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Latest News:
SSRI Antidepressants May Up Stroke Risk After Menopause
Date
Published: Thursday, December 17th, 2009
Post-menopausal women taking
selective serotonin reuptake inhibitor (SSRI) antidepressants
have a small, though statistically higher risk of stroke, according to a
newly published study. SSRIs include the drugs Prozac, Paxil, Zoloft,
Lexapro, and Celexa.
Antidepressant use in the US has more than quintupled since
the early 1990s, and SSRIs have replaced older medications called
tricyclic antidepressants, which can be toxic the heart. According to a
press release announcing this latest study, SSRI antidepressants have
fewer side effects in general and are known to have aspirin-like effects
on bleeding, which could protect against clot-related cardiovascular
disorders. But not much is known about how SSRIs affect the heart. This
is especially true in the case of postmenopausal women, who are at
increased risk for both heart disease and depression.
The study, which was published in the December 14 Archives of
Internal Medicine, involved 136,000 participants in the
Women’s Health Initiative (WHI). None of
the women were taking antidepressants when they enrolled in the WHI.
The women included in the analysis had their first follow-up
visit either one or three years after enrolling in WHI. At that time,
5,500 women reported taking either tricyclic or SSRI antidepressants.
After six years, there was no association between antidepressant use and
heart disease. However, researchers did find that women taking SSRIs had
a 45 percent increase in risk of stroke and a 32 percent increase in
risk of dying from any cause during follow up, compared with nonusers.
Use of older tricyclic antidepressants wasn’t linked to stroke, but it
did increase by 67 percent the risk of death during follow-up.
The authors of the study said it wasn’t clear if the
increased risk was the result of antidepressants or depression itself.
Depression is a known risk factor for cardiovascular problems.
“There are a lot of things this study couldn’t tell us, such
as whether this risk truly is attributable to the drugs and not to
depression itself and whether participants were being treated for
depression or for anxiety, which also has cardiovascular risks,” Jordan
W. Smoller, MD, ScD, of the Massachusetts General Hospital (MGH)
Department of Psychiatry, the study’s lead author, said in a press
release. “We also don’t know whether there is any similar association in
younger women or in men, since they were not part of this study.”
The authors of the study called for more research into the
relationship between antidepressants and death.
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March 23
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A Mix of Medicines That Can Be Lethal
By JANE E. BRODY
Published:
February 27, 2007
The death of Libby Zion, an 18-year-old college student, in a New York
hospital on March 5, 1984, led to a highly publicized court battle and
created a cause célèbre over the lack of supervision of inexperienced and
overworked young doctors. But only much later did experts zero in on the
preventable disorder that apparently led to Ms. Zion’s death: a form of drug
poisoning called serotonin syndrome.
Ms. Zion, who went to the hospital with a fever of 103.5, had been taking a
prescribed antidepressant, phenelzine (Nardil). The combination of
phenelzine and the narcotic painkiller meperidine (Demerol) given to her at
the hospital could raise the level of circulating serotonin to dangerous
levels. When she became agitated, a symptom of serotonin toxicity, and tried
to pull out her intravenous tubes, she was restrained, and the resulting
muscular tension is believed to have sent her fever soaring to lethal
heights.
Now, with the enormous rise in the use of serotonin-enhancing
antidepressants, often taken in combination with other drugs that also raise
serotonin levels, emergency medicine specialists are trying to educate
doctors and patients about this not-so-rare and potentially life-threatening
disorder. In March 2005, two such specialists, Dr. Edward W. Boyer and Dr.
Michael Shannon of Children’s Hospital Boston, noted that more than 85
percent of doctors were “unaware of the serotonin syndrome as a clinical
diagnosis.”
In their review in The New England Journal of Medicine, Dr. Boyer and Dr.
Shannon cited a report based on calls to poison control centers around the
country in 2002 showing 7,349 cases of serotonin toxicity and 93 deaths. (In
2005, the last year for which statistics are available, 118 deaths were
reported.)
The experts fear that failure to recognize serotonin syndrome in its mild or
early stages can result in improper treatment and an abrupt worsening of the
condition, leading to severe illness or death. Even more important, in hopes
of preventing it, they want doctors — and patients — to know just what drugs
and drug combinations can cause serotonin poisoning.
A Diagnostic Challenge
Serotonin syndrome was first described in medical literature in 1959 in a
patient with tuberculosis who was treated with meperidine. But it wasn’t
given its current name until 1982.
Recognizing the early signs is tricky because it has varying symptoms that
can be easily confused with less serious conditions, including tremor,
diarrhea, high blood pressure, anxiety and agitation. The examining
physician may regard early symptoms as inconsequential and may not think to
relate them to drug therapy, Dr. Boyer and Dr. Shannon noted.
In its classic form, serotonin syndrome involves three categories of
symptoms:
¶Cognitive-behavioral symptoms like confusion, disorientation, agitation,
irritability, unresponsiveness and anxiety.
¶Neuromuscular symptoms like muscle spasms, exaggerated reflexes, muscular
rigidity, tremors, loss of coordination and shivering.
¶ Autonomic nervous system symptoms like fever,
profuse sweating, rapid heart rate, raised blood pressure and dilated
pupils.
Widespread ignorance of the syndrome is another diagnostic impediment. But
even when doctors know about it, the strict diagnostic criteria may rule out
“what are now recognized as mild, early or subacute stages of the disorder,”
Dr. Boyer and Dr. Shannon wrote.
Perhaps adding to the diagnostic challenge is the fact that a huge number of
drugs — prescription, over the counter, recreational and herbal — can
trigger the syndrome. In addition to selective serotonin reuptake inhibitors
like Zoloft, Prozac and Paxil and serotonin/norepinephrine reuptake
inhibitors like Effexor, the list includes tricyclic antidepressants and
MAOIs (for monoamine oxidase inhibitors); narcotic painkillers like fentanyl
and tramadol; over-the-counter cough and cold remedies containing
dextromethorphan; the anticonvulsant valproate; triptans like Imitrex used
to treat and prevent migraines; the antibiotic Zyvox (linezolide);
antinausea drugs; the anti-Parkinson’s drug L-dopa; the weight-loss drug
Meridia (sibutramine); lithium; the dietary supplements tryptophan, St.
John’s wort and ginseng; and several drugs of abuse, including ecstasy, LSD,
amphetamines, the hallucinogens foxy methoxy and Syrian rue.
Although serotonin poisoning can be caused by an antidepressant overdose, it
more often results from a combination of an S.S.R.I. or MAOI with another
serotonin-raising substance. Patients at particular risk, some experts say,
are those taking combinations of antidepressant and antipsychotic drugs
sometimes prescribed to treat resistant depression. All it may take is a
small dose of another serotonin-inducing drug to cause the syndrome.
One patient, a 45-year-old Bostonian, had been taking four drugs to treat
depression when he had surgery on an ankle last December. He developed
several classic signs of serotonin syndrome while in the recovery room,
where he had been given fentanyl when the anesthetic wore off.
As described by his wife, he suddenly developed tremors and violent shaking
and started cracking his teeth. He was moved to the intensive care unit,
where he thrashed and flailed, was oblivious to those around him, and had to
be restrained to keep from pulling out his tubes. Two weeks later, he was
still in intensive care and still very confused, despite being taken off all
medications that could have caused his symptoms.
Serotonin syndrome can occur at any age, including in the elderly, in
newborns and even in dogs. Since 1998, the poison control center at the
American Society for the Prevention of Cruelty to Animals has gotten more
than a thousand reports of the ingestion of antidepressant medications by
dogs, which can develop symptoms rapidly and die. The syndrome can also
occur weeks after a serotonin-raising drug has been discontinued.
Some drugs remain active in the body for weeks, and the MAOIs disable an
enzyme involved in serotonin metabolism that does not recover until weeks
after the drugs are stopped.
Prevention and Treatment
Most cases of serotonin syndrome are mild and resolved within 24 hours. But
if the doctor fails to recognize them and prescribes either a larger dose of
a serotonin enhancer or another serotonin-raising drug, the consequences can
be rapid and severe.
Most important to preventing the syndrome is for patients to give each of
their doctors a complete list of drugs they regularly take — including
prescriptions, over-the-counter medication, dietary supplements and
recreational drugs — before a doctor prescribes something new.
Indeed, if you are taking any of the drugs described above, you might ask
whether a new prescription is safe. And when filling a new prescription,
it’s not a bad idea to also ask the pharmacist whether the medication, or an
over-the-counter remedy you are considering, is safe to combine with any
other drugs you take.
Once the syndrome develops, the first step is to stop the offending drugs.
It is crucial to seek immediate care, preferably in a hospital. Most cases
require only treatment of symptoms like agitation, elevated blood pressure
and body temperature, and a tincture of time.
More severe cases are treated with drugs that inhibit
serotonin and chemical sedation. Dr. Boyer and Dr. Shannon cautioned against
using physical restraints to control agitation because they could enforce
isometric muscle contractions that cause a severe buildup of lactic acid and
a life-threatening rise in body temperature.
Prozac
side effects
Body
Prozac side
effects
Dry Mouth
- The
usual amount to moisture in the mouth is noticeably less.
Prozac
side
effects
Sweating
Increased -
A large
quantity of perspiration that is medically caused.
Prozac side
effects
Cardiovascular (Involving the heart and the blood
vessels)
Prozac
side
effects
Palpitation
- Unusual and not normal heartbeat,
that is sometimes irregular, but rapid and forceful thumping or fluttering.
It can be brought on by shock, excitement, exertion, or medical stimulants.
A person is normally unaware of his/her heartbeat.
Prozac
side effects
Hypertension
- is high blood pressure, which is a
symptom of disease in the blood vessels leading away from the heart.
Hypertension is known as the “silent killer”. The symptoms are usually not
obvious, however it can lead to damage to the heart, brain, kidneys and eye, and
even to stroke and kidney failure. Treatment includes dietary and lifestyle
changes.
Prozac side effects
Bradycardia
-
The heart rate is slowed from 72 beats per minute,
which is normal, to below 60 beats per minute in an adult.
Prozac side
effects
Tachycardia
- The heart rate is speeded up to
above 100 beats per minute in an adult. Normal adult heart rate is 72
beats per minute.
Prozac
side effects
ECG
Abnormal
-
A test
called an electrocardiogram (ECG) that records the activity of the heart.
It measures heartbeats as will as the position and size of the heart’s four
chambers. It also measures if there is damage to the heart and the effects of
drugs or mechanical devices like a pacemaker on the heart. When the test
is abnormal this means that one or more of the following are present: heart
disease, defects, beating too fast or too slow, disease of the blood vessels
leading from the heart or of the heart valves, and/or a past or about to occur
heart attack.
Lexapro
side effects
Flushing
- The skin all over the body turns red.
Prozac side effects
Varicose Vein - Unusually swollen veins
near the surface of the skin that sometimes appear twisted and knotted, but
always enlarged. They are called hemorrhoids when they appear around the
rectum. The cause is attributed to hereditary weakness in the veins
aggravated by obesity, pregnancy, pressure from standing, aging, etc.
Severe cases may develop swelling in the legs, ankles and feet, eczema and/or
ulcers in the affected areas.
Prozac
side effects
Gastrointestinal
(Involving
the stomach and the intestines)
Prozac side effects
Abdominal Cramp/Pain
-
Sudden, severe, uncontrollable and painful shortening and
thickening of the muscles in the belly. The belly includes the stomach as
well as the intestines, liver, kidneys, pancreas, spleen, gall bladder, and
urinary bladder.
Prozac side effects
Belching
- Noisy release of gas from the stomach through the mouth; a burp.
Prozac
side effects
Bloating
- Swelling of the belly caused by excessive intestinal gas.
Prozac side effects
Constipation -
Difficulty in having a bowel movement where the material in the bowels is
hard due to a lack of exercise, fluid intake, and roughage in the diet, or due
to certain drugs.
Prozac side effects
Diarrhea - Unusually frequent and excessive, runny bowel movements that may
result in severe dehydration and shock.
Prozac side
effects
Dyspepsia - Indigestion. This is the discomfort you experience after eating.
It can be heartburn, gas, nausea, a bellyache or bloating.
Prozac side effects
Flatulence
- More gas than normal in the digestive organs.
Prozac side effects
Gagging
- Involuntary choking and/or involuntary throwing up.
Prozac side effects
Gastritis
- A severe irritation of the mucus lining of the stomach either short in
duration or lasting for a long period of time.
Prozac side effects
Gastroenteritis
-
A condition where the membranes
of the stomach and intestines are irritated.
Prozac
side effects
Gastroesophageal
Reflux - A
continuous state where stomach juices flow back into the throat causing acid
indigestion and heartburn and possibly injury to the throat.
Prozac
side effects
Heartburn
- A burning pain in the area of the breastbone caused by stomach juices flowing
back up into the throat.
Prozac side effects
Hemorrhoids - Small rounded
purplish swollen veins that either bleed, itch or are painful and appear around
the anus.
Prozac side effects
Increased Stool frequency
-
Diarrhea.
Prozac
side effects
Indigestion
- Unable to properly consume and absorb food in the digestive tract causing
constipation, nausea, stomach ache, gas, swollen belly, pain and general
discomfort or sickness.
Prozac side effects
Nausea - Stomach irritation with a queasy sensation similar to
motion sickness and a feeling that one is going to vomit.
Prozac
side effects
Polyposis
Gastric
- Tumors that grow on stems in the lining of the stomach, which usually become
cancerous.
Prozac side effects
Swallowing Difficulty
- A feeling that food is stuck in the throat or upper chest area and won’t go
down, making it difficult to swallow.
Prozac side effects
Toothache
- Pain in a tooth above and below the gum line.
Prozac side effects
Vomiting
- Involuntarily throwing up the contents of the stomach and usually getting a
nauseated, sick feeling just prior to doing so.
Prozac side
effects
General
Prozac side effects
Allergy -
The extreme
sensitivity of body tissues triggered by substances in the air, drugs, or foods
causing a reaction like sneezing, itching, asthma, hay fever, skin rashes,
nausea and/or vomiting.
Prozac side effects
Anaphylaxis
- A violent, sudden, and severe drop
in blood pressure caused by a re-exposure to a foreign protein or a second
dosage of a drug that may be fatal unless emergency treatment is given right
away.
Prozac side effects
Asthenia
-
A physically
weak condition.
Prozac side
effects
Chest
Pains
-
Severe discomfort in the chest caused by not enough oxygen going to the heart
because of narrowing of the blood vessels or spasms.
Prozac side
effects
Chills
-
Appearing
pale while cold and shivering; sometimes with a fever.
Prozac side effects
Edema of
Extremities
-
Abnormal
swelling of the body’s tissue caused by the collection of fluid.
Prozac side effects
Fall
- To suddenly lose your normal
standing upright position as if you were shot.
Prozac side
effects
Fatigue
- Loss of normal strength so as to
not be able to do the usual physical and mental activities.
Prozac side
effects
Fever
- Abnormally high body temperature,
the normal being 98 degrees Fahrenheit or 37 degrees Centigrade in humans, which
is a symptom of disease or disorder in the body. The body is affected by
feeling hot, chilled, sweaty, weak and exhausted. If the fever goes too
high, death can result.
Prozac side
effects
Hot
Flashes
-
Brief,
abnormal enlargement of the blood vessels that causes a sudden heat sensation
over the entire body. Women in menopause will sometimes experience this.
Prozac side
effects
Influenza-like
Symptoms -
Demonstrating irritation of the respiratory tract (organs of breathing) such as
a cold, sudden fever, aches and pains, as well as feeling weak and seeking bed
rest, which is similar to having the flu.
Prozac side
effects
Leg Pain
- A
hurtful sensation in the legs that is caused by excessive stimulation of the
nerve endings in the legs and results in extreme discomfort.
Prozac side effects
Malaise -
The somewhat
unclear feeling of discomfort you get when you start to feel sick.
Prozac side
effects
Pain in
Limb
-
Sudden, sharp and uncontrolled leg discomfort.
Prozac side
effects
Syncope
-
A short
period of light headedness or unconsciousness (black-out) also know as fainting
caused by lack of oxygen to the brain because of an interruption in blood
flowing to the brain.
Prozac side effects
Tightness
of Chest -
Mild or sharp discomfort, tightness
or pressure in the chest area (anywhere between the throat and belly). The
causes can be mild or seriously life-threatening because they include the heart,
lungs and surrounding muscles.
Prozac side
effects
Hemic and Lymphatic Disorders
(Involving
the blood and the clear fluids in the tissues that contain white blood cells)
Prozac side effects
Bruise
- Damage to the skin resulting in a
purple-green-yellow skin coloration that’s caused by breaking the blood vessels
in the area without breaking the surface of the skin.
Prozac side
effects
Anemia
-
A condition
where the blood is no longer carrying enough oxygen, so the person looks pale
and easily gets dizzy, weak and tired. More severely, a person can end up
with an abnormal heart, as well as breathing and digestive difficulties.
The causes of anemia are not enough protein in the red blood cells, or missing
and chemically destroyed red blood cells, as well as diseased or destroyed bone
marrow.
Prozac side effects
Nosebleed
- Blood lost from the part of the
face that has the organs of smell and is where the body takes in oxygen.
Prozac side
effects
Hematoma
- Broken blood vessels that cause a
swelling in an area on the body.
Prozac side
effects
Lymphadenopathy
Cervical
-
The lymph
nodes in the neck, which are part of the body’s immune system get swollen and
enlarge by reacting to the presence of a drug. The swelling is the result
of the white blood cells multiplying in order to fight the invasion of the drug.
Prozac side
effects
Metabolic and Nutritional Disorders
(Energy
and health)
Prozac side
effects
Arthralgia
-
Sudden sharp
nerve pain in one or more joints.
Prozac side
effects
Arthropathy
- Having joint disease or abnormal
joints.
Prozac side
effects
Arthritis
-
Painfully inflamed and swollen joints. The
reddened and swollen condition is brought on by a serious injury or shock to the
body either from physical or emotional causes.
Prozac
side effects
Back
Discomfort
- Severe physical distress in the area from the neck to the pelvis along the
backbone.
Prozac side effects
Bilirubin Increased
- Bilirubin is a waste product of the breakdown
of old blood cells. Bilirubin is sent to the liver to be made
water-soluble so it can be eliminated from the body through emptying the
bladder. A drug can interfere with or damage this normal liver function
creating liver disease.
Prozac side effects
Decreased Weight
- Uncontrolled and measured loss of heaviness or weight.
Prozac
side effects
Gout
- A severe arthritis condition that is caused by the dumping of a waste product
called uric acid in the tissues and joints. It can become worse and cause
the body to develop a deformity after going through stages of pain,
inflammation, severe tenderness, and stiffness.
Prozac side effects
Hepatic Enzymes Increased - An increase in the amount of paired liver proteins that
regulate liver processes causing a condition where the liver functions
abnormally.
Prozac side effects
Hypercholesterolemia
- Too much cholesterol in the blood cells.
Prozac
side effects
Hyperglycemia
- An unhealthy amount of sugar in the blood.
Prozac side effects
Increased Weight - A concentration and storage of fat in the body
accumulating over a period of time caused by unhealthy eating patterns, that can
predispose the body to many disorders and diseases.
Prozac
side effects
Jaw Pain - The pain due to irritation and swelling of the nerves associated with
the mouth area where it opens and closes just in front of the ear. Some of
the symptoms are pain when chewing, head aches, losing your balance, stuffy ears
or ringing in the ears, and teeth grinding.
Prozac side effects
Jaw Stiffness
- The result of squeezing and grinding the teeth while asleep that can cause
your teeth to deteriorate as well as the muscles and joints of the jaw.
Prozac
side effects
Joint
Stiffness
- A loss of free motion and easy flexibility where any
two bones come together.
Prozac side effects
Muscle Cramp - When muscles contract uncontrollably without warning and do not relax.
The muscles of any of the body’s organs can cramp.
Prozac
side effects
Muscle
Stiffness
- Tightening of muscles making it difficult to bend.
Prozac
side effects
Muscle
Weakness
- Loss of physical strength.
Prozac side
effects
Myalgia - A general widespread pain and tenderness of the muscles.
Prozac side
effects
Thirst
- A strong,
unnatural craving for moisture/water in the mouth and throat.
Prozac side
effects
Nervous System (Sensory channels)
Prozac side effects
Carpal
Tunnel Syndrome - A
pinched nerve in the wrist that causes pain, tingling, and numbing.
Prozac side effects
Coordination Abnormal - A lack of normal, harmonious interaction of the parts of
the body when it is in motion.
Prozac side effects
Dizziness - Losing one’s balance while feeling unsteady and lightheaded which may
lead to fainting.
Prozac
side effects
Disequilibrium
- Lack of mental and emotional balance.
Prozac side effects
Faintness - A temporary condition where one is likely to go
unconscious and fall.
Prozac side effects
Headache - A sharp or dull persistent pain in the head
Prozac side
effects
Hyperreflexia - A not normal and involuntary increased response in the
tissues connecting the bones to the muscles.
Prozac
side effects
Light-headed
Feeling –
Uncontrolled and usually brief loss of consciousness caused by lack of oxygen to
the brain.
Prozac
side effects
Migraine
- Reoccurring severe head pain usually with nausea, vomiting, dizziness, flashes
or spots before the eyes, and ringing in the ears
Prozac side effects
Muscle Contractions Involuntary
- Spontaneous and uncontrollable tightening reaction of the muscles caused by
electrical impulses from the nervous system.
Prozac side
effects
Muscular Tone Increased - Uncontrolled and exaggeration muscle tension.
Muscles are normally partially tensed and this is what gives us muscle tone.
Prozac side
effects
Paresthesia - Burning, prickly, itchy, or tingling skin with no obvious or
understood physical cause.
Prozac side effects
Restless Legs
- A need to move the legs without any apparent reason. Sometimes there is
pain, twitching, jerking, cramping, burning, or a creepy-crawly sensation
associated with the movements. It worsens when a person is inactive and
can interrupt one’s sleep so one feels the need to move to gain some relief.
Prozac
side effects
Shaking
- Uncontrolled quivering and trembling as if one is cold and chilled.
Prozac
side effects
Sluggishness
- Lack of alertness and energy, as well as being slow to respond or perform in
life.
Prozac side effects
Tics - A contraction of a muscle causing a repeated movement not
under the control of the person usually on the face or limbs.
Prozac
side effects
Tremor
- A nervous and involuntary vibrating or quivering of the body.
Prozac side effects
Twitching - Sharp, jerky and spastic motion sometimes with a
sharp sudden pain.
Prozac
side effects
Vertigo
- A sensation of dizziness with disorientation and confusion.
Prozac side
effects
Psychiatric Disorders (Mental and emotional)
Prozac side effects
Aggravated Nervousness
- A progressively worsening, irritated and troubled state of mind.
Prozac
side effects
Agitation
- Suddenly violent and forceful, emotionally disturbed state of mind.
Prozac side effects
Amnesia - Long term or short term, partial or full memory loss created by
emotional or physical shock, severe illness, or a blow to the head where the
person was caused pain and became unconsciousness.
Prozac
side effects
Anxiety
Attack
- Sudden and intense feelings of fear, terror, and dread physically creating
shortness of breath, sweating, trembling and heart palpitations.
Prozac side effects
Apathy
- Complete lack of concern or interest for things that ordinarily would be
regarded as important or would normally cause concern.
Prozac
side effects
Appetite
Decreased - Having a
lack of appetite despite the ordinary caloric demands of living with a resulting
unintentional loss of weight.
Prozac
side effects
Appetite
Increased - An
unusual hunger causing one to overeat.
Prozac
side effects
Auditory
Hallucination -
Hearing things without the voices or noises being present.
Prozac side
effects
Bruxism -
Grinding and clenching of teeth while sleeping.
Prozac side effects
Carbohydrate
Craving - A drive
and craving to eat foods rich in sugar and starches (sweets, snacks and junk
foods) that intensifies as the diet becomes more and more unbalanced due to the
unbalancing of the proper nutritional requirements of the body.
Prozac side effects
Concentration Impaired
- Unable to easily focus your attention for long periods of time.
Prozac
side effects
Confusion
- Not able to think clearly and understand in order to make a logical decision.
Prozac
side effects
Crying
Abnormal
- Unusual and not normal fits of weeping for short or long periods of time for
no apparent reason.
Prozac side effects
Depersonalization
- A condition where one has lost a normal sense of personal identity.
Prozac
side effects
Depression
- A hopeless feeling of failure, loss and sadness that can deteriorate into
thoughts of death.
Prozac
side effects
Disorientation
- A loss of sense of direction, place, time or surroundings as well as mental
confusion on personal identity.
Prozac
side effects
Dreaming
Abnormal
- Dreaming that leaves a very clear, detailed picture and impression when awake
that can last for a long period of time and sometimes be unpleasant.
Prozac
side effects
Emotional
Lability
- Suddenly breaking out
in laughter or crying or doing both without being able to control the outburst
of emotion. These episodes are unstable as they are caused by things that
normally would not have this effect on an individual.
Prozac side effects
Excitability - Uncontrollably responding to stimuli.
Prozac side effects
Feeling Unreal - The awareness that one has an undesirable emotion like
fear but can’t seem to shake off the irrational feeling. For example,
feeling like one is going crazy but rationally knowing that it is not true.
The quality of this side effect resembles being in a bad dream and not being
able to wake up.
Prozac
side effects
Forgetfulness
- Unable to remember what one ordinarily would remember.
Prozac
side effects
Insomnia
- Sleeplessness caused by physical stress, mental stress or stimulants such as
coffee or medications; it is a condition of being abnormally awake when one
would ordinarily be able to fall and remain asleep.
Prozac
side effects
Irritability
- Abnormally annoyed in response to a stimulus.
Prozac side effects
Jitteriness - Nervous fidgeting without an apparent cause.
Prozac
side effects
Lethargy
- Mental and physical sluggishness and apathy that can deteriorate into an
unconscious state resembling deep sleep. A numbed state of mind.
Prozac
side effects
Libido
Decreased
- An abnormal loss of sexual energy or desire.
Prozac side effects
Panic Reaction
- A sudden, overpowering, chaotic and confused mental state of terror resulting
in being doubt ridden often accompanied with hyperventilation, and extreme
anxiety.
Prozac
side effects
Restlessness
Aggravated - A
constantly worsening troubled state of mind characterized by the person being
increasingly nervous, unable to relax, and easily angered.
Prozac side
effects
Somnolence - Feeling sleepy all the time or having a condition of
semi-consciousness.
Prozac
side effects
Suicide
Attempt
- An unsuccessful deliberate attack on one’s own life with the intention of
ending it.
Prozac
side effects
Suicidal
Tendency
- Most likely will attempt to kill oneself.
Prozac side effects
Tremulousness
Nervous - Very
jumpy, shaky, and uneasy while feeling fearful and timid. The condition is
characterized by thoughts of dreading the future, involuntary quivering,
trembling, and feeling distressed and suddenly upset.
Prozac side effects
Yawning - involuntary opening of the mouth with deep inhalation of
air.
Prozac side
effects
Reproductive Disorder Female
Prozac side
effects
Breast
Neoplasm
-
A tumor or cancer, of either of the two milk-secreting
organs on the chest of a woman.
Prozac side
effects
Menorrhagia
- Abnormally heavy menstrual period or a
menstrual flow that has continued for an unusually long period of time.
Prozac side
effects
Menstrual
Cramps
- Painful, involuntary uterus contractions that women experience around the time
of their menstrual period, sometimes causing pain in the lower back and thighs.
Prozac side
effects
Menstrual
Disorder - A disturbance or derangement in the normal function of a woman’s
menstrual period.
Prozac side
effects
Pelvic
Inflammation - The reaction of the body to infectious, allergic, or chemical
irritation, which in turn causes tissue irritation, injury, or bacterial
infection characterized by pain, redness, swelling, and sometimes loss of
function. The reaction usually begins in the uterus and spreads to the
fallopian tubes, ovaries, and other areas
in the hipbone region of the body.
Prozac side
effects
Premenstrual
Syndrome - Various physical and mental symptoms commonly experienced by women of
childbearing age usually 2 to 7 days before the start of their monthly period.
There are over 150 symptoms including eating binges, behavioral changes,
moodiness, irritability, fatigue, fluid retention, breast tenderness, headaches,
bloating, anxiety, and depression. The symptoms cease shortly after the
period begins, and disappear with menopause.
Prozac side
effects
Spotting
Between Menses - Abnormal bleeding between periods. Unusual spotting
between menstrual cycles.
Prozac side
effects
RESPIRATORY SYSTEM
(Organs involved in breathing)
Prozac side
effects
Asthma
- A disease of the breathing system initiated by and allergic reaction
or a chemical with repeated attacks of coughing, sticky mucus, wheezing,
shortness of breath, and a tight feeling in the chest. The disease can
reach a state where it stops a person from exhaling, leading to unconsciousness
and death.
Prozac side
effects
Breath
Shortness
-
Unnatural breathing using a lot off effort resulting in not enough air taken in
by the body.
Prozac side
effects
Bronchitis
- Inflammation of the two main
breathing tubes leading from the windpipe to the lungs. The disease is
marked with coughing, a low-grade fever, chest pains, and hoarseness, caused by
an allergic reaction.
Prozac side
effects
Coughing
- A cough is the response to an
irritation, such as mucus, that causes the muscles controlling the breathing
process to expel air from the lungs suddenly and noisily to keep the air
passages free from the irritating material.
Prozac side
effects
Laryngitis
- Inflammation of the voice box
characterized by hoarseness, sore throat, and coughing. It can be cause by
straining the voice or exposure to infectious, allergic or chemical irritation.
Prozac side
effects
Nasal
Congestion
- The
presence of an abnormal amount of fluid in the nose.
Prozac side
effects
Pneumonia
Tracheitis - Bacterial infection of the air passageways and lungs that causes
redness, swelling and pain in the windpipe. Other symptoms are high fever,
chills, pain in the chest, difficulty in breathing, and coughing with mucus
discharge.
Prozac side
effects
Rhinitis
- Chemical irritation causing pain,
redness and swelling in the mucus membranes of the nose.
Prozac side
effects
Sinus
Congestion
- The
mucus-lined areas of the bones in the face that are thought to help warm and
moisten air to the nose. These areas become clogged with excess fluid or
infected.
Prozac side
effects
Sinus
Headache
- The
abnormal amount of fluid in the hollows of the face bone area especially around
the nose. This excess fluid creates pressure, causing pain in the head.
Prozac side
effects
Sinusitis
- The body reacting to chemical
irritation causing redness, swelling and pain in the area of the hollows in the
facial bones especially around the nose.
Prozac side
effects
SKELETAL
Prozac side effects
Neck/Shoulder Pain
- Hurtful sensations
of the nerve endings caused by damage to the tissues in the neck and shoulder
signaling danger of disease.
Prozac side
effects
SKIN and APPENDAGES DISORDERS (Skin, legs and arms)
Prozac side
effects
Acne
- Eruptions of the oils glands of the
skin, especially on the face, marked by pimples, blackheads, whiteheads, bumps,
and more severely, by cysts and scarring.
Prozac side effects
Alopecia -
The loss of hair or baldness.
Prozac side
effects
Eczema
- A severe or continuing skin disease
marked by redness, crusting and scaling with watery blisters and itching.
It is often difficult to treat and will sometimes go away only to reappear
again.
Prozac side
effects
Dermatitis
- Generally irritated skin that can
be caused by any of a number of irritating things such as parasites, fungus,
bacteria, or foreign substances
causing an allergic reaction. It is a general inflammation of the
skin.
Prozac side
effects
Dry Lips
- The
lack of normal moisture in the fleshy folds that surround the mouth.
Prozac side effects
Dry Skin - The lack of normal moisture/oils in the
surface layer of the body. The skin is the body’s largest organ.
Prozac side effects
Folliculitis
-
Inflammation of a follicle (small body sac) especially a hair follicle. A
hair follicle contains the root of a hair.
Prozac side effects
Furunculosis - Skin boils that show up repeatedly.
Prozac side effects
Lipoma - A tumor of mostly fat cells that is not health
endangering.
Prozac side effects
Pruritus
- Extreme itching of often-undamaged skin.
Prozac side effects
Rash - A skin eruption or discoloration that may or may not be
itching, tingling, burning, or painful. It may be caused by an allergy, an
skin irritation, a skin disease.
Prozac side effects
Skin Nodule - A bulge, knob, swelling or outgrowth in the skin
that is a mass of tissue or cells.
Prozac side effects
SPECIAL SENSES
Prozac side effects
Conjunctivitis
- Infection of the membrane that covers the eyeball and lines the eyelid, caused
by a virus, allergic reaction, or an irritating chemical. It is
characterized by redness, a discharge of fluid and itching.
Prozac side effects
Dry Eyes - Not enough moisture in the eyes.
Prozac side effects
Earache - Pain in the ear.
Prozac side effects
Eye Infection
- The invasion of the eye tissue by a bacteria, virus, fungus, etc, causing
damage to the tissue, with toxicity. Infection spreading in the body
progresses into disease.
Prozac side effects
Eye Irritation
- An inflammation of the eye.
Prozac side effects
Metallic Taste
- A range of taste impairment from distorted taste to a complete loss of taste.
Prozac side effects
Pupils Dilated
- Abnormal expansion of the blace circular opening in the center of the eye.
Prozac side effects
Taste alteration
- Abnormal flavor detection in food.
Prozac side effects
Tinnitus - A buzzing, ringing, or whistling sound in one or
both ears occurring from the internal use of certain drugs.
Prozac side effects
Vision Abnormal
- Normal images are seen differently by the viewer.
Prozac side effects
Vision Blurred
- Eyesight is dim or indistinct and hazy in outline or appearance.
Prozac side effects
Visual Disturbance
- Eyesight is interfered with or interrupted. Some disturbances are light
sensitivity and the inability to easily distinguish colors.
Prozac side
effects
URINARY SYSTEM DISORDER
Prozac side
effects
Blood in
Urine
-
Blood is present when one empties liquid waste product of the kidneys through
the bladder by urinating in the toilet turning the water pink to bright red.
Or you could see pots of blood in the water after urinating.
Prozac side
effects
Dysuria
- Difficult or painful urination.
Prozac side
effects
Kidney
Stone
- Small hard masses of salt deposits that the kidney forms.
Prozac side
effects
Urinary
Frequency - Having to urinate more often than usual or between unusually short
time periods.
Prozac side
effects
Urinary
Tract Infection - An invasion of bacteria, viruses, fungi, etc., of the
system in the body that starts with the kidneys and eliminates urine from the
body. If the invasion goes unchecked it can injure tissue and progress
into disease.
Prozac side
effects
Urinary
Urgency
- A sudden compelling urge to urinate, accompanied by discomfort in the bladder.
Prozac side
effects
UROGENITAL (Urinary tract and genital structures or functions)
Prozac side
effects
Anorgasmia
- Failure to experience an orgasm.
Prozac side
effects
Ejaculation
Disorder - Dysfunction of the discharge of semen during orgasm.
Prozac side
effects
Menstrual
Disorder - Dysfunction of the discharge during the monthly menstrual cycle.
Prozac side effects
Acute
Renal Failure - The
kidneys stop functioning properly to excrete wastes.
Prozac side effects
Angioedema
- Intensely itching and swelling welts on the skin called hives caused by an
allergic reaction to internal or external agents. The reaction is common
to a food or a drug. Chronic cases can last for a long period of time.
Prozac side
effects
Toxic
Epidermal Necrolysis - An abnormal condition where a large portion of skin
becomes intensely red and peels off like a second-degree burn. Often the
symptoms include blistering.
Prozac side
effects
Gastrointestinal
Hemorrhage - Stomach and intestinal excessive internal bleeding.
Prozac side effects
Grand Mal
Seizures (or Convulsions)
- A recurring sudden violent and involuntary attack of muscle spasms with a loss
of consciousness.
Prozac side effects
Neuroleptic Malignant Syndrome
- A life threatening, rare reaction to an anti-psychotic drug marked by fever,
muscular rigidity, changed mental status, and dysfunction of the autonomic
nervous system.
Prozac side effects
Pancreatitis - Chemical irritation with redness, swelling, and
pain in the pancreas where digestive enzymes and hormones are secreted.
Prozac side effects
QT Prolongation
- A very fast heart rhythm disturbance that is too fast for the heart to beat
effectively so the blood to the brain falls causing a sudden loss of
consciousness and may cause sudden cardiac death.
Prozac side effects
Rhabdomyolysis
- The breakdown of muscle fibers that releases the fibers into the circulatory
system. Some of the fibers are poisonous to the kidney and frequently
result in kidney damage.
Prozac side effects
Serotonin Syndrome
- A disorder brought on by excessive levels of serotonin caused by drugs and can
be fatal as death from this side effect can come very rapidly.
Prozac side effects
Thrombocytopenia
- An abnormal decrease in the number of blood platelets in the circulatory
system. A decrease in platelets would cause a decrease in the ability of the
blood to clot when necessary.
Prozac side effects
Torsades de Pointes
- Unusual rapid heart rhythm starting in the lower heart chambers. If the
short bursts of rapid heart rhythm continue for a prolonged period it can
degenerate into a more rapid rhythm and can be fatal.
Prozac
Clinical Trials
Drug-induced Brugada syndrome.
Yap YG, Behr ER, Camm AJ.
Europace. 2009 May 29. [Epub ahead of print]
PMID: 19482855 [PubMed - as supplied
by publisher]
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David DJ, Samuels BA, Rainer Q, Wang JW, Marsteller
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AM, Gerald C, Antonijevic IA, Leonardo ED, Hen R.
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Kim SH, Lee J, Yoon T, Choi J, Choi D, Kim D, Kwon
SW.
Biomed Chromatogr. 2009 May 27. [Epub ahead of
print]
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Henz SL, Cognato GD, Vuaden FC, Bogo MR, Bonan CD,
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Arch Oral Biol. 2009 May 25. [Epub ahead of print]
PMID: 19473651 [PubMed - as supplied
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Continuous Fluoxetine Administration Prevents
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Zhu SP, Mao ZF, Huang J, Wang JY.
Clin Exp Pharmacol Physiol. 2009 Mar 26. [Epub
ahead of print]
PMID: 19473340 [PubMed - as supplied
by publisher]
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Cardiac sympathetic activity in stress-induced
(Takotsubo) cardiomyopathy.
Prasad A, Madhavan M, Chareonthaitawee P; Medscape.
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Ahrold TK, Meston CM.
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Relative Cost-Effectiveness of Treatments for
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Domino ME, Foster EM, Vitiello B, Kratochvil CJ,
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J Am Acad Child Adolesc Psychiatry. 2009 May 20.
[Epub ahead of print]
PMID: 19465880 [PubMed - as supplied
by publisher]
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Why are physicians reluctant to use estrogens for
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Studd J.
Menopause Int. 2009 Jun;15(2):52-4.
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fluoxetine treatment.
Korff S, Stein DJ, Harvey BH.
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Epub 2009 Feb 6.
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Pharmacokinetics and pharmacodynamics of
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cortex.
Qu Y, Aluisio L, Lord B, Boggs J, Hoey K, Mazur C,
Lovenberg T.
Pharmacol Biochem Behav. 2009 May;92(3):469-73.
Epub 2009 Feb 5.
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Lack of in vitro interactions using human liver
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circadian system.
Cuesta M, Clesse D, Pévet P, Challet E.
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by publisher]
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High resolution micro-SPECT scanning in rats using
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Cain SM, Ruest T, Pimlott S, Patterson J, Duncan R,
Dewar D, Sills GJ.
Epilepsia. 2009 May 9. [Epub ahead of print]
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Mirtazapine: a review of its use in major depression
and other psychiatric disorders.
Croom KF, Perry CM, Plosker GL.
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Utility of atypical antipsychotics in the treatment
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Debattista C, Hawkins J.
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[Efficacy and safety of selective serotonin
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Zhonghua Nan Ke Xue. 2009 Mar;15(3):248-55.
Chinese.
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Placental transfer of SSRI and SNRI antidepressants
and effects on the neonate.
Rampono J, Simmer K, Ilett KF, Hackett LP, Doherty
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2009 May 18.
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Potentially inappropriate medication prescribing in
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health records.
Buck MD, Atreja A, Brunker CP, Jain A, Suh TT,
Palmer RM, Dorr DA, Harris CM, Wilcox AB.
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Behavioral abnormality and pharmacologic response in
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Koike H, Ibi D, Mizoguchi H, Nagai T, Nitta A,
Takuma K, Nabeshima T, Yoneda Y, Yamada K.
Behav Brain Res. 2009 Aug 24;202(1):114-21. Epub
2009 Mar 31.
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Depression in children and adolescents.
Hazell P.
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Pediatric generalized anxiety disorder:
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Keeton CP, Kolos AC, Walkup JT.
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[Effects of chronic fluoxetine treatment on
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[No authors listed]
Zh Vyssh Nerv Deiat Im I P Pavlova. 2009
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Fluoxetine treatment affects nitrogen waste
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Morando MB, Medeiros LR, McDonald MD.
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Binding of CYP2C9 with diverse drugs and its
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Wang JF, Yan JY, Wei DQ, Chou KC.
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Monoaminergic neurotransmission: the history of the
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Ascorbic acid administration produces an
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Free article at journal site
5-HT1A receptor antagonism reverses and prevents
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Zhou Z, Zhen J, Karpowich NK, Law CJ, Reith ME,
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Quantitative evaluation of serotonin release and
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Jin Y, Lim CM, Kim SW, Park JY, Seo JS, Han PL,
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Serotonin stimulates platelet receptor shedding by
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Role of dopamine transporters in the behavioral
effects of 3,4-methylenedioxymethamphetamine (MDMA) in nonhuman primates.
Fantegrossi WE, Bauzo RM, Manvich DM, Morales JC,
Votaw JR, Goodman MM, Howell LL.
Psychopharmacology (Berl). 2009 May 7. [Epub ahead
of print]
PMID: 19421742 [PubMed - as supplied
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Effect of Date of Drug Marketing on
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Pariente A, Daveluy A, Laribière-Bénard A,
Miremont-Salame G, Begaud B, Moore N.
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10.2165/00002018-200932050-00007.
PMID: 19419238 [PubMed - in process]
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[Combining Antidepressants: a Useful Strategy for
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Schmauß M, Messer T.
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Pediatric antidepressant use after the black-box
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Busch SH, Barry CL.
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Novel sequence variations in the brain-derived
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Licinio J, Dong C, Wong ML.
Arch Gen Psychiatry. 2009 May;66(5):488-97.
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Cifani C, Zanoncelli A, Tessari M, Righetti C, Di
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Addict Biol. 2009 Apr 28. [Epub ahead of print]
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Fluoxetine potentiates the effects of
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Horm Behav. 2009 Jun;56(1):177-184. Epub 2009 May
3.
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Berman RM, Fava M, Thase ME, Trivedi MH, Swanink R,
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CNS Spectr. 2009 Apr;14(4):197-206.
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Pediatric depression: issues and treatment
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Orosomucoid influences the response to
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Lee LJ.
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4.
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Sloot WN, Bowden HC, Yih TD.
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Qi H, Ma J, Liu YM, Yang L, Peng L, Wang H, Chen
HZ.
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Food restriction and streptozotocin differentially
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Gamma-aminobutyric acid amides of nortriptyline and
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Rephaeli A, Gil-Ad I, Aharoni A, Tarasenko I,
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J Med Chem. 2009 May 14;52(9):3010-7.
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Mazza M, Mazza O, Pomponi M, Di Nicola M, Padua L,
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The change in plasma GABA, glutamine and glutamate
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Küçükibrahimoğlu E, Saygın MZ, Calışkan M, Kaplan
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Escitalopram versus other antidepressive agents for
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Choi YJ.
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Chronic psychotropic drug treatment causes
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Schwarz AJ, Gozzi A, Bifone A.
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Serotonin, social status and sex change in the
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Lorenzi V, Carpenter RE, Summers CH, Earley RL,
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Mennigen JA, Harris EA, Chang JP, Moon TW, Trudeau
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Cooperative opioid and serotonergic mechanisms
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Berrocoso E, Mico JA.
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BL, Magolda R, Pangalos MN, Schechter LE, Rosenzweig-Lipson S, Andree TH.
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Novotny P.
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Clonazepam as a therapeutic adjunct to improve the
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Morishita S.
Hum Psychopharmacol. 2009 Apr;24(3):191-8.
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The SNRI venlafaxine improves emotional unawareness
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Cravello L, Caltagirone C, Spalletta G.
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[Epub ahead of print]
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Teratogenesis associated with antibipolar agents.
Nguyen HT, Sharma V, McIntyre RS.
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Development of an in-capillary approach to nanoscale
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patients.
Vieta E, Berk M, Wang W, Colom F, Tohen M,
Baldessarini RJ.
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Double-blind placebo-controlled trial of fluoxetine
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Cornelius JR, Bukstein OG, Wood DS, Kirisci L,
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Engin E, Treit D, Dickson CT.
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Incidence of major malformations in infants
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Einarson A, Choi J, Einarson TR, Koren G.
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Ramirez AJ, Brain RA, Usenko S, Mottaleb MA,
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LL, Brooks BW, Chambliss CK.
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Oxidative stress parameters after combined
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Gałecki P, Szemraj J, Bieńkiewicz M, Zboralski K,
Gałecka E.
Hum Psychopharmacol. 2009 Mar 24;24(4):277-286.
[Epub ahead of print]
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Remission, response without remission, and
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Trivedi MH, Corey-Lisle PK, Guo Z, Lennox RD,
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Baseline severity of depression predicts
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Aso E, Renoir T, Mengod G, Ledent C, Hamon M,
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Am J Respir Crit Care Med. 2009 Mar 19. [Epub ahead
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alpha(2)-Adrenoceptors mediate the acute inhibitory
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The short-term safety and efficacy of fluoxetine in
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Findling RL, Pagano ME, McNamara NK, Stansbrey RJ,
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Child Adolesc Psychiatry Ment Health. 2009 Mar
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Free article in PMC | at journal site
FLUOXETINE PROTECTS AGAINST MONOCROTALINE-INDUCED
PULMONARY ARTERIAL HYPERTENSION IS RELEVANT TO INDUCTION OF APOPTOSIS AND
UP-REGULATION OF Kv1.5 CHANNELS IN RATS.
Zhai FG, Zhang XH, Wang HL.
Clin Exp Pharmacol Physiol. 2009 Mar 2. [Epub ahead
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National Class
Action Filed against Drug-maker for Paxil-induced Suicides in Youths
The mother of an 11-year old Wichita, Kansas boy who committed suicide
on Paxil and a teenager from Pflugerville, Texas (a small town outside of
Austin) who attempted suicide while taking Paxil, jointly filed a national class
action lawsuit today in federal court in Philadelphia, Pennsylvania, the
hometown of Paxil-maker, Glaxo SmithKline. The two plaintiffs theoretically
represent all individuals under the age of 18 in the United States who attempted
suicide or the families of individuals who killed themselves as a result of an
adverse reaction to Paxil. The complaint charges include fraud, negligence,
strict liability and breach of warranty. (See attached Lawsuit Allegations.)
The FDA has required all antidepressant manufacturers to place a black
box warning in their labels alerting physicians and patients to the increased
risk of suicidality, which went into effect in January 2005.
The Plaintiffs
11-year-old Trevor Blain was prescribed Paxil for “separation anxiety
disorder” by his pediatrician in October 2000. He immediately began having
difficulty sleeping and had angry outbursts while on Paxil, but his family did
not make the connection between his deteriorating behavior and the drug. He
continued taking the medication as prescribed. In early November 2000, Trevor
hanged himself with his dog’s leash in the family laundry room. Although he
survived the suicide attempt, he remained comatose for several weeks and died on
December 7, 2000.
17-year-old Tonya Brooks was a shy high school student. Her family
doctor diagnosed her with “social anxiety disorder” and prescribed Paxil in
2004. She became agitated, aggressive and had difficulty sleeping while taking
Paxil. She first attempted suicide by taking an overdose of Paxil and a sleeping
medication, Ambien. She survived the attempt and two days later gouged a hole in
her leg with a pair of scissors. She was hospitalized for several days.
Tonya is one of six youths featured in a new documentary film entitled
“Prescription: Suicide?” The film will be screened at the upcoming Beverly Hills
Film Festival on April 8, 2006. The documentary takes an intimate look at
children and teens who have committed suicide or attempted suicide while taking
antidepressants and the impact these tragic events have had on their families.
Tonya's mother, Cheryl Brooks stated: “No parent should have to go through what
we did.” Explaining her horror when she found her daughter sprawled on the
bathroom floor after her suicide attempt, Mrs. Brooks stated: "[T]here was blood
everywhere.... [The manufacturers of these drugs] should be paying for this.
They gave these medicines to these kids - that's murder...”
Baum Hedlund partner, Karen Barth Menzies, stated regarding the lawsuit:
“Through our Paxil litigation, we've obtained documents that show a seriously
troubling mentality of profit over safety and a callous disregard for the
welfare of children. That’s about as reprehensible as you can get. Governmental
regulators around the world have now analyzed the actual data from the clinical
trials, not GSK’s version of it, and have found an increased risk of
suicidality. Yet the drug companies and their hired mouthpieces in the medical
academic community, including the pediatric arm of the APA [American Psychiatric
Association], continue to downplay the Black Box Warning as an “over-reaction”
by FDA. They continue to try to hide this risk from parents for the sake of
profits. We wanted to make sure the rights of all of these kids are protected by
filing this lawsuit.”
The Lawsuit’s Allegations
• Paxil was introduced into the U.S. market on December 29, 1992, and is
a well known antidepressant medication in the same class as Prozac, Zoloft,
Effexor, Celexa and Lexapro (selective serotonin reuptake inhibitors or
"SSRI’s”). Paxil is approved for marketing in the United States for conditions
such as depression, obsessive compulsive disorder, panic disorder, and “social
anxiety disorder.” It is not approved for pediatric use.
• Although a number of clinical trials have been conducted in the
pediatric population, Paxil has never been approved by the FDA for use in
children/adolescents because the studies show that the drug doesn’t work. (¶
18.)
• The studies show a more than doubling of the risk and in one study,
there was a nearly 6 times increase of suicidal thoughts and behavior compared
to placebo. (¶ 19.)
• Not until 2002 was it recognized that GSK had been coding suicidal
behavior as “emotional lability,” thus hiding the risk. (¶ 19.)
• Notwithstanding the clinical trials which showed Paxil to be
ineffective for pediatric patients and associated with an increased risk of
serious, and possibly deadly, side effects, GSK engaged in a campaign to promote
the use of Paxil for use with pediatric patients. (¶ 20.)
• GSK, faced with the negative results from the pediatric studies, began
a campaign to reduce the negative impact of this bad study data. GSK prepared a
medical journal article regarding Study 329 that was not only “ghost written,”
but falsely stated that Paxil was superior to placebo among “four of the
parameters,” including one which was identified as a “primary outcome measure.”
In fact, GSK knew that Paxil was not found to be superior to placebo amongst any
of the “primary outcome measures.” Further, the article stated that “most
adverse effects were not serious,” and failed to list suicide-related events as
“serious.” (¶ 20.)
• In a document directed to “all sales representatives selling Paxil,” a
GSK manager stated that, according to the “Keller” article, “Paxil demonstrates
REMARKABLE Efficacy and Safety in the treatment of adolescent depression.”
(emphasis in original). The document states that “the findings of this study
provide evidence of the efficacy and safety of Paxil in the treatment of
adolescent depression.” As GSK well knew, study 329 found Paxil to be neither
effective nor safe. (¶ 20.)
• GSK also hired doctors to go around the world and promote the use of
Paxil for pediatric patients by way of “posters” and lectures at medical
conferences. These “posters” and their presenters claimed that Paxil was
effective for treating adolescent depression and free from serious side effects.
In fact, GSK knew that to be false. (¶ 21.)
• In internal, unpublished documents, which have been kept from public
and regulatory scrutiny via the stratagem of over-broad “confidentiality”
designations, GSK has made numerous admissions about Paxil’s associated harmful
side effects and lack of effectiveness in children and adolescents.
Notwithstanding these admissions, in flagrant and conscious disregard and
indifference, GSK has denied publicly that such nexus exists, and has failed
utterly to take any measures whatsoever to alert the public, the prescribing
physicians, and the patients who take it, of the incipient dangers associated
with Paxil. (¶ 72.)
• GSK has defrauded the medical profession, the Paxil patient
population, and the general public in that it, among other acts:
(a) Hired a firm to “ghostwrite” an article that was widely publicized
which claimed, falsely, that Paxil was effective and safe for the treatment of
depression with children and adolescents;
(b) Hired doctors to present “posters” around the world at medical
conferences which claimed, falsely, that Paxil was effective and safe for the
treatment of depression with children and adolescents;
(c) Fraudulently mischaracterized and miscoded adverse events involving
self-harm with the term “emotional lability” so as to reduce the number of
occurrences and hide their existence from the public and regulators;
(d) Failed to inform the medical and research communities that a
significant number of pediatric patients taking Paxil during clinical trials
attempted acts of self-harm at a rate that was at least twice that for pediatric
patients who took placebo;
(e) Fraudulently claimed that Paxil’s characteristic side effects of
insomnia, agitation and anxiety were of little or no concern when in fact these
effects are known to be among the most critical and deadly of the short-term
risk factors for self-harm;
(f) Fraudulently denied Paxil’s association with serious or deadly
thoughts or acts of self-harm when its own investigators informed GSK (and GSK
determined itself) that Paxil was associated with such conditions;
(g) Allowing the use of concomitant medications in clinical trials to
lessen side effects in order to avoid the reporting of treatment-emergent
adverse events, such as akathisia;
(h) Aggressively promoted Paxil to doctors for use with pediatric
patients even though Paxil was not, and is not, approved for use with children
and adolescents.
(¶ 73.)
• In early 2005, GSK updated Paxil’s label to include a “black-box”
warning, which is the strongest warning allowed for by FDA regulations. That
warning states:
Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior
(suicidality) in short-term studies in children and adolescents with Major
Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering
the use of PAXIL or any other antidepressant in a child or adolescent must
balance this risk with the clinical need. Patients who are started on therapy
should be observed closely for clinical worsening, suicidality, or unusual
changes in behavior. Families and caregivers should be advised of the need for
close observation and communication with the prescriber. PAXIL is not approved
for use in pediatric patients. (See WARNINGS and PRECAUTIONS -- Pediatric Use)
Pooled analysis of short-term (4 to 16 weeks) placebo-controlled trials
of 9 antidepressant drugs (SSRIs and others) in children and adolescents with
major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other
psychiatric disorders (a total of 24 trials involving over 4,400 patients) have
revealed a greater risk of adverse events representing suicidal thinking or
behavior (suicidality) during the first few months of treatment in those
receiving antidepressants. The average risk of such events in patients receiving
antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in
these trials.
(¶ 28.)
April 25, 2006
Drip Drip Drip
- Paxil Info Leaks Out
by
Evelyn Pringle
http://www.opednews.com
Secrecy agreements in
litigation hide information about defective products or a company’s
negligence, and sometimes go so far as to prohibit the parties from
discussing that there ever was a lawsuit. Such is the case with Paxil
and as a result, unwitting patients continued to take the drug long
after its dangers were known to GlaxoSmithKline.
Many lawsuits filed against Glaxo have been settled out of court, with
confidential agreements that prevent the public from knowing about the
harmful effects of the Paxil.
Previously sealed documents and internal company memos suppressed with
protective orders, prove that Glaxo knew about the problems with Paxil
before it received FDA approval, but continued to sell the drug for over
a decade without warning consumers.
Long overdue legislation is currently pending in both the US House of
Representatives and the Senate known as Sunshine in Litigation Act of
2005, which basically says that a court shall not enter an order
restricting the disclosure of information obtained through discovery, an
order approving a settlement agreement that would restrict the
disclosure of such information, or an order restricting access to court
records in a civil case
Glaxo currently faces thousands of lawsuits over Paxil side effects
related to addiction, dependence, and a severe withdrawal syndrome.
SSRIs (selective serotonin reuptake inhibitors) like Paxil, are not
addictive in the sense that “an individual would mortgage their
livelihoods and all they hold dear for further supplies of the drug,”
according to Dr David Healy MD, FRCPsych, North Wales Department of
Psychological Medicine
SSRIs can hook patients in the sense of making you “physically
dependent,” he explains.
Dr Healy, is considered an expert on Paxil and has had access to
confidential studies from the Glaxo archives. The common symptoms of
withdrawal, he says, break down into two groups. The first group may be
unlike anything you have had before, he warns, to include:
Dizziness
Headache
Muscle Spasms
Tremor
Electric Shock-like Sensations
Other Strange Tingling or Painful Sensations
Nausea, Diarrhoea, Flatulence
Dreams, including Vivid Dreams
Agitation
The second group overlaps with general nervousness, Dr Healy says, and
may lead to you or your physician to think that all you have are
features of your original problem. These symptoms include:
Depression
Lability of Mood
Irritability
Agitation
Confusion
Fatigue/Malaise
Flu-like Feelings
Insomnia or Drowsiness
Mood Swings
Sweating
Feelings of Unreality
Feelings of being Hot or Cold
These symptoms appear in anywhere between 20% to 50% of patients taking
SSRIs, Dr Healy says, sometimes within hours of the last dose.
In the class action case against Glaxo settled in 2005, In re: Paxil
Products Liability Litigation, MDL No 1574, CD Calif, the plaintiffs
were forever silenced by a strict confidentiality clause incorporated
into the settlement agreement.
This author obtained a copy of the lawsuit’s complaint, dated August 23,
2001, as well as a copy of the settlement agreement with a secrecy
clause that states in relevant part:
Plaintiffs and their attorneys, “will not make any statements, either
directly or indirectly, by implication or innuendo, to anyone, including
but not limited to consultants, experts, the press or media, concerning
the amount or other terms of such settlement or settlements, or the
nature and substance of settlement negotiations, or describing or
characterizing the settlement in any way.”
Plaintiffs and their attorneys “will not, either directly or indirectly,
publicize the fact of the settlement and that any inquiry into the
settlement, its amount, meaning, interpretation or comparative value, or
the negotiations leading to the settlement by anyone, including but not
limited to the press or media, will be met only by a statement that the
case has been resolved, and will decline any requests for interviews by
the press or media regarding the settlement, its history or its terms.”
The clause even extends the internet specifically in that plaintiffs and
attorneys “will not maintain and instead will discontinue any website
references to Paxil discontinuation or withdrawal.”
And, it says, they “agree to refrain from any future internet postings
regarding Paxil discontinuation or withdrawal.”
Paragraph 5 of the lawsuit’s complaint says that over a 2 years period,
“plaintiffs' attorneys have been individually contacted by approximately
500 Paxil withdrawal victims.”
And, the pain and suffering experienced by each individual is the direct
result of Glaxo’s “failure to warn users of Paxil’s addictive nature,
the drug's inducement of physical or psychologic dependency, and its
infliction of dependency/withdrawal syndrome when the patient's Paxil
dosage is reduced or terminated,” the complaint states.
Paragraph 16, lists withdrawal reactions that “can summed up as one or
more of the following complaints: jolting electric "zaps," dizziness,
light headedness, vertigo, incoordination, gait disturbances, sweating,
extreme nausea, vomiting, high fever, abdominal discomfort, flu
symptoms, anorexia, diarrhea, agitation, tremulousness, irritability,
aggression, sleep disturbance, nightmares, tremor, confusion, memory and
concentration difficulties, lethargy, malaise, weakness, fatigue,
paraesthesias, ataxia, and/or myalgia.”
Paragraph 7, says: “These reactions are "unexpected" to the victims and
even their physicians because the manufacturer has deliberately failed
to properly warn of this.”
“Both physician and patient unwittingly use Paxil without knowing the
drug's addictive traits,” the complaint says.
Paragraph 8, charges that because Glaxo has suppressed the information,
patients and physicians are fooled into thinking that the reactions are
caused by another condition, such as relapse into depression, thus
prompting incorrect and unnecessary medical treatment, including
increased dosages of Paxil.
While researchers have acknowledged the potential for withdrawal
reactions with all SSRIs, Paxil is by far the worst. Citing data from
the World Health Organization, the lawsuit’s complaint states: “Paxil
has the highest incidence rate of withdrawal adverse experiences of any
antidepressant drug in the world.”
Starting in December 2001, Glaxo finally added a minimizing precaution
to Paxil’s label of some possible "discontinuation" side effects
affecting "2 percent or greater" of patients based on studies.
However, documents reveal that Glaxo has always known about the
withdrawal syndrome. For instance, in 1993, in a report that occurred 5
months after Paxil arrived on the market, Stoker and Eric noted Paxil
withdrawal at the American Psychiatric Association's annual meeting in
San Francisco, May 22-27, 1993.
The authors of the study conducted 2 week tapering off periods for 186
patients in 6 to 12 week doubled blinded comparative studies. Low dose
and high dose groups were studied. Paxil's low dose group actually did
worse than the high dose group, suffering 42% withdrawal rate, compared
to 38% in the high dose group. And, both occurred even though the
tapering off regime was initiated during dosage reduction.
The lawsuit’s complaint specifically describes close to 10 studies that
reveal a high rate of withdrawal symptoms since Paxil came on the market
that Glaxo was fully aware of.
A fact well-evidenced in internal company documents. A previously
suppressed, May 1, 1997, Glaxo memo to, “Paxil Selling Team,” on the
“discontinuation syndrome,” defines the withdrawal syndrome as, "a class
effect that can occur when an SSRI is stopped abruptly. Symptoms may
include asthenia, flu-like symptoms, fatigue, dizziness, nausea, and
sleep disturbances (insomnia, vivid dreams or nightmares)."
However, the memo instructs Glaxo sales representatives to avoid using
the term and says: "instead of 'withdrawal syndrome,' which implies
addictive properties, try to refer to this phenomenon as
'discontinuation symptoms.'"
Eight months later, in a December 1, 1997, "Business Plan Guide," sales
representatives were instructed to "minimize concerns surrounding
discontinuation symptoms," and told to explain to doctors that the
"discontinuation incident rate is two in 1,000 patients."
However, according to a 1997 review, one study found that 25% of
patients experienced at least one discontinuation symptoms, verses 5.9%
taking a placebo. In another study of patients with major depression,
42% experienced at least 1 discontinuation symptom.
Another internal memo kept hidden with a protective order, states:
“Discontinuation: why this is an issue,” followed by, “’97 Seroxat/Paxil
sales to end Sept already exceed $1 Billion“.
This particular memo carries a cartoon-like picture of a big black
money-bag.
In Paxil literature, Glaxo flat-out lied to patients and specifically
said that the drug was not addictive. For example, a pamphlet made
available at doctors’ offices and disseminated to patients, asked the
question: “Is Paxil addictive?”
The pamphlet then states: “Paxil has been studied both in short-and
long-term use and is not associated with dependence or addiction.”
The withdrawal syndrome is real and in fact, it is now known that
infants of women who take SSRIs in the last 3 months of pregnancy, may
experience symptoms of withdrawal, including convulsions, according to a
study published in the February 4, 2005 issue of the journal Lancet.
In addition, experts warn against the use of Paxil and other SSRIs with
children. According to Fred Baughman Jr, MD, an adult and child
neurologist in private practice for 35 years, "most antidepressants have
not proved effective in treating depression in children and some studies
suggest they may cause some children to become acutely suicidal.”
Yet in 2002, Dr Baughman says, “nearly 11 million prescriptions for the
drugs were given to children, 2.7 million of them to children under 12."
A report by an expert witness, previously sealed with a protective
order, reveals how Glaxo concealed and manipulated data concerning
Paxil-induced suicidality and how suicide attempts in studies by
patients on Paxil were underreported and attempts by people taking a
placebo were inflated.
Excerpts from the report were published by psychiatrist, Peter Breggin,
MD, in Ethical Human Psychology and Psychiatry, (Volume 8, Spring 2006,
pp. 77-84). Dr Breggin is a founder of the International Center for the
Study of Psychiatry and Psychology (ICSPP) and the author of the
Antidepressant Fact Book (2001).
His report also documents how Glaxo hid the incidence of akathisia
(agitation with hyperactivity) and stimulation, which he says, are known
risk factors for suicidality and violence.
Dr Breggin’s original report was based on a 3-day review of Glaxo’s
sealed files, and was written for the California case of Lacuzong v GSK,
and attached to a July 21, 2001, affidavit submitted in a case filed by
the widow of a man who drowned their two children and himself in a tub
after taking Paxil for three days.
At Glaxo’s insistence, the report remained sealed. However, in the more
recent case of Moffett v Glaxo, in the US District Court for the South
District of Mississippi, the report was filed in the public record.
“The drug companies,” says Dr Breggin, “settle almost all legal cases
brought against them in order to seal incriminating scientific data.”
“The publication of a previously sealed medical expert report is a rare
event,” he explains, “the first in my experience.”
In the book, The Antidepressant Solution, author Dr Joseph Glenmullen, a
clinical instructor in psychiatry at Harvard Medical School, recommends
tapering off antidepressants by following a 5-Step Antidepressant
Tapering Program, to reduce both the incidence and severity of
withdrawal reactions.
“Research has shown that when patients stop antidepressants cold turkey
they can have high rates of withdrawal reactions,” Dr Glenmullen
advises, “which vary depending on the particular drug.”
“In studies involving hundreds of patients, 66 percent of patients
stopping Paxil,” he says, “have withdrawal reactions.”
For more information for injured parties go to Lawyers and
Settlements.com
http://www.lawyersandsettlements.com/articles/paxil.html
Evelyn Pringle
evelyn.pringle@sbcglobal.net
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