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Health - Reuters
FDA Antidepressant Review 'Troubling'--US Lawmaker

Thu Apr 15, 6:24 PM ET
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By Lisa Richwine

WASHINGTON (Reuters) - A U.S. 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.

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Rep. Joe Barton, chairman of the House Energy and Commerce Committee, said he may call a hearing to investigate if Food and Drug Administration (news - web sites) 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 GlaxoSmithKline Plc's Paxil can make children and teenagers suicide- prone, 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 letting Mosholder present his views at a February advisory panel meeting "would be potentially harmful to the public health" because patients being 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.

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