For the first time, FDA approves antipsychotic drug for children 13-17.
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For the first time, FDA approves antipsychotic drug
for children 13-17. The AP (8/23) reported, "The
Food and Drug Administration on Wednesday approved a
widely used adult psychiatric drug for the treatment
of schizophrenia and bipolar disorder in children and
adolescents." Risperdal (risperidone), manufactured by
Janssen, L.P., was approved for use in adults in
1993,and also "approved last fall for treatment of
irritability in autism." The FDA said, "Until
now,...there has been no approved drug for the
treatment of schizophrenia in youths and only lithium
is approved for the treatment of bipolar disorder in
adolescents." The agency added that the youth dosage
is "slightly lower than the adult dose," and that side
effects included "[d]rowsiness, fatigue, increase in
appetite, anxiety, nausea, dizziness, dry mouth,
tremor, and rash."
According to the Boston Globe (8/23, Henderson),
"More than 2 million Americans have schizophrenia, a
condition characterized by the inability to
differentiate between real and unreal experiences, to
think logically, or to behave normally in social
situations." In addition, "One in 100 Americans will
be diagnosed with the disease, but the bulk of
diagnoses occur between ages 15 and 25," said Jeffrey
Lieberman, chairman of psychiatry at Columbia
University. The Globe continued, "Once the FDA
approves a drug for adults, manufacturers seldom
retest it in children." Therefore, the FDA approached
"Risperdal's maker, Janssen LP, to study it in
children." The company did so within five years. The
Globe also noted, "Because newer antipsychotic drugs,
such as Risperdal, carry serious -- and sometimes
fatal -- side effects, the FDA considers the pediatric
studies on its use significant, as does the American
Psychiatric Association." And since "Risperdal is also
in a class of drugs associated with weight gain that
can lead to diabetes, Janssen, at the FDA's request,
is conducting a longer-term trial to look at weight
gain and any impact that earlier use of the drug may
have on children's growth and development."
The Wall Street Journal (8/23, D1, Mathews,
Johnson) added, "Some doctors are concerned about the
safety of treating children whose bodies are still
growing with Risperdal and similar medications. They
point out that the FDA's decision is based on
short-term studies. Risperdal and competing drugs have
previously been tied to serious side effects including
increased blood sugar, a potential precursor to
diabetes." Jeffrey Lieberman, chairman of the
psychiatry department at Columbia University in New
York, said, "We definitely need to have longer-term
follow-up data to learn the full extent of the
side-effect liabilities." Other "experts believe that
prescribing Risperdal for severe psychiatric disorders
in children and adolescents is less risky than letting
the disorders go untreated." Roy Boorady, clinical
coordinator of the psychopharmacology service at the
New York University Child Study Center, said, "The
hope is that you catch this disease early enough and
give them medication so that the brain alters itself
in a beneficial way."
Meanwhile, Bloomberg (8/23, Rapaport) noted that
drug companies' "efforts to win approval of medicines
for teens have drawn criticism from some doctors
concerned that side effects such as weight gain may be
more pronounced in children than in adults." That is
because "[a]pproval for adolescents may help expand
the $16 billion antipsychotic market, and the FDA is
also "reviewing Zyprexa (olanzapine) and Bristol's
pill Abilify (aripiprazole) for teens." Thomas
Laughren, director of the FDA's division of psychiatry
products, said, "We are concerned about the safety
profile of these drugs, and we are very closely
looking at post-marketing data for this drug and other
drugs in pediatric patients."
MedPage Today (8/23, Peck) pointed out that the
FDA "granted the new indications on the basis of
results of two schizophrenia studies that enrolled a
total of 255 adolescents and one bipolar trial that
enrolled 109 patients. In each trial half of the
participants received risperidone and half placebo."
MedPage Today continued, "The schizophrenia trials
evaluated six to eight weeks of treatment and the
bipolar trial investigated three weeks of treatment."
HealthDay (8/23, Reinberg) noted, "Patients
taking the drug had fewer symptoms, including fewer
hallucinations and less delusional thinking." As for
bipolar disorder, "the agency relied on the outcome of
a three-week trial among children and adolescents with
bipolar I disorder. In this trial, patients taking
Risperdal had fewer symptoms, including a reduction in
elevated mood and hyperactivity, the agency noted."
WebMD (8/23, Hitti) also covered the story.




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