FDA Approves RISPERDAL(R) To Treat Adolescents With Schizophrenia And Children And Adolescents With Bipolar Mania

The U.S. Food and Drug
Administration (FDA) today approved RISPERDAL(R) (risperidone) for the
treatment of schizophrenia in adolescents ages 13-17 and for the short-term
treatment of bipolar mania associated with manic or mixed episodes of
bipolar I disorder in children and adolescents ages 10-17.



This approval is based on studies involving more than 430 adolescents,
ages 13-17, in the treatment of schizophrenia and 160 children and
adolescents, ages 10-17, for the short-term treatment of bipolar mania
associated with manic or mixed episodes of bipolar I disorder.



RISPERDAL is marketed in the U.S. by Janssen, L.P. and promoted by
McNeil Pediatrics, a division of McNeil-PPC., Inc.



Janssen is the only U.S. pharmaceutical company exclusively dedicated
to mental health. For more information about RISPERDAL, visit
janssen.



RISPERDAL(R) (risperidone) is indicated in adults for the treatment of
schizophrenia, for the treatment of manic symptoms of acute manic or mixed
episodes associated with bipolar I disorder, for the treatment of
irritability associated with autistic disorder in ages 5-16 years, for the
treatment of schizophrenia in adolescents ages 13-17 years and for the
short-term treatment of bipolar mania associated with bipolar I disorder in
children and adolescents ages 10-17 years.



Important Safety Information For RISPERDAL(R)



Elderly Patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk of death compared to placebo.
RISPERDAL(R) (risperidone) is not approved for the treatment of patients
with Dementia-Related Psychosis.



The most common adverse reactions observed in all clinical trials with
Risperdal occurring at a rate of at least 10% were: somnolence, appetite
increased, fatigue, rhinitis, upper respiratory tract infection, vomiting,
coughing, urinary incontinence, saliva increased, constipation, fever,
tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry
mouth, rash, restlessness, and indigestion.
















A rare but serious side effect that has been reported with this kind of
medicine, including RISPERDAL(R), is known as neuroleptic malignant
syndrome (NMS). NMS is characterized by muscle rigidity, fever and can be
serious.



You may have heard the term "tardive dyskinesia." These are usually
persistent, uncontrollable, slow or jerky facial or body movements that can
be caused by all medications of this type. If you have these symptoms, talk
to your health care professional.



Studies suggest an increased risk of elevated blood sugar-related side
effects, and sometimes potentially fatal, in patients treated with this
class of medications, including RISPERDAL(R). Some people may need regular
blood sugar testing.



Some people taking RISPERDAL(R) may feel faint or lightheaded when they
stand up or sit up too quickly. By standing up or sitting up slowly and
following your health care professional's dosing instructions, this side
effect may be reduced or it may go away over time.



You may have heard the term "extrapyramidal symptoms" (EPS). These are
usually persistent movement disorders or muscle disturbances, such as
restlessness, tremors and muscle stiffness. Some people taking RISPERDAL(R)
have these side effects. If you have these symptoms, talk to your health
care professional.



Some medications may interact with RISPERDAL(R). Avoid alcohol while on
RISPERDAL(R).



Inform your health care professional if you are pregnant or if you are
planning to get pregnant while taking RISPERDAL(R). Do not breastfeed if
you are taking RISPERDAL(R).



RISPERDAL(R) may affect your driving ability, therefore, do not drive
or operate machines before talking to your health care professional.



RISPERDAL(R) may affect alertness and motor skills; use caution until
the effect of RISPERDAL(R) is known.



Please see full important U.S. prescribing information for RISPERDAL(R)
at janssen.



Janssen, L.P., based in Titusville, NJ, is the only pharmaceutical
company in the U.S. dedicated solely to mental health. The company
currently markets prescription medications for the treatment of
schizophrenia, bipolar mania and irritability associated with autistic
disorder. For more information about Janssen, L.P., visit
janssen, and for more information on RISPERDAL(R), visit
RISPERDAL.



Johnson & Johnson Pharmaceutical Research and Development, L.L.C., is
headquartered in Raritan, NJ, and has facilities throughout Europe and the
U.S. The company is leveraging drug discovery and drug development in a
variety of therapeutic areas to address unmet medical needs worldwide.


Janssen, L.P.

janssen


View drug information on Risperdal Oral Formulation.