The Injectable Diabetes Drug Byetta May Cause
Pancreatitis and Pancreatic Cancer
Pancreatic cancer is the fourth leading cause
of cancer death for both men and women and is one of the most
deadly of all types of cancer. The
injectable diabetes drug, Byetta (Exenatide),
may cause an
increased risk of pancreatic cancer
in patients using Byetta. If you
have lost a loved one from Pancreatic Cancer or have suffered acute pancreatitis,
hemorrhagic pancreatitis, accute necrotizing pancreatitis, or
pancreas cancer; and have
been using Byetta (Exenatide), please report the adverse action
to the prescribing medical doctor as soon as possible. You
may also be entitled to compensation for your injuries and we
can help. For more information on a potential Byetta
Pancreatic cancer lawsuit,
please feel free
to
contact Byetta Pancreatic Cancer Lawyer, Jason
Coomer a Texas lawyer, or use
our online submission form.
Pancreatic Carinoma, Pancreatic Cancer, and Cancer
Pancreas
This year
approximately 45,000 Americans will be diagnosed with
pancreatic cancer and about 38,000 will die from it.
Unfortunately, pancreatic cancer is
difficult to diagnose, and the diagnosis is often made late
in the course of the disease. Early detection of
pancreatic cancer is essential and will greatly improve a
person's chances of surviving the disease. As such, people
that have taken Byetta, especially those with symptoms of
weight loss, dark urine and clay-colored stools, back pain,
and jaundice, should seek advice from a qualified medical
professional as to if they may have pancreatic cancer and
what symptoms they should be aware of to detect any early
onset of pancreatic cancer.
The
Diabetes Drug Market is Over $40 Billion Each Year and Growing
Rapidly Byetta had Annual Sale of Over $500 Million in 2010
More than 300
million people worldwide suffer from diabetes, including nearly
26 million Americans. The global market for products in
the management of diabetes currently stands at $41 billion and
is on pace to grow to over $114 billion by 2018.
Byetta was the first glucagon-like peptide-1
(GLP-1) receptor agonist to be approved by the FDA for the
treatment of type 2 diabetes. Byetta exhibits many of the same
effects as the human incretin hormone GLP-1. GLP-1 improves
blood sugar after food intake through multiple effects that work
in concert on the stomach, liver, pancreas and brain.
Byetta was approved in the U.S. in April 2005 and in Europe in
November 2006 and has been used by more than 1.8 million
patients since its introduction. Nearly 7 million prescriptions for Byetta
were dispensed between April 2005 and September 2008. In
2010 Byetta sales were over $500 million.
Unfortunately safety issues with Byetta began
to emerge not long after its approval by the FDA. It
appears that Byetta was not as safe as previously thought and it
is believed that the makers of the drug should have been aware
of such a strong correlation between Byetta and Pancreatic
cancers before they put it on the market.
FDA Responds to Reports that Byetta (Exenatide)
and Byetta (Exenatide)
May Cause an
Increased Risk of Hemorrhagic Pancreatitis and
Necrotizing Pancreatitis
10/2007:
the FDA has reviewed 30 postmarketing reports of acute
pancreatitis in patients taking Byetta, a drug used to treat
adults with type 2 diabetes. An association between Byetta and
acute pancreatitis is suspected in some of these cases.
The FDA
suggests healthcare professionals should instruct patients
taking Byetta to seek prompt medical care if they experience
unexplained persistent severe abdominal pain which may or may
not be accompanied by vomiting. If pancreatitis is suspected,
Byetta should be discontinued. If pancreatitis is confirmed,
Byetta should not be restarted unless an alternative etiology is
identified.
Because of
these findings the FDA has asked and the maker of Byetta, Amylin
Pharmaceuticals, Inc. has agreed to include information about
acute pancreatitis in the PRECAUTIONS section of the product
label.
Update [8/18/2008]: The
FDA received reports of 6 cases of hemorrhagic or necrotizing
pancreatitis in patients taking Byetta. Byetta is a medicine
given by subcutaneous injection to help treat adults with type 2
diabetes. Of the 6 cases of hemorrhagic or necrotizing
pancreatitis, all patients required hospitalization, two
patients died and four patients were recovering at time of
reporting. Byetta was discontinued in all 6 cases.
Byetta and other potentially
suspect drugs should be promptly discontinued if pancreatitis is
suspected. There are no known patient characteristics which
determine when pancreatitis associated with Byetta will be
complicated by the hemorrhagic or necrotizing forms of this
condition. If pancreatitis is confirmed, initiate appropriate
treatment and carefully monitor the patient until recovery.
Byetta should not be restarted. Consider antidiabetic therapies
other than Byetta in patients with a history of pancreatitis.
FDA is working with the
maker of Byetta, Amylin Pharmaceuticals, Inc., to add
stronger and more prominent warnings in the product label
about the risk of acute hemorrhagic or necrotizing pancreatitis.
Update [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 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).
Byetta Pancreatic Cancer Lawsuit Information, Byetta
Pancreas
Cancer Lawsuit Information, and Byetta Cancer Death Lawsuit
Information
Byetta
Pancreas
Cancer Lawsuits and Byetta Pancreatic Cancer Lawsuits are in
the process of being reviewed and filed as recent scientific
evidence
indicates that the injectable diabetes drug, Byetta (Exenatide),
may cause an
increased risk of pancreatitis, this side effect can and
often does lead to the development of pancreatic cancer.
Pancreatic Cancer is an extremely deadly form of cancer. Most
people diagnosed with Pancreatic Cancer or Cancer of the
Pancreas do not survive
beyond the five years and many are given much less time as
Pancreatic Cancer is hard to detect. Early detection
is the key to surviving pancreatic cancer.
Diabetics are more vulnerable to developing
pancreatitis than those without the disease, recent studies
indicate that taking Byetta can potentially increase the risk of
pancreatitis. And,
if pancreatitis becomes chronic, the inflammation of the
pancreas will alter its normal structure and functions.
This can lead to pancreatic cancer.
Prior 2009, the FDA received more than 30 reports of
acute pancreatitis in Byetta users. Armed with this
information, the FDA directed Amylin to conduct six
post-marketing studies regarding acute pancreatitis
associated with the use of Byetta, as well as to look at the
risk of Byetta cancer, including thyroid cancer and
pancreatic cancer. Additionally, the FDA has expressed
concern that all extended-release diabetes drugs belonging
to Byetta’s family of GLP-1 receptor agonists may be linked
to thyroid tumors based on tests conducted on rats and
monkeys.
Byetta Pancreas
Cancer Lawyers and Byetta
Pancreatitis Lawyers
Texas Diabetes Drug Attorney, Jason Coomer, commonly works with other lawyers throughout
the nation including National Pancreatic Cancer Lawyers,
International Byetta Pancreatic Cancer Lawyers, Chicago Byetta Pancreatic
Cancer Lawyers, Boston Byetta Pancreas Cancer
Lawyers, New York Byetta Pancreatitis Attorneys, California
Diabetes Drug Pancreatic Cancer
Attorneys, Houston Byetta Cancer Lawyers, Florida Diabetes Drug Pharmaceutical
Lawyers, Dallas Byetta Cancer Death Lawyers, and other Texas
Dangerous Drug Claim Lawyers. By sharing information
and working together, his law firm and other firms
throughout the nation and the world are able to provide
better representation for their clients.
If you
have lost a loved one from Pancreatic Cancer or have suffered acute pancreatitis,
hemorrhagic pancreatitis, accute necrotizing pancreatitis, or
pancreas cancer; and have
been using Byetta (Exenatide), please report the adverse action
to the prescribing medical doctor as soon as possible.
You may also be entitled to compensation for your injuries
and we can help. For more information on a potential Byetta
Pancreatic cancer lawsuit,
please feel free
to
contact Byetta Pancreatic Cancer Lawyer, Jason
Coomer a Texas lawyer, or use
our online submission form.
The ToxicDoseLaw.comwebsite provides information
on dangerous medications, bad drugs, dangerous products, toxic
substances, and defective products that can cause serious toxic
exposures, toxic deaths, serious diseases including mesothelioma &
cancer, or toxic exposures.
It is well established that
many large corporations have profited from selling toxic products or
products that cause toxic exposure without regard to the health
consequences of the products. Some of the most well known toxic
products are asbestos products and bad drugs. The asbestos products
have been found to cause mesothelioma and several forms of cancer
and other asbestos diseases, while dangerous drugs have been linked
to death, serious heart problems, drug interactions, and suicide.
Other dangerous products that have been linked to serious disease
include silica, chemical pollutants, lead, radon, EMFs,
welding rods,
toxic mold infestations
and other environmental toxins have caused death and serious harm to
millions. In the work environment alone undisclosed and known
toxins including asbestos, silica, and welding rods have caused
occupational diseases and fatalities including mesothelioma,
numerous forms of cancer, and Parkinson's disease.
This web site was created by Texas Toxic Tort Lawyer Jason
Coomer and is intended only as general information on some of the
most dangerous products and toxic products that have been sold by
drug manufacturers, medical device manufacturers, and asbestos
manufacturers, or are in use by large companies attempting to profit
and make money from the sale of dangerous products that can cause
serious toxic exposures. For more information on a dangerous
product or toxic exposure follow the links found above,
e-mail an inquiry to
info@toxicdoselaw.com,
or submit an inquiry.
This website provides basic
information on some well established toxins and some potential
toxins that are best to avoid. Overall, ToxicDoseLaw.com and
ToxicExposureLaw.com recommend using the precautionary principle by
minimizing exposure to potential toxins until they can be proven
nontoxic.
For more information on the ToxicDoseLaw.com or
ToxicExposureLaw.com information center, follow the links on this
website,
submit an inquiry,
email us at
info@toxicdoselaw.com
or call us at (512) 474-5577.