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Onglyza

The Onglyza injury attorneys at the Drug Law Center can assist you in resolving your legal compensation claim against the Type II diabetes drug manufacturer.

Introduction

Onglyza Drug RecallOnglyza (saxagliptin) is a popular type II diabetes drug prescribed for patients to assist them in controlling blood sugar levels. It is effective because it regulates the body’s levels of insulin just after eating. When used regularly, it can prevent serious medical conditions including kidney damage, sexual function problems, nerve issues, blindness, or loss of limbs. When used concomitantly with exercise and diet, Onglyza can assist the body in reducing A1C levels. Onglyza is prescribed as a monotherapy or adjunct therapy with other medications to treat Type II diabetes. It is not effective at treating Type I diabetes.

The History of Onglyza

Both AstraZeneca and Bristol-Myers Squibb Company manufacture, promote and market Onglyza, the brand-name for saxagliptin, a dipeptidyl peptidase-4 (DPP4) inhibitor. In July 2009, the Food and Drug Administration (FDA) approved Onglyza for the treatment of Type II diabetes mellitus in adults.

In 2015, the FDA analyze clinical trial data and warned patients using Onglyza to treat Type II diabetes that they are likely more at risk for being hospitalized due to heart failure. A few months later an additional morning by the FDA reveals that Onglyza might cause severe, disabling joint pain. Before the end of the year (2015) a Chicago woman files and Onglyza wrongful death lawsuit claiming her mother died from heart failure due to taking the AstraZeneca diabetic medication.

In 2016, the FDA mandated that the drug makers must add a warning concerning the increased potential of the drug causing heart failure. The FDA based this warning on studies that concluded that “DPP-4 inhibition with saxagliptin did not increase or decrease the rate of ischemic events, though the rate of hospitalization for heart failure was increased. Although saxagliptin improves glycemic control, other approaches are necessary to reduce cardiovascular risk in patients with diabetes.”

Even though the Food and Drug Administration approved Onglyza for the treatment of Type II diabetes, there are no studies to indicate that the medication is more effective than competitive drugs including Januvia.

Onglyza Side Effects

Nearly all prescribed medications, including Onglyza, have some form of mild to severe side effects. The AstraZeneca website states that Onglyza has serious side effects when taken, including “inflammation of the pancreas (pancreatitis), which may be severe and lead to death.” In addition, serious allergic reactions are possible when taking Onglyza or the generic form saxagliptin. These reactions include:

  • Swelling of the throat, lips or face
  • Skin swelling
  • Difficulty in breathing or swallowing
  • Skin peeling, flaking, itching, rash or hives

Common minimal side effects when taking Onglyza include:

  • Stuffy or a runny nose
  • Sore throat
  • Headache
  • Cough

Common major side effects from taking Onglyza include:

  • Anxiety
  • Unusual weakness or tiredness
  • Side or lower back pain
  • Nausea
  • Depression
  • Ear congestion
  • Cloudy or blood in urine
  • Frequent urination
  • Slurred speech
  • Shakiness

Even though Onglyza taken alone usually does not cause hypoglycemia (low blood sugar), this condition can occur if the medication is prescribed concomitantly with other drugs.These side effects can include:

  • Sudden sweating
  • Excessive hunger
  • Fast heartbeat next line Shaking
  • Tingling feet or hands
  • Dizziness
  • Blurry vision

Experiencing any of the symptoms listed above should cause alarm. Seek immediate medical attention whenever experiencing any serious side effect including a sign of pancreatic cancer, pancreatic disease, or pancreatitis. Typically, the symptoms involve severe abdominal or stomach pain that might or might not spread to the back. Additionally, persistent vomiting and nausea is an indicator of pancreatic problems.

Who Should Avoid Taking Onglyza (saxagliptin)?

It is important to discuss health issues, other medications being taken, and allergic reactions to Onglyza or its generic form saxagliptin especially if you are suffering from:

  • Shock
  • Fever
  • Acute pancreas inflammation
  • Liver Problems
  • Sudden heart failure
  • Chronic heart failure
  • Artifact
  • Alcohol Intoxication
  • Overall weakness
  • Sepsis syndrome
  • Infection
  • Low blood sugar
  • Extreme body water loss
  • Excess body acid
  • Inadequate vitamin B12 levels
  • Decreased adrenal gland function
  • Pituitary hormone deficiency
  • Decreased lymphocytes in the bloodstream
  • Moderate to severe kidney impairment
  • Habitual alcohol drinking

Before taking Onglyza, it is important that your doctor completes a comprehensive history of your current and past medical problems and discuss what can happen if you take the medication. This is because you could suffer a variety of conditions as a side effect including:

Pancreatitis (inflammation of the pancreas) – This condition can be severe and cause death. Individuals with a history of pancreatitis, alcoholism, gallstones are high triglyceride levels needs to stop taking the medication, especially if experiencing abdominal (stomach) pain that does not go away. The level of pain might extend from the abdomen to the back and cause vomiting, or not. These are the most common signs of pancreatitis.

Onglyza and the FDA

Patients suffer from Type II diabetes often have an increased potential risk of developing cardiovascular complications and as a result, often die from those complications. In 2008, the Food and Drug Administration (FDA) have growing concerns involving the safety of nearly all medications used to treat type II diabetes and recommended that drug makers provide evidence that their products would not increase the potential of heart attacks or other cardiovascular events.

Onglyza met the FDA’s challenge of proving the safety of their medication in preventing cardiovascular events. As a result, the federal agency approved the new drug to treat diabetes but still held reservations about the clinical trials AstraZeneca conducted to achieve those results. Because of that, the drug maker was required to conduct post-marketing studies.

At the end of the trials, involving 16,000 patients, the cardiovascular outcomes were alarming. It showed that patients taking Onglyza at a 27 percent higher chance of suffering some type of heart failure that required hospitalization. In addition, the study revealed a substantial increase of mortalities among patients taking Onglyza. As a result, the FDA concluded that the drug maker must ensure that specific warnings were included in its promotion and labeling such as:

  • Shortness of breath
  • Nausea
  • Fatigue
  • Impaired cognitive ability
  • Swelling of the abdomen or lower extremities
  • Increased heart rate
  • Loss of appetite

In April 2016, the FDA announced it would require the makers of Onglyza carry specific warnings in their marketing, promotional and labeling information concerning the risk of heart failure by adding:

  • A warning about pancreatic cancer and pancreatitis
  • A warning about severe joint pain

From a legal standpoint, AstraZeneca can be held legally liable for any injuries or death associated with taking Onglyza. As an example, patients who suffer Onglyza heart failure could argue in a court of law that the drug maker failed to properly warn them of any potential heart issue that could occur. In fact, it was not until 2014 that AstraZeneca revealed any of the known Onglyza heart failure side effects and did not add them to their black box warning label until 2016.

To date, the FDA has approved Onglyza only for the treatment of Type II diabetes used adjunct of Lee with exercise and diet as an effective way to lower blood sugar levels. It has not been approved to treat Type I diabetes or diabetic ketoacidosis where the patient has increased ketones in urine or blood.

Onglyza Side Effects Might Include Thyroid Cancer

Onglyza plus is a widely prescribed medication used to treat type II diabetes. However, for years it is not known to have serious and dangerous side effects including the potential development of pancreatic cancer. It is only recently that researchers believe that thyroid cancer might also be a side effect of the popular diabetes medication.

In response, the U.S. FDA warned AstraZeneca and Bristol-Myers Squibb that they must update the black box warning label to ensure this new information is available to patients, consumers, doctors, and the medical community. The FDA is warning patients to look out for detectable symptoms of thyroid cancer that include:

  • A change in voice
  • Difficulty swallowing
  • Respiratory issues
  • Swelling
  • Nodules or lumps on the center or lower front of the neck
  • Enlarged or painful lymph nodes
  • Unexplained hoarseness or coughing

Filing an Onglyza lawsuit

Many individuals who suffered serious Onglyza side effects have filed lawsuits and compensation claims against the drug maker. Some of the cases are based on wrongful death and others on product liability, alleging that the pharmaceutical giant failed to provide warnings to patients, consumers, doctors, and the medical community of the serious, life-threatening injuries that the medication is known to produce.

Attorneys working on behalf of their clients are filing lawsuits to secure monetary compensation for their damages. These damages could include ongoing medical expenses, lost wages, the loss of earning capacity, and intangible damages including pain, suffering, mental anguish and anxiety. Other lawsuits are being filed as wrongful death claims by surviving family members who lost a loved one who suffered a life-threatening injury caused by Onglyza.

Onglyza Lawsuits

  • Texas Plaintiff Seeking Financial Compensation in an Onglyza Product Liability Lawsuit

March 2017 – The makers of Onglyza are facing another product liability lawsuit, this time filed by a Texas man who alleges that the type II diabetes medication caused his heart failure. The plaintiff claims he was prescribed and took the medication between 2010 in 2015 as directed by his doctor and then suffered CHF (congestive heart failure), acute hypoxic respiratory failure and heart failure. The man claims that his sudden change of health was the direct result of the medication side effects.

Let Us Help You Resolve Your Onglyza Lawsuit

The Onglyza injury attorneys at the Drug Law Center have been successful in resolving product liability in medical malpractice claims, where victims of suffered serious harm or die prematurely in a wrongful death. Our legal team understands how frustrating it is to decide whether to take the dangerous drug and risk developing complications or avoid taking the medication and face the unpleasant risks associated with uncontrollable blood sugar levels.

We have handled many cases where our clients were never made aware of the potentially serious side effects and therefore were unable to make an informed decision before taking the drug. Our lawyers are here to provide all the legal representation required to win a lawsuit or compensation claim against AstraZeneca and Bristol-Myers Squibb for selling, marketing and promoting a drug known to have serious defects.

Diabetic patients and surviving family members who suspect that the severe adverse reaction or heart complication they have endured might be caused by Onglyza should contact us immediately. Let us begin resolving your case today through a complimentary, case evaluation with our team of legal experts. We are currently accepting all product liability lawsuits and personal injury claims on contingency, meaning we will postpone accepting payment for our legal services until we successfully negotiate a settlement on your behalf or win your case at trial.

Sources:
http://www.mayoclinic.org/drugs-supplements/saxagliptin-oral-route/description/drg-20073116
https://www.fda.gov/Drugs/DrugSafety/ucm486096.htm
https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm494252.htm
http://www.mayoclinic.org/drugs-supplements/saxagliptin-oral-route/side-effects/drg-20073116
https://health.clevelandclinic.org/2013/10/diabetes-drug-deemed-safe-for-heart/