[Diabetes-talk] Type 2 medications warning

[Doug Billiar]

FDA to Examine Pancreatic-Duct Metaplasia With Incretins

 

The US Food and Drug Administration (FDA) is evaluating an increased risk
for pancreatitis and precancerous cellular changes called pancreatic-duct
metaplasia

associated with incretin mimetic drugs used to treat patients with type 2
diabetes. This covers the glucagonlike peptide-1 (GLP-1) agonists and the
DPP-4

inhibitors, or "gliptins," both relatively new classes of agent used to
treat adults with type 2 diabetes.

 

In the

drug-safety communication,

issued today, the agency says this is in response to "unpublished new
findings by a group of academic researchers," based on examination of a
small number

of pancreatic-tissue specimens taken from patients after they died from
unspecified causes.

 

This is the first time the FDA has issued a communication with regard to the
potential risk for precancerous findings of the pancreas with incretin
mimetics.

It emphasizes, however, that it "has not concluded these drugs may cause or
contribute to the development of pancreatic cancer."

 

The FDA has asked the academic researchers to provide the tissue samples so
it can further investigate this potential toxicity. Incretin mimetic agents

on the market in the US include exenatide (Byetta/Bydureon, Lilly/Amylin
Pharmaceuticals), liraglutide (Victoza, Novo Nordisk), sitagliptin
(Januvia/Janumet/Janumet

XR/Juvisync, Merck), saxagliptin (Onglyza/Kombiglyze XR, Bristol-Myers
Squibb/AstraZeneca), alogliptin (Nesina/Kazano/Oseni, Takeda
Pharmaceuticals/Furiex),

and linagliptin (Tradjenta/Jentadueto, Boehringer Ingelheim).

 

The FDA notes, however, that it "has not reached any new conclusions about
safety risks with incretin mimetic drugs. This early communication is
intended

only to inform the public and healthcare professionals that the agency
intends to obtain and evaluate this new information."

 

And it stresses: "At this time, patients should continue to take their
medicine as directed until they talk to their healthcare professional, and
healthcare

professionals should continue to follow the prescribing recommendations in
the drug labels."

 

Not the First Warning About Pancreatitis

 

The FDA has previously alerted the public to postmarketing reports of acute
pancreatitis, including fatal and serious nonfatal cases, associated with
the

use of exenatide and sitagliptin. The "Warnings and Precautions" section of
the drug labels and the patient medication guides for incretin mimetics
contain

warnings about the risk for acute pancreatitis, it notes.

 

Most recently, a

study published last month

that examined insurance records found the use of exenatide or sitagliptin
could double the risk of developing acute pancreatitis, but the authors of
that

paper also urged patients not to stop taking their medication.

 

In addition, in a joint statement, the American Association of Clinical
Endocrinologists (AACE) and the American Diabetes Association called into
question

the strength of the study's findings, noting that the analysis linked the
drug class with a relatively small excess risk for hospitalization for acute

pancreatitis - only 2 additional cases per 100 patients over a 3-year
period. Both the AACE and ADA reiterated that patients should not change
their treatment

on the basis of this research.

 

The FDA says it is continuing to evaluate all available data to further
understand this potential safety issue and will participate in the National
Institute

of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Cancer
Institute (NCI)

Workshop on Pancreatitis-Diabetes-Pancreatic Cancer in June 2013

to gather and share additional information.

 

FDA will communicate its final conclusions and recommendations when its
review is complete or when the agency has additional information to report.

 

More information about today's drug safety communication is available on the
FDA

website.

 
 
 
 
Doug Billiar and Weaver
natemaster at atmc.net
 
 
Somedays you are the dog, somedays you are the hydrant. - Unknown
 
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