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Home > Archive > Ayurveda > October 2004 > US Orders New Youth Warnings on Antidepressants
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US Orders New Youth Warnings on Antidepressants
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| Ilena Rose 2004-10-15, 7:24 pm |
| US Orders New Youth Warnings on Antidepressants
http://news.yahoo.com/news?tmpl=sto...epressants_dc_6
Fri Oct 15,11:05 AM ET U.S. National - Reuters
By Lisa Richwine
WASHINGTON (Reuters) - U.S. health officials on Friday ordered the
makers of all antidepressants to include tough warnings explaining
that the drugs increase the chances of suicidal behavior in some
children and teens.
Reuters Photo
The Food and Drug Administration (news - web sites) said the
information, to be highlighted in a black box, must also state whether
the drug has -- or has not -- been cleared for use by children. Only
Eli Lilly and Co.'s Prozac is FDA (news - web sites)-approved for
treating pediatric depression.
A black box is the strongest type of warning the United States
requires for prescription drugs.
An FDA official told reporters that patients should see the label
changes in the pharmacy in the next month or two.
The warning will stress the need to monitor the behavior of youths who
start taking the medications. The chances of suicidal behavior appear
greater during the first few months of treatment, the FDA said in a
statement.
"The new warning language does not prohibit the use of antidepressants
in children and adolescents. Rather, it warns of the risk of suicidal
(behavior) and encourages prescribers to balance this risk with
clinical need," the FDA said.
The warnings will apply to all antidepressants "because the currently
available data are not adequate to exclude any single medication from
the increased risk," the FDA said.
The agency said it is developing a pamphlet explaining the safety
risks in patient-friendly language for pharmacists to distribute with
each antidepressant prescription or refill.
A recent FDA analysis concluded two or three out of every 100 young
people treated with antidepressants might face an elevated risk of
suicidal thoughts or actions. In clinical trials of nine
antidepressants, no child or teen actually committed suicide.
The FDA had been criticized for being slow to recognize the link
between the drugs and suicidal thoughts and actions. One agency
reviewer warned about the danger months ago, but top officials did not
acknowledge a connection until September.
Top-selling antidepressants include Prozac, Pfizer Inc.'s Zoloft,
Wyeth's Effexor and GlaxoSmithKline Plc's Paxil.
| |
| Mark Probert 2004-10-15, 7:24 pm |
|
"Ilena Rose" <ilena@san.rr.com> wrote in message
news:e480n050tgivgrcg5690v67otn7idmd9pm@4ax.com...
> US Orders New Youth Warnings on Antidepressants
>
>
http://news.yahoo.com/news?tmpl=sto...epressants_dc_6
I am persoanlly glad that they ordered extra warnings. One cannot ever be
too careful.
Copyright material snipped.
| |
| Dr. Jai Maharaj 2004-10-15, 10:08 pm |
| In article <e480n050tgivgrcg5690v67otn7idmd9pm@4ax.com>,
Ilena Rose <ilena@san.rr.com> posted:
> US Orders New Youth Warnings on Antidepressants
>
> http://news.yahoo.com/news?tmpl=sto...th_antidepressa
> nts_dc_6
>
> Fri Oct 15,11:05 AM ET U.S. National - Reuters
>
>
> By Lisa Richwine
>
> WASHINGTON (Reuters) - U.S. health officials on Friday ordered the
> makers of all antidepressants to include tough warnings explaining
> that the drugs increase the chances of suicidal behavior in some
> children and teens.
>
>
> Reuters Photo
>
>
>
> The Food and Drug Administration (news - web sites) said the
> information, to be highlighted in a black box, must also state whether
> the drug has -- or has not -- been cleared for use by children. Only
> Eli Lilly and Co.'s Prozac is FDA (news - web sites)-approved for
> treating pediatric depression.
>
>
> A black box is the strongest type of warning the United States
> requires for prescription drugs.
>
>
> An FDA official told reporters that patients should see the label
> changes in the pharmacy in the next month or two.
>
>
> The warning will stress the need to monitor the behavior of youths who
> start taking the medications. The chances of suicidal behavior appear
> greater during the first few months of treatment, the FDA said in a
> statement.
>
>
> "The new warning language does not prohibit the use of antidepressants
> in children and adolescents. Rather, it warns of the risk of suicidal
> (behavior) and encourages prescribers to balance this risk with
> clinical need," the FDA said.
>
>
> The warnings will apply to all antidepressants "because the currently
> available data are not adequate to exclude any single medication from
> the increased risk," the FDA said.
>
>
> The agency said it is developing a pamphlet explaining the safety
> risks in patient-friendly language for pharmacists to distribute with
> each antidepressant prescription or refill.
>
>
> A recent FDA analysis concluded two or three out of every 100 young
> people treated with antidepressants might face an elevated risk of
> suicidal thoughts or actions. In clinical trials of nine
> antidepressants, no child or teen actually committed suicide.
>
>
> The FDA had been criticized for being slow to recognize the link
> between the drugs and suicidal thoughts and actions. One agency
> reviewer warned about the danger months ago, but top officials did not
> acknowledge a connection until September.
>
>
> Top-selling antidepressants include Prozac, Pfizer Inc.'s Zoloft,
> Wyeth's Effexor and GlaxoSmithKline Plc's Paxil.
>
Newgroup distribution adjusted.
Jai Maharaj
http://www.mantra.com/jai
Om Shanti
| |
| Randle P. McMurphy 2004-10-16, 11:08 am |
| Well before SSRIs it was understood that a critical time that a depressed
person might attempt suicide was after they started on an anti-depressant. The
lifting of some of the psysiological symptoms often provides the energy to make
such attempts. The local paper today had a report that the meds could put
suicidal thoughts in kids heads. Poor choice of words as I don't beleive we
have a medication that implants thoughts yet. Most Docs should be aware that
anyone who is deeply depressed needs to be watched closely after the initiation
of antidepressant therapy. Maybe this does bring into question general
practice physicians who readily order the newer antidepressants for their
patients.
"Facts are stupid things." -- Ronald Reagan, 1988, a misquote of John Adams,
"Facts are stubborn things."
| |
| Mark Probert 2004-10-21, 10:09 pm |
|
"Ilena Rose" <ilena@san.rr.com> wrote in message
news:e480n050tgivgrcg5690v67otn7idmd9pm@4ax.com...
> US Orders New Youth Warnings on Antidepressants
>
>
http://news.yahoo.com/news?tmpl=sto...epressants_dc_6
I am persoanlly glad that they ordered extra warnings. One cannot ever be
too careful.
Copyright material snipped.
| |
| Dr. Jai Maharaj 2004-10-22, 2:08 am |
| In article <e480n050tgivgrcg5690v67otn7idmd9pm@4ax.com>,
Ilena Rose <ilena@san.rr.com> posted:
> US Orders New Youth Warnings on Antidepressants
>
> http://news.yahoo.com/news?tmpl=sto...th_antidepressa
> nts_dc_6
>
> Fri Oct 15,11:05 AM ET U.S. National - Reuters
>
>
> By Lisa Richwine
>
> WASHINGTON (Reuters) - U.S. health officials on Friday ordered the
> makers of all antidepressants to include tough warnings explaining
> that the drugs increase the chances of suicidal behavior in some
> children and teens.
>
>
> Reuters Photo
>
>
>
> The Food and Drug Administration (news - web sites) said the
> information, to be highlighted in a black box, must also state whether
> the drug has -- or has not -- been cleared for use by children. Only
> Eli Lilly and Co.'s Prozac is FDA (news - web sites)-approved for
> treating pediatric depression.
>
>
> A black box is the strongest type of warning the United States
> requires for prescription drugs.
>
>
> An FDA official told reporters that patients should see the label
> changes in the pharmacy in the next month or two.
>
>
> The warning will stress the need to monitor the behavior of youths who
> start taking the medications. The chances of suicidal behavior appear
> greater during the first few months of treatment, the FDA said in a
> statement.
>
>
> "The new warning language does not prohibit the use of antidepressants
> in children and adolescents. Rather, it warns of the risk of suicidal
> (behavior) and encourages prescribers to balance this risk with
> clinical need," the FDA said.
>
>
> The warnings will apply to all antidepressants "because the currently
> available data are not adequate to exclude any single medication from
> the increased risk," the FDA said.
>
>
> The agency said it is developing a pamphlet explaining the safety
> risks in patient-friendly language for pharmacists to distribute with
> each antidepressant prescription or refill.
>
>
> A recent FDA analysis concluded two or three out of every 100 young
> people treated with antidepressants might face an elevated risk of
> suicidal thoughts or actions. In clinical trials of nine
> antidepressants, no child or teen actually committed suicide.
>
>
> The FDA had been criticized for being slow to recognize the link
> between the drugs and suicidal thoughts and actions. One agency
> reviewer warned about the danger months ago, but top officials did not
> acknowledge a connection until September.
>
>
> Top-selling antidepressants include Prozac, Pfizer Inc.'s Zoloft,
> Wyeth's Effexor and GlaxoSmithKline Plc's Paxil.
>
Newgroup distribution adjusted.
Jai Maharaj
http://www.mantra.com/jai
Om Shanti
| |
| Randle P. McMurphy 2004-10-22, 2:08 am |
| Well before SSRIs it was understood that a critical time that a depressed
person might attempt suicide was after they started on an anti-depressant. The
lifting of some of the psysiological symptoms often provides the energy to make
such attempts. The local paper today had a report that the meds could put
suicidal thoughts in kids heads. Poor choice of words as I don't beleive we
have a medication that implants thoughts yet. Most Docs should be aware that
anyone who is deeply depressed needs to be watched closely after the initiation
of antidepressant therapy. Maybe this does bring into question general
practice physicians who readily order the newer antidepressants for their
patients.
"Facts are stupid things." -- Ronald Reagan, 1988, a misquote of John Adams,
"Facts are stubborn things."
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