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The physician’s psychoactive medication resource guide
25% of your patients taking an antidepressant will have
weight gain and the weight gain is directly caused by the antidepressant.
Handling Adderall side effects or for that matter the symptoms of ADD/ADHD is easy. A
supplement called Admax is quickly replacing Adderall as the study drug on college campuses,
however, Admax is not a drug! Admax was used by the Russian Olympic Team when they
began winning gold medal after gold medal in the 1960s. This is also why the Russian
Cosmonauts were able to stay in outer space longer than their American counterparts. If you
need the affect, without the drug related problems, try Admax and see and feel the difference.
We do not sell supplements, the Admax can be found at TRB Health. Click here and you will
taken directly to their Admax page.
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and read How to Get Off Psychoactive Drugs safely from Amazon.com Click here.
The U.S. Food and Drug Administration (FDA) today directed the manufacturers of all drug
products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to
develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of
adverse psychiatric symptoms associated with the medicines, and to advise them of
precautions that can be taken.
"Medicines approved for the treatment of ADHD have real benefits for many patients but they
may have serious risks as well," said Steven Galson, M.D., Director, Center for Drug Evaluation
and Research (CDER). "In our ongoing commitment to strengthen drug safety, FDA is working
closely with manufacturers of all ADHD medicines to include important information in the
product labeling and in developing new Patient Medication Guides to better inform doctors and
patients about these concerns."
Patient Medication Guides are handouts given to patients, families and caregivers when a
medicine is dispensed. The guides contain FDA-approved patient information that could help
prevent serious adverse events. Patients being treated with ADHD products should read the
information before taking the medication and talk to their doctors if they have any questions or
ADHD is a condition that affects approximately 3 percent to 7 percent of school-aged children
and approximately 4 percent of adults. The three main symptoms are inattention, hyperactivity,
and impulsivity. People with ADHD may have difficulty in school, troubled relationships with
family and peers, and low self-esteem.
An FDA review of reports of serious cardiovascular adverse events in patients taking usual
doses of ADHD products revealed reports of sudden death in patients with underlying serious
heart problems or defects, and reports of stroke and heart attack in adults with certain risk
Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for
drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no
reason, or becoming manic, even in patients who did not have previous psychiatric problems.
FDA recommends that children, adolescents, or adults who are being considered for treatment
with ADHD drug products work with their physician or other health care professional to develop
a treatment plan that includes a careful health history and evaluation of current status,
particularly for cardiovascular and psychiatric problems (including assessment for a family
history of such problems).
As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed
manufacturers of these products to revise product labeling for doctors to reflect concerns about
adverse cardiovascular and psychiatric events. These changes were based on
recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk
Management Advisory Committee. To help patients understand these risks, an additional part of
this revised labeling process is the creation of a Patient Medication Guide for each individual
The medicines that are the focus of the revised labeling and new Patient Medication Guides
include the following 15 products:
•Adderall (mixed salts of a single entity amphetamine product) Tablets
•Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
•Concerta (methylphenidate hydrochloride) Extended-Release Tablets
•Daytrana (methylphenidate) Transdermal System
•Desoxyn (methamphetamine HCl) Tablets
•Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
•Focalin (dexmethylphenidate hydrochloride) Tablets
•Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
•Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
•Methylin (methylphenidate hydrochloride) Oral Solution
•Methylin (methylphenidate hydrochloride) Chewable Tablets
•Ritalin (methylphenidate hydrochloride) Tablets
•Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
•Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
•Strattera (atomoxetine HCl) Capsules
The draft Patient Medication Guides for each product can be found at http://www.fda.gov/cder/drug/infopage/ADHD/default.htm. For
more information please visit www.fda.gov.
WASHINGTON Feb 10, 2006 (AP)— Concerned about the risk of sudden death or serious injury associated with Ritalin and other
stimulants used to treat attention deficit hyperactivity disorder, a federal advisory panel says the drugs should carry the most serious
type of warning label.
The proposed "black box" warning would inform doctors, patients and parents of the uncertainty regarding the risk the drugs may pose
to the cardiovascular system. The warnings could be rescinded if future studies fail to definitely establish any risk, officials said.
The surprise recommendation has caught the Food and Drug Administration off guard. The regulatory agency isn't obliged to follow the
advice of its outside panels of experts but it generally does.
Its first move probably will be to ask another of its advisory committees to study the issue further in March.
The FDA also may undertake short-term studies into the effect of the drugs on blood pressure, heart rate and the heart muscle itself,
said Dr. Peter Gross, chairman of the FDA's Drug Safety and Risk Management advisory committee, which eventually did outline its
thoughts on how to study the drugs.
First, however, the committee voted 8-7 to recommend requiring black box warnings on methylphenidates, which are sold as Ritalin,
Concerta, Methylin and Metadate.
Ritalin is made by Novartis Pharmaceuticals Corp.; Concerta by Johnson & Johnson; Methylin by Mallinckrodt Pharmaceuticals; and
Metadate by UCB.
The labels for the stimulants Adderall and Adderall XR, both amphetamines made by Shire Pharmaceuticals, have included the
warnings since 2004.
An earlier 15-0 vote was to recommend the drugs include a medication guide for patients and parents. There was one abstention on
each of the late Thursday votes.
"The committee plainly wanted to tell us certain things ought to be in labeling in a more forceful way," Dr. Robert Temple, director of the
FDA's Office of Medical Policy, told reporters after the votes.
Gross said most of his colleagues on the panel believe their role is to protect the public.
Canada Regulators Order ADD Drug Withdrawn Click here
Manufactured by Shire Pharmaceuticals
Please Do Not Quit Taking ADDERALL Cold Turkey. It is Not Safe to Suddenly Stop Taking This Medication!
ADDERALL is an amphetamine class drug most commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children,
adolescents and adults. The generic brand is dextroamphetamine. This class of Stimulant drug can be extremely harmful to your child
and cause side effects such as: inhibit growth, drug dependency, suicidal ideation, weight loss, insomnia, anxiety, agitation, depression
Canada Regulators Order ADD Drug Withdrawn
By THE ASSOCIATED PRESS
Filed at 9:04 a.m. ET February 10, 2005
TORONTO (AP) -- "Canadian regulators ordered a drug for attention deficit hyperactivity disorder off the market late Wednesday
because of reports that it has been linked to 20 sudden deaths and a dozen strokes, including some among children.
The U.S. Food and Drug Administration, however, said it had evaluated the same reports and doesn't believe the data warranted such
action in the United States. In a statement late Wednesday, Health Canada said it is asking makers of related stimulants used to treat
the commonly diagnosed condition to provide a thorough review of their worldwide safety data.
None of the deaths or strokes associated with Adderall XR were reported in Canada, department spokesman Ryan Baker said.
``However, Health Canada has received eight reports of adverse reactions ranging in severity from convulsions to minor skin rash,''
Baker said. ``It's not been determined yet whether these reactions were a result of Adderall XR use.''
Of the 20 cases of sudden death linked to the drug, 14 were in children. Two of the 12 strokes were suffered by children taking the
drug. The adverse reactions were not associated with overdose, misuse or abuse of the drug, the department said."
Should we be surprised? The maker of Adderall had only manufactured calcium before hiring the person at the helm of the Fen-Phen
scandal. They instantly begin manufacturing ADHD medications and turn from losing a million dollars a year to making billions.
This Web Site disagrees with the Psychiatry DSM IV criteria for diagnosing ADD or ADHD as a "mental disorder." However, we are not
implying that children or adults may not have difficulty learning, concentrating or completing task etc. There might be a problem but it
can be addressed without mind altering and addictive medication.
Ideally before you put you or your child on Adderall, you will explore at least a few other options. Diet can make a difference in many
and supplements can make a difference as well. These will treat the symptom, not the cause. The cause can be varied but one thing is
certain, it is not a deformed brain or a chemical imbalance. Ask your doctor for a blood test or any test to show you there is a chemical
imbalance and you will see a blank stare.
Physician's take an oath, "Above all do no harm." We must use that same oath as a parent and for ourselves if we are thinking of
I am not saying Adderall does not make some children calm and able to sit in their chair calmly. When they grow into puberty is is a
stimulant. Adderall can cause enlargement of the heart as well.
All medications come with side effects. You and your physician must decide risk/reward. If your physician prescribed Adderall to you or
your child after a 15 minute office visit, RUN FOR THE DOOR. This is your child's life or your life.
Adderall for adults now. Larger adult market for Adderall, more profit. Before you take Adderall, look at the background of the company
making Adderall. Their first drug was Dextrostat for ADHD.
Before that, they made calcium. Lost around $8,000,000 a year before hiring the executive who helped push Fen/Phen.
The manufacture of Dextrostat is Shire Pharmaceuticals of the United Kingdom. Since 1986 when Shire was founded, Shire's only
claim (emphasis) to fame before Dextrostat was manufacturing a Calcium Supplement sold only in the United Kingdom.
On 11 December 2000, Shire entered into an agreement to merge with BioChem Pharma Inc. Dextrostat and Adderall now have a 38%
market share in the United States.
Who is the on the Board Of Directors of Shire?
Dr. Canavan. The good Doctor joined Shire in 1994 after leaving American Home Products and American Home Product's
Pharmaceutical Company "Whyeth-Ayerst Laboratories." Dr. Canavan was Chairman of Whyeth-Ayerst Laboratories from 1987 to June
What significance does this have with Shire?
Shire Pharmaceutical list American Home Products as a partner in their business. American Home Products is the company that
manufactured and directed the marketing of the drug Fenfluramine and Dexfenfluramine also known as Fen/Phen. The Food and Drug
Administration, acting on new evidence about significant side-effects associated with Fen/Phen, has asked the manufactures to remove
it from the market (September 1997). Fen/Phen was used to help with obesity. The drug was also marketed under the name Redux.
The Fen/Phen drug causes damage to the heart, mainly the heart valve. In July 1997, the Mayo Clinic reported 24 cases of a rare
valvular disease in women who took Fen/Phen. The drug Fen/Phen has had an effect on an estimated 11 million people in the United
In November 1997, the United States Department of Health and Human Services announced "anyone who used Fen/Phen should see
a physician to see if there are signs of heart or lung disease". The Centers for Disease Control (CDC) and National Institutes of Health
(NIH) also announced the same recommendation.
What has been American Home Product's response to this?
Offer anyone who has taken the drug a free checkup. If you opt for the free checkup you must sign a waiver from all further damages
against American Home Products if your checkup is negative. The problem with this, symptoms do not always show up early after
taking this drug.
Several Class Action Law Suits have been filed against American Home Products. In December 1999, a jury in Mississippi has
awarded claimants millions in damages from American Home Products.
What do you think Shire Pharmaceutical will do after Dextrostat has caused suicides, addiction and a host of health problems. Dr.
Canavan and the Companies he has been associated with have already shown that they will not take responsibility for their effects on
While Dr. Canavan was Chairman of Whyeth-Ayerst Laboratories, Whyeth-Ayerst Laboratories begins marketing the diet drug Fen-
Adderall (another drug in the same class as Dextrostat) and Dextrostat account for 63% of all revenue for Shire Pharmaceuticals.
Before the introduction of these two drugs by Shire they were losing MILLIONS of dollars every year. Now they Net MILLIONS.
If you must use Adderall, help protect yourself or your child from the damage? Click Here
A single entity amphetamine product combining the neutral salts of dextroamphetamine and amphetamine, with the dextro isomer of
amphetamine saccharate and d, I-amphetamine aspartate. Each tablet contains:
TABLE 1 -
Each tablet contains
Dextroamphetamine Sulfate USP
Amphetamine Sulfate USP
Total amphetamine base equivalence
Inactive ingredients: sucrose, lactose, corn starch, acacia and magnesium stearate.
Colors: Adderall 10 mg contains FD & C Blue #1
Adderall 20 mg contains FD & C Yellow #6 as a color additive.
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevation of
systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action. Drugs of this class used in obesity are
commonly known as ``anorectics'' or ``anorexigenics''. It has not been established, however, that the action of such drugs in treating
obesity is primarily one of appetite suppression. For example, other central nervous system actions or metabolic effects may be
There is neither specific evidence which clearly establishes the mechanism whereby amphetamine produces mental and behavioral
effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system
dysfunction may or may not be warranted.
Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known
hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase inhibitors (Hypertensive crises may result).
Clinical experience suggests that in psychotic children, administration of amphetamine may exacerbate symptoms of behavior
disturbance and thought disorder.
Usage in Nursing Mothers: Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain
Caution is to be exercised in prescribing amphetamine for patients with mild hypertension.
Information for the Patient
Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or
vehicles; the patient should therefore be cautioned accordingly.
Drug/Laboratory Test Interactions
•Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening.
•Amphetamines may interfere with urinary steroid determinations.
Carcinogenesis/Mutagenesis: Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of
Amphetamine, have not been performed.
Pregnancy - Teratogenic Effects, Pregnancy Category C: Amphetamine has been shown to have embryotoxic and teratogenic effects
when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects
were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum
human dose. There are no adequate and well-controlled studies in pregnant women. Amphetamines should be used during pregnancy
only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects: Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low
birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and
Pediatric Use: Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended
for use as anorectic agents in children under 12 years of age.
Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics
and Tourette's syndrome in children and their families should precede use of stimulant medications.
Acidifying agents: Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower
absorption of amphetamines.
Urinary acidifying agents: (ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the
amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines.
Adrenergic blockers: Adrenergic blockers are inhibited by amphetamines.
Alkalinizing agents: Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Urinary
alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine
molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the actions of
Antidepressants, tricyclic: Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with
Desipramine or Protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of
d=amphetamine in the brain; cardiovascular effects can be potentiated.
MAO inhibitors: MAOI antidepressants, as well as a metabolite of Furazolidone, slow amphetamine metabolism. This slowing
potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve
endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant
hyperpyrexia can occur, sometimes with fatal results.
Antihistamines: Amphetamines may counteract the sedative effect of antihistamines.
Antihypertensives: Amphetamines may antagonize the hypotensive effects of antihypertensives.
Chlorpromazine: Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of
amphetamines, and can be used to treat amphetamine poisoning.
Ethosuximide: Amphetamines may delay intestinal absorption of Ethosuximide.
Haloperidol: Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines.
Lithium carbonate: The antiobesity and stimulatory effects of amphetamines may be inhibited by lithium carbonate.
Meperidine: Amphetamines potentiate the analgesic effect of Meperidine.
Methenamine therapy: Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in
Norepinephrine: Amphetamines enhance the adrenergic effect of norepinephrine.
Phenobarbital: Amphetamines may delay intestinal absorption of Phenobarbital; co-administration of Phenobarbital may product a
synergistic anticonvulsant action.
Phenytoin: Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic
Propoxyphene: In most cases of Propoxyphene overdosage, amphetamine CNS stimulation is potential and fatal convulsions can
Veratrum alkaloids: Amphetamines inhibit the hypertensive effect of veratrum alkaloids.
Cardiovascular: Palpitation, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated
with chronic amphetamine use.
Central nervous system: Over stimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic
episodes at recommended doses.
Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.
Endocrine: Impotence, changes in Libido.
Drug Abuse and Dependence:
Dextroamphetamine sulfate is a Schedule II controlled substance.
Amphetamines have been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have
occurred. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following
prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG.
Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity, and
personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from
schizophrenia. This is rare with oral amphetamines.
Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as
low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe reactions, yet doses of 400 to 500 mg are not
In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg.
Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rapid respiration, confusion,
assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomolysis.
Fatigue and depression usually follow the central stimulation.
Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse.
Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by
convulsions and coma.
Consult with a Certified Poison Control Center for up to date guidance and advice. Management of acute amphetamine intoxication is
largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic and sedation.
Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine
increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute, severe
hypertension complicates amphetamine overdosage, administration of intravenous Phentolamine (Regitine, CIBA) has been
suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved. Chlorpromazine
antagonizes the central stimulant effects of amphetamines and can be used to treat amphetamine intoxication.
Dosage and Administration:
Regardless of indication, amphetamines should be administered at the lowest effective dosage and dosage should be individually
adjusted. Late evening doses should be avoided because of the resulting insomnia.