin is released which allows the message to travel across the synapse to the next nerve cell. This process of "bridging the gap" between nerve cells continues until the message reaches its destination. Individuals suffering from depression or obsessive-compulsive disorder often lack the necessary amount of serotonin. As a result, the messages get stuck at the end of the nerve cells, affecting the person's mood (depression) or causing the person to dwell on a certain subject as the message fails to complete its journey and remains stuck at the end of the nerve cell. Selective serotonin reuptake inhibitors such as Prozac allow the body to maintain higher levels of serotonin, thus helping to relieve symptoms of depression and obsessive-compulsive disorder.

Just as a small amount of serotonin can have negative consequences, excess amounts of the chemical can result in serotonin syndrome, a potentially deadly condition. Serotonin syndrome can occur when a person takes too many serotonin enhancing drugs. There have also been reports that Prozac may cause aggressive and violent behavior, although few, if any of those reports have been validated.

In October 2003, the FDA notified healthcare professionals of reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD). FDA has completed a preliminary review of such reports for 8 antidepressant drugs (citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine) studied under the pediatric exclusivity provision, and has determined that additional data and analysis, and also a public discussion of available data, are needed.

In March 2004, the FDA issued a Public Health Advisory that provides further cautions to doctors, their patients, and families and caregivers of patients about the need to carefully monitor both adults and children with depression, particularly at the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose.

FDA is requesting manufacturers to amend the labels of ten drugs to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the emergence of suicidal ideation, regardless of the cause of such worsening.

The medications under review include bupropion, citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, escitalopram and venlafaxine. It should be noted that the only drug that has received approval for use in children with major depressive disorder is Prozac. Some of these medications are approved for the treatment of obsessive-compulsive disorder in pediatric patients, i.e., sertraline (Zoloft), fluoxetine (Prozac), and fluvoxamine (Luvox). Luvox is not approved as an antidepressant in the US.