A U.S. government medical reviewer told an advisory panel on Monday 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 data he relied upon were unclear.

Relatives of suicide victims who took antidepressants applauded when Mosholder began speaking to a Food and Drug Administration advisory panel that is considering whether the drugs should come with stronger warnings.

He told the panel that information from 23 clinical trials of nine different drugs given to 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 for 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.

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.

ANGRY FAMILIES LASH OUT

The advisory panel is considering data from trials of more than 4,000 children with ages ranging from six 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.

Angry relatives of suicide victims lashed out at the FDA for failing to warn about the chances of violent behavior.

"Why haven't parents ... been told the truth about these medications?" asked Mark Miller, who said his 13-year-old son killed himself after starting therapy with Pfizer Inc.'s Zoloft.

"We learned the hard way that these drugs can kill," Miller said.

Back in February, FDA officials said data on a possible link with suicide were too murky to interpret and needed further evaluation.

Dr. Robert Temple, head of the FDA office that reviews antidepressants, said he did not regret seeking the additional perspective, even though the FDA's most recent analyzes support Mosholder's earlier conclusions.

Officials wanted to avoid "scaring people needlessly" from the drugs because they 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. Drug makers agreed to put that advice on their product labels.

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 committee will meet again to decide whether to recommend stronger warnings or other regulatory steps for some or all of the antidepressants.

Reference Source 89
September 14, 2004

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