FDA Weighs in on Januvia Pancreas Study

These findings were composed from administrative databases from around the United States from 2005 to 2008 that showed “increased odds of hospitalization for acute pancreatitis.” Two of the drugs used in the studies were the incretin mimetics Januvia (sitagliptin) and Byetta (exenatide).

The study was taken from the April 8, 2013 issue of Journal of the American Medical Association Internal Medicine (JAMA), which published evaluations of certain observations and correlations between multiple Januvia studies. The conclusions followed nearly three years of tracking 1,269 type-2 diabetics, ages 18 to 64, who were hospitalized with an acute pancreatitis diagnosis. The average age of study participants was 52, and about 57% were men.

Januvia Used to Treat Type II Diabetes

Januvia is an oral type-2 Diabetic treatment drug that works by inhibiting the dipeptidyl peptidase-4 (DPP-4) enzyme. The DPP-4 enzyme inactivates incretin hormones, which are involved glucose regulation in the body. Januvia slows the inactivation of incretin hormones, which allows the body to properly metabolize the sugars, fats, and glucose that enters it from food. This increases the body’s insulin release, and decreases glucagon levels in the circulation in a glucose-dependent manner.

Januvia was approved by the FDA in 2006, and is manufactured by Merck & Co. Though initially a very popular drug, Merck has come under fire for recent studies finding the potential in pancreatic complications. Men and women from all over the United States have sued Merck for misleading and false advertising, aggressive marketing, and failure to disclose product safety information.

Januvia Pancreas Side Effects Revealed
 
On Sept. 25, 2009 the FDA announced, that the prescription information for Januvia and Janumet (sitagliptin/metformin) would be revised to include “information on reported cases of acute pancreatitis in patients using these products.”

Presently, the Januvia warning label already reads: “Serious side effects can happen in people who take Januvia, including pancreatitis, which may be severe and lead to death.”

In addition to studies suggesting a link between Januvia and pancreatic cancer, other studies have implicated Januvia as increasing the risk of thyroid cancer.

As for now, the FDA states that while they take JAMA’s study very seriously, they want the association to provide them the methodology used to collect and study the pancreas-specimens they used, and to provide the pancreatic tissue samples from the specimens to the FDA so they can further investigate the potential link from their side.

If you believe that you or a loved one has been the victim of a severe Januvia side effect such as cancer, you have legal options. Please visit the Type-2 Diabetes Drugs Januvia & Byetta Class Action Lawsuit Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned Januvia lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees. The Januvia attorneys working this investigation do not get paid until you do.