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 The FDA said it had identified 33 cases of severe joint pain in
patients taking a class of drugs known as DPP-4 inhibitors between
Oct. 16, 2006, when the first one was approved, through Dec. 31,
2013.
The most frequent number of cases, 28, occurred with Januvia, known
generically as sitagliptin. Five cases were reported with
AstraZeneca Plc's Onglyza (saxagliptin), two with Boehringer
Ingelheim's Tradjenta (linagliptin), and one with Takeda
Pharmaceutical's Nesina (alogliptin).
A spokesman for Merck, Steven Cragle, said the reason the number of
cases was higher with Januvia is that it was the first to market and
is the most widely prescribed, accounting for about 80 percent of
DPP-4 prescriptions in the United States.
"Merck takes all safety information seriously and we worked closely
with the FDA on this request," Cragle said. "We are confident in the
safety profile of sitagliptin."
Boehringer Ingelheim spokeswoman Emily Geary said clinical trials of
Tradjenta "do not show an imbalance between linagliptin and placebo
in musculoskeletal and connective tissue disorders or, more
specifically, in joint disorders."
A spokesman for AstraZeneca, Andrew Davis, said the company "works
with health authorities and scientific experts to help ensure
patients and physicians have a clear understanding of the risk
benefit profile of our medications."
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A spokesman for Takeda did not immediately respond to a request for
comment.
The FDA said that in 20 of the cases the DPP-4 inhibitor was
suspected as a cause of the pain and was discontinued within a month
after the onset of symptoms. In eight of the remaining 13 cases, a
period of 44 days to a year elapsed between the onset of symptoms
and discontinuation of the drug.
The drugs are used to lower blood sugar in adults with type 2
diabetes. The FDA said patients should not stop taking their drugs
but should contact their doctor if they experience severe and
persistent joint pain.
(Reporting by Toni Clarke in Washington; editing by Andrew Hay and
Dan Grebler)
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