While this filing is a departure from Waters & Kraus' continuing practice of
toxic exposure and cancer cases, the pattern and practice of improper
conduct on the part of the defendants in this case rivals that of the
asbestos corporate defendants and tobacco companies in other cases.
The suit states allegations based on fraud and conspiracy. From
approximately 1955 through 1995, the exclusive or primary manufacturer and
supplier of Ritalin in this country was defendant Ciba-Geigy Corp., U.S.A.
("Ciba"). In 1996 Ciba merged with Sandoz Pharmaceuticals Corp. to become
defendant Novartis Pharmaceuticals Corp. ("Novartis"). Ciba/Novartis has
manufactured, marketed and sold Ritalin since approximately 1955.
Ciba/Novartis planned, conspired, and colluded to create, develop and
promote the diagnosis of Attention Deficit Disorder (ADD) and Attention
Deficit Hyperactivity Disorder (ADHD) in a highly successful effort to
increase the market for its product Ritalin. In addition to its actions and
involvement with the creation of the ADD and ADHD diagnosis, Ciba/Novartis
took steps to promote and dramatically increase the sales of Ritalin by way
of the following:
Actively promoting and supporting the concept that a significant percentage
of children suffer from a "disease" which required narcotic
treatment/therapy;
Actively promoting Ritalin as the "drug of choice" to treat children
diagnosed with ADD and ADHD:
Actively supporting groups such as Defendant CHADD, both financially and
with other means, so that such organizations would promote and support (as a
supposed neutral party) the ever-increasing implementation of ADD/ADHD
diagnoses as well as directly increasing Ritalin sales;
Distributing misleading sales and promotional literature to parents, schools
and other interested persons in a successful effort to further increase the
number of diagnoses and the number of persons prescribed Ritalin.
Defendant CHADD (Children and Adults with Attention Deficit/Hyperactivity
Disorder) has been a recipient of financial donations and contributions from
Defendants Ciba/Novartis for many years. CHADD received $748,000 from
Ciba/Novartis in the period 1991 to 1994 alone. During the periods when
CHADD received funding from Ciba/Novartis, CHADD deliberately made efforts
to increase the sales of Ritalin, and to increase the supply of
methylphenidate (the generic name for Ritalin) available in the United
States, and to reduce or eliminate laws and restrictions concerning the use
of Ritalin and methylphenidate in the United States, all to the financial
benefit of Ciba/Novartis. Ciba/Novartis made such financial contributions
with the purpose of advertising and promoting sales of Ritalin - an
internationally controlled substance. Ciba/Novartis has thus repeatedly
violated Article 10 of the United Nations Convention on Psychotropic
Substances, 1019 U.N.T.S. 175 (1971).
CHADD's activities nationwide have led to significant increase in the amount
of Ritalin taken by school children and have directly resulted in enormous
profits to Ciba/Novartis.
Parents, the school districts and other interested parties are generally
unaware that use of Ritalin can cause a significant number of health
problems and risks, including but not limited to the following:
Cardiovascular
Rapid heart beat (palpitations, tachycardia)
High blood pressure (hypertension)
Unusual heart rhythm (arrythmia)
Heart attack (cardiac arrest)
Central Nervous System
Altered mental status (psychosis)
Hallucinations
Depression or excitement
Convulsions / seizures (excessive brain stimulation)
Drowsiness or "dopey" feeling
Confusion
Lack of sleep (insomnia)
Agitation, irritation, anxiety, nervousness
Hostility
Unhappiness (Dysphoria)
Impaired mental abilities (cognitive impairment on tests)
Jerky movements (Dyskinesias, tics, Tourette's syndrome)
Nervous habits (such as picking at skin or pulling hair)
Compulsive behavior
Depression/over-sensitivity
Decreased social interest
Zombie-like behavior
Gastrointestinal
Eating disorders (anorexia)
Nausea
Vomiting
Stomach ache / cramps
Dry mouth
Constipation
Abnormal liver function tests
Endocrine/Metabolic
Growth problems (pituitary dysfunction)
Weight loss
Other
Blurred vision
Headache
Dizziness
Rash/conjunctivitis/hives
Hair loss
Inflammation of the skin (dermatitis)
Blood disorders (anorexia, leukoplacia)
Involuntary discharge of urine (enuresis)
Fever
Joint pain
Unusual sweating
Withdrawal and Rebound
Sleep problems (insomnia)
Evening crash
Depression
Over-activity and irritability
Worsening of ADHD-like symptoms
In addition, it is not generally known or understood by the public that use
of Ritalin will preclude a child from ever joining the United States
military because Ritalin is classified as a Class II controlled substance,
along with morphine and other amphetamines.
They got the name right, at least. If Breggin is involved, fraud can't
be far behind.
And we all know he's full of sh*t, 'cause his wife was a (as Mark Probert would
write) $cientologi$t, right? What a perfect example of an ad hominem attack.
JG
Why, yes, a perfect example of your using ad-hominem against Mark! :)
Actually, both he and his wife, Ginger (who escaped from the cult) both
have nasty things to say about it. Publicly. They're still very much
in bed with people who think they're spiritually descended from seafood,
because the money's good.
No problem, I'm familiar with _both_ forms of the Ad Hom fallacy. Hence
the Smiley at the end of my little joke.
> I've not attacked Mark; he has, on numerous occasions, written "Scientologist"
> with dollar signs in place of the esses.
I do that too. That's in honor of their highest "dynamic," the Buck.
> >Actually, both he and his wife, Ginger (who escaped from the cult) both
> >have nasty things to say about it. Publicly. They're still very much
> >in bed with people who think they're spiritually descended from seafood,
> >because the money's good.
>
> And this invalidates Breggin's views because???
It doesn't invalidate Breggin's views. He does that himself, by citing
old information which has been superceded by more recent research, for
example. The fact that he parrots much of the same misinformation that
the cult does, makes his public distancing from the lying cult of
$cientology just a wee bit hard to believe.
That he's a hired gun for such things as the Ritalin lawsuit makes me
suspicious of his views; that they contradict both my own experience and
scientific research makes me doubt them still more. That he persists,
when corrected, makes him a liar.
But I guess I'm not supposed to call a liar a liar anymore...
>G03090103 wrote:
>> Chris Leithiser clei...@bc.cc.ca.us wrote:
>> And we all know he's full of sh*t, 'cause his wife was a (as Mark Probert
>would
>> write) $cientologi$t, right? What a perfect example of an ad hominem
>attack.
>> JG
>Why, yes, a perfect example of your using ad-hominem against Mark! :)
>
No, Chris, it isn't. Rather than debate fallacies, I'll just refer you (and
anyone else who might be remotely interested) to the Nizkor Project,
http://www.nizkor.org/features/fallacies .
I've not attacked Mark; he has, on numerous occasions, written "Scientologist"
with dollar signs in place of the esses. What you choose to infer is up to
you; I was simply pointing out (to anyone who might not be familiar with his
modus operandi) that Mr. Probert's reasoning is faulty; one's religious
affiliation alone doesn't automatically invalidate his/her assertions. Here,
from the site mentioned above, is a definition of (circumstantial) ad hominem:
1. Person A [e.g., Peter Breggin] makes claim X.
2. Person B [e.g., Mark Probert, et al.] makes an attack on A's circumstances.
3. Therefore X is false.
A Circumstantial ad Hominem is a fallacy because a person's interests and
circumstances have no bearing on the truth or falsity of the claim being made.
While a person's interests will provide them with motives to support certain
claims, the claims stand or fall on their own. It is also the case that a
person's circumstances (religion, political affiliation, etc.) do not affect
the truth or falsity of the claim. This is made quite clear by the following
example: "Bill claims that 1+1=2. But he is a Republican, so his claim is
false."
>Actually, both he and his wife, Ginger (who escaped from the cult) both
>have nasty things to say about it. Publicly. They're still very much
>in bed with people who think they're spiritually descended from seafood,
>because the money's good.
And this invalidates Breggin's views because???
JG
>
> But I guess I'm not supposed to call a liar a liar anymore...
It tends to get my suspicions when people use that word-----basically they
tend to use the word for anyone who disagrees with their opinions. No
evidence is ever provided that the said person has actually lied.
>That he persists,
>when corrected, makes him a liar.
No doubt you can provide evidence for this.
John
None that you would accept. They contain facts.
Mark Probert
A vote for Pat Buchanan is a vote for America's First Fuhrer!
Much snippage...
>That he's a hired gun for such things as the Ritalin lawsuit makes me
>suspicious of his views; that they contradict both my own experience and
>scientific research makes me doubt them still more. That he persists,
>when corrected, makes him a liar.
I have my personal doubts about the hired gun theory. I have a suspicion that
he is a prime mover. The suit is just too-Breggin.
>But I guess I'm not supposed to call a liar a liar anymore...
Of course not. That is the exclusive technique of G4444444 and the rest of
them.
>
>Chris Leithiser clei...@bc.cc.ca.us wrote:
>
>
>
>>John wrote:
>>>
>>> Ritalin Fraud http://www.ritalinfraud.com/
>
>>They got the name right, at least. If Breggin is involved, fraud can't
>>be far behind.
>
>And we all know he's full of sh*t, 'cause his wife was a (as Mark Probert
>would
>write) $cientologi$t, right? What a perfect example of an ad hominem attack.
One should know where someone is coming from. Wheni read Breggin for the first
time, I asked myself just how someone with his education could be so
intellectually dishonest. When I found that his wife was a former (can you ever
be "former", without joining Lisa McPherson?) member of the Kriminal Kult of
$cientilogy, it made sense.
In a perverse sort of way.
"When I can't stops me fiddlin' I just takes me Ritalin; I'm poppin'
and sailin', man!" (Bart Simpson)
More information at http://doctoryourself.com/adhd.html
http://doctoryourself.com/hoffer_psychosis.html
http://doctoryourself.com/hoffer_paradigm.html
--
Over 120 articles (indexed by topic, or keyword with an on-site
search engine) plus hundreds of scientific references on nutritional
therapeutics are posted at http://doctoryourself.com Links to other
clinical nutrition and alternative medicine sites are provided.
In article <8gd8ah$tkr$1...@newsg3.svr.pol.co.uk>,
Sent via Deja.com http://www.deja.com/
Before you buy.
>Whew! Thank you for the post. One may add (or is that "adhd," in child
>psych lingo) the possible side effect of Ritalin-induced cancer, which
>has been so thoroughly demonstrated in mice that a couple of years ago,
Oh, you mean the 1995 NIH study?
It's at http://ntp-server.niehs.nih.gov/htdocs/LT-studies/tr439.html.
The FDA letter you refer to is at
Http://www.fda.gov//bbs/topics/ANSWERS/ANS00705.html.
>the US government sponsored a mailing warning of this to over 100,000
>US pediatricians. No such mailing was made to patients' families.
Do you suppose the fact that the causative link is so tenuous might have
something to do with it? Or the fact that the rare, non-fatal liver tumors have
occurred *only* in lab rodents that develop tumors readily? Or perhaps that
there have been no cancers in humans related to the use of methylphenidate?
Joe Parsons
==========================================================
Frequently Asked Questions for alt.support.attn-deficit
and other resources for dealing with attention deficit
disorder are at http://www.cyber-mall.com/asad/
The FDA also noted that the kind of liver tumor found in mice is
extremely rare in people, and its occurrence in recent years has not
increased despite an increase in the use of Ritalin.
They called the research results a "weak signal." By contrast,
secondhand smoke is a "strong signal" indicator as a cause of
cancer...and the government didn't send a warning to parents either.
> >That he persists,
> >when corrected, makes him a liar.
>
> No doubt you can provide evidence for this.
>
> John
Mark has been too modest. I cannot improve on this classic:
http://x69.deja.com/[ST_rn=ps]/getdoc.xp?AN=611512829&CONTEXT=959188096.832176159&hitnum=18
>They called the research results a "weak signal." By contrast,
>secondhand smoke is a "strong signal" indicator as a cause of
>cancer...and the government didn't send a warning to parents either.
Yeah, but second hand smoke did not become a strong signal before the feds
cooked the books. They were caught after their big pronouncement a few years
ago of changing the confidence interval to 90%. It wasn't significant at 95%
(which is the CI used by almost all of the studies that the prnouncement was
based on.)
-----------------------------------------------------------------------------
"People everywhere confuse what they read in the newspapers with news."
-A.J. Liebling
--
CBI, M.D.
Please note: It is impossible to accurately diagnose medical problems
without seeing the patient and reviewing the entire history. These posts are
intended to be helpful and informative. Always check with your doctor before
following any advice given.
>That's why I never, ever, give Ritalin to rodents. Just to be safe.
You are truly a compassionate person.
It's not a nice one and one i wouldn't give to my child, especially if the
child is young as they don't know how it affects a young child yet.
Love and Light
Steven
=====================================
RITALIN
(Novartis)
Composition:
Methylphenidate hydrochloride (alpha-Phenyl-2-piperidineacetic acid methyl
ester hydrochloride).
Excipients: lactose, calcium phosphate, gelatin, magnesium stearate,
talc-purified, starch-wheat.
Pharmacology:
Ritalin is a central nervous stimulant. Its mode of action in man is not
completely understood, but Ritalin presumably exerts its
stimulant effect by activating the brainstem arousal system and cortex.
There is neither specific evidence which clearly establishes the mechanism
whereby Ritalin produces its mental and behavioural
effects in children, nor conclusive evidence as to how these effects relate
to the condition of the central nervous system.
Pharmacokinetics:
Following oral administration of Ritalin, the active substance,
methylphenidate hydrochloride, is rapidly and almost completely
absorbed from the tablets. Owing to extensive first-pass metabolism, its
systemic availability amounts to only 30% (11-51%) of the
dose. Ingestion together with food accelerates its absorption, but has no
influence on the amount absorbed. Peak plasma
concentrations of approx. 40 nmol/litre (11 ng/mL) are attained, on the
average, 2 hours after administration of 0.30 mg/kg. The
peak plasma concentrations, however, vary markedly from one person to
another. The area under the plasma concentration curve
(AUC), as well as the peak plasma concentration, are proportional to the
size of the dose administered.
In the blood, methylphenidate and its metabolites become distributed in the
plasma (57%) and the erythrocytes (43%).
Methylphenidate and its metabolites have low plasma protein-binding
(approximately 15%). The apparent volume of distribution has
been calculated at 13.1 litres/kg.
Methylphenidate is eliminated from the plasma with a mean half-life of 2 to
3 hours, and the calculated mean systemic clearance
is 4 to 10 litres/h/kg. Within 48 to 96 hours 78 to 97% of the dose
administered is excreted in the urine and 1 to 3% in the faeces
in the form of metabolites. Unchanged methylphenidate appears in the urine
only in small quantities (< 1%). The bulk of the dose
is excreted in the urine as 2-phenyl-2-piperidyl acetic acid (PPAA, 60-86%).
Peak plasma concentrations of PPAA are attained
about 2 hours after administration of methylphenidate and are 30 to 50 times
higher than those of the unchanged substance. The
half-life of PPAA is roughly twice as long as that of methylphenidate.
There are no apparent differences in the pharmacokinetic behaviour of
methylphenidate in hyperactive children and normal adults.
Indications:
Attention-deficit hyperactivity disorder (ADHD): ADHD was previously known
as attention-deficit disorder. Other terms being used
to describe this behavioural syndrome include: minimal brain dysfunction in
children, hyperkinetic child syndrome, minimal brain
damage, minimal cerebral dysfunction, minor cerebral dysfunction, and
psycho-organic syndrome of children.
Ritalin is indicated as part of a comprehensive treatment programme which
typically includes other remedial measures
(psychological, educational, social) for achieving a beneficial effect in
children with a behavioural syndrome characterised by the
following group of developmentally inappropriate symptoms: moderate to
severe distractibility, short attention span, hyperactivity
(not always present) and impulsivity. The diagnosis of this syndrome should
not be made when these symptoms are only of recent
origin. Non-localising (soft) neurological signs, emotional lability,
learning disability, and an abnormal EEG may or may not be
present, and a diagnosis of central nervous system dysfunction may or may
not be warranted.
Special diagnostic considerations for ADHD: The aetiology of this syndrome
is unknown, and there is no single diagnostic test.
Adequate diagnosis requires the use, not only of medical but also of
psychological, educational, and social resources.
Characteristics commonly reported include: chronic history of short
attention span, distractibility, emotional lability, impulsivity,
moderate to severe hyperactivity, minor neurological signs and an abnormal
EEG. Learning may or may not be impaired. The
diagnosis must be based upon a complete history and evaluation of the child
and not solely on the presence of one or more of
these characteristics.
Drug treatment is not indicated for all children with this syndrome.
Stimulants are not intended for use in children who exhibit
symptoms secondary to environmental factors (e.g. child abuse in particular)
or primary psychiatric disorders. Appropriate
educational placement is essential and psychosocial intervention is
generally necessary. When remedial measures alone are
insufficient, the decision to prescribe stimulant medication will depend
upon the physician's assessment of the chronicity and
severity of the child's symptoms.
Narcolepsy: The symptoms include daytime sleepiness, inappropriate sleep
episodes, and rapidly occurring loss of voluntary
muscle tone. Effective for symptoms of sleepiness but not for loss of
voluntary muscle tone.
Contra-indications:
Anxiety and tension states, agitation, tics, tics in siblings, a family
history or diagnosis of Tourette's syndrome, glaucoma,
hyperthyroidism, cardiac arrhythmia, severe angina pectoris, known
hypersensitivity to methylphenidate or to any component of
the formulation.
Precautions and Warnings:
Ritalin should not be used in children under 6 years of age, since safety
and efficacy in this age group have not been established.
Ritalin should not be used as treatment for severe depression of either
exogenous or endogenous origin. In psychotic patients,
administration of Ritalin may exacerbate symptoms of behavioural disturbance
and thought disorder. Ritalin should not be
employed for the prevention or treatment of normal fatigue states.
There is some clinical evidence that Ritalin may lower the convulsion
threshold in patients with a history of seizures, with prior
EEG abnormalities in the absence of seizures and rarely, in the absence of a
history of seizures and no prior EEG evidence of
seizures. Safe concomitant use of anticonvulsants and Ritalin has not been
established. In the presence of seizures, the drug
should be discontinued.
As with other stimulants, the possibility of habituation or abuse must be
considered, particularly in emotionally unstable patients
and those with a history of drug dependence or alcoholism, because such
patients may increase the dose on their own initiative.
Chronic abuse of Ritalin can lead to marked tolerance and psychic dependence
with varying degrees of abnormal behaviour. Frank
psychotic episodes may occur, especially in response to parenteral abuse.
Ritalin abuse or dependence does not appear to be a
problem in adolescents or adults who were treated with Ritalin for ADHD as
children.
Careful supervision is required during drug withdrawal, since depression as
well as the effects of chronic over-activity can be
unmasked. Long-term follow-up may be needed for some patients.
Treatment with Ritalin is not indicated in all cases of ADHD and should be
considered only in the light of the complete history and
evaluation of the child. The decision to prescribe Ritalin should depend on
the physician's assessment of the chronicity and
severity of the child's symptoms and their appropriateness to his or her
age. Prescription should not depend solely on the
presence of isolated behavioural characteristics. When the symptoms are
associated with acute stress reactions, treatment with
Ritalin is usually not indicated.
The retardation of growth referred to under Adverse Reactions below is
usually followed by catch-up growth when the medication
is discontinued. In order to minimise such complications, drug-free periods
over weekends, school holidays and long vacations are
advocated by some specialists.
Ritalin should be used cautiously in patients with hypertension. Blood
pressure should be monitored at appropriate intervals in all
patients taking Ritalin, especially in those with hypertension.
Data on safety and efficacy of long-term use of Ritalin are not complete.
Therefore, patients requiring long-term therapy should be
carefully monitored.
Periodic complete blood counts, differential, and platelet counts are
advisable during prolonged therapy.
Ritalin may affect the patient's reactions and adversely influence his or
her ability to drive and use machines.
Alcohol may exacerbate the CNS adverse reactions of psychoactive drugs,
including Ritalin. Therefore, it is advisable for patients
to abstain from alcohol during treatment.
Medicines should be kept out of the reach of children.
Use during Pregnancy and Lactation:
As a general rule no drugs should be taken during the first 3 months of
pregnancy, and the benefits and risks of taking drugs
should be carefully considered throughout the whole of the pregnancy.
There is no experience upon which to judge the safety of Ritalin in human
pregnancy, nor is there evidence from animal work that it
is free from either teratogenic potential or other adverse effects on the
embryo and/or foetus relevant to the safety assessment of
the product. Use of Ritalin should be avoided during pregnancy unless, in
the opinion of the physician, there is no safer alternative.
It is not known whether or not the active ingredient of Ritalin and/or its
metabolites pass into breast milk. For safety reasons
mothers taking Ritalin should refrain from breast-feeding their infants.
Adverse Reactions:
Central and peripheral nervous system: Nervousness, insomnia and anorexia
are the most common adverse reactions occurring at
the beginning of the treatment and are usually controlled by reducing the
dosage and omitting the drug in the afternoon or evening.
Headache, drowsiness, dizziness, depressed mood, irritability, dyskinesia,
difficulties in accommodation, and blurring of vision
may also occur. Isolated cases of hyperactivity, convulsions, muscle cramps,
cerebral arteritis and/or occlusion, choreo-athetoid
movements, tics, or exacerbation of pre-existing tics, and Tourette's
syndrome have been reported. Isolated cases of toxic
psychosis (some with visual and tactile hallucinations) have been reported,
which subsided when Ritalin was discontinued. Very
rare reports of poorly documented neuroleptic malignant syndrome have been
received.
Gastrointestinal tract: Abdominal pain, nausea, and vomiting may occur and
may be alleviated by concomitant food intake; dry
mouth; very rare reports of abnormal liver function, ranging from
transaminase elevation to hepatic coma.
Cardiovascular system: Tachycardia, palpitation, arrhythmia, changes in
blood pressure and heart rate (usually an increase),
angina pectoris.
Skin and/or hypersensitivity reactions: Rash, pruritus, urticaria, fever,
arthralgia, alopecia. Isolated cases of thrombocytopenic
purpura, of exfoliative dermatitis, and of erythema multiforme have been
reported.
Blood: Isolated cases of leucopenia, thrombocytopenia, and anaemia have been
reported.
Other adverse reactions: Moderate reduction in weight gain and minor
retardation of growth in stature may occur in children during
prolonged therapy.
Interactions:
Ritalin should be used cautiously with pressor agents and MAO inhibitors.
Human pharmacological studies have shown that Ritalin
may inhibit the metabolism of coumarin anticoagulants, anticonvulsants
(phenobarbitone, primidone, phenytoin), phenylbutazone,
and tricyclic antidepressants (imipramine, desipramine). Reduction in the
dosage of these drugs may be required when they are
given concomitantly with Ritalin.
In occasional circumstances where guanethidine and Ritalin are used
together, any antihypertensive effect of the former may be
attenuated.
Dosage and Administration:
Treatment should only be initiated by specialist physicians with experience
in the use of the drug.
The dosage must be adapted to individual case. The rate of absorption and,
therefore, onset of action is faster when the drug is
taken with food. Dosage should, therefore, be standardised in relation to
food to ensure consistency of effect.
Adults: Administer in divided doses 2 or 3 times daily. The average dose is
20 to 30 mg daily. Some patients may require 40 to 60
mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are
unable to sleep if Ritalin is taken late in the day should
take the last dose before 6pm.
Dosing for each patient requires titration to control symptoms. Single doses
greater than 20 mg are associated with
sympathomimetic side-effects. Therefore, the average single dose should be
less than 20 mg. A maximum total dose of 60 mg/day
may be required.
Doses should be administered 1-2 hours before the maximum effect is
required.
Children (6 years and over): Treatment with Ritalin should be initiated in
small doses, with gradual weekly increments. Daily
dosage should not exceed 60 mg. Timing of the drug's administration should
be aimed at coinciding with periods of greatest
academic, behavioural, or social difficulties for the patient.
Start with 5 mg once or twice daily (e.g. at breakfast and at lunch) with
gradual increments of 5 or 10 mg weekly. The total daily
dosage should be administered in divided doses.
If improvement of symptoms is not observed after appropriate dosage
adjustment over a one-month period, the drug should be
discontinued.
In some children with ADHD, sleeplessness may occur as the effect of the
drug wears off. On rare occasions, an additional dose
at about 8.00 p.m. may help; a trial dose may help to clarify the issue in
an individual case, if the symptom warrants treatment.
Ritalin should be discontinued periodically (e.g. over weekends, school
holidays and long vacation) to assess the child's condition.
Improvement may be sustained when the drug is either temporarily or
permanently discontinued. Drug treatment should not and
need not, be indefinite and usually may be discontinued during or after
puberty.
Overdosage:
Signs and symptoms of acute overdosage, resulting principally from
overstimulation of the central nervous system and from
excessive sympathomimetic effects, may include the following:
vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions
(may be followed by coma), euphoria, confusion,
hallucinations, delirium, sweating, flushing, headache, hyperpyrexia,
tachycardia, palpitation, cardiac arrhythmias, hypertension,
mydriasis, and dryness of mucous membranes.
Treatment consists of appropriate supportive measures. The patient must be
protected against self-injury and against external
stimuli that would aggravate overstimulation already present. If the signs
and symptoms are not too severe and the patient is
conscious, further absorption may be limited by administration of activated
charcoal. If gastric lavage is undertaken, and in cases
of marked agitation, intravenous doses of diazepam or haloperidol should be
given. Hypertension may be controlled by
alpha-adrenergic blocking agents or intravenous sodium nitroprusside.
Intensive care must be provided to maintain adequate circulation and
respiratory exchange; external cooling procedures may be
required for hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal haemodialysis for
overdosage of Ritalin has not been established.
Pack:
Tablets 10 mg (white, scored, marked AB, CG on reverse): 100's
All States and A.C.T.-S.8
August 1998
rtl030898i
=======================================
RITALIN - CMI
(Novartis)
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about Ritalin.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
you or your child taking Ritalin against the benefits
they expect it will have.
If you have any concerns about taking this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Ritalin is used for
Ritalin is used to treat a behavioural disorder called Attention Deficit
Hyperactivity Disorder (ADHD), although not all people with
this disorder are hyperactive.
About 3% of children suffer from ADHD. It makes them unable to sit still or
concentrate on tasks for any length of time. They may
have trouble learning and doing school work. They frequently become
difficult to manage, both in school and at home.
Ritalin is a central nervous system stimulant. It is thought to work by
regulating specific chemicals in the brain which affect
behaviour. It helps to focus attention, shut out distraction and allows
impulsive people to think before they act. If successful, it will
enhance an inattentive person's natural ability.
Ritalin is part of a treatment program which usually includes psychological,
educational and social therapy.
Ritalin is also used to treat narcolepsy, a sleep-attack disorder.
People with narcolepsy have recurring attacks of irresistible day-time
sleepiness in spite of having enough sleep at night.
Narcolepsy can be diagnosed by a doctor by recording wake-sleep patterns.
Ask your doctor if you have any questions about why Ritalin has been
prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is only available with a doctor's prescription and your doctor
has special permission to prescribe it.
Before you take Ritalin
When you must not take it
- Do not take Ritalin if you have an allergy to:
methylphenidate (the active ingredient in Ritalin)
any of the other ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include rash, itching or
hives on the skin; swelling of the face, lips, tongue or
other parts of the body; shortness of breath, wheezing or troubled
breathing.
- Do not take Ritalin if you have any of the following medical conditions:
periods of severe anxiety, tension or agitation
tics (muscle twitching which is usually in the face or shoulders) or if
your brothers or sisters have tics
Tourettes's syndrome or you have a family history of this disorder
glaucoma (increased pressure in the eye)
an overactive thyroid
an irregular heartbeat
severe angina (chest pain)
If you are not sure whether any of the above medical conditions apply to
you, check with your doctor.
- Do not take Ritalin after the expiry date printed on the pack.
If you take this medicine after the expiry date has passed, it may not work
as well as it should.
- Do not take Ritalin if the packaging is torn or shows signs of tampering.
In that case, return it to your pharmacist.
- Do not give this medicine to children under 6 years of age.
There is not enough information to recommend its use in children under 6
years old.
Before you start to take it
- Tell your doctor if you are allergic to any other medicines, foods, dyes
or preservatives.
Your doctor will want to know if you are prone to allergies.
- Tell your doctor if you have any of the following medical conditions:
severe depression or other mental illness
epilepsy (seizures or fits)
high blood pressure
alcoholism
drug dependence
Your doctor may want to take special precautions if you have any of these
conditions.
- Tell your doctor if you are pregnant or breast feeding. Ask your doctor
about the risks and benefits of taking Ritalin in this case.
Ritalin may affect your developing baby if you take it while you are
pregnant. It is not known if the active ingredient in Ritalin
passes into the breast milk. Breast feeding is not recommended.
If you have not told your doctor about any of these things, tell him/her
before you take Ritalin.
Taking other medicines
- Tell your doctor if you are taking any other medicines, including
medicines that you buy without a prescription from a pharmacy,
supermarket or health food shop.
Other medicines and Ritalin may interfere with each other. Some of these
medicines include:
medicines that increase blood pressure
warfarin, a medicine used to prevent blood clots
medicines for epilepsy (fits)
medicines for depression, such as tricyclic antidepressants and MAO
inhibitors
phenylbutazone
guanethidine
You may need to take different amounts of your medicines or you may need to
take different medicines.
Your doctor and pharmacist have more information on medicines to be careful
with or avoid while taking Ritalin.
How to take Ritalin
Follow the directions given to you by your doctor and pharmacist carefully.
These directions may differ from the information contained in this leaflet.
If you do not understand the instructions on the label, ask your doctor or
pharmacist for help.
How much to take
Children: the usual starting dose is 5 mg (half a tablet) once or twice each
day. If necessary, the dose can be increased by 5 or 10
mg each week up to a maximum of 60 mg (6 tablets) each day.
Adults: the usual dose is 20 to 30 mg (2-3 tablets) each day but some people
may need more or less than that. The maximum
dose is 60 mg (6 tablets) each day.
When to take it
Take the tablets in 2 or 3 doses over the day unless your doctor tells you
otherwise.
Each dose is usually taken 1 or 2 hours before the greatest effect is
needed. For example, a child may take a dose at 7.00 a.m.
so that improved behaviour begins when school starts. If the child tends to
misbehave during the lunchtime play period, the next
dose can be taken before the lunch break.
If you find that this medicine keeps you from sleeping, talk to your doctor
about the best time to take the last dose of the day.
How to take it
Take the tablets with a full glass of water or other liquid. If the tablets
upset your stomach, you can take them with food.
Always take the tablets in the same way (eg. always with food or always
without food).
That way the effect will always be the same.
If the dose is one-half tablet, there is a break-line on the tablet to help
you cut it. You can buy a tablet cutter from your pharmacist
to make sure the dose is accurate.
How long to take it
Continue taking Ritalin for as long as your doctor tells you to.
Ritalin helps to control your symptoms but it does not cure your condition.
Your doctor will check your progress to make sure the
medicine is working and will discuss with you how long your treatment should
continue. If you are unsure, talk to your doctor.
During treatment for ADHD, Ritalin is usually stopped every so often (eg.
over weekends, school holidays and long vacation) to see
whether it is still needed. Breaks from treatment also help to prevent a
slow-down in growth that sometimes happens when
children take Ritalin for a long time.
If you forget to take it
Take the dose as soon as you remember. Then make sure to wait the same
amount of time as usual before you take the next
dose.
For example, if there are usually 4 hours between doses, wait 4 hours before
taking the next dose and so on for the rest of that
day. On the next day go back to your usual times.
Do not take a double dose to make up for the one that you missed.
If you have trouble remembering when to take your medicine, ask your
pharmacist for some hints.
If you take too much (Overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone
13 11 26) for advice, or go to accident and emergency
at your nearest hospital if you think that you or anyone else may have taken
too much Ritalin. Do this even if there are no signs of
discomfort or poisoning.
Keep the telephone numbers for these places handy.
Symptoms of an overdose may include vomiting, agitation, headache, tremors,
muscle twitching, irregular heart beat, flushing,
fever, sweating, dilated pupils, breathing problems, confusion and seizures.
While you are taking Ritalin
Things you must do
- Take Ritalin exactly as your doctor has prescribed.
Like all stimulants, Ritalin may become habit-forming and can be abused by
some people. If you take it correctly as instructed by
your doctor, abuse or dependence should not be a problem, either now or
later in life.
Be sure to keep all of your doctor's appointments so that your progress can
be checked.
Your doctor will want to check your blood pressure and do blood tests from
time to time to prevent unwanted side effects from
happening.
- If you become pregnant while taking Ritalin, tell your doctor.
Your doctor can discuss with you the risks and benefits of taking it while
you are pregnant.
- If you are about to be started on any new medicine, remind your doctor and
pharmacist that you are taking Ritalin.
- Tell any other doctor, dentist or pharmacist who treats you that you are
taking Ritalin.
Things you must not do
- Do not stop your treatment without first checking with your doctor.
If you suddenly stop taking this medicine, your condition may reappear or
you may get unwanted effects such as depression. To
prevent this, your doctor may want to gradually reduce the amount of
medicine you take each day before stopping it completely.
- Do not take Ritalin to treat any other complaints unless your doctor tells
you to.
- Do not give this medicine to anyone else, even if their symptoms seem to
be similar to yours.
Things to be careful of
- Be careful driving, operating machinery or doing jobs that require you to
be alert while you are taking Ritalin until you know how it
affects you.
This medicine may cause dizziness, drowsiness or blurred vision in some
people. If you have any of these symptoms, do not drive
or do anything else that could be dangerous.
- Be careful when drinking alcohol while you are taking Ritalin.
Drinking alcohol during treatment with Ritalin is not recommended because
alcohol can worsen some of the unwanted effects of
Ritalin such as dizziness and drowsiness.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking Ritalin.
All medicines can have side effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment
if you get some of the side effects.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following side effects and they
worry you:
nausea (feeling sick), vomiting or abdominal pain
loss of appetite, which can lead to loss of weight or slower growth in
children
feeling nervous or unable to sleep
dry mouth
headache
drowsiness
dizziness
mood changes such as depression or irritability
blurred vision or problems focussing your eyes
muscle cramps
hair loss
Stomach upset, loss of appetite and difficulty sleeping are common,
especially at the start of treatment. Your doctor can usually
help to reduce these symptoms by lowering the dose of Ritalin or changing
the times when the tablets are taken.
Tell your doctor immediately if you notice any of the following:
signs of allergy such as swelling of the face, lips or tongue; shortness of
breath, wheezing or troubled breathing
rash, itching, red blotches, blisters or pealing of the skin
sudden increase in body temperature, sweating, fast heart beat, muscle
stiffness and fluctuating blood pressure, which may
lead to coma
constant "flu-like" symptoms such as chills, fever, sore throat, swollen
glands, aching muscles or joints
unusual bleeding or bruising
unusual tiredness, shortness of breath when exercising, dizziness, pale
skin
uncontrollable twitching, jerking or writhing movements
seizures (fits)
pain or tightness in the chest
fast or irregular heart beat, changes in blood pressure
yellow colour to the skin or eyes, dark coloured urine or light coloured
bowel motions
confusion or hallucinations (seeing or feeling things that are not really
there)
severe or persistent headache
These side effects may be serious. You may need urgent medical attention.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may happen in some people.
After taking Ritalin
Storage
Keep your tablets in the original container until it is time to take them.
Store the tablets in a cool dry place.
Do not store Ritalin or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines. Ritalin will keep well if it
is cool and dry.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good
place to store medicines.
Disposal
If your doctor tells you to stop taking Ritalin or the tablets have passed
their expiry date, ask your pharmacist what to do with any
that are left over.
Product description
What it looks like
Ritalin 10 mg: round white tablet, marked CG on one side and AB with a
break-line on the other; packs of 100 tablets.
Ingredients
Ritalin tablets contain 10 mg of methylphenidate hydrochloride as the active
ingredient.
They also contain:
lactose
calcium phosphate
gelatin
magnesium stearate
talc-purified
starch-wheat
Australian Registration Number: Ritalin 10 mg tablet AUST R 11052
Sponsor
Ritalin is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ACN 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Telephone 1-800-671-203
This leaflet was prepared in August 1998
rtl088c.cur based on PI (rtl088i.cur)
"John" <wh...@whaleto.freeserve.co.uk> wrote in message
news:8gd8ah$tkr$1...@newsg3.svr.pol.co.uk...
I sincerely appreciate your posting the links to both the Ritalin
toxicology study and the warning letter. Thank you.
My opinion on attention-deficit hyperactivity disorder is posted at
http://doctoryourself.com/adhd.html and
http://doctoryourself.com/nerves.html
The viewpoints of an M.D. with over 45 years experience as a
psychiatrist and researcher are posted at
http://doctoryourself.com/hoffer_paradigm.html
http://doctoryourself.com/hoffer_editorial.html
http://doctoryourself.com/hoffer_JOM.html
http://doctoryourself.com/hoffer_psychosis.html
Personal emails on this subject are welcome. I have no financial
connection to the supplement industry, incidently.
--
Over 120 articles (indexed by topic, or keyword with an on-site
search engine) plus hundreds of scientific references on nutritional
therapeutics are posted at http://doctoryourself.com Links to other
clinical nutrition and alternative medicine sites are provided.
In article <q72ois8tg1k0q5bsi...@4ax.com>,
j...@cyber-mall.com wrote:
> On Wed, 24 May 2000 12:52:46 GMT, Dr. S. <drs...@juno.com> wrote:
>
> >Whew! Thank you for the post. One may add (or is that "adhd," in
child
> >psych lingo) the possible side effect of Ritalin-induced cancer,
which
> >has been so thoroughly demonstrated in mice that a couple of years
ago,
>
> Oh, you mean the 1995 NIH study?
>
> It's at http://ntp-server.niehs.nih.gov/htdocs/LT-studies/tr439.html.
>
> The FDA letter you refer to is at
> Http://www.fda.gov//bbs/topics/ANSWERS/ANS00705.html.
>
> >the US government sponsored a mailing warning of this to over 100,000
> >US pediatricians. No such mailing was made to patients' families.
>
> Do you suppose the fact that the causative link is so tenuous might
have
> something to do with it? Or the fact that the rare, non-fatal liver
tumors have
> occurred *only* in lab rodents that develop tumors readily? Or
perhaps that
> there have been no cancers in humans related to the use of
methylphenidate?
>
> Joe Parsons
>
> ==========================================================
> Frequently Asked Questions for alt.support.attn-deficit
> and other resources for dealing with attention deficit
> disorder are at http://www.cyber-mall.com/asad/
>
--
All charm aside, I think the small but demonstrated carcingenic
potential of Ritalin deserves increased in caution, and more
consideration of safer alternatives.
My opinion on alternatives for attention-deficit hyperactivity disorder
The viewpoints of an M.D. with over 45 years experience as a
psychiatrist and researcher are posted at
http://doctoryourself.com/hoffer_paradigm.html
http://doctoryourself.com/hoffer_editorial.html
http://doctoryourself.com/hoffer_JOM.html
http://doctoryourself.com/hoffer_psychosis.html
Personal emails on this subject are welcome. I have no financial
connection to the supplement industry, incidently.
--
Over 120 articles (indexed by topic, or keyword with an on-site
search engine) plus hundreds of scientific references on nutritional
therapeutics are posted at http://doctoryourself.com Links to other
clinical nutrition and alternative medicine sites are provided.
In article <8ghm3a$iik$1...@slb7.atl.mindspring.net>,
"CBI" <c_ish...@mindspring.com> wrote:
> That's why I never, ever, give Ritalin to rodents. Just to be safe.
>
> --
> CBI, M.D.
>
> Please note: It is impossible to accurately diagnose medical problems
> without seeing the patient and reviewing the entire history. These
posts are
> intended to be helpful and informative. Always check with your doctor
before
> following any advice given.
>
Additional viewpoint posted at:
http://doctoryourself.com/hoffer_paradigm.html
http://doctoryourself.com/hoffer_editorial.html
http://doctoryourself.com/hoffer_JOM.html
http://doctoryourself.com/hoffer_psychosis.html
--
Over 120 articles (indexed by topic, or keyword with an on-site
search engine) plus hundreds of scientific references on nutritional
therapeutics are posted at http://doctoryourself.com Links to other
clinical nutrition and alternative medicine sites are provided.
In article <392C087C...@bc.cc.ca.us>,
Chris Leithiser <clei...@bc.cc.ca.us> wrote:
> "Dr. S." wrote:
> >
> > Whew! Thank you for the post. One may add (or is that "adhd," in
child
> > psych lingo) the possible side effect of Ritalin-induced cancer,
which
> > has been so thoroughly demonstrated in mice that a couple of years
ago,
> > the US government sponsored a mailing warning of this to over
100,000
> > US pediatricians. No such mailing was made to patients' families.
> >
>
> The FDA also noted that the kind of liver tumor found in mice is
> extremely rare in people, and its occurrence in recent years has not
> increased despite an increase in the use of Ritalin.
>
> They called the research results a "weak signal." By contrast,
> secondhand smoke is a "strong signal" indicator as a cause of
> cancer...and the government didn't send a warning to parents either.
>
However, I think that a reevaluation of the studies you mentioned was
done and achieved a higher confidence level. May I suggest a look at
or email to
http://www.smokefreeair.org or smok...@usa.net for confirmation
and additional information?
(Personal emails on this subject are welcome, especially if I do not
respond to postings promptly enough.)
--
Over 120 articles (indexed by topic, or keyword with an on-site
search engine) plus hundreds of scientific references on nutritional
therapeutics are posted at http://doctoryourself.com Links to other
clinical nutrition and alternative medicine sites are provided.
In article <NrYW4.32231$S31.6...@newsread2.prod.itd.earthlink.net>,
kurtu...@yahoo.com (Kurt Ullman) wrote:
> In article <392C087C...@bc.cc.ca.us>, Chris Leithiser
> <clei...@bc.cc.ca.us> wrote:
>
> >They called the research results a "weak signal." By contrast,
> >secondhand smoke is a "strong signal" indicator as a cause of
> >cancer...and the government didn't send a warning to parents either.
>
> Yeah, but second hand smoke did not become a strong signal before the
feds
> cooked the books. They were caught after their big pronouncement a
few years
> ago of changing the confidence interval to 90%. It wasn't significant
at 95%
> (which is the CI used by almost all of the studies that the
prnouncement was
> based on.)
>
> ----------------------------------------------------------------------
-------
> "People everywhere confuse what they read in the newspapers
with news."
> -A.J. Liebling
>
Sent via Deja.com http://www.deja.com/
Before you buy.
My opinion on attention-deficit hyperactivity disorder is posted at
The viewpoints of an M.D. with over 45 years experience as a
psychiatrist and researcher are posted at
http://doctoryourself.com/hoffer_paradigm.html
http://doctoryourself.com/hoffer_editorial.html
http://doctoryourself.com/hoffer_JOM.html
http://doctoryourself.com/hoffer_psychosis.html
Personal emails on this subject are welcome. I have no financial
connection to the supplement industry, incidently.
--
Over 120 articles (indexed by topic, or keyword with an on-site
search engine) plus hundreds of scientific references on nutritional
therapeutics are posted at http://doctoryourself.com Links to other
clinical nutrition and alternative medicine sites are provided.
--
Over 120 articles (indexed by topic, or keyword with an on-site
search engine) plus hundreds of scientific references on nutritional
therapeutics are posted at http://doctoryourself.com Links to other
clinical nutrition and alternative medicine sites are provided.
In article <4A2X4.5674$DH3....@news1.eburwd1.vic.optushome.com.au>,
--
Over 120 articles (indexed by topic, or keyword with an on-site
search engine) plus hundreds of scientific references on nutritional
therapeutics are posted at http://doctoryourself.com Links to other
clinical nutrition and alternative medicine sites are provided.
Very good. You can paste-and-copy out of the PDR. Can you _read_ the
PDR as well?
You might check out some of the known side-effects of, say, aspirin. Or
Tylenol.
I'm glad to know you wouldn't give Ritalin to your child. That's
something that should only be done under a doctor's prescription.
And by the way--it's safe and works very well in many cases of ADHD,
when administered under a doctor's prescription. Have a nice day.
All have had the opportunity, since it's on the package insert available
at any pharmacy.
Actually read? Damned few, of course. Damned few read the warning
labels on the cough syrup they give, too. Or the Advil and Tylenol
bottles.
Good thing Ritalin's such a benign substance, then.
You're so right. It is indeed bad that some folks are so
uninformed--more to the point, misinformed--about Ritalin and ADHD.
Much of the active misinformation comes straight from the cult of
$cientology, which believes a) that they are spiritually descended from
seafood, and b) that when they starved Lisa McPherson to death over 17
days at the Fort Harrison hotel in Clearwater, Florida, it was a
"protected religious practice."
They also believe that many of mankind's ills stem from an incident
75,000,000 years ago when Xenu the evil dictator nuked trillions of
souls on Earth's volcanoes, then tortured them by forcing the recaptured
souls to watch "Battlefield Earth*" again and again for three days until
they clumped together into "body thetans." These ghostly aliens must be
removed from your body, at a high cost per alien, before you can
exercise your godlike powers over Matter, Energy, Space, and Time.
Which is _another_ reason I don't trust them for pharmaceutical advice.
YMMV, right "Tools?"
*(OK, I was kidding about this part. BE hadn't even been filmed yet at
that time. Rest assured it will be one of the standard torture tools in
any _future_ galactic dictator's tool kit.)
What, you thought he was out? Let's go to the videotape.
Yes, "safe." As in "millions of satisfied users, a track record of
decades, not a single reported case of addiction resulting from
medicinal use. "Safe" as in "recognized and controllable side-effects
much less than many other, commonly-prescribed medications.
To misquote Arthur Dent, "This is obviously some strange usage of the
word 'safe' that you weren't previously aware of?"