Januvia (sitaglipin) is a drug
used in the treatment of Type 2 diabetes, and manufactured by Merck & Co.
The FDA approved Januvia for sale in the United States in 2006, yet within the
next three years had received 88 reports of pancreatitis from Januvia users.
Sixty-six of those submitting adverse reports were hospitalized due to the
severity of the illness. Nineteen of the Januvia patients had been taking the
drug for a month or less. The FDA required Merck to increase the warnings
regarding pancreatitis, pancreatic cancer and thyroid cancer on the labeling of
Januvia first in 2009, then again in 2012. Despite the FDA safety concerns and
the fact that the agency seems to believe Januvia may be linked to an increase
in the incidence of pancreatitis, pancreatic cancer and thyroid cancer there
has been no Januvia recall as of yet.
Januvia may be used alone or
in combination with other anti-hyperglycemic drugs such as metformin. Januvia
is in a class of drugs known as incretin mimetics which essentially mimic the
body’s own production of insulin in those with Type 2 diabetes. A recent report
in the JAMA Internal Medicine Journal showed Januvia patients were at a much
higher risk—as much as two times that of those not taking the drug—of
developing pancreatitis as compared to those who took other drugs to control
their Type 2 diabetes. A UCLA study put the numbers even higher; stating those
taking Januvia had six times the risk of developing pancreatitis and 2.9 times
the risk of developing pancreatic cancer.
Pancreatitis can be serious,
or even life-threatening and pancreatic cancer is considered to be one of the
most deadly forms of cancer. Those patients who suffer chronic pancreatitis may
have a higher risk of developing pancreatic cancer. Another study concluded
that those taking sitaglipin could be at a higher risk of thyroid cancer as
well. The FDA is currently declining to definitively state that Januvia and
other drugs like it could be responsible for the development of pancreatitis or
pancreatic cancer and are simply advising Januvia patients to continue taking
the drug until they have had a chance to speak with their doctor regarding the
potential risks.
Merck brought in $3.3 billion
dollars from sales of Januvia in 2012 alone, although it appears revenues are
down approximately 4% in the first quarter of 2013. Even so, the company is
still making huge profits from a drug which may be dangerous or unsafe. While
the FDA ordered Merck & Co to conduct a safety study on rats to determine
whether Januvia was responsible for a higher incidence of pancreatic cancer or
pancreatitis. The study was meant to be concluded and reported to the FDA by
2011, yet by February, 2012 the FDA sent a warning to Merck to conclude the study
and get the report in. By all accounts
the study has not yet been concluded or reported.
A serious illness can
devastate a family; medical bills pile up and the person who is sick may be
unable to work and bring home a regular paycheck. It could be beneficial for
those harmed by taking Januvia to look into whether a lawsuit is advisable.
Sullo & Sullo, LLP prides itself on being a
client-focused law firm. With a reputation for exceptional personal attention,
unmatched professionalism, zealous advocacy, and a commitment to the
utilization of innovative and interactive technologies, our firm has been able
to serve over 160,000 clients for more than a decade. We wish you the best in your pursuits and
encourage you to engage our firm for legal representation. For more
information, visit Sullolaw - Januvia Dangers
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