FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents

Evidence to support this approval was collected through studies the FDA requested as part of its pediatric drug development initiatives.

The efficacy of Risperdal in the treatment of schizophrenia in adolescents was demonstrated in two short-term (6 to 8 weeks), double-blind, controlled trials. All patients were experiencing an acute episode of schizophrenia at the time of enrollment. Treated patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.

The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.

Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported.

Schizophrenia is a serious and disabling psychiatric disorder. Symptoms may include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person's mood, energy, and ability to function.

Risperdal is manufactured by Janssen, L.P. of Titusville, N.J.

For more information:

FDA Office of Pediatric Therapeutics
www.fda.gov/oc/opt/default.htm

National Institute of Mental Health—Schizophrenia
www.nimh.nih.gov/healthinformation/schizophreniamenu.cfm

National Institute of Mental Health—Bipolar Disorder
www.nimh.nih.gov/healthinformation/bipolarmenu.cfm

Is this a good thing, or another attempt to put our youth under the influence of synthetic molecules? It seems to me, that any child that is different will likely now be prescribed Risperidone.

This is not a good thing. IF and ONLY IF it is supervised with FDA oversight (which they can do by randomly interviewing children who have filled DSHS funded prescriptions) could this be a good thing, to treat children who suffer from schizophrenic symptoms. There is some evidence to show that the SOONER a child is treated for schizophrenic symptoms, the better the recovery is down the line in adulthood.

I hope Pharma Giles, Dr. Peter Rost, and Pharma Gossip are all doing well. I miss you guys so much. Thank you so much for all the support you have given me. I hope to see you all soon ON A NEW BLOG I WILL START SOON - ACADEMIC GILES/GOSSIP. Remember Gentlemen, imitation is the most sincere form of flattery. Sometimes humor makes the best of horrible life circumstances... Stay tuned.