US reviewer says depression drugs, suicide linked

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A U.S. government medical reviewer told an advisory panel Monday that new findings confirmed his conclusion months ago that certain antidepressants increase the chances of suicidal behavior among children and teens.

Dr. Andrew Mosholder was prevented from giving his analysis to the panel at a public meeting in February because his supervisors thought the information he relied on was unclear.

Family members of suicide victims who took antidepressants applauded when Mosholder began his presentation Monday to a Food and Drug Administration advisory panel, which will consider findings from 23 clinical trials of nine different antidepressants.

He told the panel that information from these studies on children and teens “indicate an association of suicidal (behavior) with antidepressant treatment” over the short term. Studies only lasted as long as 16 weeks, so long-term risks are unknown.

The FDA has come under fire as being too slow to recognize the potential hazards. The agency first became aware of a possible link to suicidal behavior among children in May 2003, agency officials said.

“Obviously opinions on this are different,” Mosholder told reporters when asked how he felt about being denied the chance to speak publicly earlier. Mosholder is an epidemiologist in the FDA’s Office of Drug Safety.

Another FDA reviewer, Dr. Tarek Hammad, also said the studies reviewed by Mosholder, other FDA staff and Columbia University suggested a link between antidepressant use and suicidal tendencies in youth.

For every 100 patients treated with an antidepressant, two or three might have a higher risk of suicidal behavior, beyond the risk inherent from depression, Hammad estimated.

The advisory panel will consider the data, which stem from clinical trials dating back as far as 1983. More than 4,000 children participated, their ages ranging from 6 to 18.

No actual suicides occurred during any of the trials, but there were dozens of reports of suicidal thoughts and actions such as writing suicide notes or attempting overdoses.

At the February meeting, FDA officials said the data were murky and the agency asked Columbia University to help interpret the data.

Dr. Robert Temple, head of the FDA office that reviews antidepressants, said he did not regret asking for the Columbia review, even though the FDA’s most recent analyses support Mosholder’s earlier conclusions.

Officials wanted to avoid “scaring people needlessly” from the drugs, which can save lives by preventing suicides caused by depression, Temple told reporters.

The agency now advises doctors and parents to watch for signs of worsening depression or suicidal thoughts in patients taking the newer antidepressants.

Most of the drugs in question are in a class called selective serotonin reuptake inhibitors, or SSRIs.

Most, however, have not been shown to work for children. Only Eli Lilly and Co.’s Prozac, also sold generically as fluoxetine, is approved for treating pediatric depression.

The panel will hear later Monday from relatives of suicide victims. On Tuesday, the committee will consider whether to recommend stronger warnings for some or all of the antidepressants.

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