Jentadueto and Tradjenta: Health Risks and Legal Information

Tradjenta is a type 2 diabetes medication used to regulate high blood sugar levels. A brand-name version of the generic drug linagliptin, Tradjenta is the product of an ongoing collaboration between Boehringer Ingelheim (BI) and Eli Lilly (EL), two of the largest pharmaceutical companies in the world. The U.S. Food and Drug Administration (FDA) approved Tradjenta in 2011.

Healthcare professionals often prescribe Tradjenta in conjunction with other diabetes medications. As a result, BI and EL manufactured a new drug called Jentadueto that combines Tradjenta (linagliptin) and metformin (a common type 2 diabetes medication). The FDA approved Jentadueto in 2012.

Concerns have been raised regarding the suspected side effects of Tradjenta and Jentadueto. With possible links to serious complications, these drugs could subject their patients to significant harm. Manufacturers may be subject to government fines and product liability lawsuits.

If you are concerned about taking Jentadueto and Tradjenta, speak with your doctor. If you have suffered health problems after taking these drugs, consider contacting a product liability attorney. An attorney near you can evaluate your claim and advise whether pursuing a lawsuit is worth your time and effort. If so, they will advocate for you throughout the legal process and seek fair compensation for your injuries.

Treating Diabetes

Patients diagnosed with type 2 diabetes may receive a prescription for a type of medication called incretin mimetics. These drugs are designed to increase the body’s absorption of glucose and pancreas’s production of insulin. This dual-action drug treatment approach can help many patients lower their blood sugar levels.

Some diabetes medications can also speed the pace of digestion, another contributing factor to diabetes.

What are Jentadueto and Tradjenta?

Marketed by Eli Lilly and Boehringer Ingelheim, Jentadueto and Tradjenta are designed to lower blood sugar levels by reducing glucose buildup in diabetes patients. The U.S. Food and Drug Administration (FDA) approved Tradjenta in May 2011 and Jentadueto in January 2012.

Jentadueto and Tradjenta are similar, but not identical. Tradjenta’s active ingredient is linagliptin, which seeks to increase the pancreas’s production of insulin. Around the time Tradjenta reached the market, a series of studies endorsed treating diabetes patients with a combination of linagliptin and metformin, another diabetes drug.

Jentadueto was designed to offer such a combination to patients in a single drug. Many medical sources treat Jentadueto and Tradjenta as essentially the same drug.

Tradjenta and Jentadueto Help Regulate Blood Sugar Levels

Diabetics have difficulty producing insulin, a hormone that prevents sugar from building up in the bloodstream. Insulin is produced by the pancreas until the enzyme dipeptidyl peptidase-4 (DPP-4) causes the pancreas to stop production.

Tradjenta and Jentadueto are part of a class of drugs known as incretin mimetics that mimic incretin, a hormone that blocks the DPP-4 enzyme. By raising incretin levels, Tradjenta and Jentadueto are both DPP-4 inhibitors, allowing the pancreas to continue producing insulin. Ultimately, this results in lower blood sugar levels.

Tradjenta and Jentadueto: Potential Serious Complications

While Tradjenta and Jentadueto are commonly prescribed to help manage type 2 diabetes, they are not without risks. Both medications have been associated with serious complications, including lactic acidosis, pancreatitis, and potentially pancreatic cancer.

Understanding these risks is essential for patients to make informed decisions and respond quickly to changes in their health. Let’s take a look at each one.

Increased Risk of Lactic Acidosis

Packages of Jentadueto carry a black box warning, the FDA’s strongest type of warning. A black box warning indicates a potentially serious health risk or life-threatening complication.

The black box warning for Jentadueto alerts consumers to the risk of lactic acidosis, which is attributed to the metformin used in Jentadueto. Lactic acidosis is the buildup of lactic acid in the bloodstream. It requires immediate medical attention and can sometimes be fatal.

Some who use Jentadueto have an even higher risk of lactic acidosis. Patients at a higher risk include those:

• With severe kidney problems
• Who drink alcohol often or binge drink
• Have a heart attack, surgery, stroke, or infection
• Get dehydrated

If taking Jentadueto, make sure you understand what can cause issues.

Increased Risk of Pancreatitis and Pancreatic Cancer

In 2013, FDA Drug Safety Communication announced that it would evaluate a research study suggesting that incretin mimetics pose a serious risk of pancreatitis (inflammation of the pancreas) and possibly even pancreatic cancer.

The study found evidence of pancreatitis. This study is consistent with the results of previous clinical trials that had linked incretin mimetics to pancreatitis. Even before the results of this study were disclosed, warning labels on Tradjenta and Jentadueto informed consumers of reports of acute pancreatitis (short duration of inflammation).

The study also found that a small group of patients who took incretin mimetics developed pancreatic-duct metaplasia, a cellular change that can precede pancreatic cancer. Similar concerns have been expressed by medical publications.

The research study’s conclusion that incretin mimetics may lead to pancreatic cancer are relatively novel. The FDA has asked the academics behind the study to provide their data and methodology for verification. The FDA has not reached any conclusions as to whether incretin mimetics cause or contribute to the development of pancreatic cancer. It continues to evaluate all relevant material connected to this issue.

In June 2013, the British Medical Journal (BMJ) published the results of an investigation that found drug companies had not told doctors and patients of the risk of pancreatic cancer associated with incretin mimetic treatment. The FDA has informed the public about this risk but has not taken further action so far.

Boehringer Ingelheim and Eli Lilly Legal Liability

If the FDA corroborates the study’s assertion that incretin mimetics lead to pancreatic cancer, or if new evidence emerges linking the two together, consumers will likely file Tradjenta and Jentadueto lawsuits against Boehringer Ingelheim and Eli Lilly.

If this occurs, the lawsuits will be based on product liability law. Under product liability, manufacturers and sellers have a duty to ensure that their products are free from any unexpected dangers or defects. A successful product liability lawsuit must prove two important elements:

• The product was defective
• This defect caused plaintiff’s injuries

A likely claim in a potential Tradjenta lawsuit or Jentadueto lawsuit is a defect in warnings. Manufacturers have a duty to provide proper instructions and warnings about any dangers associated with their products. If manufacturers fail to fulfill this obligation, then their products have a warning defect.

For example, a plaintiff may allege that BI and EL were aware that Tradjenta could cause pancreatic cancer but failed to warn consumers. The plaintiff may further argue that if they had known of the risk of pancreatic cancer, the plaintiff wouldn’t have used the drug in the first place.

Tradjenta and Jentadueto are newer to the market than similar DPP-4 inhibitors, like Januvia, Janumet, and Byetta. The manufacturers of these drugs have faced many lawsuits.

Since Tradjenta and Jentadueto haven’t been on the market as long, there has been very little litigation focused on them. If more reports of links to pancreatitis or pancreatic cancer emerge, more lawsuits against BI and EL will follow.

Jentadueto and Tradjenta Side Effects

Jentadueto and Tradjenta may have several side effects. Many of these side effects are common concerns for patients with diabetes. The least serious and most common side effects associated with these drugs include:

• Diarrhea and gas
• Feeling of fullness
• Heartburn
• Loss of strength
• Muscle aches
• Runny nose
• Sore throat

Less common side effects include:

• Anxiety
• Blurred vision
• Chills
• Cold sweats
• Confusion
• Cool, pale skin
• Depression
• Dizziness
• Fast heartbeat
• Headache
• Increased appetite
• Nausea
• Nightmares
• Seizures
• Shakiness
• Slurred speech
• Unusual tiredness or fatigue

Patients may also experience digestive issues, severe joint pain, fainting spells, and yellowing eyes. These side effects have been reported by some patients, but the occurrence rate is unknown.

Patients who experience any mild or serious side effects should speak with their doctor. Your healthcare provider may be able to switch you to a drug with fewer side effects.

If You’ve Been Harmed by Your Diabetes Medicine, Get Legal Help

Prescription drug manufacturers have a legal responsibility to ensure their products are free of defects and safe for consumer use. If you’ve been harmed by your diabetes drug, you have legal rights under product liability laws.

If you’re considering filing a Tradjenta or Jentadueto lawsuit, consult a product liability attorney to discuss your options. Most states have statutes of limitations (time limits) on filing a product liability claim, so it helps to have a legal advocate who knows what to expect. Many attorneys offer free case reviews.