Woodcock said It's a huge undertaking, as FDA to Study Suicide Risks in Adults

[Guest guest]

" We drew the line at 18, " Goodman said. " But some of the same

mechanisms that could be responsible for suicidality in a small

fraction of patients would be operative in people who are 19, 20,

21. Who is to say?................. "

FDA to Study Suicide Risks in Adults

Analysis of Children's Suicide Risks Spurs FDA Follow-Up Study on

Depressed Adults

The Associated Press

http://abcnews.go.com/wire/Living/ap20040928_1387.html?HEALTHAd=true

WASHINGTON Sept. 28, 2004 — The Food and Drug Administration will

examine clinical trial data for thousands of depressed adults to see

if they, like children, suffered increased suicidal thoughts and

behaviors while taking antidepressants.

Dr. Janet Woodcock, acting FDA deputy commissioner, could not say

how long the exhaustive analysis would take or how much it would

cost.

" It's a huge undertaking, " Woodcock said Tuesday.

Columbia University's analysis of pediatric clinical trial data

examined just one-tenth of the information contained in adult

databases.

That pediatric study and the FDA's own internal reviews established

a link between antidepressants and children's worsened conditions.

For every 100 children taking antidepressants, an extra two to three

suffered heightened suicidal tendencies.

Those findings prompted federal advisers this month to push for

strident black-box warnings to be added to labels for Celexa,

Effexor, Luvox, Paxil, Prozac, Remeron, Serzone, Wellbutrin and

Zoloft.

The FDA now will begin to consider the same question for depressed

adults.

It will start by analyzing a few of the larger drug trials.

Ultimately, Columbia's new analysis technique will be applied to all

234 clinical trials, representing 40,000 depressed adults.

" We'll be able to see, for adults, if this type of analysis shows

any change in their thinking or expression, " Woodcock said.

Already, the agency knows that depressed adults in clinical trials

complete suicides at the same rate, whether they're taking

antidepressants or placebos. That earlier study was driven by the

ethical dilemma raised by denying drugs to depressed adults.

Researchers worried about a spike in suicides among the adults

taking sugar pills.

" We found that wasn't the case, " Woodcock said.

An analysis already conducted by the FDA found no differences in

behavior or action of depressed children and adults taking Paxil.

" I'm not sure it was done the exact Columbia way, " Woodcock said.

Dr. Wayne K. Goodman, chair of the joint meeting of two federal

advisory panels that called for the black-box warnings, said the new

analysis could make it easier to see trends among young adults.

" We drew the line at 18, " Goodman said. " But some of the same

mechanisms that could be responsible for suicidality in a small

fraction of patients would be operative in people who are 19, 20,

21. Who is to say? "

On the Net:

Food and Drug Administration:

Copyright 2004 The Associated Press. All rights reserved. This

material may not be published, broadcast, rewritten, or

redistributed.

[Guest guest]

" We drew the line at 18, " Goodman said. " But some of the same

mechanisms that could be responsible for suicidality in a small

fraction of patients would be operative in people who are 19, 20,

21. Who is to say?................. "

FDA to Study Suicide Risks in Adults

Analysis of Children's Suicide Risks Spurs FDA Follow-Up Study on

Depressed Adults

The Associated Press

http://abcnews.go.com/wire/Living/ap20040928_1387.html?HEALTHAd=true

WASHINGTON Sept. 28, 2004 — The Food and Drug Administration will

examine clinical trial data for thousands of depressed adults to see

if they, like children, suffered increased suicidal thoughts and

behaviors while taking antidepressants.

Dr. Janet Woodcock, acting FDA deputy commissioner, could not say

how long the exhaustive analysis would take or how much it would

cost.

" It's a huge undertaking, " Woodcock said Tuesday.

Columbia University's analysis of pediatric clinical trial data

examined just one-tenth of the information contained in adult

databases.

That pediatric study and the FDA's own internal reviews established

a link between antidepressants and children's worsened conditions.

For every 100 children taking antidepressants, an extra two to three

suffered heightened suicidal tendencies.

Those findings prompted federal advisers this month to push for

strident black-box warnings to be added to labels for Celexa,

Effexor, Luvox, Paxil, Prozac, Remeron, Serzone, Wellbutrin and

Zoloft.

The FDA now will begin to consider the same question for depressed

adults.

It will start by analyzing a few of the larger drug trials.

Ultimately, Columbia's new analysis technique will be applied to all

234 clinical trials, representing 40,000 depressed adults.

" We'll be able to see, for adults, if this type of analysis shows

any change in their thinking or expression, " Woodcock said.

Already, the agency knows that depressed adults in clinical trials

complete suicides at the same rate, whether they're taking

antidepressants or placebos. That earlier study was driven by the

ethical dilemma raised by denying drugs to depressed adults.

Researchers worried about a spike in suicides among the adults

taking sugar pills.

" We found that wasn't the case, " Woodcock said.

An analysis already conducted by the FDA found no differences in

behavior or action of depressed children and adults taking Paxil.

" I'm not sure it was done the exact Columbia way, " Woodcock said.

Dr. Wayne K. Goodman, chair of the joint meeting of two federal

advisory panels that called for the black-box warnings, said the new

analysis could make it easier to see trends among young adults.

" We drew the line at 18, " Goodman said. " But some of the same

mechanisms that could be responsible for suicidality in a small

fraction of patients would be operative in people who are 19, 20,

21. Who is to say? "

On the Net:

Food and Drug Administration:

Copyright 2004 The Associated Press. All rights reserved. This

material may not be published, broadcast, rewritten, or

redistributed.