ADHD DRUG WARNINGS

While the real quacks like Doc PigPills scream and try to shut down
clinical trials of nutrients for ADHD ... these Drug Pushers remain
silent on these very dangerous drugs given to children.


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.

"Ilena Rose" wrote in message
...
While the real quacks like Doc PigPills scream and try to shut down
clinical trials of nutrients for ADHD ... these Drug Pushers remain
silent on these very dangerous drugs given to children.

Actually, we want clincial trials of nutrients for treating ADHD. It is the
only way to know if they work. Right now, there is no reason to think they
work and no evidence that they do.

You say that these are "very dangerous drugs." No doubt that you list real
risks of the ADHD drugs. However, the benefits outweigh the risks. And, of
course, you have to watch out for the side-effects of any medicine and make
changes in the dose or medicine (or discontinue the meds) if there are
side-effects.

Jeff


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.