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 veggie
Registered: 07/25/04
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 FDA Broadens Antidepressants Suicide Warnings 
#6866368 - 05/03/07 08:29 AM (16 years, 11 months ago) |
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FDA Proposes Suicide Warnings on Antidepressant Medications
May 2, 2007 - salem-news.com
Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.
 The U.S. Food and Drug Administration today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality.
The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."
People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.
The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.
The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants.
At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications.
In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.
Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.
In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants.
Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.
FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products.
Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.
Products involved in today's action include:
Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/amitriptyline)
fluvoxamine maleate
Lexapro (escitalopram hydrobromide)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
nefazodone HCl
Norpramin (desipramine HCl)
Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Seroquel (quetiapine)
Sinequan (doxepin)
Surmontil (trimipramine)
Symbyax (olanzapine/fluoxetine)
Tofranil (imipramine)
Tofranil-PM (imipramine pamoate)
Triavil (perphenazine/amitriptyline)
Vivactil (protriptyline)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)
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 ApJunkie
part-time Ninja
Registered: 08/17/06
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: veggie]
#6866489 - 05/03/07 09:14 AM (16 years, 11 months ago) |
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Doesn't it seem a little backwards that anti-depressants can contribute to suicide?
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Salvia_Antics
DMT Convert
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Posts: 378
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: ApJunkie]
#6866509 - 05/03/07 09:19 AM (16 years, 11 months ago) |
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Yeah i dont really get that.
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"The dream is dreaming itself"--Kalahari Bushmen
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badchad
Mad Scientist
Registered: 03/02/05
Posts: 13,378
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: Salvia_Antics]
#6866618 - 05/03/07 09:47 AM (16 years, 11 months ago) |
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The warning concerns the initial phase of treatment (e.g. the first three weeks or so).
The problem with associating antidepressants with suicide (as the article mentions) is the patient population you are treating. Depressed adolescents/young adults are more likely to attempt suicide than the "average population".
Even in light of the black box warning the risk is probably very low. It was only after completion of many clinical trials that the risk for sucide became statistically significant.
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...the whole experience is (and is as) a profound piece of knowledge. It is an indellible experience; it is forever known. I have known myself in a way I doubt I would have ever occurred except as it did.
Smith, P. Bull. Menninger Clinic (1959) 23:20-27; p. 27.
...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.
Osmond, H. Annals, NY Acad Science (1957) 66:418-434; p.436
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Polyrhythmanaut
BaphometicServitude
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: badchad]
#6866916 - 05/03/07 10:41 AM (16 years, 11 months ago) |
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Id expect those numbers to increase if the study included getting off of them. Im glad i quit.
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dedjam
Electro Penguin
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Posts: 2,139
Loc: Moralton, Statesota
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: ApJunkie]
#6866969 - 05/03/07 10:47 AM (16 years, 11 months ago) |
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Quote:
ApJunkie said:
Doesn't it seem a little backwards that anti-depressants can contribute to suicide?
you are fucking with the brains chemical balance. If doctors didnt give antidepressants to every person that walked into their office, it wouldnt be as bad as a problem.
I remember going into the doc because I had an panic attack because of alot of things going on at once. Doctor tried HARD to convince me I was severely depressed and needed to be on like 3 different anti-depressants (this is for a 1 time panic attack). I walked out and found myself a new doctor...
Ive actually had a couple friends attempt suicide on anti-depressants and for that I blame their doctors. Switching up brain altering chemicals every few weeks in some cases because the results werent what the doctor thought they should be. Of course, if you arent an emotionless drone, then they are going to say you are depressed.
I understand real clinical depression does exist, but the majority of the people out there on anti-depressants, are only on them because docs get nice kick-backs from the pharm companies for writing out scripts. I dont think ive been to a docs office where there havent been multiple drug company representatives present...
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Available
Stranger
Registered: 04/10/07
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: dedjam]
#6867698 - 05/03/07 02:03 PM (16 years, 11 months ago) |
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Good thing MJ doesn't act as a anti depressant.
because if it did......well shit, people wouldn't commit suicide or have those thoughts.
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deucydoo
Endless Tinkerer
Registered: 02/08/07
Posts: 41
Last seen: 10 years, 3 months
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: Available]
#6868058 - 05/03/07 03:43 PM (16 years, 11 months ago) |
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its intersting, after being told i was depressed and being treated with meds for some time it wasnt untill after i quit taking them that i finaly felt better. after the few that i tried didnt really do much for me, i did some thinking and decided that that shit wasnt going to make me better and it was up to me. thats when things turned around. I think alot of people on them are expecting a magic pill to turn there life around and make them happy the next day. most things dont work that way. effedra(sp) was one exception to that rule. once i figured tht out, if i was having a shitty day take a few stashed away hydroxy cuts and the energy levels and mood came right in to line.
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I have been there and back, although it was somthing i had to do i dont recomend it for others, at least not with my travel agent.
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aelephant
Stranger
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: deucydoo]
#6869253 - 05/03/07 08:10 PM (16 years, 11 months ago) |
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The suicide warning comes from the fact that a lot of people with major depression are so unmotivated they are incapable of following through with their own suicide. Many times the depressed will have a plan but be too unmotivated to carry it out. Once they get on antidepressants they've got new found energy and motivation, but the depression hasn't receded. They end up using this burst of energy to finish themselves off.
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As we live a life of ease,
Everyone of us has all we need
Sky of blue and Sea of Green
In our Yellow Submarine
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pabloescabar
Stranger thanyou
Registered: 05/02/07
Posts: 383
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: aelephant]
#6870812 - 05/04/07 01:56 AM (16 years, 11 months ago) |
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No offense but that sounds like something you pulled out yer ass
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Bridgeburner
Not spiritual at all.
Registered: 09/16/06
Posts: 20,010
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: pabloescabar]
#6871034 - 05/04/07 04:49 AM (16 years, 11 months ago) |
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my friend tried to OD on anti-depressants once. now she epileptic seizures from them after recovering. anti-depressants, imo, are like putting bandages over cancer. i agree it works for some people but it SHOULDN'T.
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dedjam
Electro Penguin
Registered: 12/14/05
Posts: 2,139
Loc: Moralton, Statesota
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: pabloescabar]
#6871129 - 05/04/07 06:16 AM (16 years, 11 months ago) |
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Quote:
pabloescabar said:
No offense but that sounds like something you pulled out yer ass
.
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hooksbooks
Fun Guy
Registered: 06/26/06
Posts: 417
Loc: Central, TX
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: dedjam]
#6871220 - 05/04/07 07:32 AM (16 years, 11 months ago) |
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some people can find one that works for them. At a point my bro was taking several different ones, case the fuckhead doctor he was seeing was pretty much just throwing anything at him. He ended up becoming delerious and checking himself into a psych ward. I have a history of manic depression in my family, and I believe I may have it to some degree. Fortunately, I have learned to cope with it, take the good with the bad and enjoy the ride. I've seen antidepressants work in really wierd ways, and I always vowed that I wouldnt be convinced that they were right for me as I believe my depressive symptoms are very mild and easily overcome with a long draw off a spliff. Spliff relief.
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schmutzen
King of the side-pins
Registered: 12/03/02
Posts: 15,770
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: aelephant]
#6876268 - 05/05/07 02:03 PM (16 years, 11 months ago) |
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Quote:
aelephant said:
The suicide warning comes from the fact that a lot of people with major depression are so unmotivated they are incapable of following through with their own suicide. Many times the depressed will have a plan but be too unmotivated to carry it out. Once they get on antidepressants they've got new found energy and motivation, but the depression hasn't receded. They end up using this burst of energy to finish themselves off.
That's the exact same thing my MD said.
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"Blow up your TV, throw away your paper. Go to the country, build you a home."
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elbisivni
Registered: 10/01/06
Posts: 2,839
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Re: FDA Broadens Antidepressants Suicide Warnings [Re: badchad]
#6882480 - 05/06/07 10:24 PM (16 years, 11 months ago) |
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Quote:
The problem with associating antidepressants with suicide (as the article mentions) is the patient population you are treating. Depressed adolescents/young adults are more likely to attempt suicide than the "average population".
This is what pisses me off. They're willing to make this connection here, when it comes to dealing with the big pharmaceutical companies that gain support from it (not saying the connection is false). But when they look at illicit drug users and mental health problems they immediately link the two. It's hypocrisy at its finest.
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From dust you are made and to dust you shall return.
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