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8, 2007
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Syndrome
By EVELYN PRINGLE
I n addition to recent reports that the
drugs work no better than sugar pills, the latest warnings added
to the long list of adverse events linked to selective serotonin
reuptake inhibitor antidepressants have focused on birth defects,
suicide risks and violence.
However, the massive over-prescribing
of SSRIs, including Prozac, Paxil, Zoloft, Celexa and Lexapro
in combination with many other drugs now has medical experts
scrambling to educate doctors about a life-threatening condition
known as "serotonin syndrome."
According to the report, "A
Mix of Medicines That Can Be Lethal," by Jane Brody, in
the February 27, 2007 New York Times, "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."
According to the Times, patients
at particular risk, some experts say, are those taking a combination
of antidepressants and antipsychotic drugs prescribed to treat
resistant depression.
Ms Brody notes that in the
March 2005 New England Journal of Medicine, two specialists,
Dr Edward Boyer of the University of Massachusetts Medical School
and Dr Michael Shannon of Children's Hospital Boston, found that
more than 85% of doctors were "unaware of the serotonin
syndrome as a clinical diagnosis."
In a report based on calls
made to poison control centers in the US in 2002, the doctors
found 7,349 cases of serotonin toxicity and a total of 93 deaths.
In 2004, the Toxic Exposure Surveillance System identified 48,204
exposures to SSRIs that resulted in moderate or major outcomes
in 8,187 patients and death in 103 patients, according to the
September 2005 American Journal of Emergency Medicine.
In 2005, the last year for
which statistics are available, a total of 118 deaths were reported,
according to the New York Times.
The true incidence of serotonin
syndrome, experts say, may be under-reported in these figures
because the syndrome may be wrongly attributed to another cause,
mild cases may be dismissed or medical professionals may not
suspect the condition.
Studies have shown that when
an expectant mother takes an SSRI, her system is flooded with
extra serotonin, which then passes across the placenta into the
womb, soaking the developing fetus in serotonin, according to
Houston Attorney Robert Kwok.
"It is this prolonged
and unanticipated exposure to serotonin," he says, "that
our experts believe leads to the baby's birth defects. "
Studies indicate," he
explains, "that mothers who take an SSRI during pregnancy
have 1.5 to 2 times the risk of giving birth to a baby with a
heart defect such as an atrial septal defect or ventricular septal
defect, and are 6 times more likely to give birth to a baby with
a severe and life-threatening lung disorder known as persistent
pulmonary hypertension (PPHN).
And the cases of birth defects
are on the rise. "Our group has over 100 SSRI baby birth
defect cases in medical review," Mr Kwok states, "with
most babies bearing strikingly similar heart and lung defects."
Mr Kwok is representing the
family of Chase Steele, a baby born with severe heart defects
after his mother took an SSRI during her pregnancy and the family
of Gavin Shore, an infant also with severe heart defects to a
mother who took the SSRI Celexa during her pregnancy.
"You would think by now,"
Mr Kwok says, "that the FDA would ban SSRIs for children,
since the same logic applies to developing adolescents and developing
babies in the womb during pregnancy."
Serotonergic receptors are
found throughout the central nervous system and are involved
in the regulation of the sleep-wake cycle, behavior, appetite,
temperature and muscle tone, and serotonin neurotransmission
is involved with the regulation of gastrointestinal motility
and vascular tone. Serotonin syndrome results from excessive
stimulation or agonism at postsynaptic serotonin receptors.
According to the FDA, symptoms
of the syndrome may include restlessness, hallucinations, loss
of coordination, fast heart beat, rapid changes in blood pressure,
increased body temperature, overactive reflexes, nausea, vomiting
and diarrhea.
The patients often have changes
in mental status, including agitation, hypervigilance and pressured
speech, and in severe cases, may present with profound hypertension
and tachycardia, and proceed rapidly to shock.
In severe cases, patients may
exhibit delirium, seizures, muscular rigidity and hypertonicity.
A core temperature may exceed 40º C (104 F), and may be
accompanied by metabolic acidosis, rhabdomyolysis, renal failure
and disseminated intravascular coagulation.
Experts say the most important
information for doctors to know when dealing with a possible
case of serotonin syndrome is what drugs have been ingested,
because in addition to SSRIs, there are other classes of drugs
with different mechanisms that can also increase serotonin levels
to differing degrees.
A greater awareness of the
combinations that trigger the syndrome could lead to prevention,
but a diagnostic challenge exists due to the fact that the list
not only includes prescription drugs, but also over-the-counter
medications and herbal supplements. The following are some of
the products known to be associated with serotonin syndrome:
Monoamine oxidase inhibitors
(MAOIs)
Tricyclic antidepressants (TCAs)
Selective serotonin reuptake inhibitors (Zoloft, Prozac, Paxil,
Lexapro, Celexa)
Venlafaxine (Effexor)
Trazodone (Desyrel)
Nefazodone (Serzone)
Meperidine (Demerol)
Dextromethorphan (Cold Remedies)
Chlorpheniramine
Sumatriptan (Imitrex)
Atypical antipsychotic (Zyprexa, Risperdal, Seroquel)
L-dopa
Meridia
Lithium
Valproic acid (Depakene)
Linezolid (Zyvox)
St John's Wort
Ginkgo Biloba
Many experts blame the rise
in cases of serotonin syndrome on the fact that so many different
drugs are being prescribed to patients at the same time in combinations,
or "drug cocktails," which have never been approved
as safe and effective by the FDA for any use and without considering
the over-the-counter medications that patients may be taking.
The syndrome has become more
prevalent in children as the off-label use of drug cocktails
with children has increased. Some experts suspect serotonin syndrome
in the death of 4-year-old, Rebecca Riley in Massachusetts, on
December 13, 2006.
Critics say the Riley case
highlights the need to put an end to the rampant off-label prescribing
of adult psychiatric drugs to children. "The general public
is unaware that almost no psychiatric drugs have ever truly been
tested for children," according to David Oaks, director
of MindFreedom, an international human rights organization.
"All psychiatric drugging
of children," he says, "is essentially 'off label'
in the sense that doctors have an enormous range of discretion
when prescribing psychiatric drugs to young people."
"It's time for society
to get hands-on with the mental health system," Mr Oaks
warns, "and rein in the immense tyrannical power that doctors
now have."
The State Police investigator's
report in this case said psychiatrist Dr Kayoko Kifuji, at the
Tufts-New England Medical Center, prescribed 3 medications for
Rebecca: 750 milligrams a day of Depakote; 200 milligrams a day
of Seroquel; and .35 milligrams a day of clonidine.
Rebecca was given Seroquel,
for bipolar disorder, a drug only approved to treat adults with
schizophrenia or bipolar, Clonidine, for attention deficit disorder,
a drug approved only to treat adults with high blood pressure,
and Depakote, an anti-convulsant drug approved to treat epilepsy
in adults.
She was kept on this 3-drug
cocktail since she was 2 and a-half-years-old, until she was
found dead on the floor of her parent's home on December 13,
2006. At the time of her death, there were also over-the-counter
cold medications in her system including Children's Tylenol Cough
and Runny Nose, which contain acetaminophen, dextromethorphan
and chlorpheniramine.
According to a report by investigators,
Rebecca's teachers and a school nurse repeatedly complained about
the child's extreme lethargy and how she seemed better when the
drugs wore off, and the nurse also pointed out that Rebecca did
not exhibit the kind of behavior that might justify prescribing
these types of drugs.
A therapist who treated the
children also told investigators she was concerned about the
medications prescribed to Rebecca because she never noticed symptoms
of attention deficit or bipolar disorder.
A state trooper's affidavit
said a Walgreen's pharmacy filled a number of clonidine prescriptions
for the Riley's when they should have had an ample supply and
that several times, Dr Kifuji approved extra pills because Carolyn
Riley said she had run out or lost her supply.
Carolyn Riley told investigators
that Dr Kifuji had authorized the extra doses to help Rebecca
get to sleep, the affidavit said. The trooper also reported that
Dr Kifuji received calls from a therapist and a nurse at Elden
Johnson Early Childhood Center, where Rebecca was a student,
saying they were concerned about her medication.
The affidavit shows that no
testing was conducted on Rebecca in making the diagnosis of attention
deficit or bipolar disorder and that Dr Kifuji said she diagnosed
Rebecca based on the parents' statements and "brief visits"
in her office as frequently as twice a month and as seldom as
once every two months.
In July 2006, a social worker
treating Rebecca filed a complaint with the agency reporting
that Carolyn Riley was "neglecting her children" and
"appeared heavily drugged and unable to respond" on
one of her visits to the family home.
The social worker said that
during one visit, Carolyn told her that urine on the floor was
from when Rebecca had taken a nap on the floor, according to
an affidavit from investigators, and the social worker said she
had to tell Carolyn to clean the floor.
When checking out the social
worker's complaint, the DSS Commissioner said all the doctors
and a psychiatric hospital caring for one of the children in
July 2006 said the medications were appropriate and there was
no one else to consult, so the department did not substantiate
the complaint.
The medical examiner's office
determined that Rebecca died from "intoxication due to the
combined effects" of the drugs clonidine, Depakote, dextromethorphan,
and chlorpheniramine, the district attorney's office said in
a statement.
The official autopsy report
states that Rebecca died of the "combined effects"
of the drugs and that her lungs and heart were damaged by "prolonged
abuse of these prescription drugs, rather than one incident."
Those findings have some experts
wondering whether the medical examiner may be a member of the
85% of doctors identified by the New England Journal of Medicine
study who are unaware of the serotonin syndrome as a clinical
diagnosis.
The statement released by the
DA states, "This occurred as a result of the intentional
overdose of Rebecca with clonidine," and the manner of death
"was determined to be homicide."
Rebecca's parents have both
been charged with murdering their daughter.
However, psychiatrist Dr Grace
Jackson, a leading authority on psychotropic drugs, takes issue
with the claim of the manner of death being homicide.
"I'd put my money on serotonin
syndrome as the cause of death," she says, "a potentially
lethal condition of serotonin excess, leading to signs and symptoms
which include autonomic instability, heart dysrhythmias (sudden
death), hyperthermia (high fever), changes in mental status (including
possible coma), hyperreflexia, and myoclonus."
"In this case," Dr
Jackson says, "the primary culprits were dextromethorphan
and chlorpheniramine, an antihistamine which also boosts serotonin
levels."
"It is probably quite
likely," she explains, "that the family had not been
warned by any doctor or pharmacist that this combination of medications
could cause death particularly, in a toddler."
"It is also possible,"
she adds, "that the psychiatrist did not realize that the
family was administering dextromethorphan to the child --- it
might have been given from an over-the-counter cough remedy by
unsuspecting parents."
Dr Jackson also notes that
Depakote has been shown to increase levels of serotonin in many
brain regions, "hence," she says, "it was factor
#3 in the serotonin syndrome which presumably killed this child."
"This toddler," she
explains, "may have been receiving tiny doses of the medications
prescribed, but that did not protect her from serotonin syndrome."
Reports by investigators, based
on interviews of relatives in the home who observed Rebecca in
the days before she died, describe symptoms typical of serotonin
syndrome. They said she became restless, disorientated, incoherent,
would not respond to her name and that she appeared dazed and
"out of it."
She was lethargic at school
and at home, and a neighbor described her as zombie-like, according
to interviews in an affidavit filed in Plymouth District Court.
The day before she died, Rebecca
developed a fever and was coughing uncontrollably, so her parents
went to Wal-Mart to buy cold and flu medicine. While at Wal-Mart,
Rebecca began to vomit, so Carolyn Riley purchased Pedialyte
and a plastic bowl for Rebecca to vomit in during the ride home,
and she reportedly vomited about 5 times over the course of that
day.
Rebecca's grandmother told
reporters that the doctor never told the parents not to give
her the over-the-counter cold medications now listed as contributing
to her death because of the prescription drugs she was on.
Dr Jackson suspects that Rebecca
like so many patients was the unwitting victim of
"Evidence Based Psychiatry," which means drug, drug,
and more drug, because "somebody, somewhere, published a
study that showed a three year old responded to five or six or
seven drugs in combination," she states.
Dr Jackson is the author of,
"Rethinking Psychiatric Drugs: A Guide for Informed Consent,"
a book that provides a critical appraisal of 3 classes of psychiatric
drugs that an estimated 20% of Americans consume on a regular
basis, including antidepressants, antipsychotics and stimulants.
According to Harvard Instructor
Dr John Abramson, author of, "Overdosed America," this
"gruesome story" seems to have two separate and distinct
components. "First," he says, "is the question
of whether or not the child was being given medication as it
was prescribed."
"And the second,"
he notes, "is the question of why such medicines were prescribed
for such a young child."
Dr Abraham points out that
there has been a progressive medicalization of other than desirable
behaviors in children. "We have seen this in the enormous
proliferation of stimulant medication use," he notes, "far
out of proportion to use in other countries."
Now, he says, the diagnosis
of bipolar disorder in children is rising in parallel, and clearly,
it is the drug industry driving this medicalization to sell more
products.
In what can only be described
as assembly-line customer recruitment, Rebecca's psychiatrist,
Dr Kifuji, also prescribed the same powerful drug cocktail to
Rebecca's older brother and sister when they were diagnosed with
the same illnesses several years earlier.
The Rileys' attorneys say the
parents are unsophisticated people who did not question the doctor.
Michael Riley's lawyer, John Darrell, told the Boston Globe on
February 7, 2007, that neither parent knew enough treatment to
have challenged Kifuji. "You've got two poor parents here
of minor means financially, of minor education," he said.
A reading of all the official
reports and court documents in this case definitely indicate
that be true.
As so often happens with families
like the Riley's, who are covered by public health care programs,
and with the great assistance of Dr Kifuji, the entire Riley
family become a cash cow for the psychiatric-pharmaceutical industry,
including the mother and father.
Another incentive certainly
worth noting is the potential monthly income Dr Kifuji generated
for herself by the legal pill-pushing to the Riley family. A
2003 study by the American Psychiatric Association found doctors
could earn about $263 an hour for holding three 15-minute medication
management sessions per hour, compared to about $156 for a single
therapy session. That represents an hourly pay cut of 41% for
doctors doing therapy only, the APA study said.
Critics say more blame should
be focused on the prescribing doctors. "While the pharmaceutical
companies certainly are getting rich providing mind-altering
drugs for psychiatry's made-up mental disorders, the fault lies
with the psychiatric community," says Kelly Patricia O'Meara,
author of "PSYCHED OUT: How Psychiatry Sells Mental Illness
and Pushes Pills That Kill".
"Until the fraud of psychiatric
diagnosing is exposed," Ms O'Meara warns, "the American
people will continue to hear about more and more of these tragic
outcomes."
And it always goes back to
the chicken and the egg theory. Was there an epidemic in this
family where all 5 family members were so severely mentally ill?
Or did the psychiatric-pharmaceutical industry convert them into
life-long disabled customers through the administration of a
powerful drug cocktail for years on end?
According to Dr Ann Blake Tracy,
Director of International Coalition for Drug Awareness, and author
of "Prozac: Panacea or Pandora?", she expects a person
placed on one of these drug cocktails to be on disability within
a 3- to 5-year window of time.
"And for a decade and
a half," she says, "she has been trying to figure out
how our economy will survive the skyrocketing disability rates."
The chicken and the egg theory
arises a second time in this case when reviewing the allegations
lodged against the parents. Were the bizarre behaviors of the
parents cited in official reports and the media the result of
ignorance, bad parenting or a wish to harm Rebecca? Or were the
behaviors in fact brought on by the combination of drugs the
parents were ingesting?
"Naturally," Ms O'Meara
notes, "one has to wonder that if the entire family was
being 'treated' for their alleged mental illnesses, why then
didn't the drugs work?"
Dr Tracy says, "Is it
absolutely possible that some of the alleged behaviors of the
parents in this family could have been caused by the prescribed
drugs they were taking."
She explains that the hypothesis
behind these psychiatric drugs is backwards, meaning they often
end up causing the conditions that they were prescribed to treat.
Leonard Frank, author of "Zyprexa:
A Prescription for Diabetes, Disease and Early Death", concurs.
"Psychiatrists and other physicians," he explains,
"prescribe drugs in attempt to suppress objectionable conduct
but the drugs often make the conduct even more objectionable,
in which event the prescription is changed."
Then he explains, one drug
may be substituted for another, or one or more drugs may be added
to the mix, or the dosage may be decreased, or more likely increased,
and this process may go on endlessly, he says.
Following Rebecca's death,
the Department of Social Services placed the other two Riley
children, Kaitlynne 6, and Gerald 11, in foster care and sought
an independent opinion on their medical care, and doctors determined
that their medication needed to be changed.
Persons injured by Serotonin
Syndrome and seeking legal advice can contact the Robert Kwok
& Associates Law Firm, at (713) 773-3380; http://www.kwoklaw.com/about.php (Related)
Evelyn Pringle can be reached at: Evelyn-pringle@sbcglobal.net (Related)
(This article is written as
part of a series on emerging issues involving the pharmaceutical
industry and is sponsored by Robert Kwok & Associated, LLP)
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