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FDA News
FOR IMMEDIATE RELEASE
P07-26
February 21, 2007 |
Media Inquiries:
Sandy Walsh, 301-827-6242
Consumer Inquiries:
888-INFO-FDA |
FDA Directs ADHD Drug Manufacturers to Notify Patients about
Cardiovascular Adverse Events and Psychiatric Adverse Events
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 concerns.
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 factors.
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 product.
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
ADDERALL
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 among others.
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 taking Adderall.
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 1990.
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 States alone.
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 society.
While Dr.
Canavan was Chairman of Whyeth-Ayerst Laboratories, Whyeth-Ayerst
Laboratories begins marketing the diet drug Fen-Phen.
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
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Adderall
Description:
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 |
10 mg |
20 mg |
| Dextroamphetamine Saccharate |
2.5 mg |
5 mg |
| Amphetamine Aspartate |
2.5 mg |
5 mg |
| Dextroamphetamine Sulfate USP |
2.5 mg |
5 mg |
| Amphetamine Sulfate USP |
2.5 mg |
5 mg |
| Total amphetamine base equivalence |
6.3 mg |
12.6 mg |
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.
Clinical Pharmacology:
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 involved.
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.
Agitated states.
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 from nursing.
Precautions:
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.
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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 significant lassitude.
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 amphetamines.
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.
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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.
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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 methenamine therapy.
Norepinephrine: Amphetamines enhance the adrenergic effect of
norepinephrine.
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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 anticonvulsant action.
Propoxyphene: In most cases of Propoxyphene overdosage, amphetamine CNS stimulation is potential and fatal convulsions can occur.
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.
Allergic: Urticaria.
Endocrine: Impotence, changes in Libido.
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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 necessarily fatal.
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.
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