Posted on 10/15/2004 6:02:04 PM PDT by neverdem
After concluding that the use of antidepressants could increase thoughts of suicide among children and adolescents, the Food and Drug Administration said today that it was ordering manufacturers of all such drugs to post "black box" warnings on their products.
A black box message is the most serious warning placed in the labeling of prescription medication, the F.D.A. said today. While the new labeling will not prohibit the use of antidepressants in children and adolescents, it warns of the risk of suicide and encourages doctors to balance that risk with the clinical needs of the patient.
The warnings did not come as a surprise. Last month, during an all-day Congressional hearing on the drugs and their problems with children, a top F.D.A. official predicted that the agency would probably move to order the warnings.
During the tempestous hearing, members of the House Energy and Commerce Committee accused the agency of attemping to suppress documents and failing to safeguard the health of children. Some members said the F.D.A. failed for years to recognize obvious signals that the drugs were unsafe. F.D.A. officials strongly disagreed with that assessment, saying in the hearings that they were already examining ways to warn the public.
"Today's actions represent F.D.A.'s conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them," Dr. Lester M. Crawford, the acting F.D.A. Commissioner, said in a statement issued today.
"Our conclusions are based on the latest and best science," he said. "They reflect what we heard from our advisory committee last month, as well as what many members of the public have told us."
In letters sent to drug manufacturers today, the F.D.A. directed them to add the black box warning that describes the increased risk of suicidal tendencies in children and adolescents given antidepressant medications and notes what uses the drugs have been approved or not approved for in these patients.
Currently, Prozac is the only medication approved by the F.D.A. for the treatment of depression in children and adolescents. A large government-financed trial recently found that Prozac worked better than talk therapy in helping teenagers overcome depression. And when British health officials announced a sweeping ban of antidepressant use in children, which touched off the debate last year, they specifically exempted Prozac.
But today's labeling requirements will apply to all antidepressants, the F.D.A. said, "because the currently available data are not adequate to exclude any single medication from the increased risk of suicidality."
FReepmail me if you want on or off my health and science ping list.
I wonder If Neil Bush had a hand in making this happen. I know he's been pretty outspoken about the dangers of anti depressants in children for a few years now.
Both the Columbine killers were taking prescription antidepressants. That little fact escaped the media, they preferred to blame the NRA.
You may need to keep a watch on kids who need them, but IF they need them, and the dosing is right, it can make a world of difference. And if they are wrong, it can be horrid.
My son is on Straterra and Welbutrin after one serious and one potential suicide episode...he is so very much better now it is amazing.. He is open, non-suicidal, talking to us, happy again and doing well in school.. .but other people have had disasters with these drugs.
What it shows is:
They are not panaceas.
There needs to be more research into psychoactive medicine.
You probably do better have a psychiatrist monitor this rather than your family doctor (he knows about things like serotonin syndrome, while your family doctor might not at all).
All these meds are being worked over and relabled, for good reason. They are powerful, and although they can really make a difference, they aren't problem resolvers by themselves. And if you think they are, you may be in for a real suprise. But if you run away from them when you need help, you might be giving yourself more pain than necessary.
Around here and I assume elsewhere schools suggest these drugs. My sisters son was kicked out of the 3rd grade till she got him on ritalin or something similar.
It seems that schools want nice compliant little zombies. When I was in school the teachers knew how to handle kids that acted up.
People who take away the parent's right to do what is right for their kids ought to be locked up. Meds like these don't work in a one size fits all category. And you are right, some people would like you to invent a happy pill that keeps the kids sitting in their desks, responsive enough to learn, but not active enough to cause trouble or spend their time socializing. Just ain't going to happen.
Agreed. Parents who give their kids these "happy pills" are within a hop skip and a jump of child abuse.
My nephew became pretty problematic, downright dangerous actually. He was listless most of the time but would fly into uncontrollable rages without warning. Sis wouldn't leave him alone with his sisters because she was afraid of what he would do to them.
My sister eventually got him off the drugs and worked his energy out of him. These days he's still a ball of energy but the energy is directed into constructive projects.
Ping
Well, I suspect that the suicide rate could be more closely correlated with the frame of mind, regardless of the presence of the drug. In fact, the frame of mind is why they are taking the drug in the first place.
There's a serotonin syndrome and a SSRI discontinuation syndrome, aka serotonin withdrawal syndrome as well.
They need the most scrutiny when they first start to take them for about a month.
Study of Antidepressants Finds Little Disparity in Suicide Risk
"Patients were three to four times more likely to report thoughts of suicide or attempts at it in the first month of treatment than they were after three months on the drugs, the analysis found. The findings were similar for each medication, whether prescribed for adults or children."
It does not appear to be the case when they are going through the period the other way.
It seems initial dosage, until such time that there is equilibration between daily dose and steady state, is the most worrisome. Since the danger does pass, the question that needs study is:
Is the introduction of the drug initially a flooding of the target cells prior to their ability to metabolize the drug, resulting in a short period of overload,so it appears that the patient, who feels better than originally, but goes through a period of less ability to control his/her actions?
Or, does the initial introduction of the drug cause metabloites to initialy concentrate, that are indeed "toxic", but then are better removed as the body gears up to the new task?
metabloites = metabolites
So, doctor, what do you suggest for a suicidal adolescent?
It does not appear to be the case when they are going through the period the other way.
Check the links in comment# 13. I believe this initial period of increased suicidal ideation is akin to a psychiatric serotonin syndrome, as opposed to a medical serotonin syndrome with clinical signs and symptoms. Removal of these SSRI's can cause the serotonin withdrawal syndrome, which has caused a switch to Prozac, aka fluoxetine, because of its much longer half-life, if somebody decides that they don't want to take this class of antidepressants anymore.
It seems initial dosage, until such time that there is equilibration between daily dose and steady state, is the most worrisome. Since the danger does pass, the question that needs study is:
Is the introduction of the drug initially a flooding of the target cells prior to their ability to metabolize the drug, resulting in a short period of overload,so it appears that the patient, who feels better than originally, but goes through a period of less ability to control his/her actions?
Or, does the initial introduction of the drug cause metabloites to initialy concentrate, that are indeed "toxic", but then are better removed as the body gears up to the new task?
I believe you just stated the same thing, in effect, two different ways. Until the body adjusts its metaboism, the initial concentrations are too high.
"In fact, the frame of mind is why they are taking the drug in the first place."
What about the people who take Zyban to stop smoking? Zyban is Welbutrin, and I can't believe that stuff is good for anyone.
That would mean determining if their parents or ( school) has something to do with their depression- many of the adults who give their kids these drugs hate that fact more then the issues of the side effects of these drugs.
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