Consumer Alert: FDA Panel Urges Stronger Child and Adolescent Suicide Warnings on Antidepressants, including Paxil, Zoloft and Effexor
September 15, 2004
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A panel of expert advisers recommended on September 15, 2004 to the FDA that antidepressants should come with the nation's strongest warning -- in a black box on the label -- that children and teenagers taking these drugs may be at an increased risk for suicidal behavior. The recommendation applies to all antidepressants, including Paxil, Zoloft and Effexor.
In addition, the panel recommended that antidepressants prescribed to minors should be accompanied by an easy-to-read pamphlet that explains how to decide if a child is a good patient for the drug, and lists the warning signs of suicide. The panel also urged the FDA to consider having parents sign a form indicating that they understand the risks before the child receives antidepressants. The panel's actions are based upon its review of scientific studies concerning the drugs. FDA predicts that it will act upon the recommendations– FDA usually follows the recommendations of its advisory panels– within a few months.
The drugs are approved by the FDA for use in adults, but there has not been a showing that Paxil, Zoloft or Effexor are effective in treating depression in children. Paxil is manufactured GlaxoSmithKline, Zoloft by Pfizer and Effexor by Wyeth.
There have been some legal cases involving antidepressants, including Paxil. If you have questions of a legal nature, please contact Gary Wilson or Tara Sutton at Robins, Kaplan, Miller & Ciresi L.L.P.
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