Januvia, a drug which is used in the treatment of type 2 diabetes—along with
diet and exercise—has recently come under fire for its potential risks from
consumers and from the FDA. Type 2 diabetes affects how the body metabolizes sugar;
the body is either resistant to insulin or fails to manufacture sufficient levels
of insulin. Januvia is a relatively new class of drugs known as sitagliptin which
inhibits or blocks dipeptidyl peptidase-4 (DPP-4). By blocking DPP-4 the body is
able to better control levels of glucose in the body, increasing the levels of insulin
produced by the pancreas when blood sugars are at their highest levels. When the
body does not need excess sugar, the DPP-4 blockers can help can lower that amount.
Januvia issues began surfacing fairly soon after the drug gained FDA approval in
2006. Accounts of severe allergic reactions as well as the occurrence of Stevens
- Johnson syndrome – a skin condition which has caused fatalities in some
instances—surfaced soon after Januvia was marketed. By 2009, 88 reports of
acute pancreatitis had been received by the FDA, with 19 of those patients developing
pancreatitis within 30 days of starting Januvia. Acute pancreatitis involves unexpected
swelling of the pancreas and can be very serious or even life-threatening. Symptoms
of pancreatitis include abdominal pain which worsens after eating, abdominal pain
which radiates to the back, nausea, vomiting and tenderness of the abdomen. Januvia
problems continued to grow; the FDA issued a warning to healthcare professionals
in 2009 and again in 2012 although they have stopped short of a recall.
The FDA has Januvia safety concerns due to the high number of patients who have
developed acute pancreatitis while taking Januvia. More than half of the patients
who developed pancreatitis required hospitalization, while four ended up in intensive
care. More than 50% of these patients resolved their pancreatitis soon after they
stopped taking Januvia. A recent UCLA study found users of Januvia had six times
the risk of pancreatitis and were 2.7 times more likely to develop pancreatic cancer.
These Januvia dangers have led to a significant number of Januvia lawsuits from
those harmed by the drug although a recall has not yet been issued. Pancreatic cancer
is the fourth leading cause of all cancer deaths and is rarely diagnosed until it
is in the latter stages. In addition to pancreatitis and pancreatic cancer, at least
one study suggests an increase in thyroid cancer among Januvia users as well.
It seems that perhaps Merck & Co. failed to warn consumers and physicians regarding
the potential Januvia dangers. It is likely that claims against Merck will allege
product liability and negligence as well as failure to warn. In the end this failure
to warn could relate to financial gain: in 2011 the annual sales for Januvia rose
nearly 40% to $3.3 billion dollars. Combined with its sister drug, Janumet (a combination
of Januvia and metformin) sales reached $4.7 billion for 2011. Those who believe
they should pursue Januvia legal action should take care to speak to a reputable
attorney who will carefully evaluate the specific facts and determine whether a
Januvia lawsuit is in the best interests of the patient. Sullo & Sullo attorneys
have spent many years helping victims of harmful drugs and defective medical devices.
We advocate tirelessly for our clients, working hard to ensure they receive a fair
settlement for their injuries. If you have been injured by Januvia—a drug
you were likely told was perfectly safe—we want to speak with you about your
options and your future.