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Tradjenta

The Tradjenta injury case attorneys at the Drug Law Center are currently evaluating cases where patients have suffered serious injuries after taking the Type II diabetes treatment medication.

Introduction

Tradjenta Drug RecallTradjenta (linagliptin) is a prescription drug that treats Type II diabetes when used along with exercise and healthy diet. The drug manufacturer says that the once-daily medication helps the body produce more insulin while controlling sugar levels and potentially can help lower A-1 C levels. The nephron protective effects of the active ingredient in Tradjenta, linagliptin, can eliminate many of the common symptoms associated with Type II diabetes mellitus including chronic high blood sugar levels that can develop into serious health problems later on.

The History of Tradjenta

The dipeptidyl peptidase-4 inhibitor (DPP-4) medication Tradjenta (linagliptin) was initially developed by Boehringer Ingelheim and marketed by Eli Lilly & Co. under two different tradenames Tradjenta (in the United States) and Trajenta (in the global market).

With unique formulated properties, Tradjenta can prevent the degradation of hormone incretin to allow pancreatic beta cells to release insulin. The drug is affected because the longer incretin remains in the body’s bloodstream, the more stimulation is provided to the pancreas to produce insulin.

In 2011, the U.S. Food and Drug Administration (FDA) approved once-daily oral linagliptin medicine for treatment of Type II diabetes. It is ineffective and not recommended for the treatment of type I diabetes. The FDA determined that the drug was safe after results from a face 3 clinical trial in 2010 revealed that the drug was effective but reducing blood sugar levels. However, there are serious side effects from taking the medication, where some patients have suffered pancreatitis, kidney issues, and a multitude of other complications.

Who Should Avoid Taking Tradjenta?

Individuals with a history of hypersensitivity to linagliptin, the active ingredient in Tradjenta, including exfoliative skin conditions, angioedema, anaphylaxis, bronchial hyperactivity, or urticaria should avoid taking Tradjenta and any medicine containing linagliptin. Individuals diagnosed with pancreatitis or low blood sugar levels should also avoid taking the medication as should individuals who have an allergic reaction to gliptins (dipeptidyl peptidase-4 inhibitors (DPP-4)).

Tradjenta is not safe for patients to use who have been diagnosed with Type I diabetes and those suffering from diabetic ketoacidosis (high blood ketone levels). Linagliptin, the active ingredient in Tradjenta, can interact with numerous medicines including Rifamycin and insulin. Many medical conditions can also interact with the medication including:

  • Pregnancy, or women who are planning to become pregnant
  • Allergic reaction to food, medicines, or other substances
  • History of swelling of the throat, eyes, lips, face, hands, or tone
  • History of a difficulty in breathing or swallowing
  • Hoarseness
  • History of pancreatitis (inflamed pancreas)
  • Currently taking any prescription or over-the-counter medication, dietary supplement, or verbal preparation

Tradjenta Side Effects

All prescription medications, including Tradjenta, have some form of minor to severe side effects and adverse reactions. The most common minor Tradjenta side effects include:

  • Sore throat
  • Muscle aches
  • Running or stuffy nose
  • Diarrhea

Serious Tradjenta side effects include:

  • Pancreatitis (inflammation of the pancreas)
  • Hypoglycemia (low blood sugar)
  • Thyroid Cancer
  • Serious allergic reactions
  • Joint pain
  • Skin reaction
  • Anxiety
  • Coma
  • Headaches
  • Dizziness
  • Depression
  • Fast heart rate
  • Confusion
  • Cold sweats
  • Slurry speech
  • Seizures
  • Nausea
  • Cool, pale skin
  • Unusual tiredness
  • Shakiness
  • Increase hunger

Tradjenta and the FDA

When the FDA finally approved Tradjenta as the Type II diabetes medication treatment, the federal agency based this conclusion on eight specific studies involving model therapy and adjunct therapy with metformin, pioglitazone, and glimepiride therapies. To ensure that the medication is taken safely and effectively, the FDA continually updates its safety announcements and warnings to the drug makers to update their Black box warning label information. The FDA concluded that there are specific contraindications based on evidence from reports for individuals taking Tradjenta or its generic form linagliptin. This includes:

  • “Contraindications – History of hypersensitivity reaction to linagliptin, such as urticaria, angioedema, and bronchial hyperactivity.”

The FDA also noted that reports of adverse reactions in individuals receiving Tradjenta happen bore often compared to patients taking placebos. The federal agency also provided precautions and warnings that include:

  • “When used with an insulin secretagogue (e.g., sulfonylurea), consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia.
  • There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Tradjenta or any other antibiotic drug.”

Use in Specific Populations

The FDA has indicated the specific populations should consider all risk factors involved in taking Tradjenta. These include:

  • “Pregnancy: there is no adequate or well-controlled studies concerning pregnant women. Tradjenta tablets should be used during pregnancy only if clearly needed.
  • Nursing mothers: Caution should be exercised when Tradjenta is administered to a nursing woman.
  • Pediatric patients: Safety and effectiveness of Tradjenta in patients below the age of 18 have not been established.
  • Renal or hepatic impairment: No dose adjustment recommended.”

May 2011 – The Food and Drug Administration approved the use of Tradjenta for the treatment of Type II diabetes.

August 2012 – The FDA approved updating the prescribing information to consumers using Tradjenta plus for “any add-on therapy to insulin in adults with Type II diabetes.”

August 2015 – The Food and Drug Adminstration issues a safety announcement to consumers sending a warning that Tradjenta plus has the potential of causing disabling, severe joint pain.

Lawsuits

Over 700 lawsuits have been filed against Boehringer Ingelheim and Eli Lilly & Co., where many plaintiffs have suffered pancreatic side effects after taking the anti-diabetes medication. Because of that, federal judges have consolidated these lawsuits and formed a multidistrict litigation case (MDL) in California.

Unlike a traditional class action lawsuit, MDL cases provide access to necessary resources while saving time and money to allow each plaintiff to present the evidence in their own lawsuit to secure their outcome. This is different than class action lawsuits because they eliminate duplicating discovery while improving efficiency and avoiding conflicting rulings that could occur in multiple state and federal courtrooms.

Tradjenta Drug Recall

Even though Tradjenta plus is known to cause serious artifacts and extremely harsh adverse reactions that often result in life-threatening medical issues, neither the Food and Drug Administration nor the pharmaceutical companies have yet to recall Tradjenta from the medical marketplace.

However, the benefits and risks of the medication continue to remain under investigation by federal agencies and attorneys working on behalf of victims who have been injured after taking the antidiabetic medication. In fact, every time a Tradjenta lawsuit is hurting open court, injure consumers and expert medical researchers providing evidence in the courtroom bring much more attention to the problems with the medication and the previously undisclosed health hazards at a much faster response than the slow-paced of federal agencies responding to serious reports of harsh adverse events and drug-related deaths.

Filing a Tradjenta Plus Lawsuit

Unlike other dipeptidyl peptidase-4 inhibitor (DPP-4) diabetic medications that have been used for decades, Tradjenta is relatively new in the medical marketplace. In recent years, the Food and Drug Administration has issued a series of Safety Announcements warning consumers of the potential development of cancer in pancreatitis when taking antibiotic medications.

Most of the lawsuits that have been filed against Boehringer Ingelheim, Eli Lilly & Co., Merck & Company, Bayer Healthcare Pharmaceuticals, and others have all been based on a failure to warn. Plaintiffs injured by these medications have built their cases on the negligent behaviors of the drug makers who did not warn the public, consumers, doctors and the medical community of the potential risks other unsafe products.

Lawyers working on behalf of their plaintiffs have made claims that the drug manufacturers engaged in numerous incidents of wrongdoing. As a result, these cases are asking for not only compensatory damages but also punitive damages to ensure the victims receive adequate financial recompense for their injuries and losses. These cases include personal injury, product liability, medical malpractice, and wrongful death.

Most plaintiffs that have suffered an injury after taking the Type II diabetes medication were not aware that the drug they were taking was causing serious harm. In addition to feeling blindsided most plaintiffs were stuck with extensive medical bills, ongoing medical care, hospitalization costs, and some lost income because they had become too sick to continue working.

While the victims might seem overwhelmed with the effort it takes to file a lawsuit against the drug manufacturer for the harm that because it is typically the most reasonable course of action. However, these cases are complex and often require the skills of the dedicated personal injury attorneys specializes in medical malpractice, product liability, and wrongful death cases.

If the Tradjenta injury case is accepted through a contingency fee arrangement, the injured patient does not need to put up any upfront fees to pay for legal services. This means the victims can spend their time healing from their injuries and seeking new methods for improving their physical and emotional health while their attorneys move the case forward to obtain financial recompense. With the assistance of a competent legal team, victims can improve the financial outlook for their future once the Tradjenta lawsuit has been successfully resolved.

Typically, lawyers will build a case against every party that is responsible for causing their clients harm. This could include the physician who prescribed the drug, the pharmacist who dispensed the medication, the hospital where the prescription was written and of course the drug manufacturers who developed, marketed, promoted, and sold the medication to generate profits, even though they likely knew that there were serious side effects and adverse reactions caused by their defective drug.

Obtain Financial Compensation through a Tradjenta Lawsuit

The defective medication and product liability litigation attorneys at the Drug Law Center are currently evaluating new cases involving injuries caused by Type II diabetes medications, including Tradjenta. We handle both class action litigation cases and individual lawsuits to ensure that our clients receive the highest level of financial compensation available based on the evidence and expert testimony in their case.

To minimize the financial burden on families pursuing compensation through a Tradjenta lawsuit, our law firm will postpone payment of our legal services until after we successfully conclude the lawsuit by negotiating an acceptable out of court settlement or winning the case at trial. Additionally, we offer a “No Win / No Fee” guarantee. This means if we are unable to obtain financial compensation on your behalf, you always nothing. However, our team of attorneys has years of experience in successfully resolving all our cases.

Contact us now to schedule an appointment to speak with one of our lawyers who is handling other cases exactly like yours. We provide complimentary case reviews to discuss the merits of your claim and provide numerous options on how to legally move forward in pursuing compensation.

Sources:

http://www.mdedge.com/ccjm/dsm/8521/drug-therapy/linagliptin

http://www.mayoclinic.org/drugs-supplements/linagliptin-and-metformin-oral-route/description/drg-20075407

http://jamanetwork.com/journals/jamadermatology/fullarticle/2458755