FDA Approves Risperdal For Children
13 CommentsBy Ed Silverman // August 22nd, 2007 // 1:26 pm
In a move that is likely to stir controversy, the agency will allow Johnson & Johnson’s antipsychotic to be used to treat schizophrenia in teenagers between 13 and 17 years old, and to treat bipolar disorder for children between ages 10 and 17. The med was already approved last fall for treating irritability in autistic children as young as 5 years old.
Until now, Risperdal, or any other antipsychotic, wasn’t approved generally for kids, but recent reports indicated docs have, nonetheless, widely prescribed these meds for youngsters. The trend sparked a controversy because some experts contend there’s insufficient data to say these drugs are safe for children. And the off-label usage prompted investigations by into various authorities, Johnson & Johnson’s Janssen unit.
But in a statement, the FDA says that’s not the case. “The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population,†says Dianne Murphy, who directs the FDA’s Office of Pediatric Therapeutics. “These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients.â€
The FDA cited different studies. Two short-term (6 to 8 weeks), double-blind, controlled trials in schizophrenic teenagers, who had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness. And a three-week, randomized, double-blind, placebo-controlled trial in kids with bipolar disorder, who had had fewer symptoms, including a decrease in their elevated mood and hyperactivity.
Now, Janssen can start distributing Risperdal legos, candy dispensers and popcorn without having to worry about accusations of improper marketing. There may still be concerns, however, over tooth decay, drowsiness and depression.
Lisa Van Syckel
“FDA NEEDS A HUGE DOSE OF RISPERDAL”
“THEY HAVE JUST CLEARLY DISPLAYED INSANITY IN APPROVING THIS DRUG”
WHERE IS THE LONG TERM SAFETY DATA?….
WHAT A BUNCH OF IDIOTS!!!!………
David McGuire
http://www.otago.ac.nz/news/news/2007/18-07-07_press_release.html
A world-first nationwide study of children’s treatment with “atypical antipsychotic” drugs is providing new insights into why they are being prescribed and what adverse reactions can result.
More than 90 per cent of the prescriptions in the 420 children were for Risperidone, sold under the trade names Risperdal and Ridal in New Zealand. Risperidone was added to the list of government-subsidised medicines in 1998. Adverse events were identified in 30 per cent of the children and the researchers linked one-third of these to the antipsychotics.
Lisa Van Syckel
We will begin to see an increase in “driving fatalities of our nations children” Already the #1 cause of Teen deaths.
M.A.D.D (Mothers against Drunk Drivers) should seriously consider investigating the issue of Involuntary Intoxication associated with these type of Medications.
J&J Who promotes,and Physicians who haphazardly prescribe this med should be charged with Voluntary Manslaughter of any driving fatality that involves Risperdal.Because we know the warnings will not be strong enough in warning teens to the dangers of driving while on this medication.
“HELL”,Teenagers already ignore the dangers of “Drinking and Driving”
THIS IS FRIGHTENING,DRIVERS BEWARE……
David McGuire
Maybe a reporter can start doing some research and use the FDA’s Adverse Reporting System http://www.fda.gov/cder/aers/default.htm
Age Drug Name Reported By Reactions
3 Years Risperdal PH Abnormal Behaviour, Depressed Level of Consciousness
3 Years Risperdal MD Tardive Dyskinesia
3 Years Risperdal MD Confusional State
4 Years Risperdal CN Anger
5 Years Risperdal CN Aggression
6 Years Risperdal MD Tardive Dyskinesia
6 Years Risperdal MD Cardiac Arrest
6 Years Risperdal MD Insomnia
7 Years Risperdal MD Dystonia
7 Years Risperdal MD Hallucination
7 Years Risperdal Aggression, Agitation
8 Years Risperdal OT Abnormal Behaviour
8 Years Risperdal MD Aggression, Dyskinesia
8 Years Risperdal MD Dystonia
8 Years Risperdal Akathisia, Dyskinesia, Tardive Dyskinesia
8 Years Risperdal MD Abnormal Behaviour, Tardive Dyskinesia
8 Years Risperdal OT Akinesia, Depressed Level of Consciousness, Dyskinesia, Oppositional Defiant Disorder, Social Avoidant Behaviour
8 Years Risperdal MD Attention Deficit/Hyperactivity Disorder
8 Years Risperdal CN Aggression
9 Years Risperdal PH Dystonia
9 Years Risperdal OT Dystonia
9 Years Risperdal MD Tardive Dyskinesia
10 Years Risperdal MD Agitation, Anxiety, Fear, Hallucination (Auditory), Suspiciousness, Thinking Abnormal
10 Years Risperdal PH Tardive Dyskinesia
10 Years Risperdal CN Akathisia, Dementia, Tardive Dyskinesia
10 Years Risperdal MD Abnormal Behaviour
10 Years Risperdal CN Aggression, Crying, Suicide Attempt
10 Years Risperdal MD Aphasia, Mental Impairment
10 Years Risperdal OT Anxiety, Tardive Dyskinesia
10 Years Risperdal Suicide Attempt
10 Years Risperdal OT Depression, Hallucination (Auditory), Hallucination (Visual), Insomnia
10 Years Risperdal MD Dyskinesia, Tardive Dyskinesia
12 Years Risperdal MD Agitation, Hallucination (Auditory), Tardive Dyskinesia
12 Years Risperdal OT Tardive Dyskinesia
12 Years Risperdal OT Malaise
12 Years Risperdal MD Homicidal Ideation, Malaise
12 Years Risperdal CN Depression
12 Years Risperdal Completed Suicide
12 Years Risperdal OT Agitation, Cardiac Arrest, Death
13 Years Risperdal CN Aggression, Anxiety, Cognitive Disorder, Delusion, Fear, Hallucination, Mental Impairment, Paranoia, Psychotic Disorder, School Refusal, Social Avoidant Behaviour, Suicidal Ideation, Suicide Attempt
13 Years Risperdal CN Dyskinesia
13 Years Risperdal Aggression, Depression, Suicidal Ideation
13 Years Risperdal CN Abnormal Behaviour
13 Years Risperdal PH Confusional State
13 Years Risperdal OT Aggression, Disorientation
13 Years Risperdal MD Emotional Distress
14 Years Risperdal OT Agitation, Anxiety, Epilepsy, Sudden Death
14 Years Risperdal PH Completed Suicide
14 Years Risperdal CN Abnormal Behaviour, Aggression
15 Years Risperdal Self Injurious Behaviour, Suicidal Ideation
15 Years Risperdal MD Apathy
16 Years Risperdal OT Malaise
16 Years Risperdal MD Anxiety, Insomnia
16 Years Risperdal OT Epilepsy, Death
16 Years Risperdal Hallucination, Mania
16 Years Risperdal PH Abnormal Behaviour
16 Years Risperdal CN Hallucination, Mania
17 Years Risperdal CN Tardive Dyskinesia
17 Years Risperdal Suicide Attempt
17 Years Risperdal MD Schizophrenia
17 Years Risperdal MD Obsessive-Compulsive Disorder
18 Years Risperdal Abnormal Behaviour, Dyskinesia, Hallucination, Mental Disorder, Obsessive Thoughts, Social Avoidant Behaviour
18 Years Risperdal Agitation, Suicidal Ideation
18 Years Risperdal CN Suicidal Ideation
19 Years Risperdal PH Dystonia
19 Years Risperdal MD Psychotic Disorder
19 Years Risperdal Hallucination (Auditory), Suicide Attempt
19 Years Risperdal MD Agitation
19 Years Risperdal MD Agitation, Anxiety, Restlessness
19 Years Risperdal MD Agitation, Anxiety, Restlessness
19 Years Risperdal MD Completed Suicide
19 Years Risperdal CN Agitation, Anxiety, Insomnia
7 Years Risperidone Abnormal Behaviour, Anxiety, Depression, Insomnia, Paranoia
18 Years Risperidone Hallucination (Visual), Self Mutilation, Suicide Attempt
Lisa Van Syckel
ATTENTION MEDICAL STUDENTS
J&J JUST RECVD APPROVAL FOR RISPERDAL IN CHILDREN.
PHYSICIANS WHO SPECIALIZE IN DIABETES IN THE PEDIATRIC POPULATION WILL BE IN HUGE DEMAND.
Lisa Van Syckel
Jack,
Is that just a partial list?
What was FDA thinking!
You should check out the AP story and Dr. Laughren’s statement..
He is clearly “DILUSIONAL”
Lisa Van Syckel
Ed,
FDA’s approval of Risperdal,can be seen as perfect timing…
Congress is on vacation!!
Laurie
Jee, they tested it for a whole “6 to 8 weeks”! But it will be prescribed for YEARS for children. We have seen the devastating effects that this drug has on adults with long term use, so we approve it for children??This is a disgrace!
Lisa Van Syckel
Hey Ed,
As we see the increase sales of Risperdal in children along with all of its lovely side effects…Has anyone asked the Manufacturer of LEGOS about the decline in LEGO sales that they will see for their popular toys.Children will be so sedated, their involuntary movements so severe,that it will prohibit them of the pleasure of playing with these wonderful toys.
If I were CEO of LEGO I would seek to prohibit J&J from using the famous LEGO BLOCKS for use in promoting a dangerous drug for children….
Concerened
This approval will be a HUGE problem! This class is very tough to take with lots and lots of nasty adverse reactions. The drug was only studied for a very limited time and the patients will be on it for much longer. I sure hope that a long-term post-marketing safety study is mandated!
Melanie
If you had a child with severe symptoms of bipolar disorder you would understand that there are times when the side effects of the medication are worth the risk. The benefits to the child and the family as a whole are defintely worth the risk of taking the medication. The decision of a parent to put one of their children on a drug of this classification is not an easy choice to make. When the home is being destroyed and other siblings are put in danger, then you do what you have to do.
Bathroom Remodeling Fort Wayne Indiana
Bathroom Remodeling Fort Wayne Indiana…
The normal everyday user would believe investing the time to score intellect on this topic is a waste of time….
Suzanne
I agree with Melanie. If you have ever had a suicidal 8, 9, or 10- year old with presenting symptoms of PTSD and bipolar — and yes, it is indeed very, very real — and witnessed that child lying on the floor BEGGING for the adults in his life to help him after seven years of consistent therapy(sensory therapy, occupational therapy, physical therapy, play therapy, cognitive behavioral therapy) and holistic, alternative approaches to treatment, you might see the other side of the picture. The decision to investigate psychotropic medication for a child is incredibly difficult to make, and for many, a last-resort in an effort to provide a child with an opportunity to be successful in a world that feels completely out of control.