FDA Readying New Warning on Antidepressants-Kids' Suicide Link
Health Highlights: Aug. 21, 2004
Source: HealthDay
FDA Readying New Warning on Antidepressants-Kids' Suicide Link
The U.S. Food and Drug Administration is preparing new warnings on the link between antidepressant use and suicidal tendencies in children, according to agency documents released Friday.
The new warnings were prompted by a new FDA analysis that backed earlier studies of the link, the Associated Press reported.
Exactly what the warnings will say, and which drugs will be affected, hasn't been settled, according to the FDA documents. The agency will take the debate to its scientific advisers next month for help in deciding.
"While there remains a signal of risk ... for some drugs in some trials, it is important to note that the data are not black-and-white in providing a clear and definitive answer," FDA psychiatric drugs chief Dr. Thomas Laughren wrote the advisory panel this week.
The agency's move follows release of an internal memo this week, written by one of its top scientists, who claimed the new research confirmed last year's findings that antidepressants increase the risk of suicide in children.
Dr. Andrew D. Mosholder, a senior FDA epidemiologist who assesses the safety of medicines, concluded last year that the results of 22 studies showed an almost-doubled risk of suicide for children taking antidepressants, The New York Times reported. But Mosholder's superiors disputed his findings and sought a new analysis.
In this week's internal memo, Mosholder wrote that the new analysis found that the antidepressants Paxil and Effexor are even more likely to cause suicidal behavior in children than last year's studies showed, his memo said.
The controversy over antidepressant use by kids has simmered since last year, when British health authorities declared that a list of popular antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers, and declared all but one -- Prozac -- unsuitable for depressed youth, AP reported.