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SSRIs (selective serotonin reuptake inhibitors) have been under investigation, especially for the safety concerns among children. Eight out of 10 of the SSRIs have added warnings on suicidality to labeling, and Zoloft maker Pfizer is negotiating language for its labeling. The target of a lawsuit charging Pfizer misled physicians and patients about the safety, efficacy and side effects of antidepressant drug Zoloft, Pfizer has been facing an increasing amount of negative press in recent days.

In February 2004, the FDA withheld an internal finding that antidepressants like Zoloft were associated to an increased risk of suicide among children. A second analysis has arrived at the same Zoloft and children risk conclusion, though the federal agency has failed to disclose either report. As mounting pressure from Congress and critics continue, the FDA has held to its refusal to publicly disclose the reports until it has had its September 2004 scheduled meeting. The FDA has been criticized for its long delay in acting on potential Zoloft and children risks that British authorities warned of in January 2004 telling physicians not to prescribe Zoloft, Paxil and similar drugs to children.

Concerns regarding the safety of Zoloft and children use first came to light in 2003, with sales of the popular drug generating $3.1 billion in one year alone. The September 2004 meeting will be the first meeting of the full Pediatric Advisory Committee, joined with the Psychopharmacologic Drugs Advisory Committee as a follow up of the early February 2004 meeting where advisory committee members expressed concern about the "high degree of variability and lack of categorization of events believed to be suicide related" amongst Zoloft and children and other SSRIs.

Although a leading expert and former director of the National Institute of Mental Health Steven Hyman initially believed British regulators had overreacted with its warning to doctors to avoid prescribing Zoloft and children and other SSRIs, after reviewing the two FDA internal analyses he changed his opinion saying, "now I would say from the data in front of me, with the exception of Prozac, there is concern about the risk-benefit ratio of antidepressants in children." Currently, multiple congressional investigations are underway and some congressional members have been very vocal in their disapproval of the lack of FDA ruling on the safety of Zoloft and children and other antidepressants thus far.

The FDA Medical Reviewer Tarek Hammad showed an increased risk for use of Zoloft and children to be 1.78 times the risk of making a suicide attempt or "preparatory actions toward imminent suicidal behavior" when compared to children who got sugar pills. Hammad''s findings are similar to the findings Andrew Mosholder found in February 2004, another FDA scientist, yet the risk Zoloft and children may pose is still being presented. International and Canadian reports have also indicated that some newborns whose mothers took SSRIs, like Zoloft, developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding.

"Possible Link Between SSRI Antidepressants and Autism"

A Northern California study of children and their mothers suggests that a woman taking SSRI antidepressants, such as Zoloft, especially during the first trimester o...

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"Fifteen-year-old boy sentenced to 30 years in Zoloft case"

A 15-year old boy, Chris Pittman, was convicted by a jury on two counts of murder in the 2001 killings of his paternal grandparents.

The defense attorney for Pittman argued popular antidepressant Zoloft drove the boy to kill. Zoloft ...

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"FDA recommends stronger warnings on 10 antidepressants"

At last month''s FDA meeting families of suicide victims emotionally asked the drug agency to provide stronger warnings on antidepressants. The warnings come a year after British health authorities first became alarmed about how newer generation an...

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