FDA Approves Prozac for Children

FDA ^ | 4 jan 2003 | FDA

[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.

[First Amendment]

I have read articles about children as young as 2 and 3 years old being given psycho-active drugs. I have a friend who was given Ritalin for years and is still dealing with its effects.

I am no stranger to clinical depression. No life story right now, just take my word for it. Started in early teens (12). Cured through meditation and prayer. The most drugs like Prozac can do is ease one through a tough time. But many people take them forever, becuase of the false idea that consciousness is chemically based.

The path out of depression necessitates soul-searching and that is often uncomfortable. It's easier to take mental novacain. Also, there are many other therapies available that could be used with people of any age that can take the "edge" off of depression or anxiety, or reduce it tremendously. I am not talking about psychotherapy but stuff like massage. You can flame me if you like --- I used to be a masssage therapist and studied a lot of other therapies...

This is very very sad - to drug little children. It sounds like money and mind control.

[Mfkmmof4]

Well I stopped feeling guilty about giving meds to my children long ago. If they had diabetes I would give them insulin. In my children's case I would have a dead 13 year old through suicide...she already survived one attempt so Prozac has helped and I will keep her on it and I am guilt free. Additionally, I have the help of our church who supports us through this period of her life.!!!!!

[af_vet_rr]

Pay close attention: you're watching the dumbing down of America first hand. The negative effects of these drugs far outweigh any supposed positives.

While I'm sure there are a few kids here and there who have serious problems, I think most kids would be better off if they spent an extra half hour or more out on the playground (and I'm talking a real playground and not this little rinky-dink pieces of grass that the school systems call playgrounds these days (because buying a little extra land for the kids to play on would cost too much and drugs are cheaper)).

My daughter is going into education (she's doing her student-teaching now), and she tells me all the time that the kids in her district don't get enough time on the playground/physical activity and they get antsy in the classroom and parents would rather drug them or throw them on the couch in front of the TV when they get home than actually do something about it, such as complaining to the school boards or making sure the kids get enough exercise themselves.

This country will be dumbed down because parents don't want to be parents.

[galt-jw]

If I had told people twenty years ago that, in the future, there would be a drug that was mandated in state run institutions for the express purpose of controlling behavior, and asked them to guess where this would be occurring, most would have replied the soviet union or east germany.

Had I said it would, in fact, be the US, I would have been met with laughter and ridicule.

Here we are, , with ritalin, and now, prozac as well..

The longest clinical studies, I believe, on prozac were six months. We have NO idea what happens in the long term.

[galt-jw]

consider what food alone can do. The sugar content of one soda equals around twelve or so teaspoons per soda. In a small body, that drinks a full, adult serving, it is no wonder, combined with sugary cereals, etc, that anyone would be hyperactive.

Let alone preservatives, dyes and chemicals. See: exitotoxins.

[realpatriot71]

Marijuana ha no medicinal uses, and children can now be given Prozac . . . riiiiiight . . . whatever you say FDA

[pollywog]

AMEN AND AMEN to your post krodriguesdc!! I am SICK TO DEATH of these meds. Parents are running themselves to death fixing homes up, going to parties, run, run, run , run!! When are we going to STOP THIS and start being families again! OH for the LITTLE HOUSE IN THE PRAIRE DAYS AGAIN!!

[realpatriot71]

I'm with you ritalin and prozac have their time and place for adults, but in the developing brians of children?! You have to be kidding me. Most of the school shooters the last few years were on some sort of SSRI.

[Idlewise]

You are doing the right thing for your children regarding their safety and well being.
I agree that some medications are passed out like snacks to children. Unfortunately they are often recommended by a teacher who cannot tell hyperactivity from plain boredom or a natural need to burn off energy. The play ground activity mentioned earlier is a good thing.
There is a big difference from "dumbing down medications" given for inappropriate reasons and life saving medications. For parents who never had to make this choice consider yourself very fortunate. For those who have had to make this choice you are also fortunate if the medication helps and there is hope for recovery and home serenity.
If I didn't know the parental pain and the hope a carefully prescribed and monitored medication could provide I would not dare step into this arena with a parent. Since Mfkmmof4 is a mother, I'd back off with harsh opinions of her and be very respectful of a mother protecting her children.
You have my understanding and high regard for dealing with a very difficult situation, the church support is invaluable. Take care.

[cavtrooper21]

Yes, you did. Amazin' how that sorta ties right on in there, isn't it? My wife and I have found DECREASING the amount of processed sugar in our son's diet had a profound effect on his behavior, along with decreasing the amount of TV and increasing the amount of brain and muscle activity. Work hard, play hard and eat right. Calmed him right down!

[Capriole]

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.

Apparently your institutional subscriptions to Brain Behavior and Physiology, Brain Research, Neuroscience-Net, and The Journal of Newuroscience, among other refereed scholarly journals, have expired. It is unclear what you mean when you say that "There is not one shred of valid science behind the notion that depression is due to a chemical imbalance"; the mechanisms and pathways have been quite thoroughly elucidated. A visit to the National Library of Medicine would clarify this for you.

[First Amendment]

Well I stopped feeling guilty about giving meds to my children long ago

I have no wish to judge you as an individual - what decisions you may have had to make are not mine, and I am not God in your heart to know.

But generally speaking, there are so many things that can contribute to a child or an adolescent's depression that should be attended to before giving them psycho-active drugs that have tremendous potential for harm.

Some of the influences that can cause children (or adults for that matter) to feel depression are - lack of physical exercise and fresh air, lack of affection, allergies or reactions to chemicals in food or their home or work environment, mass media -excess TV or movie watching, game playing, kids listening to crap "music" for hours...and most important, lack of religious or spiritual depth in their life. Add any or all of these to an individual who may have more of a proneness to depression or emotional lows, and there you have a prescription for Prozac.

I can personally testify as having "been there" - I tried suicide seriously when I was 13. Self-medicated for several years. But turned my life around - and so I know that drugs are not the answer.

[ApesForEvolution]

You are so right. Attention, excercise and nutrition would go a long, long way to helping children...without psychotropic drugs!

[Domestic Church]

"Let alone preservatives, dyes and chemicals. See: exitotoxins."

This is the right track...and there are metabolic problems cropping up and there are chemical allergies that aren't being diagnosed... and there are subclinical auto immune problems growing in the population as well and these could easily show up in behavioral problems in the younger kids.

I'd rather try B6 with magnesium than prozac and the odds are better that I'd actually be treating part of the problem.

[steplock]

Prozac does have its uses,yes. One of my sisters has to take it and since she went on Prozac years ago, she has been almost a new person. It did not change her personality, (like ritalin, etc for kids) prozac simply controlled down her hysterical reactions to minor (to the rest of us) problems and occurences.

I would say that 90%+ of drug prescriptions for children are simply to mentally control them.

I bet they wished they could do that to the rest of us too!

[steplock]

FDA Approves Prozac for Children?
Ritalin? Kiddie cocaine?

Here's the results (different string):

Five Decades of 'Dumbing Down'

[Rudder]

The negative effects of these drugs far outweigh any supposed positives.

Pure, unadulterated BS!

[Rudder]

Clinical depression is brought about by a chemical imbalance in the brain due to malabsorbtion of serotonin

Maybe, maybe not. Your succinct statement leaves out the cause of serotonis "malabsorbtion." "Chemical imbalance" is NOT the root cause in the great majority of depression cases. The term, "chemical imbalance" is an oversimplfication used by quacks to sooth patients' probing curiosity about what the hell is happening to them.

[Rudder]

"...depression is due to a chemical imbalance..."

Do you know what causes the "chemical imbalance?"

The chemcial imbalance school subscribes to the same logic that an airplane wreck was "caused" by the plane's contact with the ground.

[Domestic Church]

the cause of serotonis "malabsorbtion."

From what I've read, certain immunological and autoimmune illnesses, pediatric asthma and lupus(these often are undiagnosed too) have a metabolic disorder that is sensitive to depleted magnesium and/or B6 levels which in turn has something to do with the failure of normal serotonin uptake. It would make sense to have some sort of screening prior to administering these drugs but then that wouldn't churn the pharmaceutical industry.