PAXIL: Athlete Wrongly Given Pacemaker for Paxil-Induced Heart Malfunction – FL

NOTE FROM Ann Blake-Tracy (

Although Paul’s case is an older case I have only this week found my copy
of excellent this article so had not been able to send it out before now,
but feel it is extremely important to include in our database. Others need to be
aware of the effects of SSRI antidepressants upon the heart, even in those who
are in excellent physical condition. I would encourage you to read the entire
article as it is full of very important information of drug approvals, financial
ties between drug companies and the FDA, Paxil withdrawal effects, the common
ignorance of doctors about these adverse effects and their unwillingness to
admit them even in the face of glaring evidence.
His “abnormal” heart rhythms come from having the benign “athletic
heart syndrome,” a sign of a super heart. The original fainting was probably due
to taking Paxil; the later problems were likely due to withdrawal from it.
Even with this confirmation, Paul had to go to more than 20 doctors
before he found one who would remove the pacemaker. Paul is recovering from his
ordeal; he is able to walk a mile now, although previously he could run 50.

The Science
of Deceit

by Burton Goldberg

The mainstream media
regularly reports on the “dangers” of “unproven” herbal remedies and
supplements. But what is the reported number of people who have died from using
herbs and supplements? According to the FDA, between 1993 and 1998, federal,
state and local agencies reported a total of 184 deaths, most of which were
associated with weight loss formulas. Compare that to the reported number of
people who die in hospitals because of the side effects of properly prescribed
pharmaceutical drugs: more than 100,000, every year. You can add to that the
number of patients killed in hospitals because of “medical errors”: another
100,000 or so. Those statistics are from the Journal of the American Medical
Association (JAMA). This means that the ordained guardians of our health kill as
many people every week as died in the September 11 terrorist attacks.

And that number only includes people who died in hospitals. A 1998
JAMA article estimated that more than 2 million people require hospitalization
every year because of the adverse side effects of drugs. Moreover, it is widely
conceded that the number of adverse reactions and fatalities attributable to
prescription drugs is actually many times the number

Statistics aside, let’s put a face on what I’m
talking about. Paul Domb is the son of a dear friend of mine. Two years ago,
Paul was a 41-year-old endurance athlete who had run thousands of road races,
hundreds of triathlons and other world-class endurance events. Paul had
regularly trained twice a day for 20 years to stay in competitive shape, so it
was hard for him to understand why he should begin to experience anxiety and
panic attacks. He went to a psychologist who, after a few sessions, recommended
that Paul take the antidepressant drug Paxil. Paul was reluctant, but his
anxiety was affecting his work in corporate real estate, so he started taking a
daily dose of 20 mg.

About three weeks later, Paul was set to begin
an early morning swim when he felt his heart suddenly speed up. For the first
time in his life, he felt faint and lost consciousness. He fell backward,
crashing onto a metal pool chair. He revived after several seconds, and felt
ready to continue his workout, but his training partner convinced him to take it
easy and go home. Paul related the incident to his wife, who insisted he go to
the hospital for an examination.

At the hospital, he underwent an
extensive battery of tests. They took Paul’s medical history, asking what
medications he was on, and took brain scans, electrocardiograms and various
other tests. Paul’s electrocardiogram measuring his heartbeat rhythms showed an
unusual pattern. A cardiologist specializing in heart rhythms was called in. He
told Paul that he needed to put a catheter up Paul’s groin to stimulate the

heart in an effort to reproduce the earlier arrhythmia. Paul refused, but the
physician told him that a previous patient with the same symptoms who refused
the test died soon after. Scared into it, Paul took the test. Afterward, the
doctor came back with the bad news: Paul had a rare disorder called Brugada
Syndrome. Without having a pacemaker/defibrillator inserted, he was told, his
heart could suddenly stop and he could drop dead at any moment.

There was worse news: The disease was genetic and the possibility
existed that Paul’s 5-year-old daughter had the same condition and could die at
any time.

Paul had the pacemaker inserted. Unfortunately, his
doctors did not take into account that he was a competitive athlete, and they
set the parameters of the pacemaker wrong. Whenever Paul went to sleep, his

heart rate dropped below “standard,” and the device would rapidly pace his
heart. Paul was unable to get more than two hours of sleep at a time. Although
the doctors eventually reset his pacemaker, that was just the beginning of what
became almost six months of physical and emotional hell. He was nauseated, but
vomiting brought no relief. He frequently had convulsions. Electric shocks would
shoot through his body 30 or 40 times a day, sometimes violent enough to cause
him to fall. He started having recurring thoughts of suicide ‹or violence
toward others. And through it all he was tortured by the fear that his daughter
was going to die because of the genes he had passed on to her. Paul traveled the
country, seeking an answer, but no doctor could help him. So Paul buried himself
in research, trying to find a solution to his problems. And then one day he
happened to catch the TV news show 20/20. On it were people describing exactly
the same symptoms as he had, only they didn’t have Brugada Syndrome ‹they were
suffering side effects of trying to withdraw from Paxil.

Paul could
hardly believe it. His doctor had told him to stop taking Paxil before his heart
surgery. Paul started studying Paxil, and what he found shocked and enraged him.
He discovered an astounding pattern of apparently deliberate deception by
SmithKline Beecham (now called GlaxoSmithKline), the manufacturer of Paxil,
withholding information on the dangers of this drug from the FDA and the medical
community. In June 2001, GlaxoSmithKline lost a lawsuit when a Wyoming jury
awarded $6.4 million to the family of a man who killed three relatives and
himself after taking the antidepressant. The verdict was based on the company’s
failure to sufficiently warn doctors and patients that the effects of the drug
could include violence. It has since come to light that 20% of patients
worldwide who were prescribed Paxil for depression stopped taking it because of
suffering adverse effects. And effects of withdrawal include intense insomnia;
vertigo; electric shocks; profuse night sweats; nausea; extreme confusion;
intense fear of losing sanity; and thoughts of suicide and homicide. A class
action filed in San Diego, representing thousands of victims of Paxil is

Paul then went to an expert: Pedro Brugada, the physician
son of Dr. Ramon Brugada, for whom the condition is named. Brugada the younger
looked at all of Paul’s records and told him that he didn’t have Brugada
Syndrome. Other experts concurred. Paul was told that the hospital’s original
procedure to reproduce arrhythmia “would’ve brought a horse down.” His
“abnormal” heart rhythms come from having the benign “athletic heart syndrome,”
a sign of a super heart. The original fainting was probably due to taking Paxil;
the later problems were likely due to withdrawal from it.

Even with
this confirmation, Paul had to go to more than 20 doctors before he found one
who would remove the pacemaker. Paul is recovering from his ordeal; he is able
to walk a mile now, although previously he could run 50. Despite off-the-record
confirmations of incompetence and negligence in Paul’s misdiagnosis and
treatment, not one physician would sign a letter to that effect, or agree to
testify on his behalf. Now, multiply Paul’s story by thousands, by millions,
every year, and you can understand my anger over sensationalistic headlines
about the “dangers” of taking herbs like St. John’s wort.

Here are
some truths about the “scientific” testing of pharmaceutical drugs that you
probably are not aware of. Did you know that the research information contained
in the Physicians’ Desk Reference  (the pharmaceutical bible used by M.D.s
)is supplied by the drug manufacturers themselves? Did you know that the FDA
approves drugs not by actually doing the testing, but simply by reviewing
studies submitted by the drug manufacturers? Did you know that a drug
manufacturer needs to submit only two studies showing satisfactory results to
get a drug approved by the FDA‹even if there are even more studies showing the
drug causes adverse reactions in an unacceptably high number of cases?

Did you know that most of the articles discussing the efficacy of
drugs that are published in medical journals are studies paid for by the drug
manufacturer? And that often, as the New York Times reported last summer, the
academic scientists listed as lead authors are often just “window dressing, to
lend credibility to papers that are really the work of drug companies. The
academic scientists’ main role in such studies is to recruit patients and
administer experimental treatments. The scientists or their universities are
paid for this work.”

And did you know that a study conducted by USA
Today found that more than half of the experts hired to advise the government on
the safety and effectiveness of medicine had a direct financial interest in the
drug or topic were asked to evaluate? An analysis of financial conflicts of
interest at 159 FDA advisory committee meetings from January 1, 1998, through
June 30, 2000, found that at 92% of the meetings, at least one member had a
financial conflict of interest, while at 55% of meetings, half or more of the
FDA advisers had conflicts of interest. These conflicts included helping a
pharmaceutical company develop a medicine, then serving on an FDA advisory
committee that judges the drug.

You may not know that a significant
portion of your tax dollars earmarked for healthcare goes to research on
patentable drugs that make billions of dollars for drug companies. The
government should fund research into nontoxic, non-patentable remedies at a much
higher level than it is presently doing. This situation again points out the
need for political action, for campaign reform. For 2001, the budget for the
National Institutes of Health was $20 billion. This amount could be doubled by
2003. Approximately 83% of this is spent on research performed outside the NIH.
This is serious money, and most of it goes to developing patentable drugs.

A recent article in the New York Times revealed that the
pharmaceutical industry spent $177 million on lobbying in 1999 and 2000: That’s
$50 million more than their nearest rival, the insurance industry. They employ
more lobbyists (625) than there are members of Congress ‹and more than half of
the lobbyists are former members of Congress, congressional staff members or
government employees.

This shows how important it is to get involved
politically, and work for campaign-finance reform. It’s also time for individual
physicians to take responsibility for their actions, and stop being pawns in the
economic games played by the drug and health insurance industries. Physicians
will change only if their patients demand it. Reform will only come from market
forces, which means you: how you spend your money on healthcare, and on
charitable and political donations. Get informed, take responsibility for your
own health, and choose your doctors and medicines wisely.

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Understanding Paxil Birth Defects

Ann Blake-Tracy says:

Your comment is awaiting moderation.

After two decades of tracking mothers and babies exposed to SSRI
antidepressants during pregnancy I shutter to ever see a mother take one of
these drugs. If those adverse effects listed in this article are not bad enough
to consider exposing a baby to, we have yet to witness the full effects of these
drugs upon offspring. These babies brains will not be fully developed until they
are in their 20’s. The full negative effects upon that developing brain will not
be known until then. Knowing what I know after 20 years of researching these
drugs and tracking patients who have taken them, I DO NOT WANT TO SEE WHAT IS

Ann Blake-Tracy, Executive Director,
International Coalition for Drug
Awareness &

Understanding Paxil Birth Defects

In December 2005, GlaxoSmithKline (GSK) posted its Paxil findings on its
website regarding pregnant women taking antidepressants. In this announcement,
GSK noted that it was revising its pregnancy precaution category from C to D.
This revision was based on recent studies that indicated positive evidence of
human fetal risk. In addition, GSK was placing this information in the WARNINGS
section of the Paxil label.
The FDA then advised pregnant women to switch from Paxil to another SSRI
drug, such as Prozac or Zoloft. This warning was based on the results of an
analysis of Sweden’s birth registry that showed women who took Paxil were 1.5 to
2 times more likely to give birth to a baby with heart defects than women who
took other selective serotonin reuptake inhibitors (SSRIs) or no antidepressant
at all.
Studies also showed that complications were reported for babies born to
mothers who had taken antidepressants such as Paxil in the third month of
pregnancy. Such complications included breathing difficulties, turning blue,
seizures, changing body temperature, feeding problems, vomiting, low blood
sugar, stiffness, tremor, irritability or constant crying. In other words, just
like adults, newborn babies of mothers who have taken Paxil while pregnant,
experience similar withdrawal symptoms. Because of this, tube feeding, help with
breathing and longer hospitalization may be needed. Premature births in pregnant
women exposed to SSRIs such as Paxil have also been reported.
Based on such reports obstetricians went so far as to recommend that
women avoid Paxil and reconsider using any SSRI antidepressant during pregnancy.
Still, other physicians maintain that the benefits of mothers getting treatment
for their depression outweigh the risks to the fetus.
The most common birth defects caused by antidepressants have been found
to be holes or other malformations in the chambers of the heart. Often the

defects heal on their own, but more severe cases need surgical procedures. GSK
is investigating how Paxil could be causing such defects.
In addition, antidepressant drugs are known to imbalance blood sugar
metabolism thereby worsening gestational diabetes. However, it is doubtful that
this is explained to expectant mothers who are given such drugs.
Medical professionals in women’s mental health point out that it is
important to aptly gauge the timing of medications prescribed for women who are
pregnant. Paxil is currently one of the most popular antidepressants in the
world, and roughly 25 percent of its users are women of childbearing age —
between 18 and 45.

Nick Johnson serves as lead counsel with Johnson Law Group, with principal
offices located in Houston, Texas. Johnson represents plaintiffs with injury
cases involving Defective Drugs. Contact Nick Johnson at 1-888-311-5522 or visit

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ZOLOFT: Violent Behavior in Young Girl: USA CNN

First two sentences read: “My daughter was treated for anxiety with Zoloft around a year ago. However, her school reported alarming, violent behavior (she never had that before), and we stopped it after only a week.”

Is my daughter’s violent reaction to a drug an allergy?

Asked by Sharon, USA

My daughter was treated for anxiety with Zoloft around a year ago. However, her school reported alarming, violent behavior (she never had that before), and we stopped it after only a week. I always understood this to be an “adverse effect,” but a nurse today told me it was an allergy. An allergy means she should never take it again, but an adverse effect could be grown out of, and doesn’t rule out similar drugs. Was the nurse just dumbing things down, or was she correct?

Mental Health Expert Dr. Charles Raison Psychiatrist,
Emory University Medical School

Expert answer

Dear Sharon,

The nurse may have been trying to “dumb it down” as you say, but she was not correct. We’ll talk about bad reactions to antidepressants in a moment, but let’s talk about allergies first. An allergy is a very specific type of reaction that is caused by an arm of the immune system often referred to as Th2. Allergies can be mild or extremely serious, but whatever their intensity, what they share in common is that the immune system is needlessly going into overdrive in response to something that is not really dangerous.

Because allergies are a type of inflammatory response, their symptoms tend to be fairly stereotyped: itching, redness, swelling, runny nose and eyes, hives and shortness of breath (from airway swelling) when severe. When one takes a medication and has this type of reaction, that is an allergic response to the medicine. While all medications can cause an allergic reaction, some (for complicated reasons) are much more likely to do this than others. The classic example is penicillin, to which many people are allergic. Antidepressants have a very low likelihood of inducing an allergic response.

OK, that’s the scoop on allergies. So your daughter didn’t have an allergic response, but she did have a serious side effect to the Zoloft and one that is not uncommon. In fact, behavioral agitation –while not as common as other side effects such as loss of sexual function or stomach upset — is one of the most worrisome reactions elicited by antidepressants. One reason why you don’t want your doctor to start you on an antidepressant and tell you to “come back in six weeks” is that he or she should be on much closer lookout to make sure that you don’t develop severe anxiety or agitation in the first week or two of treatment.

Psychiatrists have debated endlessly about what causes antidepressant-induced agitation. There are probably several explanations, with each being true for individual patients. There is evidence that the acute effects of antidepressants can directly cause agitation in some people. There is also evidence that many people who get agitated may have, or be at risk for, having bipolar disorder (i.e. manic depression). We have known for years that many bipolar patients will have a first manic or hypomanic episode in response to being placed on an antidepressant. That is why I always tell patients to call me immediately if they start feeling too happy or too jazzed up too quickly, as that can be a sign of developing mania. Mania can also manifest as extreme agitation or irritability, especially in children and adolescents.

I am not suggesting that your daughter has a bipolar condition. I noticed that you chose the topic “autism” when you submitted your question. If your daughter has an autistic disorder, this might also put her at increased risk of having a bad reaction to an antidepressant.

I do not think your daughter needs to avoid all antidepressants forever, because each of these agents is different. Frequently, someone who can’t tolerate one antidepressant does just fine on another. But it goes without saying that I would certainly be cautious if you elect to try another antidepressant with your daughter. You might think about doing it during a break from school so that you can watch her closely and also so that if the agitation happens again, she won’t be in a place where it might affect her social relationships outside the family.

Finally, as the director of my residency program told me years ago, “Any medication that actually works will have side effects.” I’ve never forgotten that.

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10/17/1999 – Fen-Phen Settlement on Shaky Ground

To our ICFDA Subscribers–

It was announced on Friday that American Home Products, maker of Redux
and Pondimin, is being sued by 11,000 plaintiffs. Now the majority
of those afflicted with heart and lung problems from the drug, 8,000
in all, say they are not interested in the proposed $3.75 billion
settlement offer.

Why should they be?

“I don’t know if there is an individual in the United States that would
qualify for $1.5 million under this settlement,” said Marc Bern, whose
New York City law firm represents 5,000 plaintiffs.

This case should serve as a warning to those companies now marketing
other SSRI medications which can have similar adverse effects in their
patient population. The users of these serotonergic medications
represent a much larger population than Fen-Phen users–now upwards
of 50 million individuals worldwide!

If this is the largest product liability suit to date, what might the
future bring?

For the full story, click on the link below.–Dr Ann Tracy, Executive
Director, ICFDA

Settlement on Shaky Ground
Thousands of Fen-Phen Users May Reject Offer

By Amy Westfeldt
The Associated Press

N E W A R K, N.J., Oct. 14 — Thousands of people suing American Home
Products Corp. for injuries allegedly suffered while taking the
fen-phen diet drug combination won’t participate in a proposed $3.75
billion settlement, threatening the resolution of one of the largest
product liability cases ever, lawyers say.

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