Today, the FDA approved Risperdal for the treatment of schizophrenia in adolescents 13 to 17 years old and for the short-term (three week) treatment of bipolar I disorder in children and adolescents 10 to 17 years old. This makes Risperdal the first medication to be FDA-approved for the treatment of schizophrenia in adolescents and the second to be approved for the treatment of bipolar disorder in children or adolescents. Lithium was previously approved for the treatment of bipolar disorder in adolescents aged 12 years and above.
Risperdal is classified as an atypical antipsychotic medication, a class that has been the subject of warnings and controversy. In clinical trials, the adverse events (side effects) that occurred at a rate of 10% of more included: abdominal pain, akathisia (uncontrollable motor restlessness), anxiety, constipation, coughing, dizziness, dry mouth, dyspepsia (indigestion), dystonia (syndrome of sustained muscle contractions that produce twisting and repetitive movements or abnormal postures), fatigue, fever, increased appetite, increased salivation, nausea, Parkinsonism, rash, rhinitis (inflammation of the mucous membrane of the nose), somnolence (sleepiness), tremor, upper respiratory tract infection, urinary incontinence, and vomiting.
Dr. Charles Goodstein, clinical professor of psychiatry at New York University Medical School,welcomed the approval, but expressed the need for caution:
"This is a drug that has real value... But one has to exercise a degree of caution when using what amount to be heavy-duty medications in young children and adolescents. One has to very careful that this medication is not overused... Bottom line, it's a valuable medication, one that can produce momentous changes in a person's functioning, but a medication that should be used with great care, because it does have side effects, and too often diagnoses are made more readily than they should be made."
The FDA approval of Risperdal for treating adolescents with schizophrenia was based on two short-term clinical trials. The results indicated fewer symptoms including fewer hallucinations and less delusional thinking. The approval for children and adolescents with bipolar I disorder was based on a three-week clinical trial in which patients saw a reduction in elevated mood and hyperactivity.
Commentary:
Yes, some children need treatment for schizophrenia and bipolar disorder, but this approval -- under our current system -- concerns me. The approval for children and adolescents with bipolar I disorder was based on a single three-week trial.
This approval does not indicate that Risperdal is better than other medications doctors may currently be prescribing off-label. It only indicates that the manufacturer was willing to expend the resources to do clinical trials and obtain FDA approval.
Once a medication is approved as this one has been, pharmaceutical company sales representatives may legally discuss such use with physicians. I've seen the results of this before:
