Diabetes Drugs Januvia and Janumet 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.
According to the FDA, the
diabetes drug, Sitagliptin (marketed as Januvia and Janumet)
may cause an
increased risk of pancreatic cancer
in patients using Januvia. 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 Januvia or Janumet, please report the adverse action
to the prescribing medical doctor as soon as possible. For more
information on a potential legal claim regarding Januvia,
please contact Januvia
Pancreatic Cancer Lawyer Jason
Coomer a Texas lawyer, or
use
our online submission form for a free consultation .
The
Diabetes Drug Market is Over $40 Billion Each Year and Growing
Rapidly: Januvia and Janumet had Annual Sales of $4.7 Billion in 2011
More than 300
million people worldwide suffer from diabetes, including about
30 million Americans. In 2010, the global
prevalence of diabetes was estimated to have reached 285 million
and predicted to reach 438 million in 2030. The corresponding
figures for North America were 37.4 million in 2010 and 53.2
million by 2030 and in Europe 55.2 million in 2010 and 66.2
million in 2030. 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.
Merck’s Januvia (sitagliptin) is the first in a new class of diabetic
drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors. It
is approved by the FDA as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes
mellitus.
In 2011, Januvia annual sales rose 39%, to
$3.3 billion, from $2.4 billion the year before and $1.9 in
2009. Januvia along with its sister drug Janumet (a combination
of Januvia and metformin) has combined for sales of $4.7 billion
for 2011. Sales of Januvia and Merck’s Januvia (sitagliptin)
is approved in all major markets and have outdone initial
estimates for the drugs.
FDA Revision of safety information on Sitagliptin (marketed
as Januvia and Janumet)
Between October 16, 2006 and February 9,
2009, the FDA received 88 post-marketing cases of acute
pancreatitis, of which 66 required hospitalization. The FDA
review also found that in over half of these cases, the
patient’s pancreatitis resolved once Januvia was discontinued.
While diabetics are more vulnerable to developing pancreatitis
than those without the disease, it does appear that taking
Januvia can potentially increase that risk. And, if pancreatitis
becomes chronic, the inflammation of the pancreas will alter its
normal structure and functions.
As of September 2009, the FDA is revising the prescribing
information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin)
to include information on reported cases of acute pancreatitis
in patients using these products.
The FDA is recommending that healthcare
professionals monitor patients carefully for the development of
pancreatitis after initiation or dose increases of sitagliptin
or sitagliptin/metformin, and to discontinue sitagliptin or
sitagliptin/metformin if pancreatitis is suspected while using
these products. Information noting that sitagliptin has not been
studied in patients with a history of pancreatitis. Therefore,
it is not known whether these patients are at an increased risk
for developing pancreatitis while using sitagliptin or
sitagliptin/metformin. Sitagliptin or sitagliptin/metformin
should be used with caution and with appropriate monitoring in
patients with a history of pancreatitis.
Pancreatic cancer is one of the most deadly
of all types of cancer. It is the fourth leading
cause of cancer death for both men and women. Each
year approximately 45,000 Americans are 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 Januvia or Janumet, 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.
Pancreatic Cancer, Exocrine Pancreas Cancers (Pancreatic
Adenocarcinoma) and Endocrine Pancreatic Cancers
The pancreas is a large organ located
behind the stomach and in front of the spine above the level
of the belly button. The pancreas performs two main
functions: 1) it makes insulin, a hormone that
regulates blood sugar levels, and 2) it makes enzymes. The
pancreas makes and releases enzymes into the intestines that
help the body absorb foods, especially fats. The
pancreas is made of Exocrine cells and Endocrine cells.
Exocrine cells are cells that produce a pancreatic juice
that includes enzymes which aid in the digestion of food in
the small intestine, breaking up proteins, carbohydrates,
and fats.
The most common kind of pancreatic cancer
is pancreatic adenocarcinoma and includes about 90% of the
cases of pancreatic cancer. Pancreatic adenocarcinoma
is a cancerous overgrowth of exocrine pancreatic cells and
is unfortunately commonly undetected until it is too late
for the patient. Pancreatic adenocarcinoma because of
late detection can often result a fatal diagnosis with very
limited survival time. Other forms of exocrine pancreas
cancer include: intraductal papillary mucinous neoplasm
(IPMN), adenosquamous carcinomas, acinar cell carcinomas,
mucinous cystadenocarcinomas, signet ring cell carcinomas,
hepatoid carcinomas, colloid carcinomas, undifferentiated
carcinomas, pancreatoblastomas, and undifferentiated
carcinomas with osteoclast-like giant cells.
Endocrine cells are clustered in small
groups (called the Islets of Langerhans) scattered
throughout the pancreas. These endocrine cells produce
important hormones such as insulin, glucagon, and
somatostatin. The hormones called insulin and glucagon
help your body control blood sugar levels. Tumors can also
occur in these cells, but they are called islet cell tumors
and are rare.
The exact cause of pancreatic cancer is
unknown. However, it is more common in people with diabetes
and people with long-term inflammation of the pancreas
(chronic pancreatitis). It is also thought that the
use of Byetta can cause pancreatitis resulting in pancreatic
cancer.
Symptoms of pancreatic cancer can
include: dark urine and clay-colored stools, fatigue and
weakness, jaundice (a yellow color in the skin, mucus
membranes, or eyes), loss of appetite and weight loss,
nausea and vomiting, pain or discomfort in the upper part of
the belly or abdomen, back pain, blood clots, diarrhea, and
indigestion.
Pancreatic cancer is often not detected
early on and is often advanced when it is first found.
As such, ninety-five percent of the people diagnosed with
this cancer will not be alive 5 years later. Some
patients have pancreatic cancer that can be surgically
removed are cured. However, in more than 80% of patients the
tumor has already spread and cannot be completely removed at
the time of diagnosis. In the few cases where
pancreatic tumors can be removed by surgery. The standard
surgical procedure to remove pancreatic tumors is called a
Whipple procedure (pancreatoduodenectomy or
pancreaticoduodenectomy). This surgery should be done by an
experienced surgeon and at a medical center that performs
the procedure often. Some studies suggest that the Whipple
procedure is best performed at hospitals that do more than
five of these surgeries per year.
When the tumor has not spread out of the
pancreas, but cannot be removed, radiation therapy and
chemotherapy together may be recommended. When the tumor has
spread (metastasized) to other organs such as the liver,
chemotherapy alone is usually used. The standard
chemotherapy drug is gemcitabine, but other drugs may be
used. Gemcitabine can help about 25% of patients.
Patients whose tumor cannot be totally
removed, but who have a blockage of the tubes that transport
bile (biliary obstruction) must have that blockage relieved.
There are two approaches including surgery and placement of
a tiny metal tube (biliary stent) during ERCP.
Managing pain and other symptoms is an
important part of treating advanced pancreatic cancer.
Palliative care tams and hospice can help with pain and
symptom management, and provide psychological support for
patients and their families during the illness.
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.
Several
medications, products, and drugs have been linked pancreatitis.
Some of these medications were intentionally marketed by drug
manufacturers while hiding the real dangers of their product in
order to sell more of their product and seemingly valuing
profits over the health of their customers. For these
manufacturers, they may have short term profits, but over the
long term they should be held accountable for the insurmountable
harm that they have caused people who unwittingly took
their product.
Potential Lawsuits for victims of
Pancreatic cancer as a result of taking Janumet or Januvia
Texas Pancreatic Cancer Attorney, Jason Coomer, commonly works with other lawyers
in Texas amd throughout
the nation who are investigating potential Januvia
lawsuits on behalf of diabetics who took Januvia or Janumet and
have suffered from acute pancreatitis (including hemorrhagic or
necrotizing pancreatitis.) By sharing information and
working together, his law firm and other firms throughout the
nation are able to provide better representation for there
clients. As Lawyers we seek compensation from negligent
drug companies, medical providers, and other companies that have
severely injured their customers through selling and using
dangerous toxic products, medications, and drugs that they did
know or should have know were dangerous, but instead decided to
conceal significant research in order to sell more product to
make a profit.
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 Januvia or Janumet, please report the adverse action
to the prescribing medical doctor as soon as possible.
For more information on a potential legal claim regarding Januvia,
please contact Januvia
Pancreatic Cancer Lawyer Jason
Coomer (a Texas lawyer,) or
use
our online submission form for a free consultation . |