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WHAT ARE INCRETIN DRUGS USED FOR?

For decades, insulin was the only injectable diabetes medication. But in the past seven years, several more have come on the market, including three incretin mimetics:exenatide (Byetta), long-acting exenatide (Bydureon), and liraglutide (Victoza). These medications are approved only for the treatment of type 2 diabetes, though they may someday be used by people with type 1 as well (“Incretin Mimetics and Type 1,” below). 

Many have heralded this class of medications as a monumental advance in diabetes care, and indeed their attractive characteristics include promoting weight loss and carrying a low risk for hypoglycemia (low blood glucose). Here’s the skinny on incretin mimetics: how they work, how they differ, and what to consider discussing with your doctor

HOW INCRETIN DRUGS WORKS?

Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Incretin Drug Brands

Januvia

Also known as sitagliptin, is a DPP-4 inhibitor manufactured by Merck. It was approved by the FDA in 2006 and still ranks as the 2nd most prescribed diabetes drug with over $3.9 billion in annual sales.

Victoza

Also known as liraglutide, is a GLP-1 incretin made by Novo Nordisk. It was approved by the FDA in 2010 and currently ranks as the 3rd most prescribed diabetes drug with $2.8 billion in sales.

Janumet

Janumet is a combination drug sold by Merck, consisting of Januvia and metformin. It ranks as the 7th most prescribed diabetes medication with over $2.2 billion in annual sales.

Tradjenta

Also known as linagliptin, is a DPP-4 inhibitor developed by Boehringer Ingelheim. It was approved by the FDA in 2011 and is the 11th most-prescribed drug for type 2 diabetes.

Trulicity

Also know as dulaglutide, is a GLP-1 incretin made by Eli Lilly. It was approved by the FDA in 2014 and is currently the fastest-growing incretin mimetic drug for type 2 diabetes.

Onglyza

Also known as saxagliptin, is a DPP-4 inhibitor sold jointly by Bristol-Myers Squibb and AstraZeneca. It was approved by the FDA in 2009.

Lyxumia

Also known as lixisenatide, is a GLP-1 incretin mimetic made by French pharmaceutical company Sanofi. It was approved by the FDA in 2016.

Nesina

Also known as alogliptin, is a DPP-4 inhibitor drug made by Japanese pharmaceutical company Takeda. It was approved by the FDA in 2013.

Byetta – Bydureon

Also known as exenatide, is a GLP-1 incretin manufactured by AstraZeneca. It was the first-ever incretin drug approved by the FDA in 2005.

Court Approves Hundreds of Lawsuits

On December 6, 2017, the 9th Circuit U.S. Court of Appeals ruled that patients taking Incretin diabetes drugs who’ve been diagnosed with pancreatic cancer, as well as families of those who’ve passed away, can proceed with lawsuits against the manufacturers for failure to warn about the risks.

The decision reversed a 2015 dismissal of 749 cases pending in a special Incretin drugs multidistrict litigation court and paved the way for new lawsuits to be filed by those diagnosed with pancreatic cancer.

It also comes as new research (link to 2/23/18 article) shows those prescribed incretin drugs for type 2 diabetes could have more than three times the risk for pancreatic cancer as those taking other drugs.

Lawyers are currently investigating claims and filing new lawsuits on behalf of any patient diagnosed with pancreatic cancer after taking the following:

Cases are also available for families of those who have passed away from pancreatic cancer after taking these drugs. However, the time to file a case is limited. Contact us today to speak directly with a lawyer.

SYMPTOMS & SIDE EFFECTS OF INCRETIN DRUGS

Incretin Drugs Linked to Pancreatic Cancer

Incretins are the common name for a class of drugs prescribed to treat type 2 diabetes through the manipulation of certain hormones called incretins. These hormones promote insulin production, inhibit sugar being released into the bloodstream and block some food absorption after meals.

Incretin drugs are further divided into 2 classes: GLP-1 agonists, called incretin mimetics, and DPP-4 inhibitors.

GLP-1 drugs include brand names such as Victoza, Trulicity, Byetta and Lyxumia. These are taken via injection either daily or once per week and work by promoting production of the incretin hormone Glucagon-like peptide-1.

DPP-4 drugs include brand names such as Januvia, Janumet, Nesina, Onglyza and Tradjenta. These are taken orally once per day and work by blocking the enzyme Dipeptidyl peptidase-4, which normally inactivates the GLP-1 hormone.

Beginning in 2011, researchers cautioned that those taking incretins may have a higher rate of pancreatic cancer. However, the FDA has maintained that the drugs are safe and refused to add new warnings.

Now, a new study of more than 550,000 patients in Europe has discovered that those taking incretin drugs have as much as 3.35 times the risk for pancreatic cancer as those taking other types of drugs for type 2 diabetes.

LATEST INCRETIN DRUGS NEWS & RECALLS

FDA Warnings

Latest FDA warnings on incretin drugs.

2013 March
FDA warns of studies showing pancreatitis and pre-cancerous pancreatic cells in patients who’ve died after taking incretin mimetic drugs like Januvia, Victoza, Bydureon, Tradjenta, Onglyza and Nesina.
2012 Feb
FDA sends warning letter to Merck advising that Januvia and Janumet are misbranded, since the company has delayed conducting studies on the risk for pancreatitis as ordered in 2009.
2009 Sept
The FDA warns of a link between Januvia/Janumet and pancreatitis after receiving nearly 90 reports over a three-year period. Merck is required to add new label warnings.
2007 Oct
The FDA first warns that patients taking the incretin drug Byetta may have a higher risk for pancreatitis. Based on data from 30 post-marketing studies. The warnings note that 73% of patients improve after they stop taking the drug.

LAWSUITS & SETTLEMENTS

Class Action

On August 26, 2013, the Judicial Panel on Multidistrict Litigation created MDL 2452 to handle a growing number of lawsuits filed around the country by patients who’d developed pancreatic cancer after taking incretin drugs.

Incretin Drug Class Action Lawsuit

The formal name of this court is MDL-2452, IN RE: Incretin-Based Therapies Products Liability Litigation. However, it is sometimes referred to as the Incretin drug class action lawsuit.

The incretin MDL is established to handle cases filed around the country by patients who’ve been diagnosed with pancreatic cancer after taking the following drugs:

  • Januvia
  • Janumet
  • Victoza
  • Lyxumia
  • Trulicity
  • Tradjenta
  • Onglyza
  • Nesina
  • Byetta.

By late 2015, the litigation had grown to nearly 750 cases. However, a judge erroneously dismissed all pending cases, stating that a federal law prohibited the victims from filing lawsuits against the manufacturers.

In December 2017, a U.S. Circuit Court of Appeals ruled that the incretin cases had been wrongly dismissed, that they would be reinstated and allowed to proceed, along with any new cases filed.

At the present time, 970 cases have been filed in the Incretin Drug MDL. Lawyers expect hundreds more will join, based on the ruling of the appeals court and recent studies showing a stronger link to pancreatic cancer.

While the MDL court is somewhat similar to an incretin drug class action lawsuit, it is actually more advantageous for victims since the cases are filed apart from one another. This means plaintiffs can choose their own attorney and make settlement decisions for their own case, rather than be bound by the decisions of the entire group.

Unfortunately, however, there is a statute of limitations that can expire if victims wait too long to file a claim. This is usually several years from the date of diagnosis or time of death. In order to make sure your legal rights are protected, anyone affected should speak with a lawyer as soon as possible.

Medical Studies

Below are the studies related to incretin drugs.

UCLA Study – February 2011

Study from UCLA finds subjects administered Janumet/Januvia have 6 times the risk of pancreatitis and 2.7 times the risk of pancreatic cancer. Those given Byetta had 4.7 times the risk for pancreatitis and 2.9 times the risk of pancreatic cancer.

Journal for the AMA – April 2013

Journal for the AMA publishes study from Johns Hopkins finding incretin mimetic drugs could increase risks for pancreatitis, pancreatic cancer and kidney failure.

British Medical Journal – June 2013

British Medical Journal accuses incretin drug manufacturers of withholding raw data from their own clinical trials that could uncover whether cancer risks are present.

FDA Sponsored Study – February 2014

Comprehensive FDA-sponsored study of effects of incretin drugs on animals finds no causal relationship between incretins and pancreatitis/pancreatic cancer.

European Study – October 2017

European study of 559,025 diabetes patients finds those taking incretin drugs have a 3.35 times higher risk of pancreatic cancer in early months of treatment.