Januvia Food & Drug Administration
Recently the FDA has conceded that there could be risks associated with taking the
type 2 diabetes drug Januvia (sitaglipin). It now appears that those taking Januvia
have a higher-than-normal risk of developing pancreatitis, pancreatic cancer or
thyroid cancer. Pancreatic cancer is one of the deadliest forms of cancer and by
the time it is diagnosed it has usually progressed far past the initial stages.
Soon after Januvia was introduced to the pharmaceutical market, adverse reports
from those taking the drug began coming into the FDA. The safety issues related
to Januvia have been known since 2007 however Merck neglected to fully inform patients
of those risks. The FDA is now examining data reported in the JAMA Internal Medicine
journal which found that those suffering from pancreatitis that ended up in the
hospital were two times as likely to have been taking Januvia as diabetics without
The outcome of one study which viewed insurance records related to Januvia harm
was publicized last month leading Merck & Co.—the manufacturer of Januvia—to
jump to the drug’s defense. Merck claims there are no safety issues surrounding
Januvia, alluding to the fact that those with diabetes may be at a higher risk of
developing pancreatitis. In fact, Merck told Bloomberg that after reviewing the
data they found “no compelling evidence of a causal relationship” between
Januvia and pancreatitis or pancreatic cancer. In 2009 the FDA added information
to the labels of Januvia however noted they had not concluded that Januvia either
caused or contributed to the development of pancreatic cancer. They advised Januvia
patients to continue to take their medications as directed by their physician.
Januvia FDA Safety Study
In 2009 the FDA requested that Merck & Co. conduct a safety study on rats to
determine whether Januvia subjected patients to a higher-than-normal risk of pancreatitis
or pancreatic cancer. The study was to be completed and submitted to the FDA by
June 15, 2011. On February 17, 2012, the FDA issued a warning letter to Merck, stating
the drug company was several months late in submitting information about the required
study. At the time of the warning letter Merck was instructed by the FDA to submit
a final study design within one month to take steps to address the requirement.
Merck posted a written statement online stating it would submit a final protocol
for the required study within the thirty days. The study, Merck stated at the time,
would begin within six months barring any other revisions to the proposal. Until
the completion of this study, it raises concerns that there could be a “Januvia”
failure to warn on the behalf of Merck & Co.
Considering that by February, 2009, the FDA had received 88 post-marketing cases
of acute pancreatitis among those taking Januvia, it appears both the FDA and Merck
have been very slow to warn patients of potential problems associated with the drug.
Nineteen of those 88 patients developed pancreatitis within thirty days of when
they began taking Januvia. Due to this lack of transparency, Merck could end up
being accused of “failure to warn” as the lawsuits continue to mount.
If you or a loved one has suffered harm as a result of taking Januvia, it is important
to seek experienced legal counsel. The attorneys of Sullo & Sullo have been
helping their clients who have had their health compromised through harmful drugs
or defective medical devices for many years. We advocate tirelessly for those who
believed they were taking a drug which had been thoroughly tested and was safe,
finding out later neither was true.