Re: U.S. FDA urges caution over antidepressant use

[Guest guest]

How concerned should we be about this?

Love to all,

Carol in FL

[ ] U.S. FDA urges caution over antidepressant use

U.S. FDA urges caution over antidepressant use

Last Updated: 2004-03-22 12:50:51 -0400 (Reuters Health)

WASHINGTON (Reuters) - Patients taking antidepressants, including

children and teenagers, should be closely monitored for signs of

worsening depression and suicidal thoughts, U.S. health authorities said

on Monday.

The warning comes after a panel of experts last month called on the U.S.

Food and Drug Administration to issue stronger warnings about the

possible risks of suicidal behavior among children and teenagers taking

antidepressant drugs.

U.S. health officials are studying whether antidepressants can make

children and teenagers suicide-prone but have not yet reached a

conclusion.

" It is not yet clear whether antidepressants contribute to the emergence

of suicidal thinking and behavior, " the FDA said in a statement.

Questions about a possible link with suicidal behavior arose last year

when regulators were reviewing clinical trials of children who took

GlaxoKline Plc's Paxil.

The other antidepressants the FDA is evaluating include Forest

Laboratories Inc.'s Celexa, Solvay's Luvox, Akzo Nobel's Remeron,

Bristol-Myers Squibb's Serzone, Pfizer's Zoloft, Eli Lilly and Co.'s

Prozac, and Wyeth's Effexor.

Only Prozac, sold generically as fluoxetine, is approved for treating

pediatric depression.

The FDA advised patients and doctors watch for signs of hostility,

anxiety, insomnia and other behaviors that could signal worsening

depression and suicidal thoughts.

The agency asked manufacturers to change the labels of 10 drugs to

include stronger warnings about patient monitoring.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[Guest guest]

We had a educational meeting today about depression. A psyciatrist spoke on

medications. He said there should always be follow through with meds of any

kind, but at this point, it still is hard to say if the meds are causing

suicide, or the fact that the people are on meds for depression, means they were

suicidal in the beginning. In other words,

the drug didn't make them kill themselves, they had thoughts before they went on

the drug.

Noreen

[Guest guest]

This warning should be taken very seriously, Carol.

The possibility of an increased risk of suicide associated with the use

of some antidepressants is by no means a new concern - it came up

formally before the FDA as early as 1991; however, as usual, the FDA has

been very slow to act. And when they do, it seems as though they would

rather side with the pharmaceutical companies than to err on the side of

caution for the sake of consumers.

The way the FDA conducts its hearings when under pressure from consumer

groups to reexamine certain approvals or labeling is, in my opinion,

less than scientific and fair.

Aside from possibly hurting sales of the drugs, what is the harm in

making sure the warnings are stronger, especially in light of the fact

that we have so many children on these drugs?

Of note, too, is that one of the ten antidepressant drugs in question is

Serzone (nefazodone) which Public Citizen petitioned the FDA in March

2003 to remove from the market because of the unacceptable rate of liver

failure and fatalities associated with it. Since the FDA hasn't moved on

the petition, Public Citizen filed suit against the FDA in March 2004.

Serzone has already been banned in Canada in November 2003 and in Europe

before that. It is scheduled to be removed from the Australian and New

Zealand markets in May. Why is it still on the market here?

Another disturbing and related story that didn't get much press is that,

in February of this year, a 19-year-old woman who was participating in a

study of Eli Lilly's for a new antidepressant (duloxetine) hanged

herself during the trial at their research facility at Indiana

University. She was screened before entering the trial and not found to

be suffering from depression. Not to be heartless, but, statistically,

she is just one person, yet her tragic death raises some very troubling

questions. After her death, about 20% of study participants withdrew.

None of this is to suggest that everyone should abandon the use of

antidepressants or panic. The truth is though that there is much we

don't understand about depression, the mind, these drugs, and we can't

predict who might respond in an adverse way to them. The warnings about

suicide should be there, and it shouldn't be merely a request of the FDA

either. It should be mandatory - a black box warning.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[ ] U.S. FDA urges caution over antidepressant use

>

> U.S. FDA urges caution over antidepressant use

>

> Last Updated: 2004-03-22 12:50:51 -0400 (Reuters Health)

>

> WASHINGTON (Reuters) - Patients taking antidepressants, including

> children and teenagers, should be closely monitored for signs of

> worsening depression and suicidal thoughts, U.S. health authorities

said

> on Monday.

>

> The warning comes after a panel of experts last month called on the

U.S.

> Food and Drug Administration to issue stronger warnings about the

> possible risks of suicidal behavior among children and teenagers

taking

> antidepressant drugs.

>

> U.S. health officials are studying whether antidepressants can make

> children and teenagers suicide-prone but have not yet reached a

> conclusion.

>

> " It is not yet clear whether antidepressants contribute to the

emergence

> of suicidal thinking and behavior, " the FDA said in a statement.

>

> Questions about a possible link with suicidal behavior arose last year

> when regulators were reviewing clinical trials of children who took

> GlaxoKline Plc's Paxil.

>

> The other antidepressants the FDA is evaluating include Forest

> Laboratories Inc.'s Celexa, Solvay's Luvox, Akzo Nobel's Remeron,

> Bristol-Myers Squibb's Serzone, Pfizer's Zoloft, Eli Lilly and Co.'s

> Prozac, and Wyeth's Effexor.

>

> Only Prozac, sold generically as fluoxetine, is approved for treating

> pediatric depression.

>

> The FDA advised patients and doctors watch for signs of hostility,

> anxiety, insomnia and other behaviors that could signal worsening

> depression and suicidal thoughts.

>

> The agency asked manufacturers to change the labels of 10 drugs to

> include stronger warnings about patient monitoring.

>

>

>