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Cancer Risk with Byetta and Januvia Downplayed by FDA

According to the FDA, there is no scientific evidence to confirm that a group of type 2 diabetes drugs called GLP-1 inhibitors is linked to pancreatic cancer. The FDA decision comes on the heels of the European Medicines Agency, which stated that they have been unable to confirm an increased risk of pancreatic cancer linked to side effects of Byetta, Januvia, Janumet, Victoza and other incretin mimetic drugs.

The FDA has apparently completed its safety review into the new group of medications, known as incretin mimetics, and is preparing to report that it has found no conclusive connection between the medications and pancreatic cancer. According to the EMA, its experts reviewed the data and found “methodological limitations and potential sources of bias” and decided the available data don’t bear out worries about an increased risk of “pancreatic adverse events.”

The report addresses the entire group of incretin mimetics, which comprises GLP-1 agonists, which mimic a key hormone, and DPP-4 inhibitors, which interfere with a protein that breaks down the same hormone.

Incretin Mimetic Medical Studies

A number of medical studies have connected Januvia, Byetta and others to an increased risk of acute pancreatitis, which experts have found leads to an increased risk of pancreatic cancer. Investigations were launched this year by the FDA and EMA regulatory agencies, after a study found evidence of precancerous cells in patients using the drugs.

Pancreatitis Risk Factor for Pancreatic Cancer

The risk of pancreatitis associated with Januvia, Byetta, Victoza and other incretin mimetics has been warned by the manufacturers, resulting in new label warnings. Chronic pancreatitis is a known risk factor for pancreatic cancer, and some experts advocate removing these medications due to known safety concerns and limited benefits over other available older drugs, exercise and weight reduction treatments.

What are Incretin Mimetics Januvia, Byetta, Victoza?

Incretin mimetics are a new class of drugs used to treat type 2 diabetes. Byetta (exenatide) was approved by the FDA in 2005, and is manufactured by Amylin Pharmaceuticals as a twice daily injection. Januvia (sitagliptin) was approved by the FDA in 2006 and and is manufactured by Merck as an oral medication, and as a combination pill containing Januvia and another diabetic medication metformin, under the brand name Janumet.

Victoza (liraglutide) was approved by the FDA in 2010, and manufactured by Novo Nordisk as a daily injection. Onglyza (saxagliptin) was approved by the FDA in 2009 and is manufactured by Bristol-Myers Squibb and AstraZeneca. Tradjenta (linagliptin) is manufactured by Eli Lilly and Boehringer Ingelheim and approved for sale in 2011.

Incretin Mimetics have blockbuster drug status for treatment of type 2 diabetes, generating billions in annual sales. Merck’s Januvia and Janumet, has over $4 billion in sales last year. Novo Nordisk’s Victoza sales were about $1.8 billion and Amylin Pharmaceuticals’ Byetta earned a reported $149 million last year.

Incretic Mimetic Lawsuits

Many patients diagnosed with pancreatic cancer have filed product liability lawsuits. The plaintiffs allege that the drug makers failed to adequately research the medications or warn about the potential risk of pancreatic cancer. Last week, a motion was heard to centralize and consolidate all Byetta, Januvia, Janumet and Victoza federal lawsuits. The parties are expecting that the US District Court for the Southern District of California, in San Diego, will be the MDL court.

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