Since its approval in 1987, over thirty-five million people have used Prozac, an antidepressant drug
manufactured by Eli Lilly & Company. Prozac is classified as a selective serotonin reuptake inhibitor or "SSRI."
Nerve cells that carry messages to the brain are not connected 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. People 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 low amount of serotonin can have negative consequences, too much 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 Food and Drug Administration issued a Public Health Advisory that provides further cautions to physicians, their patients, and families and caregivers of patients about the need to closely monitor both adults and children with depression, especially at the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose.
FDA is asking manufacturers to change 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 drugs 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. Several of these drugs 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 United States.'''
According to a story in the January 2005 issue of the British Medical Journal, Eli Lilly & Co. was aware in the 1980s that Prozac may cause serious behavioral problems. The journal reportedly received drug company documents from an anonymous source detailing a link between the anti-depressant and an increased risk of suicide and violence.
See your doctor if you have experienced serious side effects associated with Prozac. In addition, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.
- Antidepressants & Other Psychiatric Drugs
- Addiction: Overview
- Digestive Disorders: Overview
- Excessive Bleeding: Overview
- Violent Behavior: Overview