Merck Welcomes Independent Review of the Safety Profile of JANUVIA®
(sitagliptin) and Other Diabetes Medicines
WHITEHOUSE STATION, N.J. -- June 12, 2013
Merck, known as MSD outside the United States and Canada, today issued the
following statement regarding this week's NIDDK-NCI Workshop and the American
Diabetes Association’s (ADA) call for an independent review of data about the
safety of incretin-based diabetes medicines, including GLP-1 analogs and DPP-4
inhibitors such as JANUVIA^® (sitagliptin).
“Nothing is more important to Merck than the safety of our medicines and the
people who take them. We welcome opportunities to discuss the data that
support the safety profile of sitagliptin in the treatment of adults with type
2 diabetes. Type 2 diabetes is a disease with serious consequences if left
untreated,” said Michael Rosenblatt, M.D., chief medical officer, Merck. “We
are committed to participating in an independent review of our data, and will
join the ADA in planning for such an initiative.”
Merck will participate in the NIDDK-NCI Workshop on
Pancreatitis-Diabetes-Pancreatic Cancer that starts today. During the meeting,
Merck researchers will present data and the company’s perspective on the
safety profile of sitagliptin, including an updated analysis of data in more
than 14,000 patients from 25 randomized clinical trials of sitagliptin that
was recently published^1.Merck has carefully reviewed all of the available
safety data from these clinical trials, from our nonclinical studies,
post-approval adverse event reports, independent observational studies, and a
meta-analysis conducted by an academic research group of published clinical
trials with DPP-4 inhibitors involving more than 33,000 patients^2. Based on
that review, Merck remains confident in the safety profile of sitagliptin.
About JANUVIA^® (sitagliptin) 50 mg, 100 mg tablets
JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus.
JANUVIA should not be used in patients with type 1 diabetes or for the
treatment of diabetic ketoacidosis.
JANUVIA has not been studied in patients with a history of pancreatitis. It is
unknown whether patients with a history of pancreatitis are at increased risk
of developing pancreatitis while taking JANUVIA.
There have been no clinical studies establishing conclusive evidence of
macrovascular risk reduction with JANUVIA or with any other antidiabetic drug.
Selected Important Risk Information About JANUVIA^® (sitagliptin)
JANUVIA is contraindicated in patients with a history of a serious
hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.
There have been postmarketing reports of acute pancreatitis, including fatal
and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking
JANUVIA. After initiating JANUVIA, observe patients carefully for signs and
symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue
JANUVIA and initiate appropriate management. It is unknown whether patients
with a history of pancreatitis are at increased risk of developing
pancreatitis while taking JANUVIA.
Assessment of renal function is recommended prior to initiating JANUVIA and
periodically thereafter. A dosage adjustment is recommended in patients with
moderate or severe renal insufficiency and in patients with end-stage renal
disease requiring hemodialysis or peritoneal dialysis. Caution should be used
to ensure that the correct dose of JANUVIA is prescribed.
There have been postmarketing reports of worsening renal function, including
acute renal failure, sometimes requiring dialysis. A subset of these reports
involved patients with renal insufficiency, some of whom were prescribed
inappropriate doses of sitagliptin.
When JANUVIA was used in combination with a sulfonylurea or insulin,
medications known to cause hypoglycemia, the incidence of hypoglycemia was
increased over that of placebo. Therefore, a lower dose of sulfonylurea or
insulin may be required to reduce the risk of hypoglycemia.
The incidence (and rate) of hypoglycemia based on all reports of symptomatic
hypoglycemia were: 12.2 percent (0.59 episodes per patient-year) for JANUVIA
100 mg in combination with glimepiride (with or without metformin), 1.8
percent (0.24 episodes per patient-year) for placebo in combination with
glimepiride (with or without metformin), 15.5 percent (1.06 episodes per
patient-year) for JANUVIA 100 mg in combination with insulin (with or without
metformin), and 7.8 percent (0.51 episodes per patient-year) for placebo in
combination with insulin (with or without metformin).
There have been postmarketing reports of serious hypersensitivity reactions in
patients treated with JANUVIA^® (sitagliptin), such as anaphylaxis,
angioedema, and exfoliative skin conditions including Stevens-Johnson
syndrome. Onset of these reactions occurred within the first 3 months after
initiation of treatment with JANUVIA, with some reports occurring after the
first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA,
assess for other potential causes for the event, and institute alternative
treatment for diabetes.
Angioedema has also been reported with other dipeptidyl peptidase-4 (DPP-4)
inhibitors. Use caution in a patient with a history of angioedema with another
DPP-4 inhibitor because it is unknown whether such patients will be
predisposed to angioedema with JANUVIA. There have been no clinical studies
establishing conclusive evidence of macrovascular risk reduction with JANUVIA
or with any other antidiabetic drug.
In clinical studies, the adverse reactions reported, regardless of
investigator assessment of causality, in greater than or equal to 5 percent of
patients treated with JANUVIA as monotherapy and in combination therapy and
more commonly than in patients treated with placebo, were upper respiratory
tract infection, nasopharyngitis, and headache.
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Merck is known as MSD outside the United States and Canada. Through our
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This news release includes “forward-looking statements” within the meaning of
the safe harbor provisions of the United States Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs and
expectations of Merck’s management and are subject to significant risks and
uncertainties. If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially from those set
forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest rate
and currency exchange rate fluctuations; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; global trends toward health care cost containment;
technological advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining regulatory
approval; Merck’s ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of international
economies and sovereign risk; dependence on the effectiveness of Merck’s
patents and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or otherwise.
Additional factors that could cause results to differ materially from those
described in the forward-looking statements can be found in Merck’s 2012
Annual Report on Form 10-K and the company’s other filings with the Securities
and Exchange Commission (SEC) available at the SEC’s Internet site
Prescribing Information and Medication Guide for JANUVIA^® (sitagliptin) are
^1 Engel, S. et al. Diabetes Ther. 2013, 4:1
^2 Current Medical Research & Opinion Vol. 27, No. S3, 2011, 57–64
JANUVIA^® (sitagliptin) is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc..
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