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Common Drugs Linked To Sudden
Cardiac Death
Drugs prescribed for everyday ailments could be causing thousands of sudden
heart attack deaths each year, reported seven newspapers (11 May 2005). The
reports were based on a large observational study investigating the use of
medications, known to affect heart rhythm, by people who suffered a sudden
cardiac death.
* Seven newspapers (1-7) reported that seven common drugs, including
antibiotics and medications for mental illness and stomach problems could
be causing up to 15,000 sudden deaths from heart attacks each year in
Europe and the US. Most newspapers reported that a Dutch study found that
users of the drugs were nearly three times more likely to suffer a sudden
cardiac death.
* The articles are based on the findings of a large, well-conducted
case-control study from the Netherlands (8). This compared 775 cases of
sudden cardiac death with 6,297 matched controls, with respect to the use
of seven drugs (two antibiotics, two stomach and three antipsychotic
medications). This found a significantly increased risk of sudden cardiac
death for current users (by three times), particularly those with less than
90 days use (by four times) compared with non-users.
* Most newspapers reported the research fairly accurately but three (1,6,7)
incorrectly stated that the drugs were responsible for 320 of the 775
sudden cardiac deaths in the study, when the authors report that they may
be linked to 320 cases per year in the Netherlands, based on the rate of
sudden cardiac death in the study. They all reported that the researchers
state that patients taking these drugs should not stop taking them without
consulting their GP.
Evaluation of the evidence base for the association between the use of
QTc-prolonging drugs and sudden cardiac death
Where does the evidence come from?
The study was conducted by Dr Bruno Stricker and colleagues from the
Erasmus Medical Centre, Medicines Evaluation Board, Inspectorate for Health
Care, and the University of Groningen in the Netherlands.
What were the authors' objectives?
The authors' objectives were to assess the risk of sudden cardiac death and
the use of non-cardiac QTc-prolonging drugs. QTc-prolonging drugs are known
to prolong the QT interval in the heart, which can lead to an irregular
heart rhythm. The drugs assessed included antibiotics and antipsychotic and
gastro-intestinal medications.
What was the nature of the evidence?
This was a population-based case-control study. The data came from the IPCI
project, an observational database containing the complete medical records
of more than 500,000 people, from 150 GPs who were participating in the
project. Cases were all patients registered with a GP between January 1995
and September 2003, who had died and the cause of death was classed as
sudden cardiac death. There were 775 cases of sudden cardiac death and
these were matched with 6,297 controls for age, gender and GP practice.
How did participants differ on their levels of exposure to the factor of
interest?
The exposure of interest was the use of the following non-cardiac
QTc-prolonging drugs: cisapride and domperidone (gastro-intestinal);
erythromycin and clarithromycin (antibiotic); and chlorpromazine,
haloperidol and pimozide (antipsychotic). Use of these drugs, based on
prescription details, was compared between cases of sudden cardiac death
and the matched controls. Drug exposure at the date of death (or the same
date for the controls) was split into current use, past use or never used.
For current users the duration of use was also assessed.
What were the findings?
The risk of sudden cardiac death for current users of non-cardiac
QTc-prolonging drugs was almost three times the risk for non-users. Past
use was not associated with an increased risk. The risk was also
significantly higher (by nearly four times) for patients who had only been
taking the drugs for less than 90 days before their death.
The risk of sudden cardiac death was significantly increased in users of
gastro-intestinal medication and antipsychotics, but not for antibiotic
users. Adjusted analyses showed that the risk of sudden cardiac death in
users of the drugs was higher for women than for men and also higher for
older patients (aged greater than 65), but these differences were not
statistically significant.
The incidence of sudden cardiac death in the study population was
approximately one per 1,000 person-years and the population attributable
risk of non-cardiac QTc-prolonging drugs was calculated to be 2%.
What were the authors' conclusions?
The authors concluded that current use of non-cardiac QTc-prolonging drugs
in a general population is associated with a significantly increased risk
by almost three-fold, of sudden cardiac death. In addition, their results
suggest that 320 cases of sudden cardiac death per year in the Netherlands
can be attributed to the use of non-cardiac QTc-prolonging drugs.
How reliable are the conclusions?
This was a well-conducted case-control study and the conclusions are likely
to be reliable. It was based on a large general practice based dataset of
patients, with data collected over an eight year period, and so is less
likely to be affected by selection bias. The cases of sudden cardiac death
were identified without prior knowledge of drug exposure and were matched
with up to ten controls, with matching for appropriate factors. The
statistical analysis was correct, and presents the results adjusted for
just the matching factors alone, and also including other potentially
important risk factors for cardiovascular disease.
The authors acknowledge some of the limitations of this study, mainly that
they may have missed some deaths and misclassified others; however they
conclude that this was unlikely due to the comprehensive medical records
available. In addition, the data on the use of non-cardiac QTc-prolonging
drugs was based on outpatient prescription records and there was no record
of whether the patient actually took the drug and for how long. It should
also be noted that there were only a small number of cases who were current
users of QTc-prolonging drugs at the time of sudden cardiac death (24 out
of 775 patients), and of these only four were taking an antibiotic, so it
is difficult to draw conclusions about the risks of individual drugs.
Systematic reviews
Information staff at CRD searched for systematic reviews relevant to this
topic. Systematic reviews are valuable sources of evidence as they locate,
appraise and synthesize all available evidence on a particular topic.
There were no related systematic reviews identified on the Cochrane
Database of Systematic Reviews (CDSR) or on the Database of
Abstracts of Reviews of
Effects (DARE).
References and resources
1.
Common
drugs 'cause 1,200 heart attack deaths a year'. The Independent, 11 May
2005, p17.
2.
Prescription
drugs linked to 15,000 deaths each year. The Times, 11 May 2005, p2.
3. Antibiotic link to hundreds of deaths. Daily Mail, 11 May 2005, p31.
4. Common drugs raise risk of heart attack. Daily Express, 11 May 2005, p2.
5. Stomach pill heart warning. The Sun, 11 May 2005, p27.
6. Drugs in death link. Daily Mirror, 11 May 2005, p16.
7. Range of drugs linked to sudden heart deaths. Daily Telegraph, 11 May
2005, p8.
8. Straus SMJM, Sturkenboom MCJM,
Bleumink GS, Dieleman JP, van der Lei J, de Graeff PA, Kingma JH, Stricker
BH. Non-cardiac QTc-prolonging drugs and the risk of sudden cardiac death.
European Heart Journal. Advance Access, published online on May 11, 2005,
doi:10.1093/eurheartj/ehi312
Consumer information
British Heart Foundation
NHS Direct - Heart Attack
--------------------------------
Good one!
Will most physicians stop prescribing these for patients who are on these,
or just cut back on their dosage?
Steve
[CO-CURE] antibiotic warning: Erythromycin & Clarithromycin linked to
sudden death.
Please pass this on to other groups.
Blessings
Shan
* * * * * * * * * * * * * * * * * * * * * * * * * * *
MYCOPLASMA REGISTRY REPORTS
for gulf war syndrome & chronic fatigue syndrome
© Sean Dudley & Leslee Dudley 2005. All rights reserved.
https://groups.yahoo.com/group/MycoplasmaRegistry/ MycoReg@juno.com
* * * * * * * * * * * * * * * * * * * * * * * * * * *
Seven drugs interfere with electrical activity controlling the heartbeat
and may increased risk of sudden cardiac death. (see article and abstract
below: 'Antibiotics linked to sudden deaths' and 'Non-cardiac
QTc-prolonging drugs and the risk of sudden cardiac death')
Two of the drugs are used to treat mycoplasmal infections:
Etrythromycin is prescribed to treat M. pneumoniae and M. penetrans.
Clarithromycin is prescribed to treat M. pneumoniae, M. penetrans and M. purim.
RISK LIST:
1. Erythromycin (Brand names: E-Base; E-Mycin; E.E.S.; Ery-Tab; ERYC;
EryPed; Erythrocin; Ilosone)
2. Clarithromycin. (Brand name: Biaxin)
3. Cisapride (Brand names: Propulsid, Prepulsid) 4. Domperidone (Brand
names: Motilium®)
5. Chlorpromazine (Brand name: Largactil, Thorazine)
6. Haloperidol (Brand names: Haldol, Haldol Decanoate, Apo-Haloperidol,
Haldol, Haldol LA, Novo-Peridol, Peridol, PMS Haloperidol)
7. Pimozide (Brand name: Orap)
Sean Dudley & Leslee Dudley © 2005 All Rights Reserved.
* * * * * * * * * * * * * * * * * * * * * * * * * * *
Antibiotics
linked to sudden deaths
Daily Mail - UK, UK - May 11, 2005
A range of commonly prescribed drugs including antibiotics may be
responsible for around 15,000 sudden deaths each year in Europe and the
United States, researchers claim.
The drugs interfere with electrical activity controlling the heartbeat. A
study in the Netherlands found they were associated with a three-fold
increased risk of sudden death due to cardiac arrest.
Two of the drugs are the antibiotics erythromycin and clarithromycin.
Others on the risk list are cisapride domperidone used to treat
gastro-intestinal conditions, and the anti-psychotic medications
chlorpromazine, haloperidol and pimozide.
All prolong the heart's QTc interval - a measurement of the electrical
activity linked to the contraction of heart muscle cells. Drugs that
increase the QTc interval can cause life-threatening disruptions of heart
rhythms.
Widespread research
The findings emerged from a study of 775 cases of sudden heart death.
Researchers found that the seven drugs were probably responsible for 320 of
these deaths.
This equated to about 15,000 deaths per year across Europe and the United
States.
But the study's senior author, Dr Bruno Stricker, from the Erasmus Medical
Centre in Rotterdam, said that although the findings were significant, it
was important to keep them in proportion.
It was normal to expect one or two sudden cardiac deaths per thousand of
the population each year in Western countries.
The risk for people taking the drugs rose to around three per thousand.
Vital treatments
"These drugs are vital treatments for serious conditions in many cases, so
it is essential that patients should not stop taking them on their own
initiative," said Dr Stricker, who is also a senior medical officer at the
Inspectorate for Healthcare in The Hague.
"If they are concerned they should talk to their doctor."
The drugs have all previously been implicated in abnormal heart rhythms
(arrhythmia). But the new study is thought to be the first to investigate
links with sudden death.
The findings appeared in the European Heart Journal.
2005 Associated Newspapers Ltd · Terms & Conditions ·
* * * * * * * * * * * * * * * * * * * * * * * * * * *
Non-cardiac
QTc-prolonging drugs and the risk of sudden cardiac death
European Heart Journal Advance Access published online on May 11, 2005.
European Heart Journal, doi:10.1093/eurheartj/ehi312
European Heart Journal © The European Society of Cardiology 2005; All
rights reserved. Received February 6, 2005, Revised April 1, 2005, Accepted
April 7, 2005
Sabine M.J.M. Straus 1, Miriam C.J.M. Sturkenboom 2, Gysèle S. Bleumink 3,
Jeanne P. Dieleman 2, Johan van der Lei 4, Pieter A. de Graeff 5, Jan Herre
Kingma 6, and Bruno H.Ch. Stricker 7*
1 Pharmaco-Epidemiology Unit, Departments of Epidemiology and Biostatistics
and Internal Medicine, Erasmus Medical Center, PO Box 1738, 3000 DR
Rotterdam, The Netherlands; Department of Medical Informatics, Erasmus
Medical Center, 3000 DR Rotterdam, The Netherlands; Medicines Evaluation
Board, The Hague, The Netherlands
2 Pharmaco-Epidemiology Unit, Departments of Epidemiology and Biostatistics
and Internal Medicine, Erasmus Medical Center, PO Box 1738, 3000 DR
Rotterdam, The Netherlands; Department of Medical Informatics, Erasmus
Medical Center, 3000 DR Rotterdam, The Netherlands
3 Pharmaco-Epidemiology Unit, Departments of Epidemiology and Biostatistics
and Internal Medicine, Erasmus Medical Center, PO Box 1738, 3000 DR
Rotterdam, The Netherlands; Inspectorate for Health Care, The Hague, The
Netherlands
4 Department of Medical Informatics, Erasmus Medical Center, 3000 DR
Rotterdam, The Netherlands
5 Medicines Evaluation Board, The Hague, The Netherlands; Department of
Clinical Pharmacology, University of Groningen, Groningen, The Netherlands
6 Inspectorate for Health Care, The Hague, The Netherlands; Department of
Clinical Pharmacology, University of Groningen, Groningen, The Netherlands
7 Pharmaco-Epidemiology Unit, Departments of Epidemiology and Biostatistics
and Internal Medicine, Erasmus Medical Center, PO Box 1738, 3000 DR
Rotterdam, The Netherlands; Inspectorate for Health Care, The Hague, The
Netherlands
* To whom correspondence should be addressed.
Bruno H.Ch. Stricker, E-mail: b.stricker@erasmusmc.nl
ABSTRACT
Aims: To assess the association between the use of non-cardiac
QTc-prolonging drugs and the risk of sudden cardiac death.
Methods and results: A population-based case-control study was performed in
the Integrated Primary Care Information (IPCI) project, a longitudinal
observational database with complete medical records from more than 500 000
persons. All deaths between 1 January 1995 and 1 September 2003 were
reviewed. Sudden cardiac death was classified based on the time between
onset of cardiovascular symptoms and death. For each case, up to 10 random
controls were matched for age, gender, date of sudden death, and general
practice. The exposure of interest was the use of non-cardiac
QTc-prolonging drugs. Exposure at the index date was categorized into three
mutually exclusive groups of current use, past use, and non-use. The study
population comprised 775 cases of sudden cardiac death and 6297 matched
controls. Current use of any non-cardiac QTc-prolonging drug was associated
with a significantly increased risk of sudden cardiac death (adjusted OR:
2.7; 95% CI: 1.6-4.7). The risk of death was highest in women and in recent
starters.
Conclusion: The use of non-cardiac QTc-prolonging drugs in a general
population is associated with an increased risk of sudden cardiac death.
antibiotic warning: Erythromycin & Clarithromycin linked to sudden deaths-study
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