Skip to content

Diabetes Health Center

Font Size

Diabetes Meds Face FDA Scrutiny for Pancreas Risks

By Lisa Nainggolan
Medscape Medical News

March 14, 2013 -- The FDA is looking into an increased risk of pancreatitis and precancerous changes to the pancreas from widely used drugs to treat type 2 diabetes.

The medications are called incretin mimetics, which mimic a natural hormone in the body that tells the pancreas to release more insulin after eating. Insulin, in turn, lowers the person's blood sugar. Included in this class are the drugs Bydureon, Byetta, Janumet, Janumet XR, Januvia, Juvisync,  Kazano, Kombiglyze XR, Nesina, Onglyza, Oseni, Tradjenta, and Victoza.

Some are a pill and others are an injection.

This is the first time the FDA has issued a communication with regard to the potential risk of precancerous findings of the pancreas with these types of drugs. It emphasizes, however, that it "has not concluded these drugs may cause or contribute to the development of pancreatic cancer."

The FDA wants to further investigate this potential risk, but says it "has not reached any new conclusions about safety risks with incretin mimetic drugs."

And it stresses: "At this time, patients should continue to take their medicine as directed until they talk to their health care professional, and health care professionals should continue to follow the prescribing recommendations in the drug labels."

Not the First Warning

The FDA has previously alerted the public to reports of acute pancreatitis, including fatal and serious nonfatal cases, linked to Byetta and Januvia. The drug labels and medication guides for incretin mimetics contain warnings about the risk of acute pancreatitis, it notes.

Most recently, a study published last month that examined insurance records found the use of Byetta or Januvia could double the risk of developing acute pancreatitis. But the researchers of that study also urged patients not to stop taking their medication.

A joint statement from 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 of hospitalization for acute pancreatitis (only 2 additional cases per 100 patients over a 3-year period). Both 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.

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

In the meantime, it urges both patients and health care professionals to report adverse events involving incretin mimetics to the FDA MedWatch program.

To see a version of this story for physicians, visit Medscape, the leading site for physicians and health care professionals. 

Is This Normal? Get the Facts Fast!

Check Your Blood Sugar Level Now
What type of diabetes do you have?
Your gender:

Get the latest Diabetes newsletter delivered to your inbox!


or
Answer:
Low
0-69
Normal
70-130
High
131+

Your level is currently

If the level is below 70 or you are experiencing symptoms such as shaking, sweating or difficulty thinking, you will need to raise the number immediately. A quick solution is to eat a few pieces of hard candy or 1 tablespoon of sugar or honey. Recheck your numbers again in 15 minutes to see if the number has gone up. If not, repeat the steps above or call your doctor.

People who experience hypoglycemia several times in a week should call their health care provider. It's important to monitor your levels each day so you can make sure your numbers are within the range. If you are pregnant always consult with your health care provider.

Congratulations on taking steps to manage your health.

However, it's important to continue to track your numbers so that you can make lifestyle changes if needed. If you are pregnant always consult with your physician.

Your level is high if this reading was taken before eating. Aim for 70-130 before meals and less than 180 two hours after meals.

Even if your number is high, it's not too late for you to take control of your health and lower your blood sugar.

One of the first steps is to monitor your levels each day. If you are pregnant always consult with your physician.

Did You Know Your Lifestyle Choices
Affect Your Blood Sugar?

Use the Blood Glucose Tracker to monitor
how well you manage your blood sugar over time.

Get Started

This tool is not intended for women who are pregnant.

Start Over

Step:  of 

Today on WebMD

Diabetic tools
Symptoms, diagnosis, treatment, and more.
woman flexing muscles
10 strength training exercises.
 
Blood sugar test
12 practical tips.
Tom Hanks
Stars living with type 1 or type 2.
 
Woman serving fast food from window
Video
Can Vinegar Treat Diabetes
Video
 
Middle aged person
Tool
are battery operated toothbrushes really better
Video
 

Prediabetes How to Prevent Type 2 Diabetes
Article
type 2 diabetes
Slideshow
 
food fitness planner
Tool
Are You at Risk for Dupuytrens Contracture
Article