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FDA Issues Warning on Some Antidepressants
Government Urges Close Monitoring for Signs of Suicide

By Lauran Neergaard
Associated Press
Monday, March 22, 2004; 11:25 AM

Patients on some popular antidepressants should be closely monitored for warning
signs of suicide, the government warned Monday in asking the makers of 10 drugs to
add the caution to their labels.

Although the Food and Drug Administration's investigation into the possible suicide
connection initially focused on children given the drugs, its warning is aimed at
both adult and pediatric use of the pills to alleviate depression.

It isn't clear yet that the drugs actually do lead to suicide, the FDA stressed.
After all, depression itself can lead to suicide.

But until that is settled, advisers to the FDA called last month for stronger
warnings to doctors and parents that the antidepressants may cause agitation,
anxiety and hostility in a subset of patients who may be unusually prone to rare
side effects.

On Monday, the FDA followed its advisers' recommendation and issued a public health
advisory putting doctors, patients, families and other caregivers on notice to be
particularly vigilant for signs of worsening depression or suicidal thoughts at the
beginning of anti-depressant therapy or whenever the dose is changed.

The drugs of concern are all newer-generation antidepressants: Prozac, Paxil,
Zoloft, Effexor, Celexa, Remeron, Lexapro, Luvox, Serzone and Wellbutrin. Most are
known to affect the brain chemical serotonin.

British health authorities sounded the alarm last year, saying long-suppressed
research suggests certain antidepressants might sometimes increase the risk of
suicidal behavior in children and teenagers. Because only one drug, Prozac, has been
proven to alleviate pediatric depression, Britain declared others -- drugs called
SSRIs and their close relatives -- unsuitable for depressed youth.

The FDA issued a caution on pediatric use last year, but Monday's action --
especially the addition of the warning to drug labels -- goes significantly further.

Dozens of anguished parents pleaded with FDA in a meeting last month to add such
warnings, citing preteens and teenagers who hanged themselves or slashed their
wrists shortly after starting the antidepressants. Parent after parent described
children who had become extremely agitated or anxious shortly after starting
the antidepressants, and seemingly sudden impulses that turned deadly.

Among 25 studies of the suspect medications involving 4,000 children and teens,
there were no completed suicides. But 109 patients experienced one or more possibly
suicide-related behaviors or attempts, the FDA says.

The studies varied dramatically in what was considered suicidal behavior, making a
clear link difficult, FDA scientists have contended. For example, among 19 patients
classified as cutting themselves, almost all were superficial, with little bleeding.

Worse, the youths most likely to commit suicide weren't allowed into those studies,
so existing data likely won't settle the issue, the FDA's scientific advisers have

Depression occurs in up to 10 percent of youth, and 1,883 10- to 19-year-olds killed
themselves in 2001. Some 1.8 million teenagers attempted suicide that year, a
quarter of them requiring medical attention, according to Columbia University
scientists who are helping the FDA's probe.

In 2002, almost 11 million prescriptions were dispensed to patients under 18 for
SSRIs and other newer antidepressants, to treat depression and a host of other
conditions, FDA said.

2004 The Associated Press


( 10 comments — Leave a comment )
Mar. 22nd, 2004 03:52 pm (UTC)
Damned it ya do damned if ya don't?
If I didn't take my Lexapro I'd probably off myself.
Mar. 24th, 2004 02:57 am (UTC)
Re: Damned it ya do damned if ya don't?
Love ya and because of that I have to ask - How Do You Know?
Mar. 22nd, 2004 07:19 pm (UTC)
I use prozac, myself - without it I'd be unable to work, feed myself, or even get out of bed to use the toilet. I have noticed that if my dosage gets too high, I get very irritable and hostile. If my stress is low, my dosage needs to drop a little - like by ~5- 10 mg/day. If I'm PMS, I need to be on full dose.

Fortunately, I have a good enough awareness of my mental state that I can correct before I wig out. My doctor was really good in telling me how to gauge things, too. If the person taking it doesn't know their own mental state, or abrogates responsibility for it, they are potentially in trouble.
Mar. 23rd, 2004 04:21 am (UTC)
labels, schmabels
i read that article (and immediately thought - well, DUH!) & was going to post it - you saved me the trouble! society gets more fucked up by the day, it seems.
Mar. 24th, 2004 02:55 am (UTC)
Related- and '2 cents worth'
No I am not arguing for or against but - the following seems related.

In Nottingham England we have just three Neuro-Surgeons. Queen's Hospital Nottingham is a centre of excellence, and leading hospital for Neuro Science. Out of the three neuro surgeons the best and most qualifeid has been suspended, pending investigation,for helping himself to an extra bowl of soup and not paying for it. He is on full pay but cannot work until the case is fully investigated. As a result three patients (by yesterday) have had their operations cancelled (which he alone is qualified to deal with) and more have had their appoinments cancelled.

I guess there is a link to your posting.

Medication is prescribed for 'mental illnesses' because, it is argued, it is caused by 'changes in or dysfunction in brain chemistry. But past or present situations can cause brain chemistry to change and reversal or the passing of such symptoms can be much more effectively achieved by therapy or by improving individual and social conditions and our general attitude towards people who experience such suffering. I have personal experience of this as a patient and as a health care worker.

Now, IF mental Illness is really caused by changes in brain chemistry that are chronic ( have always been there and cannot be explaied then, strictly speaking they are (or rather should be) classified as Neurological Ilnesses.

As for mental illness I do not beleive in it - I do, however, believe IT should be correctly dsignated as 'emotional dysfunction'or 'reactive illness'.

There are only two real Mental/Neurological illnesses:- Schizophrenia and Manic Depressive Psychosis and these are chronic and hard to manage by their nature. If they are neurological don't live in Nottingham. (Furthermore they are open to different interpretations within different societies and cultures.)

What keeps people hooked on meds is FEAR and lack of support or proper understanding.
(and incidentally the 'side effects of these drugs are not side effects at all they are the body reacting as a warning that it is being 'poisoned'.)

Fundamentally I am opposed to medication being used for longer than 6 months absolute maximum. A chronic, motor function-retarded, patholgically depressed patient may need a period on medication for these symptoms to lift enough and allow him/her to begin therapy. But,it is understandable but irrational to believe that they cannot be stopped without relapse.

I have given up smoking again, I am thus irritable, bad tempered and have headaches. If this was a prescription drug for depression or anxiety I would say I can't live without it because I am more prone to explosive over-reacting, lack of concentration and headaches anxiety and lethargy. But if I said that I have to smoke because of these symptoms NOBODY would agree. Quite right too. In the absence of Nerological disease these symptoms are self limiting.I will get over them.

There are NO new illnesses so we never needed new drugs. We needed, and still desperately need, social change and education and patience and toleration of others and from others. Achieving this is far harder than giving pills out.It would also be more effective in the long run.

Mental or emotional illness in individuals is the reaction of a healthy mind to a deeply sick, profoundly narcissistic society.

That's IT.Love as ever

Mar. 24th, 2004 07:24 am (UTC)
Re: Related- and '2 cents worth'
Thank you for your sensitivity on this subject, and for the thoughtful post. I love the analogy with (to?) smoking! I am sure I'll use it myself! (I never have smoked but I know many people who have or do)

It is sad, to me, that those who unashamedly stand outside the mainstream, like R.D. Laing, are mocked, ridiculed, considered crazy themselves. I am reminded of John Adams, our second president, who chose to follow his own path and not partake in early party politics, and who was ostracized, misunderstood, and underappreciated. To this day Jefferson is the name schoolchildren revere, while Adams was so much more valuable in the creation of this country, was so much more principled, did so much more. (This comment seems unrelated but Adams is the person who came to mind when I read your comment on mental illness.)
Mar. 24th, 2004 09:17 am (UTC)
Re: Related- and '2 cents worth'
Thank you. I wanted to say something but be sure of being balanced.

I share uour feelings about meds and I've experienced for myself and in others the fear factor of giving them up - and doctors, ordinary and psychiatric feed this fear because one thing that Meds do for certain is damage your confidence. However if one uses reason to say to oneself

"The meds must facilitate something I but was unaware or afraid to use - now I know that I'll carry on acting as I've come to act on meds - but without them."

It worked for me. However I also know that meds can be used to 'Kick Start someone out of depression and into therapy. So I favout their use for a short term. And there is no doubt that the socalled side effects are the body resisting a poison. Doctors will say otherwise but they never take the stuff themselves. Psyche meds are less and less prescribed here but alas there isn't enough therapy or therapists around.

But enough. Thanks for your response. I've heard of Adams and must look him up. Jefferson seemed like a bit of a butterfly to me.

As Ever

Mar. 24th, 2004 09:49 am (UTC)
Damn I should EDIT first...
ABOVE Should read

...and doctors, ordinary and psychiatric, feed this fear because it makes people compliant:- one thing that Meds do for certain is damage one's self confidence so one doesn't complain - another is that some can make you distrust your own reason. I was asked to leave psych work but I was ready to go...The Policing!
Mar. 25th, 2004 09:10 am (UTC)
Re: Damn I should EDIT first...
greetings x's and hope you've had a nap and feel renewed.
hrmph this week IS going fat.
Mar. 25th, 2004 09:53 am (UTC)
Re: Damn I should EDIT first...
I do feel better. I agree, though, that this week is going fat. AT least for me. I ate almost a pint of ice cream last night, heath bar coffee...
( 10 comments — Leave a comment )


Judith Lautner
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