A study in the July edition of the American Journal of Psychiatry, which was sponsored by the National Institute of Mental Health (NIMH), has found that children with autism characterized by tantrums, aggression, and/or self-injury respond favorably to the antipsychotic medication, risperidone (Risperdal).

The study involving 101 subjects (82 boys and 19 girls – ages 5 to 17) claims that these positive results were obtained with limited side effects. Those side effects were stated to be well-tolerated with some complaints of weight gain.

Treatment was for an intermediate term of up to six months for those subjects who improved substantially after the first eight weeks on the drug. The study did find, however, that discontinuation of the medication after six months prompted a rapid return of disruptive and aggressive behavior in most cases.
While autism is unquestionably a debilitating chronic condition that impairs social interaction, delays language development, and causes restricted patterns of behavior, this off-label use of a powerful atypical antipsychotic drug should be given more study for a number of reasons.

The prescribing of drugs beyond the scope of their approval by the FDA is referred to as “off-label” use of the drug. The FDA regularly discourages and even warns against such uses of drugs. This has been especially true in the case of powerful antipsychotic medications.

The strange thing about off-label use, however, is that doctors may prescribe drugs to treat conditions for which the FDA has denied approval. Thus, while a manufacturer cannot market a drug for an unapproved off-label use, a doctor may prescribe the drug for that use.    

In the case of risperidone (Risperdal), while it might very well be that favorable results were obtained, it would seem to be somewhat premature to use a limited 6-month study involving only 101 subjects to conclude the drug is “safe” for children.

Risperdal is manufactured by Jannsen Pharmaceuticals, a division of Johnson & Johnson and is prescribed for the treatment of schizophrenia (not autism).

The package label submitted by the company and approved by the FDA clearly states under the heading “Pediatric Use,” that: “Safety and effectiveness in children have not been established.”

Risperdal also comes with some very serious warnings and side effects which should not be so easily discounted simply because a very limited study group using the drug for a short period of time showed limited adverse reactions.

Some of the drugs more common side effects may include: Abdominal pain, abnormal walk, agitation, aggression, anxiety, chest pain, constipation, coughing, decreased activity, diarrhea, difficulty with orgasm, diminished sexual desire, dizziness, dry skin, erection and ejaculation problems, excessive menstrual bleeding, fever, headache, inability to sleep, increased dreaming, increased duration of sleep, indigestion, involuntary movements, joint pain, lack of coordination, nasal inflammation, nausea, overactivity, rapid heartbeat, rash, reduced salivation, respiratory infection, sleepiness, sore throat, tremor, underactive reflexes, urination problems, vomiting, weight gain

Less common (but recognized) side effects may include: Abnormal vision, back pain, dandruff, difficult or labored breathing, increased saliva, sinus inflammation, toothache.

Risperdal should be used with caution by patients with kidney, liver, or heart disease, seizures, breast cancer, thyroid disorders, or any other diseases that affect the metabolism (conversion of food into energy and tissue) as well as by those who have had a stroke or mini-strokes, suffer from fluid loss or dehydration, or expect to be exposed to extremes of temperature.

Risperdal may mask signs and symptoms of drug overdose and of conditions such as intestinal obstruction, brain tumor, and Reye’s syndrome (a dangerous neurological condition that may follow viral infections, usually occurring in children). Risperdal can also cause difficulty when swallowing, which in turn can cause a type of pneumonia.

Risperdal may cause Neuroleptic Malignant Syndrome (NMS), a condition marked by muscle stiffness or rigidity, fast heartbeat or irregular pulse, increased sweating, high fever, and high or low blood pressure. Unchecked, this condition can prove fatal.

Patients at high risk for suicide attempts will be prescribed the lowest dose possible to reduce the risk of intentional overdose.

Risperdal may impair your ability to drive a car or operate dangerous machinery and patients should not participate in any activities that require being fully alert.

Risperdal can cause orthostatic hypotension (low blood pressure when rising to a standing position), with dizziness, rapid heartbeat, and fainting, especially when you first start to take it.
Risperdal has been linked to diabetes. This prompted the FDA to request Johnson and Johnson issue a warning to patients and prospective patients. In one recent study, Risperdal increased a patient’s chances of developing diabetes by about 50% as compared with older antipsychotics.

Risperdal has also been linked to stroke and 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.

Risperdal has also been linked to tardive dyskinesia (TD), a disorder of the central nervous system, which results in involuntary movement of the limbs and twitching of the face and tongue.

Risperdal has been known to cause irregular heartbeats, muscle weakness and spasms, high fever, constipation, weight gain and headaches.

On April 11, 2005, the FDA announced that older patients with dementia who are given antipsychotic medicines are far more likely to die prematurely than those given placebos. The drug now carries a black-box warning (the FDA’s most severe) on the labels.

The FDA’s own warnings can be found at:

Thus, it would seem to be a bit presumptuous to conclude that this powerful and quite dangerous drug is “safe” for children based upon this one limited study. While no weapon in the war on autism should be discounted, a very careful risk versus benefit analysis should be done before such a risky medication is routinely prescribed to children with autism.

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