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Byetta Hemorrhagic Pancreatitis Lawsuit, Byetta Necrotizing Pancreatitis Lawsuit,
Byetta Bleeding
Pancreas Lawsuit, and Byetta Acute Pancreatitis Lawsuit
Information by Texas Byetta Hemorrhagic Pancreatitis Lawyer,
Byetta Acute Pancreatitis Lawyer and Byetta Necrotizing
Pancreatitis Lawyer Jason S. Coomer
Evidence
recently confirmed that the diabetes drug, Byetta (Exenatide),
may cause an
increased risk of hemorrhagic or necrotizing pancreatitis
in patients using Byetta.
Further, there is evidence that both the Food and Drug
Administration (FDA) and the drug maker may have been aware
of the problems for quite a while. If you have suffered acute pancreatitis,
hemorrhagic pancreatitis, accute necrotizing pancreatitis, or
pancreas cancer; and have
been using Byetta (Exenatide), please seek
medical advice as soon as possible. For more
Byetta Hemorrhagic Pancreatitis Lawsuit or Byetta Necrotizing
Pancreatitis Lawsuit information,
please feel free
to
contact Byetta Hemorrhagic Pancreatitis Lawyer, Byetta Pancreas
Cancer Lawyer, and Byetta
Necrotizing Pancreatitis Lawyer Jason
Coomer a Texas lawyer, or
use
our online submission form.
FDA Responds to Reports that Byetta (Exenatide)
and Byetta (Exenatide)
May Cause an
Increased Risk of Hemorrhagic Pancreatitis and
Necrotizing Pancreatitis
In November 2009, the FDA revised the prescribing
information for Byetta
to include information on reported cases of acute pancreatitis
in patients using this drug. Below is information
from the FDA regarding Byetta safety warnings.
Byetta Safety Update for Healthcare
Professionals
As part of our ongoing efforts to keep
you informed, we want to make you aware of recent safety
information for Byetta, an anti-diabetic drug. On October
30, 2009, FDA approved a Risk Evaluation and Mitigation
Strategy (REMS) for Byetta. The REMS was part of an approval
for a new indication of Byetta to be used as an adjunct to
diet and exercise to improve glycemic control in adults with
type 2 diabetes mellitus. Previously Byetta was only
approved for use in combination with other anti-diabetic
drugs.
The REMS is the result of new safety
information associated with the use of Byetta, including
postmarketing reports of acute pancreatitis and altered
kidney function. Acute pancreatitis was previously listed in
the prescribing information for Byetta, but more severe
forms of pancreatitis, including hemorrhagic and necrotizing
pancreatitis, have been reported to FDA since the initial
label update. FDA issued safety communications on these
adverse event reports in 2007 (acute pancreatitis), 2008
(hemorrhagic and necrotizing pancreatitis) and 2009 (altered
kidney function).
Over 7 million prescriptions for Byetta
have been dispensed since it was first approved by FDA in
2005. Therefore, while these adverse events are very
serious, the number of reported cases of acute pancreatitis,
hemorrhagic and necrotizing pancreatitis, and altered kidney
function represent a small percentage of the total number of
patients who have used Byetta.
To ensure that healthcare professionals
and patients fully understand the benefits and potential
risks associated with the use of Byetta, the REMS contains
several elements including:
A Medication Guide given to patients each
time they receive a prescription for Byetta from a pharmacy.
The Medication Guide explains the benefits and risks
associated with using Byetta A Communication Plan requiring
the manufacturer of Byetta to distribute a Dear Healthcare
Professional letter discussing the potential for altered
kidney function to occur in patients using Byetta Evaluating
healthcare professional and patient understanding of the
potential for acute pancreatitis and altered kidney function
in patients using Byetta
Additionally, the sponsor, Amylin
Pharmaceuticals Inc, is being required to conduct six
post-marketing studies (Postmarketing Requirements [PMRs])
to help further define the mechanism, incidence, and risk
factors for the development of acute pancreatitis, including
hemorrhagic and necrotizing pancreatitis, associated with
the use of Byetta, as well as to explore a potential signal
of a serious risk of thyroid cancer and pancreatic cancer.
Home News & Events Newsroom Press Announcements
- FDA NEWS RELEASE
For Immediate Release: Nov. 2, 2009
Media Inquiries: Sandy Walsh,
301-796-4669, sandy.walsh@fda.hhs.gov Consumer Inquiries:
888-INFO-FDA FDA: Byetta Label Revised to Include Safety
Information on Possible Kidney Problems
The U.S. Food and Drug Administration
today acted on new safety information about possible kidney
function problems, including kidney failure, in patients
taking Byetta (exenatide), a drug used to treat Type 2
diabetes.
From April 2005 through October 2008, the
FDA received 78 reports of problems with kidney function in
patients using Byetta. Some cases occurred in patients with
pre-existing kidney disease or in patients with one or more
risk factors for developing kidney problems.
Nearly 7 million prescriptions for Byetta
were dispensed between April 2005 and September 2008. The 78
cases represent a small percentage of the total number of
patients using the drug to control blood sugar (glucose)
levels.
The most common side effects associated
with Byetta include nausea, vomiting, and diarrhea. These
side effects may have contributed to the development of
altered kidney function. Kidney malfunction can result in a
build-up of waste products in the blood, leading to serious
illness or life-threatening conditions.
“Health care professionals and patients
taking Byetta should pay close attention to any signs or
symptoms of kidney problems,” said Amy Egan, M.D. M.P.H., of
the Division of Metabolism and Endocrinology Products at the
FDA’s Center for Drug Evaluation and Research. “Patients
also should be aware that problems with kidney function
could lead to changes in urine color, frequency of urination
or the amount of urine, unexplained swelling of the hands or
feet, fatigue, changes in appetite or digestion, or dull
ache in mid to lower back.”
Patients who experience any of these
symptoms should immediately discuss them with their health
care professional.
Exenatide (marketed as Byetta) Information
[11/02/2009] FDA has approved revisions
to the drug label for Byetta (exenatide) to include
information on post-marketing reports of altered kidney
function, including acute renal failure and insufficiency.
Byetta, an incretin-mimetic, is approved as an adjunct to
diet and exercise to improve glycemic control in adults with
type 2 diabetes mellitus.
From April 2005 through October 2008, FDA
received 78 cases of altered kidney function (62 cases of
acute renal failure and 16 cases of renal insufficiency), in
patients using Byetta. Some cases occurred in patients with
pre-existing kidney disease or in patients with one or more
risk factors for developing kidney problems. From April 2005
through September 2008, more than 6.6 million prescriptions1
for Byetta were dispensed. Therefore, the 78 reported cases
of altered renal function represent a small percentage of
the total number of patients who have used the drug.
Some of the 78 patients reported nausea,
vomiting, and diarrhea--the most common side effects
associated with Byetta in clinical trials. These side
effects may have contributed to the development of altered
kidney function in the reported cases.
The revisions to the drug label allow
healthcare professionals to better weigh the known benefits
of Byetta with the potential risks that exist for certain
patients. Changes include:
Information regarding post-market reports
of acute renal failure and insufficiency, highlighting that
Byetta should not be used in patients with severe renal
impairment (creatinine clearance <30 ml/min) or end-stage
renal disease. Recommendations to healthcare professionals
that caution should be applied when initiating or increasing
doses of Byetta from 5 mcg to 10 mcg in patients with
moderate renal impairment (creatinine clearance 30 to 50
ml/min). Recommendations that healthcare professionals
monitor patients carefully for the development of kidney
dysfunction, and evaluate the continued need for Byetta if
kidney dysfunction is suspected while using the product.
Information about kidney dysfunction in the patient
Medication Guide to help patients understand the benefits
and potential risks associated with Byetta.
Acute pancreatitis, Hemorrhagic
Pancreatitis, Necrotizing Pancreatitis
Acute pancreatitis is a sudden inflammation of the pancreas
that occurs over a short period of time. The pancreas is a
digestive organ behind the stomach that secretes essential
enzymes needed for the digestion of certain foods, including
fats, carbohydrates and proteins. During an episode of acute
hemorrhagic pancreatitis, several symptoms relating to digestion
and abdomen may occur. In severe cases, the person may
experience confusion, difficulty breathing, or respiratory
failure. The person may also fall into a coma.
The severity of acute
pancreatitis may range from mild abdominal discomfort to a
severe, life-threatening illness. However, the majority of
people with acute pancreatitis (more than 80%) recover
completely after receiving the appropriate treatment. In
very severe cases, acute pancreatitis can result in bleeding
into the gland, serious tissue damage, infection, and cyst
formation. Severe pancreatitis can also create conditions which
can harm other vital organs such as the heart, lungs, and
kidneys.
The warning signs of pancreatitis include: 1) Upper abdominal
pain that radiates into the back. Patients may describe this as
a "boring sensation" that may be aggravated by eating,
especially foods high in fat. 2) Swollen and tender abdomen 3)
Nausea and vomiting 4) Fever and 5) Increased heart rate.
Acute hemorrhagic pancreatitis is the sudden
inflammation of the pancreas. This leads to death of pancreatic
tissue and the formation of lesions, causing extensive bleeding.
Necrotizing pancreatitis is a serious health condition where
a person's pancreas is inflamed and bleeding. In Necrotizing
Pancreatitis patients, there is inflammation and tissue death,
with the pancreas destroying itself. Whereas in
Hemorrhagic Pancreatitis patients, the pancreas is bleeding.
Both are serious conditions and should be treated immediately.
Byetta Hemorrhagic Pancreatitis Lawyer,
Byetta Necrotizing Pancreatitis Lawyer, Byetta Death Lawyer,
Byetta
Hemorrhagic Pancreatitis Lawyers and Byetta Necrotizing
Pancreatitis Lawyers
Texas Dangerous Drug Attorney, Jason Coomer, commonly works with other lawyers throughout
the nation including Chicago Byetta Pancreatitis Lawyers, Boston
Byetta Pancreatis
Lawyers, New York Byetta Acute Pancreatitis Attorneys, California
Diabetes Drug Pancreatitis
Attorneys, Houston Byetta Lawyers, Oklahoma Diabetes Drug Pharmaceutical
Lawyers, Dallas Byetta Death Lawyers, and other Texas Dangerous
Drug Claim Lawyers. By sharing information and working
together, his law firm and other firms throughout the nation are
able to provide better representation for there clients. If you have suffered acute pancreatitis,
hemorrhagic pancreatitis, accute necrotizing pancreatitis, or
pancreas cancer; and have
been using Byetta (Exenatide), please seek
medical advice as soon as possible. For more
Byetta Hemorrhagic Pancreatitis Lawsuit or Byetta Necrotizing
Pancreatitis Lawsuit information,
please feel free
to
contact Byetta Hemorrhagic Pancreatitis Lawyer, Byetta Pancreas
Cancer Lawyer, and Byetta
Necrotizing Pancreatitis Lawyer Jason
Coomer a Texas lawyer, or
use
our online submission form.
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