Pancreatitis, pancreatic
cancer and thyroid cancer may be just the tip of the iceberg regarding the type
2 diabetes drug, Januvia. Januvia safety concerns have increased steadily,
almost from the time the drug received FDA approval in 2006. Between the time
the drug was approved and February 9, 2009, the FDA received 88 reports of
patients with acute pancreatitis, 75% of which required hospitalization. In
over half of these cases, the patient’s pancreatitis resolved once they
discontinued Januvia.
Is Januvia Pancreatitis a Precursor to Pancreatic Cancer?
Although diabetics are
generally more susceptible to pancreatitis than the general population, studies
show that there is an increased risk among those taking Januvia. Should the
pancreatitis become chronic, the inflammation in the pancreas can alter the
normal functioning of the pancreas and potentially lead to pancreatic cancer.
The FDA revised Januvia’s prescribing information in 2009 and again in 2012 to
include information regarding the potential of developing acute pancreatitis
for those taking the drug.
Januvia (sitagliptin) is known
as a dipeptidyl peptidase-4 (DPP-4) inhibitor. The drug works by mimicking the
action of incretin hormones which are found in the gastrointestinal tract and
stimulate the release of insulin following a meal. Recent research suggests a
link between these incretin mimetics and the potential development of
pancreatitis, pancreatic cancer and thyroid cancer. Although some experts argue
the benefits of Januvia outweigh the risks involved, it is important to note
that pancreatic cancer is one of the most deadly forms of cancer with a
five-year survival rate of 4%.
Januvia Safety Concerns
The development of
pancreatitis increases the overall risk of pancreatic cancer, therefore Januvia
safety concerns appear to be significant. In fact, in the latest issue of
Diabetes Care, Peter Butler, MD argued against the use of Type 2 diabetes drugs
such as Januvia stating that while evidence of harm accumulates it is
“vigorously discounted.” Dr. Butler went on to note that “We should be thankful
that those responsible for aircraft safety do not operate on the assumption
that the absence of evidence is evidence of absence.”
Risks of Januvia Thyroid Cancer
Januvia has also been shown to
increase the proliferation of precancerous thyroid cells in rats, therefore the
risk of Januvia users developing thyroid cancer may be higher than for the
general population. A UCLA study, published in the journal Gastroenterology
found a definite link between the use of Januvia and the development of
pancreatitis and pancreatic cancer. This study placed the risk of developing
pancreatitis among those taking Januvia at six times the normal risk.
Merck Sales Sluggish
Merck’s first quarter
financial statements showed a drop in Januvia sales of four percent, compared
to a sales growth of nearly fifteen percent in the previous quarter.
Additionally, the FDA has asked Merck to update Januvia’s warning label to
reflect the risks of pancreatitis, pancreatic cancer and thyroid cancer. The
new labeling recommends that healthcare professionals carefully monitor Januvia
patients for the development of pancreatitis and that for those with a history
of pancreatitis Januvia should be used with extreme caution and regular monitoring.
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