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FDA calls for black box warning for Zoloft and other antidepressants

June 23rd, 2011

The Food and Drug Administration has announced that Zoloft and all other antidepressants must carry a black box warning that they may increase the risk of suicide when taken by children and teens. A black box warning is the FDA’s strongest possible label to alert doctors and patients of possible side effects from a drug.

According to researchers at Columbia University, about 2-3% of children and teens who take antidepressants have an increase in suicidal thoughts. Clinical trials involving thousands of antidepressant patients also found an increased risk of suicidal thoughts.

Because black box warnings are seen mainly by doctors, the FDA is also creating an information guide for patients about the link between antidepressants and suicide. The guide will be included with all antidepressant prescriptions and will advise parents to be alert for warning signs that could be indicative of suicidal thinking.

Several parents of children who committed suicide while taking antidepressants have filed lawsuits against the manufacturers of these drugs. These lawsuits have alleged that the drug companies failed to properly warn about the risk of suicide for young patients who are prescribed antidepressants.

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