If you were diagnosed with heart failure, pancreatitis or pancreatic cancer while taking the type 2 diabetes drug Onglyza, you should contact an attorney to review your legal options.
An experienced defective drug lawyer may be able to help you file an Onglyza lawsuit to try to hold the manufacturer accountable and possibly provide compensation for the effects of your injuries, from medical bills to other damages like pain and suffering. While compensation cannot change your medical condition, it can help prevent your health problems from causing a financial catastrophe for you and your family.
The licensed defective drug lawyers at Roden Law can review your situation in a free, no obligation legal consultation to determine if you have grounds for a lawsuit. We will not charge you for our services unless you receive compensation. We can help you with every step of the legal process, from investigating and filing legal documents to negotiating compensation or representing you at trial.
Complete a Free Case Evaluation form today to schedule your free legal consultation.
What is Onglyza?
In 2009, Onglyza was approved by the U.S. Food and Drug Administration (FDA) for treating type 2 diabetes.
Onglyza is part of a group of drugs called dipeptidyl peptidase 4 (DPP-4) inhibitors. These medications work by inhibiting the enzyme DPP-4, which causes the pancreas to produce more insulin after the patient eats. Increasing insulin can help lower blood sugar levels, which are high in people with type 2 diabetes.
One of the advantages of Onglyza over other type 2 diabetes medications is that it does not encourage weight gain. This is significant because controlling blood sugar in type 2 diabetes patients becomes even harder as the patient gains weight.
Onglyza has become one of the most popular type 2 diabetes medications on the market, reaching more than $750 million in sales in 2015 alone.
Call Roden Law to discuss an Onglyza lawsuit today. 1-844-RESULTS
Onglyza Linked to Heart Failure
It did not take long for patients and health care providers to discover Onglyza had serious, potentially life-threatening side effects. Since the drug was released, there have been multiple studies and FDA warnings about these side effects.
On Oct. 3, 2013, a landmark study was published in The New England Journal of Medicine that found an alarming link between saxagliptin and heart failure in patients with type 2 diabetes. Saxagliptin is the active ingredient in Onglyza.
Researchers studied a group of 16,492 type 2 diabetes patients who either had a history of cardiovascular problems or were at risk for suffering cardiovascular problems. These patients were randomly given saxagliptin or a placebo and observed for an average of about two years.
The patients taking saxagliptin did not see an increase or decrease in ischemic events, which occur when there is a restriction of blood supply to tissues. However, 35 out of every 1,000 were hospitalized for heart failure, compared to 28 out of every 1,000 patients who took a placebo. This amounts to a 27 percent increase in the risk of heart failure hospitalization compared to patients taking the placebo.
FDA Warning About Heart Failure Risk
In a nearly unanimous vote by an FDA advisory panel in 2015, the committee decided saxagliptin was safe, but recommended that the drug label be updated with information about the risk of heart failure.
In April 2016, the FDA released a drug safety communication saying that medications containing saxagliptin could increase the risk of heart failure, particularly for patients who already have heart disease. The FDA also announced the drug label would be updated to warn about the potential increased risk of heart failure.
Signs and Symptoms of Heart Failure
If you are taking Onglyza and notice any signs of heart failure, seek medical treatment immediately:
- Difficulty breathing when lying down
- Swelling in the feet, legs and ankles
- Weight gain
- Weakness or fatigue
- Loss of appetite
- Heart palpitations
- Bulging neck veins
- Enlargement of the abdomen
- Persistent cough unrelated to another illness
- Waking up at night to urinate
- Unusual shortness of breath during daily activities
If you report these symptoms to your doctor and are diagnosed with heart failure, you may be able to file an Onglyza lawsuit to obtain compensation for medical bills and other damages.
Contact our defective drug attorneys today by calling 1-844-RESULTS.
Link to Pancreatitis and Pancreatic Cancer
Medications containing saxagliptin have also been linked to an increased risk of pancreatitis. In 2011, the prescribing information for Kombiglyze XR was updated to advise doctors and patients of the danger. Kombiglyze XR is equivalent to corresponding doses of Onglyza and metformin extended release tablets.
The prescribing information notes there have been reports of acute pancreatitis, or inflammation of the pancreas, in patients taking saxagliptin. If a doctor suspects a patient is suffering pancreatitis, he or she should have the patient discontinue taking saxagliptin promptly.
However, the prescribing information also says it is not known if patients with a history of pancreatitis have an increased risk of developing pancreatitis while taking medications containing saxagliptin.
Other Research on Pancreatic Problems
In a March 2013 drug safety communication, the FDA revealed it was evaluating unpublished research showing an increased risk of pancreatitis and pre-cancerous cells in the pancreas. The research was based on examinations of pancreatic tissue from patients who died from unspecified causes.
That same month, a study was published in an issue of Diabetes showing that incretin therapy caused a significant increase in the development of pre-cancerous cells in the pancreas. Saxagliptin is an incretin therapy because it breaks down a hormone to help type 2 diabetes patients regulate blood sugar levels.
In 2015, another study came out showing an increased risk of pancreatic and thyroid cancer in patients taking DPP-4 inhibitors, like Onglyza. Researchers said current evidence shows the need for continuous monitoring of patients on incretin-based therapies for the development of cancer or pre-cancer cells in the pancreas.
The study was published in The Journal of Environmental Science and Health. It consisted of an analysis of various studies that had been conducted before Dec. 15, 2014.
Signs of Pancreatitis
There are various signs of pancreatitis to watch for, such as:
- Fever accompanied by an increased heart rate
- Swelling of the abdomen
- Nausea
- Weight loss you cannot explain
- Yellowing of the skin or eyes
- Worsening abdominal pain after eating, particularly after eating high-fat foods
- Oily stool
- Abdominal pain that radiates to the back
If you experience any of these symptoms, you may have pancreatitis caused by Onglyza. You should strongly consider contacting an experienced attorney to determine if you can file an Onglyza lawsuit to obtain compensation.
Fill out a Free Case Evaluation form today.
Current Onglyza Lawsuits
Onglyza manufacturers AstraZeneca and Bristol-Myers Squibb Co. are facing dozens of Onglyza lawsuits over heart failure and other cardiovascular issues.
In early February 2018, the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a multidistrict litigation (MDL) for all federally-filed product liability lawsuits involving Onglyza and Kombiglyze XR. That means these lawsuits have common questions of fact and will be overseen by one judge. The JPML sent these cases to the U.S. District Court, Eastern District of Kentucky.
According to court documents, there are more than 80 pending lawsuits that could be included in this MDL. Centralizing these cases is meant to streamline the legal process, avoid duplicate discovery and prevent inconsistent rulings. Discovery is the process where both sides in a lawsuit gather evidence to build a case.
If you suffered heart failure or other side effects while taking Onglyza, you may be able to file an Onglyza lawsuit to pursue fair compensation for damages.
Call Roden Law today to schedule your free consultation. 1-844-RESULTS
Contact Us Today About Filing an Onglyza Lawsuit
Type 2 diabetes medications can go a long way toward helping patients with this condition manage their health. Unfortunately, some of these medications can cause extremely dangerous side effects that could lead to death if they are not dealt with as soon as possible.
This is the case with the drug Onglyza, which has been linked to an increase in the risk of heart failure and problems with the pancreas. The manufacturer could be held responsible for producing a dangerous drug and failing to adequately warn doctors and their patients about the risks.
Working with an attorney on your Onglyza lawsuit has several benefits. Not only is an attorney familiar with the legal process, he or she will also know how to investigate to build a strong case.