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The Blood Thinner Pradaxa May Cause Fatal Blood Loss,
Internal Bleeding, Hemorrhaging, And Death: Persons Taking
Pradaxa Should Be Aware of These Health Risks by Texas
Pradaxa Lawyer, Texas Pradaxa Fatal Blood Loss Lawyer, Texas
Pradaxa Hemorrhaging Death Lawyer, and Texas Pradaxa Death
Lawyer Jason S. Coomer
Scientific evidence has recently confirmed
that the the blood thinner, Pradaxa, may cause serious
health problems including internal bleeding and hemorrhaging
in certain populations of patients that may cause death. Further, there
are allegations that the drug manufacturer may have
been aware of certain dangers of the drug's use, but did
not warn the public in a timely manner of these health
dangers.
If you have been given Pradaxa and have
suffered severe blood loss from internal bleeding or
hemorrhaging, or have lost a person that you love from
excessive blood loss and that person was given Pradaxa,
please feel free to e-mail Texas
Pradaxa Blood Loss Lawyer Jason
Coomer with your name & contact
information or use our online
form for a free case evaluation.
Pradaxa Internal Bleeding Lawyer, Pradaxa
Hemorrhaging Death Lawyer, Pradaxa Internal Bleeding Death
Lawyer, and Pradaxa Lawyer
On December 7, 2011, the Federal Food and
Drug Administration (FDA) issued a FDA Drug
Safety Communication: Safety review of post-market reports
of serious bleeding events with the anticoagulant Pradaxa (dabigatran
etexilate mesylate)
The U.S. Food and Drug Administration
(FDA) is evaluating post-marketing reports of serious
bleeding events in patients taking Pradaxa (dabigatran
etexilate mesylate). Pradaxa is a blood thinning
(anticoagulant) medication used to reduce the risk of stroke
in patients with non-valvular atrial fibrillation (AF), the
most common type of heart rhythm abnormality.
Facts about Pradaxa (dabigatran etexilate
mesylate)
Pradaxa (dabigatran etexilate) is a blood thinner that
was approved by the U.S. Food & Drug Administration (FDA) in
October 2010 to prevent blood clots in patients with atrial
fibrillation.
A blood thinner (anticoagulant) known as
a direct thrombin inhibitor. Approved to reduce the risk of
stroke and blood clots (systemic embolism) in patients with
non-valvular atrial fibrillation. Available as 75 mg and 150
mg oral capsules. From approval in October 2010 through
August 2011, a total of approximately 1.1 million Pradaxa
prescriptions were dispensed and approximately 371,000
patients received Pradaxa prescriptions from U.S. outpatient
retail pharmacies.1
At this time, FDA continues to believe
that Pradaxa provides an important health benefit when used
as directed and recommends that healthcare professionals who
prescribe Pradaxa follow the recommendations in the approved
drug label (See Additional Information for Healthcare
Professionals).
Patients with AF should not stop taking
Pradaxa without talking to their healthcare professional.
Stopping use of blood thinning medications can increase
their risk of stroke. Strokes can lead to permanent
disability and death.
Bleeding that may lead to serious or even
fatal outcomes is a well-recognized complication of all
anticoagulant therapies. The Pradaxa drug label contains a
warning about significant and sometimes fatal bleeds. In a
large clinical trial (18,000 patients) comparing Pradaxa and
warfarin, major bleeding events occurred at similar rates
with the two drugs.
FDA is working to determine whether the
reports of bleeding in patients taking Pradaxa are occurring
more commonly than would be expected, based on observations
in the large clinical trial that supported the approval of
Pradaxa. (See Data Summary). FDA is working closely with the
manufacturer of Pradaxa (Boehringer Ingelheim) to evaluate
the post-market reports of bleeding.
FDA will communicate any new information
on the risk of bleeding and Pradaxa when it becomes
available.
Additional Information for Patients
Pradaxa is an anticoagulant medicine that
reduces the risk of blood clots forming in your body and
causing a stroke. Having a stroke can cause permanent
disability and death. Do not stop taking Pradaxa without
talking to your healthcare professional. Stopping use of
your blood thinner suddenly can put you at risk of a stroke.
Be aware that while taking Pradaxa you may bruise more
easily and it may take longer for any bleeding to stop.
Call your healthcare professional and
seek immediate care if you develop any signs or symptoms of
bleeding such a
unusual bleeding from the gums
nose bleeding that happens often
menstrual or vaginal bleeding that is
heavier than normal
bleeding that is severe or you cannot
control
pink or brown urine
red or black stools (looks like tar)
bruises that happen without a known cause
or that get larger
coughing up blood or blood clots
vomiting blood or vomit that looks like
coffee grounds.
Other symptoms of Pradaxa internal bleeding
may include:
Tiredness and Lethargy, Joint pain or
swelling
Headaches Dizziness Weakness
swelling of the arms, hands, feet, ankles
or lower legs
Death
Discuss any questions or concerns about
Pradaxa with your healthcare professional.
Report any side effects you experience to
your healthcare professional and the FDA MedWatch program
using the information in the “Contact Us” box at the bottom
of the page.
Additional Information for Healthcare
Professionals
If you prescribe Pradaxa, carefully
follow the approved indication and other recommendations,
such as dosage and administration, in the professional drug
label. Make sure your patients know the signs and symptoms
of bleeding and when to seek care. Pradaxa is eliminated by
the kidneys, therefore: Renal function should be assessed
prior to treatment with Pradaxa to determine the appropriate
dose. Renal function should be reassessed during treatment
with Pradaxa if clinically indicated (fluctuating renal
function, diuretic use, hypovolemia), and the dose should be
adjusted following recommendations in the label.
There is no need for dosage adjustment in
patients with mild to moderate renal impairment (creatinine
clearance [CrCl] > 30 mL/min). These patients should be
given a dose of Pradaxa 150 mg orally twice daily. For
patients with severe renal impairment, follow the
recommended doses: For patients with CrCl 15-30 mL/min, the
recommended dose is 75 mg orally twice daily. Dosing
recommendations for patients with a CrCl <15 mL/min or on
dialysis cannot be provided.
Report adverse events involving Pradaxa
to the FDA MedWatch program, using the information in the
“Contact Us” box at the bottom of the page.
Data Summary Bleeding that may lead to
serious or even fatal outcomes is a well-recognized
complication of all anticoagulant therapies. In a large
clinical trial (18,000 patients) comparing Pradaxa (dabigatran
etexilate mesylate) and warfarin, major bleeding events
occurred at similar rates with the two drugs. At present,
the FDA is evaluating the post-marketing reports of serious
bleeding in patients taking Pradaxa submitted to the Adverse
Events Reporting System (AERS) database. While serious, even
fatal events have been reported, the FDA is analyzing the
events to determine whether the reports of bleeding in
patients taking Pradaxa are occurring more commonly than
would be expected, based on observations in the large
clinical trial that supported the approval of Pradaxa.
Complicating this analysis, many factors
can influence whether or not adverse effects are reported,
particularly the length of time a drug has been marketed,
whether or not the adverse effect is described in the drug
label, and the amount of publicity about an event or safety
concern.
For patients with non-valvular AF, the
main alternative to Pradaxa is warfarin. Because warfarin
has been marketed for over 50 years and is well-known to
cause bleeding, patients and healthcare professionals are
not likely to report bleeding in association with warfarin.
Thus, a simple comparison between Pradaxa and warfarin with
respect to the numbers of post-marketing reports of bleeding
is of limited value.
FDA is working with the manufacturer,
Boehringer Ingelheim, to analyze the post-market reports for
evidence of inappropriate dosing, use of interacting drugs,
or other clinical factors that might lead to a bleeding
event.
FDA is also using its Mini-Sentinel
active surveillance system to compare new users of Pradaxa
and warfarin with respect to the likelihood of being
hospitalized for bleeding.
At this time, FDA believes the benefits
of Pradaxa continue to exceed the potential risks when the
drug is used appropriately following the approved drug
label. FDA recommends that healthcare professionals continue
to prescribe Pradaxa following the recommendations in the
drug label.
Pradaxa Internal Bleeding Lawyer, Pradaxa
Hemorrhaging Death Lawyer, Pradaxa Internal Bleeding Death
Lawyer, and Pradaxa Lawyer
In September 2011, Pradaxa became the
subject of an investigation in New Zealand after as many as
five elderly Pradaxa patients reportedly died as a result of
internal bleeding / hemorrhaging. Another 36 patients
reportedly suffered bouts of serious internal bleeding /
hemorrhaging. New Zealand media outlets reported that some
families claimed the chain of events leading to their
relatives' deaths began when they switched from warfarin to
Pradaxa, and infections set in after their conditions had
deteriorated to the point of hospital admission.
The New Zealand reports came weeks after
regulators in Japan asked the maker of Pradaxa to notify
doctors about potentially deadly bleeding / hemorrhaging in
some Pradaxa patients. According to a letter sent to
Boehringer Ingelheim by the country's health ministry,
between March 14 and August11, 81 elderly patients taking
Pradaxa suffered heavy bleeding / hemorrhaging, leading to
five deaths. Japanese officials suggested that patients
older than 70 may need a lower dose of Pradaxa. Bleeding /
hemorrhaging is also a side effect of older blood thinners,
such a warfarin. But warfarin bleeding can be treated with
vitamin K. There is no antidote available for bleeding
caused by Pradaxa and similar drugs, known as direct
thrombin inhibitors.
Pradaxa Internal Bleeding Lawyers, Pradaxa
Hemorrhaging Death Lawyers, Pradaxa Internal Bleeding Death
Lawyers, and Pradaxa Lawyers
Texas Dangerous Drug Attorney Jason
Coomer commonly works with other lawyers throughout Texas
and the United States
including Houston Pradaxa Lawyers, San Antonio
Pradaxa Lawyers, Dallas Pradaxa Lawyers, Chicago Pradaxa
Lawyers, Illinois Pradaxa Lawyers,
and other Dangerous Drug Claim Lawyers. By
sharing information and working together, his law firm and
other firms throughout Texas are able to provide better
representation for there clients.
If you have been given Pradaxa and have
suffered severe blood loss from internal bleeing or
hemorrhaging, or have lost a person that you love
that was given Pradaxa,
please feel free to e-mail Texas
Pradaxa Lawyer Jason
Coomer with your name & contact
information or use our online
form for a free case evaluation.
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