FDA antidepressant review troubling-- US lawmaker

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FDA antidepressant review " troubling " -- US lawmaker

Last Updated: 2004-04-16 9:17:02 -0400 (Reuters Health)

By Richwine

WASHINGTON (Reuters) - A US congressional probe has raised " troubling

questions " about whether regulators tried to keep secret information

about a possible link between antidepressants and suicidal behavior in

children, a lawmaker said on Thursday.

Rep. Joe Barton, chairman of the House Energy and Commerce Committee,

said he may call a hearing to investigate if Food and Drug

Administration officials tried to hide a medical reviewer's conclusion

that there was a link.

" There are troubling questions of whether FDA supervisors

inappropriately suppressed significant information that would have been

of consequence to their own advisory committee, not to mention the

public, " Barton, a Texas Republican, said in a statement.

The FDA is studying whether widely used antidepressants such as Eli

Lilly and Co.'s Prozac and GlaxoKline Plc's Paxil can make children

and teenagers suicidal, but officials said they have not yet reached a

conclusion.

The primary medical reviewer on the issue, Dr. Andy Mosholder, concluded

there was a connection, according to a letter from the FDA to the

congressional committee.

Other reviewers, including Mosholder's direct supervisors, disagreed,

saying more analyzes were needed before the agency could reach a

conclusion, the FDA letter said.

FDA officials decided that letting Mosholder present his views at a

February advisory panel meeting " would be potentially harmful to the

public health " because patients who are helped by the drugs might stop

using them, the agency's letter said.

But officials did not try to hide the information, the FDA said.

" We specifically acknowledged at the public meeting that some within the

agency had reached different conclusions, " the letter said.

The advisory panel, a group of experts from outside the agency, urged

officials to issue stronger warnings about the possible risks of

suicidal behavior in children, while the agency review proceeds.

Last month, the FDA warned that patients taking antidepressants should

be closely monitored for signs of worsening depression and suicidal

thoughts.

In the letter to the congressional panel, the agency said it was

evaluating data carefully and did not want to make a premature

determination.

" The health risks of incorrect conclusions are potentially great, " the

letter said.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org