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FDA: New Antidepressant Warning for Kids?

Aug. 20, 2004 — A new FDA analysis shows that kids taking most antidepressants have an increased risk of suicidal thoughts and actions.

After evaluating recent studies, Andrew D. Mosholder, MD, MPH, says in a memo to the FDA that antidepressants are associated with nearly a twofold increase in suicide risk in kids. Full evaluation of the data — including results on individual antidepressants — will come later. Mosholder is an epidemiologist with the FDA’s division of drug risk evaluations.

What does this means to kids suffering from depression? That’s “a substantial challenge,” according to an FDA statement. An FDA advisory panel will wrangle with the question when it meets on Sept. 13-14.

But the FDA promises the new information will be added to product labels as quickly as possible.

“Although specific new labeling language has yet to be developed, [the] FDA will assure that the labels of the antidepressants used in pediatric patients reflect the most recent information obtained from these studies and analyses,” the FDA today announced.

Most experts who have discussed the issue with WebMD say that antidepressant drugs are extremely useful in treating pediatric depression. Without treatment — with either antidepressant drugs or psychotherapy — kids who are severely depressed have a high risk of suicide. It’s been difficult to tease out exactly what role the drugs play in suicide risk.

The FDA asked manufacturers to add suicide warnings — requiring close monitoring of pediatric patients during the early weeks of treatment — to the labels of 10 antidepressants after its advisory panel met last February.

These 10 antidepressants are:

  • Prozac (also sold generically as fluoxetine)
  • Zoloft
  • Paxil
  • Luvox
  • Celexa
  • Lexapro
  • Wellbutrin
  • Effexor
  • Serzone
  • Remeron

In his memo dated Aug. 16, Mosholder says his analysis results are similar to those later found by Columbia University experts — who were convened by the FDA — and to those found by another FDA unit, the Division of Neuropharmacological Drug Products.

Mosholder wanted the FDA advisory panel to recommend a ban all antidepressant drugs — except Prozac — for children. But he wasn’t allowed to present his findings to the February 2004 panel meeting.

In his memo, Mosholder says the new FDA analysis “does not materially affect the recommendations I made previously.”

SOURCES: FDA news release, Aug. 20, 2004. Memorandum from Andrew D. Mosholder, MD, MPH, epidemiologist, Division of Drug Risk Evaluation, FDA, to Paul J. Seligman, MD, MPH, acting director, office of drug safety, FDA and Anne Trontell, MD, MPH, deputy director, office of drug safety, FDA, accessed on FDA web site Aug. 20, 2004. WebMD Medical News, “FAQ: FDA Suicide Warning on Antidepressants,” March 22, 2004.

Posted by: Dr.Health

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