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Darvocet Heart Attack Lawsuits, Darvon Cardiac Arrest
Toxicity Lawsuits, Darvocet Heart Abnormal Rhythm Lawsuits,
Darvocet Deadly Overdose Lawsuits, Propoxyphene
Painkiller Cardiac Blackout Lawsuits, and Propoxyphene
Painkiller Overdose Lawsuits by Texas Darvon and Darvocet
Heart Damage and Fatal Heart Attack Lawyer Jason S. Coomer
Fatal Heart Attack Darvocet Lawsuits,
Propoxyphene Cardiac Arrest and Abnormal Heart Rhythm
Lawsuits, Deadly Darvocet Overdose Lawsuits, and other
Propoxyphene Cardiac Toxicity Lawsuits can arise when a
person suffers an accumulated cardiac toxicity from a
propoxyphene drug such as Darvocet or Darvon, and then
suffers an abnormal heart rhythm that causes death, heart
damage, or other serious health problems. If you or a
loved one is taking Darvocet, Darvon, or other Propoxyphene
painkiller, it is important to contact your doctor to
determine how new safety concerns regarding propoxyphene
drugs may impact you or your loved one.
If you have questions regarding a Fatal
Heart Attack Darvocet Lawsuit, Toxic Propoxyphene Abnormal
Heart Rhythm Lawsuit, Deadly Darvocet Overdose Lawsuit, or
Fatal Propoxyphene Overdose Lawsuit,
please feel free to e-mail Texas
Propoxyphene Death and Heart Damage Lawyer Jason Coomer or use our online
form for a free case evaluation.
Darvocet Fatal Overdoses, Darvon Deadly Overdoses, and
Propoxyphene Painkiller Overdoses Combined with Questions as
to Propoxyphene Effectiveness Lead to Europe and UK Banning
Propoxyphene and the FDA Issuing Box Warnings
The U.S. Food and Drug Administration
(FDA) has called for a boxed warning of overdose risk on
packages of Darvon, Darvocet and other painkillers
containing the drug propoxyphene. The drugs have not
been withdrawn from the market like they have been in Europe
and the UK, but the FDA has warned that Darvocet-N, Darvon,
and other painkillers containing the drug propoxyphene
have been linked to fatal overdoses.
Prior to the FDA box warnings, in the
United States there were an estimated over 10 million
Americans taking Darvocet and other propoxyphene painkillers
with tens of millions prescriptions being written each year.
Darvon, Darvocet, and other brand/generic drugs containing
propoxyphene are painkillers from the 1950s that have a long
history of safety concerns. Based on growing
scientific research propoxyophene drugs cause
accumulated heart toxicity, heart problems, and cardiac side
effects including abnormal and fatal heart rhythm
abnormalities.
The Public Citizen’s Health Research
Group has long been pushing for the U.S. Food & Drug
Administration to ban Darvon (generic: propoxyphene) and
Darvocet (generic: propoxyphene and acetaminophen ) due to
evidence goes back more than 30 years which indicates that
propoxyphene is not very effective as a pain relieving drug
and is toxic at doses not much higher than the recommended
dose. Strong scientific research indicates that Darvon
and Darvocet cause a heart toxic metabolite to accumulate in
the body. This heart toxic metabolite combined with
limited effectiveness in relieving pain and the addictive
nature of the propoxyphene drugs may have caused many
thousands of U.S. deaths since 1981, a large proportion of
these deaths were likely caused by cardiac toxicity.
Cardiac toxicity can cause the interruption of electrical
conduction in the heart, ventricular fibrillation, cardiac
arrest, cardiac blackouts, and other heart problems.
Researchers know that ventricular
fibrillation occurs when the heart’s electrical system
malfunctions, the electrical signals that control the
pumping of the heart become rapid and chaotic causing the
lower chambers of the heart to quiver instead of contract.
Those chambers can no longer pump blood to the rest of the
body, which leads to sudden cardiac death without
defibrillation - a successful emergency shock to jump start
the heart back into a regular beat.
This fatal cardiac toxicity may occur in
patients that use the propoxyphene drugs with a small
multiple of the normal therapeutic dose. Thus, a
proportion of cardiac toxicity fatalities may have been
caused by inadvertent overdose in an effort to relieve pain.
Recent studies have indicated that there is a confirmed link
between propoxyphene and over 10,000 confirmed deaths and
2,110 reported accidental deaths since the early 1980’s.
"The FDA’s deadly delay in this case
starkly illustrates how one of the most important public
health concepts, the precautionary principle, was embraced
by the UK and Europe, but was for too long recklessly
rejected by the FDA."
Delayed FDA Removal of Painkiller Propoxyphene
(Darvon, Darvocet) From U.S. Market Has Cost More Than 1,000
U.S. Lives, Statement by Dr. Sidney Wolfe,
Director, Public Citizen’s Health Research Group.
Propoxyphene has been associated with
2,110 reported accidental deaths in the United States since
1981. A large proportion of these deaths occur because most
of the drug is converted into a metabolite that is highly
toxic to the heart and lasts longer in the body than the
original compound, resulting in cardiac depression. Adverse
cardiac events associated with propoxyphene include an
interruption of heart transmission of electrical impulses,
slowed heartbeats and a decreased ability of the heart to
contract properly.
Scientific evidence shows that the
propoxyphene drugs have a very small margin of safety.
A dangerous dose is only slightly higher, or may be no
higher than an effective dose. Further, the safety margin
for the propoxyphene drugs can become even more unfavorable
to patients taking the drug who have not experienced relief
and thus take more of the drug, accidentally causing heart
toxicity.
FDA Rulings and Action
Darvocet-N is a prescription medicine
that contains two medicines: propoxyphene and acetaminophen.
Darvocet-N is used to relieve mild to moderate pain.
Darvocet-N is a federally controlled substance (C-IV)
because it is a strong opioid pain medicine that can be
abused by people who abuse prescription medicines or street
drugs.
The U.S. Food and Drug Administration
(FDA) has received requests to remove the propoxyphene drugs
from the market since 1978, but has previously determined
the benefits outweighed the risks. More recently a FDA
advisory committee recommended banning the drug, but decided
instead to issue strong warnings and require the company to
do a new safety study. As such, the FDA has called for
a boxed warning of overdose risk on packages of Darvon,
Darvocet and other painkillers containing the drug
propoxyphene. The medicines that contain propoxyphene can
cause serious side effects, including: Overdoses by accident
or on purpose (intentional overdose).
Overdoses with Darvocet-N may happen when
it is taken by itself, or with alcohol or other medicines
that can also decrease your breathing and make you very
sleepy. Death can happen within 1 hour of taking an overdose
of Darvocet-N. Many of the deaths that happen in people who
take Darvocet-N happen in those who have emotional problems,
have thoughts of suicide or attempted suicide, or also take
antidepressants, sedatives, tranquilizers, muscle relaxants,
or other medicines that affect your breathing and make you
very sleepy.
The FDA notified healthcare professionals
that it is taking several actions to reduce the risk of
overdose in patients using pain medications that contain
propoxyphene because of data linking propoxyphene and fatal
overdoses. The agency will require manufacturers of
propoxyphene-containing products to strengthen the label,
including the boxed warning, emphasizing the potential for
overdose when using these products and to provide a
medication guide to patients stressing the importance of
using the drugs as directed. The FDA is also requiring a new
safety study assessing unanswered questions about the
effects of propoxyphene on the heart at higher than
recommended doses. Findings from this study, as well as
other data, could lead to additional regulatory action. To
further evaluate the safety of propoxyphene, the FDA plans
to work with several groups including the Centers for
Medicare & Medicaid Services and the Veterans Health
Administration to study how often the elderly are prescribed
propoxyphene instead of other pain relievers and the
difference in the safety profiles of propoxyphene compared
to other drugs.
Pharmaceutical Companies Often Choose Profits Over Safety
All too often big drug companies and
others in the pharmaceutical industry begin to value money
and profits over the health of the consumer. When this
happens these pharmaceutical companies can deceptively
market drugs or hide known dangers of dangerous drugs.
In the case of Darvon, Darvocet and other painkillers
containing the drug propoxyphene, the drug producers may
have used deceptive
information to push their drugs and made hundreds of
millions of dollars from continuing to manufacture, market,
and sell these drugs with limited effectiveness and known
safety concerns.
The Pharmaceutical industry or "Big
Pharma" has become extremely rich and powerful over the last
decade as the industry has changed the way drugs are
regulated and marketed in the United States and throughout
the World. It is estimated that the drug industry will have
drug sales of over $300 Billion in the United States in 2010
and over $750 Billion Worldwide. These revenues are over
twice what they were 10 years ago.
The main reasons for this rapid growth
are that the drug industry has been able to put their own
people in top positions in the United States Food and Drug
Administration to change regulations to relax the drug
approval process, been able to help push through Medicare D
(a major giveaway to the drug companies that increased
government purchasing of drugs & limited competition), and
been more aggressively marketing their drugs including
off-label marketing regardless of dangers or effectiveness
of the drug.
This article is intended to help explain
the economic incentives that are encouraging the
pharmaceutical industry to aggressively push drugs for
approved and off label uses regardless of the effectiveness
or potential dangerous side effects of the drugs as well as
explain why additional safe guards are needed to help
protect consumers from dangerous drugs and to curtail the
drug industry's aggressive pursuit of profits regardless of
the potential dangers or effectiveness of specific drugs.
Significant Investments in Research and
Development Create Economic Incentives for Pharmaceutical
Companies to Aggressively Market Drugs Regardless of
Effectiveness or Potential Dangers
Because of the significant cost of
researching and developing a drug, pharmaceutical companies
have tremendous investments in making sure that a drug is
profitable regardless of the effectiveness or potential
dangers of a drug. Pharmaceutical professionals that have
spent years and significant resources developing a new drug
often cannot afford to risk their careers and company's
profitability by having a drug's approval delayed, a drug
taken off the market, or a drug sent back for further
research. These precautions though often safer for consumers
could allow another drug company or pharmaceutical
professional to develop a similar drug and steal the
potential market or cause potential profits to be delayed.
Thus, the significant investment that a drug company has in
a particular drug combined with fierce competition and the
need for short term profitability create a strong economic
incentive for a drug company to aggressively push patenting,
approval, and marketing of a drug regardless of its
effectiveness or potential dangerous side effects.
Further, once a drug is approved for a
specific use there is also tremendous economic pressure to
start marketing and pushing a drug for off label uses to
increase the drug's profitability regardless of
effectiveness or potential dangers. Even in cases where one
drug company has been warned by the FDA not to market a drug
for off label uses, other companies have purchased the drug
and found it more profitable at least in the short term to
market the drug and later pay any fines and/or lawsuits.
For more information on dangerous drug
lawsuits, feel free to click on the following links:
Paxil Infant Death, Birth Injury, and Birth Defect Lawsuits
,
Isotretinoin and Accutane Inflammatory Bowel Disease (IBD)
Lawsuits,
Reglan Tardive Dyskinesia Lawsuits,
Defective Birth Control (Yaz, Yasmine, & Ocella) Lawsuits,
Avandia Lawsuits,
Chantix Suicide Lawsuits,
Ketek Lawsuits,
Gadolinium Contrast Dye Lawsuits,
Antidepressant (SSRI) drug Lawsuits,
Infant Heart Defect Lawsuits and Paxil Birth Injury Lawsuits,
Accutane Ulcerative Colitis Lawsuits (Acne Drug Ulcerative
Colitis Lawsuits),and
Paroxetine, Seroxat, and Paxil Persistent Pulmonary
Hypertension Lawsuits
Darvocet Heart Attack Lawyer, Darvon Cardiac Arrest
Toxicity Lawyer, Darvocet Heart Abnormal Rhythm Lawyer, Darvocet Deadly Overdose Lawyer, Propoxyphene
Painkiller Cardiac Blackout Lawyer, and Propoxyphene
Painkiller Overdose Lawyer (Darvon, Darvocet and
Propoxyphene
Heart Damage and Fatal Heart Attack Lawsuits)
Texas Darvocet, Darvon, Propoxyphene, and
other dangerous drugs Attorney Jason
Coomer commonly works with other lawyers throughout Texas
and the United States
including Houston Darvocet Lawyers, San Antonio
Darvocet Heart Damage Lawyers, Dallas Propoxyphene
Painkiller Fatal Overdose Lawyers,
and other Austin Darvocet Heart Damage Lawyers. By
sharing information and working together, his law firm and
other firms throughout Texas and the United States are able to provide better
representation for there clients.
If you have questions regarding a Fatal
Heart Attack Darvocet Lawsuit, Toxic Propoxyphene Abnormal
Heart Rhythm Lawsuit, Deadly Darvocet Overdose Lawsuit, or
Fatal Propoxyphene Overdose Lawsuit,
please feel free to e-mail Texas
Propoxyphene Death and Heart Damage Lawyer Jason Coomer or use our online
form for a free case evaluation.
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