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Nesina

The Nesina injury case attorneys at the Drug Law Center are evaluating potential lawsuits for individuals who developed heart failure, pancreatic cancer, or other condition after taking the Type II diabetes medication.

Introduction

Nesina Drug RecallNesina is a diabetic treatment medication that improves glycemic control in individuals suffering with Type II diabetes mellitus. The dipeptidyl peptidase-4 inhibitor (DPP-4) medication is most effective when used as an adjunct to exercise and healthy diet. The drug is not to be prescribed for patients suffering from Type I diabetes mellitus or those with diabetic ketoacidosis. The active ingredient in Nesina, alogliptin, regulates insulin levels in the body that is produced after eating. While the drug has been effective in the treatment of Type II diabetes, it can produce serious side effects including pancreas and liver problems.

The History of Nesina

In January 2008, the pharmaceutical company Syrrx submitted a new medication application to the Food and Drug Administration seeking approval for alogliptin, the active ingredient in what would later become Nesina. In 2005, Takeda Pharmaceutical Company acquired Syrrx and continued seeking approval for its diabetic medications. The FDA approved Nesina, a dipeptidyl peptidase-4 inhibitor (DPP-4) for treating Type II diabetes mellitus in 2013. Three years later (April 2016), the Food and Drug Administration issued a safety warning to alert consumers taking Nesina of the increased potential of developing heart failure.

Who Should Avoid Taking Nesina?

All prescription drugs and over-the-counter medications have some form of contraindication, where a patient might experience an adverse reaction if they take the medication while suffering from another condition, taking a different medication or being allergic to the drug ingredients. Before taking Nesina, it is important to talk to give the prescribing doctor a comprehensive medical history. Individuals that have specific conditions should not use Nesina (alogliptin) including:

  • Chronic heart failure (CHF)
  • Kidney impairment
  • Liver disease
  • Abnormal liver function tests
  • Acute pancreatic inflammation
  • Renal impairment
  • Gallstones
  • A history of pancreatitis
  • Diabetic ketoacidosis
  • Low blood sugar levels
  • Alcohol dependency

Additionally, an individual with a history of hypersensitive reaction to products containing alogliptin should avoid taking the drug because it could cause angioedema, anaphylaxis, or severe cutaneous adverse events.

No comprehensive studies have been conducted to determine whether unborn babies would be harmed if the mother was taking Nesina (alogliptin). Additionally, no reports have indicated that alogliptin can pass through breast milk to the nursing baby. However, it is advisable to discuss ongoing breastfeeding routines with the prescribing doctor before taking the antidiabetic medication. The FDA is not approved Nesina for any pediatric patient 17 years or younger.

Nesina Side Effects

Some individuals have an allergic reaction when taking Nesina (alogliptin) and should seek immediate medical help at the first signs of swelling of the throat, tongue, lips, face, or difficulty in breathing. In addition, it is important to stop taking Nesina and see the doctor immediately if any symptoms of pancreatitis occur. These include vomiting, nausea, fast heart rate, loss of appetite, and/or severe upper stomach pain that radiates to the back. Mild Nesina side effects involve:

  • Headaches
  • Sinus pain
  • Sinus infection
  • Sore throat
  • Stuffy nose
  • Anxiety
  • Confusion

Serious Nesina side effects include:

  • Ongoing severe pain in the joints.
  • Liver problems including dark urine, loss of appetite, tired feeling, itchy sensation, upper stomach pain, nausea, jaundice, or clay-colored stools.
  • Heart problems including rapid weight gain, shortness of breath, swelling of the midsection, legs, or feet.
  • Severe skin reactions including swelling of the tongue or face, sore throat, fever, skin pain, and burning of the eyes.
  • Confusion
  • Shakiness
  • Nightmares
  • Seizures
  • Coma
  • Chest pain
  • Extreme fatigue
  • Dilated neck veins

Nesina and the FDA

April 2016 – The U.S. FDA (Food and Drug Administration) issued a safety announcement warning for consumers taking the Type II diabetes medicine containing held alogliptin has a potential of increasing the risk of developing heart failure, especially in those who already suffer from kidney or heart disease. The FDA warns that “heart failure can result when the heart is not being able to pump and of blood to meet the body’s needs. As a result, [the FDA is] adding new warnings to the drug labels about the safety issue.”

As a part of the safety announcement, the FDA is recommending that “patients taking these medicines should contact their health care professionals right away if they develop signs and symptoms of heart failure such as:

  • Unusual shortness of breath during daily activities
  • Difficulty in breathing
  • Tiredness, weakness, or fatigue
  • Weight gain was swelling of ankles, feet, legs, or stomach.

December 2016 – In December 2016, the FDA updated its warnings and precautions for consumers taking Nesina (alogliptin), noting that the most common adverse reactions occurring at or rate of 4% or higher include nasopharyngitis, headaches, and upper respiratory tract infection. The FDA alerted the consumers who might have developed some of the side effects of taking Nesina (alogliptin). These include:

  • Acute Pancreatitis – The FDA has received post-market reports of acute pancreatitis and warned consumers to discontinue Nesina at the first suspected signs of the condition.
  • Heart Failure – The FDA warned consumers to weigh the risks vs. benefits of taking Nesina before initiating diabetic treatment in patients who have a potential risk of developing heart failure.
  • Hypersensitivity – The number of postmarking reports of patients suffering serious hypersensitivity reactions when taking Nesina have been increasing. These include anaphylaxis, angioedema, and severe cutaneous adverse reactions, including Stevens-Johnson
  • Hepatic Effects – Nearly any type of hepatic failure could be fatal and causality cannot be excluded. Any time it injury to the liver is detected, the FDA recommends properly interrupting the use of Nesina.
  • Hypoglycemia – The FDA warns that it might be necessary to lower the dose of insulin or insulin secretagogue to minimize the risk of the patient experiencing hypoglycemia.
  • Arthralgia – Debilitating or severe cases of arthralgia have been reported to the FDA in individuals taking the dipeptidyl peptidase-4 inhibitor (DPP-4) medication. Many of those taking the drug have been affected by severe joint pain.
  • Bullous Pemphigoid – The FDA has received many reports of bullous pemphigoid (a rare condition of the skin that causes large fluid-filled blisters) that require hospitalization in individuals currently taking Nesina (alogliptin) or another dipeptidyl peptidase-4 inhibitor (DPP-4) drug.
  • Macrovascular Outcomes – The FDA has announced there are no clinical studies that have been conducted to establish evidence of macrovascular risk reduction conclusively in patients taking antidiabetic medications including Nesina.

Nesina Recalls

Even though Nesina has been linked to serious side effects including congestive heart failure, kidney problems, and difficulty in breathing, neither the Food and Drug Administration nor to Takeda Pharmaceutical Company have recalled the antidiabetic medication, or the generic form, from the medical marketplace.

Filing a Nesina Lawsuit

Many attorneys working on behalf of their client will file product liability claims to pursue financial compensation for the injury, harm or damage the product causes. Most claims and lawsuits are based on the serious side effects and wrongful death occurring in patients taking dangerous drugs that have yet to be recalled voluntarily by the drug maker or the U.S. Food and Drug Administration.

The antidiabetic medication Nesina and other alogliptin formulated medications including Kazano and Oseni have been at the forefront of pharmaceutical product liability litigation cases. This is because doctors still prescribe these dangerous medications due to a lack of knowledge on the product or a lack of care and concern that would ensure their patient’s safety.

To successfully resolve a case involving defective drugs, the attorney will need to prove one of three specific factors in a court of law or to the defendant’s attorneys. These include:

  • The product is defective in its design,
  • The product causes unreasonably dangerous side effects or adverse events, or
  • The product was improperly marketed which led to the patient’s injuries or premature death

Determining what is wrong with the product will help the attorney build the case for financial compensation. The lawyer may base the lawsuit on a failure to warn the consumer of the known defects of the product, the concealment of known defects, a breach of express manufacturer’s warranty, fraud, product misrepresentation, and/or false advertising.

The patient may not have been made aware of the known side effects or was given the wrong instructions/directions on how to take the medication properly. The product might have been defective in its design, packaging, shipping, or labeling or there may have been egregious misconduct where the manufacturer or doctor knew of the serious side effects the product could cause a deliberately concealed the risks.

Once the attorneys working on behalf of the victim understands exactly what happened, they can begin the process of identifying exactly who the defendants will be in the case to ensure that all parties responsible for causing the harm are held legally and financially accountable. Defendants in a Nesina lawsuit could include:

  • The Pharmaceutical Company – Most drug makers will develop medical products and drugs to rush through the approval process to ensure they can begin generating quick profits, often at the expense of patient to suffer injuries because the product was never fully tested through clinical trials.
  • The Testing Laboratory – patients consumed the testing laboratory for their failure to test the product adequately before it reached the medical marketplace.
  • The Pharmaceutical Distributor – Independent sales companies will usually market or promote the sales of a new medication by convincing doctors to recommend defective drugs to patients.
  • The Pharmacy – The pharmacy can be sued if they provide at the wrong directions or instructions on how to take the medication properly.
  • The Physician – finally, the victim can sue their own doctor for prescribing a dangerous medication that was known to cause severe injury.

How Can I File a Nesina Lawsuit?

The Nesina injury attorneys at the Drug Law Center are offering complimentary legal reviews to any individual who was diagnosed with pancreatic cancer, pancreatitis, or heart failure while they were taking Nesina (alogliptin). Our legal team of specialized attorneys has successfully resolved wrongful death lawsuits, product liability cases, and medical malpractice compensation claims.

Our law firm provides families and victims exceptional legal representation when pursuing financial recovery for their damages. Our lawyers integrate our extensive experience and comprehensive understanding of tort law with compassion to ensure that our clients find solace in receiving the monetary recompense they rightfully deserve.

If you have suffered serious injuries or lost a loved one to pancreatic cancer, pancreatitis, or other severe adverse effect caused by Nesina or the generic form alogliptin, contact us today. Allow us to begin the process of handling your case by protecting your rights and explaining your legal options in pursuing compensation.

We are currently accepting Nesina injury lawsuits through contingency fee agreements. This means you receive immediate comprehensive legal representation while we postpone accepting payment for our legal services until after your case has been settled out of court or successfully concluded at trial with a jury award.

 

Sources:

http://www.mayoclinic.org/drugs-supplements/alogliptin-oral-route/description/drg-20060796

https://my.clevelandclinic.org/health/articles/oral-diabetes-medications

http://www.bmj.com/content/suppl/2013/06/17/bmj.f3680.DC1/glp050613.ww1.pdf