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Injured by Zoloft?

On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky. The agency proposed expanding the labels of all antidepressants to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age. The newly presented change would expand a warning now on the labels that pertain only to children and adolescents treated with antidepressant drugs. The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment.

The FDA recently completed a bulk evaluation of 372 studies involving approximately 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated risk for suicidal thoughts and behavior among adults 18 to 25 that approaches that seen in children, the FDA said in documents released before their scheduled December 13, 2006 meeting of its psychopharmacologic drugs advisory committee.

In May 2006, GlaxoSmithKline and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too and changed the drug’s label to reflect that risk. The FDA has recently urged the makers of Zoloft and other SSRI antidepressants to add a warning about suicidal behavior. The FDA stated that patients using Zoloft and other antidepressants should be watched closely for suicidal tendencies. The FDA advisory panel suggested the new warnings after an emotional hearing with testimony from the parents of children and teenagers who attempted suicide or took their own lives after starting antidepressants. The expanded warnings on antidepressant labels advise health-care providers to "carefully monitor patients receiving antidepressants for possible worsening of depression or suicidality, especially at the beginning of therapy or when the dose either decreases or increases."

Antidepressant Suicide Risk
Zoloft belongs to a newer class of antidepressants called SSRIs, or selective serotonin reuptake inhibitors. A British study found an increase in suicide attempts among children taking antidepressants versus those taking sugar pills. The U.S. surgeon general estimates there are 30,000 suicides every year in the United States. According to researchers with Columbia University, 10 percent of all youth suffer from depression, and 1,883 children ages 10 to 19 years old killed themselves in 2001.

Antidepressant Risk in Heart Disease Patients
In addition to the aforementioned side effects associated with antidepressants, a new study has linked these drugs to an increased risk of death amongst patients with coronary artery disease. This study, which was conducted at Duke University, analyzed the survival rate of heart disease patients using antidepressants compared with those not using these drugs.  During an average of three years of follow-up, 21.4% of the patients taking antidepressants died compared with 12.5% of those not on antidepressants. After adjusting for demographic factors, cardiac risk factors, scores on the Beck Depression Inventory test, and the presence of other illness, antidepressant use was an independent risk factor for mortality, increasing the risk by 62%. Researchers do not fully understand why antidepressants increase the risk of mortality in these patients. However, their findings are statistically significant and show that these drugs do increase the risk of death in heart disease patients. Current and former heart disease patients should weigh the risks and benefits of antidepressants before using these medications.

If you or a loved one took Zoloft and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
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Jan 17, 2008 | Parker Waichman Alonso LLP
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FDA Again Warns About Suicidal Thoughts and Behavior Among Young Adults on Antidepressants

May 3, 2007 | NewsInferno.com
The U.S. Food and Drug Administration (FDA) today issued new warnings about suicidal thoughts and behavior related to young adults taking antidepressants, and they have asked drug makers to update their label warnings appropriately. The FDA uses the term “suicidality” to describe what they call suicidal thinking and behavior. The new “black-box” label warnings, the most strident type of warning, would reflect the increased risks of suicidality in young adults, ages 18...

FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

May 2, 2007 | www.fda.gov
The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months). The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older...

FDA plans to expand antidepressant warning

Dec 14, 2006 | Los Angeles Times
A Food and Drug Administration federal panel Wednesday recommended the agency issue its strongest possible warning to alert patients and doctors that antidepressants can increase the risk of suicidal thoughts and behavior in young adults. The panel called for placing the so-called black-box warning on product labels and in medication guides distributed to patients. Following the vote, FDA officials said they intended to expand the warning to include young adults. Since 2004, antidepressants...

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