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FDA Approves Prozac for Children
FDA ^ | 4 jan 2003 | FDA

Posted on 01/04/2003 11:27:19 AM PST by steplock

Be Afraid! Be VERY Afraid!

FDA Approves Prozac for Children, Teens
Fri Jan 3, 6:03 PM

The US Food and Drug Administration (news - web sites) said on Friday that it has approved Eli Lilly & Co.'s Prozac (fluoxetine) to treat depression and obsessive compulsive disorder (OCD) in children and adolescents aged seven to 17 years.

According to the FDA, Prozac is the first selective serotonin reuptake inhibitor (SSRI) to receive approval for treating depression in children. The approval was based on two studies of children and adolescents with depression, which showed that the drug produced a statistically significant effect compared with placebo. The drug also produced a statistically significant effect compared with placebo in studies of children and adolescents with OCD.

Side effects associated with Prozac use among children and adolescents were similar to those observed in adults and included nausea, tiredness, nervousness, dizziness and difficulty concentrating.

The FDA noted that in one of the clinical studies, after 19 weeks of treatment with Prozac, children gained, on average, about 1.1 cm less in height (about a half an inch) and about one kilogram less in weight (about two pounds) compared with children treated with a placebo. According to the agency, "the clinical significance of this observation on long-term growth is unknown."

Lilly will conduct a phase IV post-marketing study to further evaluate the potential impact of Prozac on long-term growth in children.

Citing figures from the National Institute of Mental Health, the FDA said depression affects up to 2.5% of children and 8.3% of adolescents in the US. OCD affects roughly 2% of the population and typically begins during adolescence or childhood.

Indianapolis-based Lilly lost patent protection on Prozac in August 2001. The drug was once a blockbuster, pulling in sales of $2.5 billion in 2000. Since losing patent protection, several generic formulations of Prozac have flooded the US market, cutting sharply into Lilly's revenues.


TOPICS: Crime/Corruption; Culture/Society; Government
KEYWORDS: children; crime; drug; medical; prisoner; prozac; stupid; torture
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1 posted on 01/04/2003 11:27:20 AM PST by steplock
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To: steplock
Very few children manifest the somatic signs of depression that characterizes the condition among adults, namely sleep disorder, appetite problems, morbid thinking, sexual disinterest, etc.

Many children though look depressed or sad. Typically this is because they're doing poorly in school, involved in substances, got caught doing something they shouldn't have done or have some sort of family dysfunction. They've got good reason to be sad.

If Prozac can benefit that very small minority of kids who have a true clinical depression, then I hope it helps.

2 posted on 01/04/2003 11:41:26 AM PST by billorites
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To: steplock
I guess they aren't shooting enough of each other on Ritalin, or is that patent about to expire and a more profitable product needed?
3 posted on 01/04/2003 11:44:16 AM PST by steve50
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To: steplock
Children on Prozac should be much easier to brainwash.
4 posted on 01/04/2003 11:46:01 AM PST by philetus
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To: steve50
is that patent about to expire

The Prozac patent has expired. It is available as a generic.

It has also been used 'off label' for children for a long time.

5 posted on 01/04/2003 12:01:49 PM PST by RJCogburn
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To: steplock
this is wonderful news - I can't wait to put my nephew on it!
6 posted on 01/04/2003 12:02:45 PM PST by krodriguesdc
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To: billorites
If Prozac can benefit that very small minority of kids who have a true clinical depression, then I hope it helps.

that's the problem - any kid that looks depressed will be taking that stuff...

I am sure glad I grew up before Eli Lilly & Co came to town...

7 posted on 01/04/2003 12:06:36 PM PST by krodriguesdc
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To: steplock
Pay close attention: you're watching the dumbing down of America first hand. The negative effects of these drugs far outweigh any supposed positives.
8 posted on 01/04/2003 12:08:00 PM PST by ApesForEvolution
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To: krodriguesdc
"that's the problem - any kid that looks depressed will be taking that stuff..."

Yes, you're right. However that doesn't mean that the drug is not appropriate or effective for some kids, but that it's being prescribed inappropriately.

Similar situation with Ritalin. It's over-prescribed wildly, but for a small fraction of kids it's a lifesaver. Fortunately, in adults I don't know about children, the side effect profile of Prozac is such that if given to someone who doesn't have those somatic symtoms of depression, it just doesn't do anything.

9 posted on 01/04/2003 12:43:59 PM PST by billorites
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To: billorites
come on kids don't need prozac they need family and love - President Bush #1 said it begins with the family and I agree...

it doesn't take a village or prozac just some good old fashioned love and care and patience with children...

what a cold world it is with prozac!

10 posted on 01/04/2003 12:51:15 PM PST by krodriguesdc
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To: krodriguesdc
come on kids don't need prozac they need family and love - President Bush #1 said it begins with the family and I agree... it doesn't take a village or prozac just some good old fashioned love and care and patience with children... what a cold world it is with prozac!

Come on, folks, have some compassion. Sometimes children have to deal with more tragedy and loss than they can endure. Death, divorce, more death, more death, various types of losses--these things can send someone spiralling down into a clinical depression no matter how much love surrounds them. And if you had experienced first-hand the agony that is true clinical depression you wouldn't want to see any child suffer this way. And you wouldn't want to risk having the child commit suicide from the pain, either.

11 posted on 01/04/2003 1:45:47 PM PST by Capriole
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To: Capriole
Clinical depression is brought about by a chemical imbalance in the brain due to malabsorbtion of serotonin. It is this imbalance that Selective Serotonin Re-uptake Inhibitors (SSRI) are meant to correct. These pharmaceuticals are sold under the names of Prozac, Zoloft, Paxil, Celexa and a few others.

Depression can be a real illness just as diabetes is. People cannot just "snap out of it." It is not a character deficit.

Depression sufferers include Abraham Lincoln and Winston Churchill, neither of whom lacked character or courage.
12 posted on 01/04/2003 2:08:01 PM PST by Anarchist
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To: Capriole
And if you had experienced first-hand the agony that is true clinical depression you wouldn't want to see any child suffer this way. And you wouldn't want to risk having the child commit suicide from the pain, either.


I have 2 children who suffer from depression and within days of taking Prozac I had smiling children. My 13 year old suffers from it because it runs in the family and my 8 year old is a cancer survivor. I am greatful this medication is on the market!!


13 posted on 01/04/2003 2:23:32 PM PST by Mfkmmof4
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To: Anarchist
Clinical depression is brought about by a chemical imbalance in the brain due to malabsorbtion of serotonin. It is this imbalance that Selective Serotonin Re-uptake Inhibitors (SSRI) are meant to correct.

One thing to keep in mind is that placebos were shown to have the same effect (correcting the imbalance). Another is that the root cause of imbalances is hormones, sometimes due to mental conditions, but often a easily treatable gland problem.

SSRI drugs are the crudest possible tool for helping people improve their mental health. I agree with their use in extreme cases where the patient would be completely disfunctional without it, and the hormones have been thoroughly examined. But the path to mental health in general is to attain a condition where your own body corrects the imbalances itself. Often this is done using the drugs in the short term while using counseling to overcome stress and anxiety over the long run.

14 posted on 01/04/2003 2:45:56 PM PST by palmer
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To: steplock
Clockwork Orange time just around the corner...
15 posted on 01/04/2003 3:09:01 PM PST by Domestic Church
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To: steplock
Anybody remember the movie "THX 1138"?
I'm starting to see some startling parallels between that movie and what is goin on in today' world. "Better living through chemicals!"
16 posted on 01/04/2003 3:24:23 PM PST by cavtrooper21
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To: Anarchist
Clinical depression is brought about by a chemical imbalance in the brain due to malabsorbtion of serotonin. It is this imbalance that Selective Serotonin Re-uptake Inhibitors (SSRI) are meant to correct. These pharmaceuticals are sold under the names of Prozac, Zoloft, Paxil, Celexa and a few others. Depression can be a real illness just as diabetes is. People cannot just "snap out of it." It is not a character deficit.

Thanks for mentioning this. Yes, I did my graduate work in neuropharmacology at a major medical school, so I know how it works. Depression is very different than sadness. But it is also true that one agonizing blow after another can potentiate depression.

17 posted on 01/04/2003 4:50:41 PM PST by Capriole
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To: Capriole
"But it is also true that one agonizing blow after another can potentiate depression."

So, could the present pending war/terrorism situation in this country also be a factor for the FDA approval? Should we read something between the lines here?
18 posted on 01/04/2003 5:17:02 PM PST by Domestic Church
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To: Capriole
Re:  serotonin imbalances, depression and your statement:

Yes, I did my graduate work in neuropharmacology at a major medical school, so I know how it works.

There is not one shred of valid science behind the notion that depression is due to a chemical imbalance.  NIMH is still honest enough to admit this.  Too bad your med school isn't.  You should ask for your money back.

19 posted on 01/04/2003 5:24:32 PM PST by Al B.
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To: cavtrooper21
I do remember seeing something on the financial channel a couple weeks ago about the manufacturer of Prozac sales being down ???
20 posted on 01/04/2003 6:18:07 PM PST by steplock
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