Risperdal (Risperidone) not approved for children

Use of Risperdal for Aspergers and PDD is not FDA approved

adhd - Drugs for ADHD

Article Index
Use with children has not been established:
Warnings:
Normal dosage:
Oral:
Side Effects:
How to Stop Taking Risperdal:

Risperdal (Risperidone) is an antipsychotic drug developed, tested, approved and used to treatment disorganized or psychotic thinking in adults. Extrapolating from use with adults, it is prescribed as an “ Off-label” (not FDA approved) use for Autistic Spectrum Disorders such as aspergers Syndrome and Pervasive Developmental Disorders in children.

For a discussion of the wisdom of this extrapolation read see article, Doctors Dilemma on this website.

Use with children has not been established:

There is has been very little research on the use of Risperdal with children, and most of what there is has been withheld by the manufacturer.

Here is one publicly available study, inserted below.

Risperidone (Risperdal) Tolerability in Children

Presented at the American Psychiatric Association, 2002 Annual Meeting

Hong Chen, M.D., Department of Psychiatry, Hershey Medical Center; Christopher A. Petersen, M.D.

Introduction: Little published data is available to determine the tolerability of Risperidone in children in an acute setting.

Method: In this prospective pilot study, hospitalized children (n = 10) with age range of 7 to 10 year, were administered Risperidone gradually to 0.04 mg/kg/day as clinically indicated and only if tolerated. Side effect rating scales were completed at baseline, within 24 hours of first dose to assess acute change, at 0.04mg/kg/day if possible to assess effects of therapeutic dosage, and prior to discharge. The average study period is 10 days.

Results: Among 10 hospitalized children with newly started on Risperidone, three (30%) developed a mild degree of loss of appetite with one also having diarrhea, one (10%) developed mild rigidity, drooling, slurred speech within 24 hours of first dose, one(10%) had mild sedation. In terms of short term weight change by discharge, three (30%) children gained average weight of 0.9 kg, one (10%) lost 0.7 kg. Nine children were discharged on Risperidone without remaining problems of loss of appetite, diarrhea and sedation except weight change, and one child had to discontinue and switch to another neuroleptics.

Warnings:

Risperdal has been linked to Diabetes prompting the FDA to request that Johnson and Johnson issue a warning to patients and prospective patients. In a recent study Risperdal increased a patient's chances of developing diabetes by about 50 percent compared with older antipsychotics.

Risperdal has also been linked to Neuroleptic Malignant Syndrome (NMS), stroke and Tardive Dyskinesia. There have been 37 reports of stroke or stroke-like events, including 16 deaths linked to Risperdal. In April 2003, Johnson & Johnson sent warning letters to U.S. Physicians citing the drug’s elevated risk of stroke in elderly patients.

NMS is a potentially fatal syndrome involving muscle rigidity, and irregular blood pressure and irregular pulse. Tardive Dyskinesia is a central nervous system disorder, which results in involuntary movement of the limbs and twitching of the face and tongue.

This medicine may make it more difficult for your body to keep a constant temperature.
Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heatstroke. Hot baths or saunas may make you feel dizzy or faint while you are taking this medicine. Also, use extra care not to become too cold while you are taking risperidone. If you become too cold, you may feel drowsy, confused, or clumsy.

In other words, you should ask you physician a lot of questions before you agree to put your child on this drug.

Normal dosage:

If under 18 years of age, undetermined.
18 to 60 years of age, 1mg two times daily.
Over 60 years of age, 0.5mg two times daily, increased cautiously in one week intervals.

Oral:

Start: 1mg 2 times daily.
Increases: 1mg increase after two days and another 1mg on the third day, for a total of 3mg 2 times daily.
Maximum: 6mg in 24 hours.

Antacids containing aluminum or magnesium should not be taken one hour before taking this drug and never right after.

Side Effects:

Common: Lethargy / sleepiness, low blood pressure, dry mouth, blurred vision, constipation, weight gain, difficulty urinating, nasal irritation / stuffiness, or stiffness.

Rare: Dizziness, racing heartbeat / palpitations, weakness, sexual problems, restlessness, skin rash, seizures, low white blood cell count, tremors, involuntary facial / tongue movements, or reduced urinary output.

See physician always: Low blood pressure, dizziness, racing heartbeat / palpitations, weakness, sexual problems, restlessness, skin rash, stiffness, seizures, low white blood cell count, tremors, reduced urinary output, difficulty urinating, involuntary facial / tongue movements, or nasal irritation / stuffiness.

See physician if severe: Blurred vision, constipation, dry mouth, Lethargy / sleepiness, or weight gain.

Check with your physician if you are taking central nervous system depressants like antihistamines, hay fever medicines, sedatives, narcotics, anesthetics, barbiturates, or muscle relaxants. Also check with your physician if you are taking a vasodilator (drug that dilate blood vessels.)

How to Stop Taking Risperdal:

Your doctor should be recommending that you reduce your dosage by 0.25 or 0.5mg a day every 4 to 5 days.

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ADHD

behavior problems.

Therapy

ADHD diagnosis

school problems

diagnosis of ADHD