Zoloft, also known as Sertraline, is an anti-depressant
manufactured by Pfizer Pharmaceuticals. Zoloft is part of a family of drugs called selective serotonin re-uptake inhibitors (SSRIs). With too little serotonin, people tend to harbor negative feelings about themselves and everyone around them. SSRIs such as Zoloft keep serotonin circulating in the body longer and help to alleviate the symptoms of clinical depression, anxiety
and other manifestations of low serotonin levels.
Recently, researchers discovered that some SSRIs like Zoloft may actually cause patients' depression and other emotional problems. One study performed at the Department of Psychosocial Medicine in Bangor, North Wales, found that Zoloft alleviated depression in one third of the study's participants, did nothing in another third, and actually caused emotional deterioration in another third. In addition, two otherwise healthy people in the study became extremely suicidal after taking Zoloft for just two weeks.
In November 2002, at the request of the U.S. Food and Drug Administration, Pfizer issued an important drug warning letter announcing the addition of new information to the CONTRAINDICATIONS and PRECAUTIONS sections of the Zoloft label, contraindicating the concomitant use of pimozide (a tranquilizer) with the antidepressant.
Since the highest recommended pimozide dose (10 mg) has not been evaluated in combination with Zoloft, its effect on QT interval and PK parameters at doses higher than 2 mg at this time are not known. While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide, concomitant administration of Zoloft and pimozide is now contraindicated.
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 fluoxetine (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.
See your doctor if you have experienced serious health problems after taking Zoloft. 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.
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- Depression: Overview
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- Excessive Bleeding: Overview
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