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Psychiatric Adverse Events



 
 
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  #1  
Old October 1st 06, 06:47 AM posted to misc.health.alternative,misc.kids.health
Ilena Rose
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Posts: 1,139
Default Psychiatric Adverse Events


http://www.fda.gov/medwatch/safety/2...HCP_Letter.pdf

Psychiatric Adverse Events
Pre-Existing Psychosis
Administration of stimulants may exacerbate symptoms of behavior
disturbance and thought disorder in
patients with a pre-existing psychotic disorder.
Bipolar Illness
Particular care should be taken in using stimulants to treat ADHD in
patients with comorbid bipolar disorder
because of concern for possible induction of a mixed/manic episode in
such patients. Prior to initiating
treatment with a stimulant, patients with comorbid depressive symptoms
should be adequately screened to
determine if they are at risk for bipolar disorder; such screening
should include a detailed psychiatric history,
including a family history of suicide, bipolar disorder, and
depression.
Emergence of New Psychotic or Manic Symptoms
Treatment emergent psychotic or manic symptoms, e.g., hallucinations,
delusional thinking, or mania in children
and adolescents without a prior history of psychotic illness or mania
can be caused by stimulants at usual
doses. If such symptoms occur, consideration should be given to a
possible causal role of the stimulant, and
discontinuation of treatment may be appropriate. In a pooled analysis
of multiple short-term, placebo-controlled
studies, such symptoms occurred in about 0.1% (4 patients with events
out of 3,482 exposed to
methylphenidate or amphetamine for several weeks at usual doses) of
stimulant-treated patients compared to 0
in placebo-treated patients.
Aggression
Aggressive behavior or hostility is often observed in children and
adolescents with ADHD, and has been
reported in clinical trials and the postmarketing experience of some
medications indicated for the treatment of
ADHD. Although there is no systematic evidence that stimulants cause
aggressive behavior or hostility, patients
beginning treatment for ADHD should be monitored for the appearance
of, or worsening of, aggressive
behavior or hostility.
Long-Term Suppression of Growth
Careful follow-up of weight and height in children ages 7 to 10 years
who were randomized to either
methylphenidate or non-medication treatment groups over 14 months, as
well as in naturalistic subgroups of
newly methylphenidate-treated and non-medication treated children over
36 months (to the ages of 10 to 13
years), suggests that consistently medicated children (i.e., treatment
for 7 days per week throughout the year)
have a temporary slowing in growth rate (on average, a total of about
2 cm less growth in height and 2.7 kg
less growth in weight over 3 years), without evidence of growth
rebound during this period of development.
Published data are inadequate to determine whether chronic use of
amphetamines may cause a similar
suppression of growth, however, it is anticipated that they likely
have this effect as well. Therefore, growth
should be monitored during treatment with stimulants, and patients who
are not growing or gaining height or
weight as expected may need to have their treatment interrupted.
Seizures
There is some clinical evidence that stimulants may lower the
convulsive threshold in patients with prior history
of seizures, in patients with prior EEG abnormalities in absence of
seizures, and, very rarely, in patients without
a history of seizures and no prior EEG evidence of seizures. In the
presence of seizures, the drug should be
discontinued.
Visual Disturbance
Difficulties with accommodation and blurring of vision have been
reported with stimulant treatment.
Additional Change to Prescribing Information
Lastly, the following statement has been deleted from the PRECAUTIONS
section of the DEXEDRINE
prescribing information as it is explained in the new WARNINGS
section:
Caution is to be exercised in prescribing amphetamines for patients
with even mild hypertension.
  #2  
Old October 1st 06, 03:22 PM posted to misc.health.alternative,misc.kids.health
Jeff
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Posts: 780
Default Psychiatric Adverse Events

Thanks for the warning.

As with *any* medication, there are risks. It is up to the parents, child
and doctor to weigh the risks and benefits of any medication. Based on this,
they can determine if the medication is in the child's best interest. And,
if a side-effect does occur, they can stop the medicaiton. They can also try
using a different medication.

No medication is without side-effects. Even water is not 100% safe. You can
choke on it. And water can contain dangerous organisms.

Antibiotics can cause allergic reactions and other problems. Tylenol can
cause liver failure.

Jeff


 




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