What is Januvia?
Sitagliptin is the drug found in Januvia which reduces blood sugar levels in patients
with type 2 diabetes. Sitagliptin inhibits the DPP-4 enzymes in the body which destroy
GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent isnsulinotropic polypeptide).
The effect of GLP-1 and GIP are to reduce blood glucose levels so when sitagliptin
inhibits the enzyme that destroys them, blood glucose levels fall. After a meal,
incretin hormones are released from the intestine, increasing their levels in the
bloodstream. Januvia, when combined with diet and exercise, can improve blood glucose
levels in those with type 2 diabetes and is combined I some cases with other types
of oral drugs for diabetes such as Janumet which combines sitagliptin with metformin.
What is the Problem with Januvia?
Research has found that Januvia may cause pancreatic abnormalities which can in
turn lead to pancreatitis, and, ultimately, to pancreatic cancer. It is believed
that Januvia’s ability to spur the production of the cells lining the pancreatic
ducts can sometimes lead serious medical issues. In short, Januvia has been found
to cause abnormalities in the pancreas that are recognized as risk factors in the
development of pancreatitis, and, in time, pancreatic cancer.
Is Januvia Safe or is Januvia Dangerous?
According to a recent Bloomberg report, Januvia, sold by Merck & Co., may double
the patient’s risk of developing inflammation of the pancreas. When the pancreas
becomes inflamed, cancer and kidney failure may occur. Patients who were hospitalized
due to pancreatitis were twice as likely to be taking a diabetic drug containing
sitagliptin—like Januvia—than diabetics without pancreatitis according
to a journal article in the JAMA Internal Medicine. The FDA issues an alert for
Januvia in 2009 based in part on one study which analyzed data from 2005 to 2008
showing that the number of pancreatitis cases had more than doubled. While Januvia
does appear to do well in regulating blood sugar, patients should carefully weigh
the risks against the benefits.
What are the DPP-4 Inhibitor Side Effects of Januvia?
Allergic reactions are always a possibility with any prescription drug and Januvia
is no different. Patients who have difficulty breathing, hives or swelling of the
face, lips, tongue or throat after taking Januvia should seek emergency medical
help immediately. Some of the more common, less serious, side effects of Januvia
include runny or stuffy nose, sore throat, nausea, stomach pain, diarrhea, constipation,
joint or muscle pain, back pain and headache. More serious side effects include
pancreatitis—a severe pain in the upper stomach which spreads to the back
along with vomiting and nausea—infrequent urination, a red or purple skin
rash which causes blistering and peeling (Stevens-Johnson syndrome), weight gain
with swelling and shortness of breath. Hypoglycemia has been reported by some patients
as well as upper respiratory tract infections, worsening renal function or renal
failure and musculoskeletal pain.
Is Januvia Linked to Pancreatic Cancer?
When cancerous cells develop in the tissue of the pancreas, pancreatic cancer—a
rapidly spreading cancer that is rarely discovered in the beginning stages—can
develop. A diagnosis of pancreatic cancer comes with a very poor prognosis. Approximately
45,000 Americans are diagnosed with pancreatic cancer each year, and only about
3% of those will survive five years past the diagnosis. Signs of pancreatic cancer
include jaundice, loss of appetite and weight loss, upper abdominal pain which radiates
to the back, depression and blood clots. A study published in Gastroenterology tied
the use of Januvia to an increased risk of pancreatic cancer; researchers noted
that patients taking Januvia had 2.7 times the risk of pancreatic cancer as those
who were not taking the drug. Because Januvia stimulates the pancreas to produce
more insulin, the pancreas gland can become inflamed, leading to the risk of pancreatic
Is Januvia Linked to Thyroid Cancer?
The thyroid can be adversely affected by the medication in Januvia as it affects
the glucagon-like-peptide-1 (GLP-1), increasing the number of precancerous thyroid
cells in rats. Although still serious, thyroid cancer has a much better prognosis
than pancreatic cancer. The 2011 journal article in Gastroenterology also noted
that Januvia had been linked to thyroid cancer however this is still under investigation.
Thyroid cancer is relatively rare, however those taking Januvia should be aware
of the symptoms of thyroid cancer such as a lump or nodule in the front center part
of the neck, hoarseness, pain in the neck and throat, swallowing problems, cough,
enlarged lymph nodes, itching and diarrhea. Researchers from the University of California
determined that Januvia could increase the risk of thyroid cancer 148% and pancreatic
cancer by 270%.
Did Januvia Have a Failure to Warn?
Although Merck has continued to maintain that Januvia is a safe drug, a number of
lawsuits have been filed against the company from patients who suffered adverse
health effects from Januvia. According to FDA data there were hundreds of reports
of acute and chronic pancreatitis attributed to Januvia in 2011. The lawsuits which
have been filed most all claim that Merck & Co. failed to warn patients of the
dangers and risks they were exposing themselves to when they began taking Januvia
even though Merck was aware of adverse reports from patients taking the drug. Between
October, 2006 and February, 2009, the FDA received 88 reports of acute pancreatitis;
in over half these cases the patient’s pancreatitis resolved once Januvia
Has There Been a Januvia Recall?
Although the FDA has issued warnings to health care providers and consumers regarding
the potential risks of Januvia there has been no recall of the drug. Consumers were
advised in 2009 and 2013 that Januvia had been linked to pancreatitis and pancreatic
cancer. While the FDA required additional label warnings, there were no restrictions
on its use. The FDA directed Merck to conduct new studies regarding the potential
risks of Januvia and was forced to issue a notice of violation of that order in
February, 2012, because Merck delayed the testing. Your Januvia attorney can keep
you apprised of any new information regarding Januvia, particularly should a recall
be issued in the future.
Do I Have a Januvia Case?
If you or a loved one has suffered damages from the drug Januvia, it is important
that you speak with a knowledgeable attorney who fully understands every aspect
of this drug. A Sullo & Sullo attorney will discuss the specifics surrounding
your use of Januvia, taking into consideration the extent of your injuries. Together
you will determine whether a lawsuit against Januvia is warranted. Your Sullo &
Sullo lawyer will ensure you understand all the steps in filing such a lawsuit and
will offer professionalism and compassion while fighting aggressively for your rights
and your future.
What are my Januvia Damages?
Your specific Januvia damages will depend largely on the extent of your injuries.
If you or a loved one developed potentially deadly pancreatic cancer as a result
of taking Januvia for your type 2 diabetes then your damages could be extensive.
Medical expenses, lost wages—both past, present and future—and pain
and suffering may all be a part of your claim. If you suffered an attack of pancreatitis
but did not develop pancreatic cancer from Januvia, then your damages may not be
as high, however you still may be entitled to compensation.
How Do I Protect My Januvia Case and my Right to File my Januvia Claim?
Your potential Januvia case may be protected by speaking with an experienced Sullo
& Sullo attorney. Our attorneys are well aware of the statute of limitations
regarding defective drug cases and can help to make sure that time limit is not
exceeded. Regardless of the extent of injury you have received from taking Januvia,
our highly skilled attorneys will fight aggressively to protect your case and will
file your claim in a timely manner.
What is the Januvia Statute of Limitations?
The statute of limitations for defective drugs or medical devices differs from state
to state. Most states, such as Texas, operate under a two-year statute while some
have a three-year limit and a handful have time limits of four or more years. In
defective drug cases, the time when the statute begins can be rather fuzzy. If there
was a recall issued for the drug, the statute likely begins at that time. In some
cases companies claim that a warning they issued was sufficient notice and the time
of that warning is when the statute should begin. In any case, should you discover
the statute in your state has expired, speak to a Sullo & Sullo attorney before
you give up—there are certain instances in which the statute may be extended.
How likely is a Januvia Settlement?
Like many big drug companies, Merck & Co. may very well blame the adverse health
effects suffered by Januvia users on other factors in their life. For instance,
it is more common for diabetics to develop pancreatitis than for non-diabetics therefore
Merck may attempt to say any side effects are simply the effect of the diabetes,
rather than the drug. Any pre-existing health issues suffered by Januvia users might
be used against them to deny a settlement. For this reason it is imperative that
you consider the knowledge and experience of the attorney you choose.
How Do I Get the Help I Need?
Each attorney at Sullo & Sullo, LLP fully understands that every case is different.
We treat each client as an individual, offering exceptional personal attention and
compassion. Our reputation is outstanding in the industry and we are zealous advocates
for every single client. If you have been harmed by Januvia—or any other harmful
drug or defective medical device—strongly consider speaking to a Sullo &
Sullo Januvia lawyer today to get the help you need.