Onglyza Lawsuit
An Onglyza lawsuit may be an option for patients who have been injured by the drug. The diabetes drug Onglyza has been linked to severe health consequences, including pancreatitis, pancreatic cancer, thyroid cancer, heart failure, and even death. Additionally, the drug has faced scrutiny following safety warnings issued by the U.S. Food and Drug Administration (FDA). Affected patients and their families may be able to file a lawsuit and recover damages with the help of a bad drug attorney.
For more information, contact Attorney Group. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Onglyza lawsuit attorney who can assist you throughout the legal process.
What is Onglyza and How Does It Work?
Onglyza is an oral diabetes medicine that helps control blood sugar levels. It works by regulating the levels of insulin the body produces after eating. Onglyza is for people with type 2 diabetes and it is sometimes used in combination with other diabetes medications.
Onglyza is manufactured by AstraZeneca and belongs to a group of type 2 diabetes medications called incretin-based therapies. Specifically, they belong to a class of drugs called DPP-4 inhibitors and are designed to enhance insulin levels within the body and also mitigate glucose absorption rates. Approved by the U.S. Food and Drug Administration (FDA) in 2009, Onglyza and other DPP-4 inhibitors work by helping the pancreas secrete more insulin and stop the liver from making excess sugar after food is consumed, ultimately lowering blood sugar levels.
Since this medication is unlikely to lower the level of sugar within the blood to a dangerous level, it is not likely that hypoglycemia will develop as a side effect. However, those who take Onglyza are at a higher risk for hypoglycemia if they take another type of medication for their diabetes, such as insulin, at the same time.
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Lauren A. on May 16, 2016
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Who Can Take Onglyza?
According to the FDA, approximately 9.3 percent of the population has diabetes, and 90 to 95 percent of people with the disease have type 2 diabetes. People who have diabetes either cannot produce insulin or cannot produce enough quality insulin for their body to make sure that the glucose in food is able to successfully reach their cells and produce energy.
To help adults with type 2 diabetes manage the effects of this disease, prescription medications, such as Onglyza, are often recommended by medical providers. This results in an excess amount of sugar building up in the blood. Although there are two types of diabetes, type 1 and type 2, Onglyza is strictly designed for people who have type 2. While it can help those with diabetes manage this disease, it is not meant to cure the disease and should be used in conjunction with a healthy diet and exercise to lower blood sugar levels.
Onglyza Side Effects
Although most prescription medications do cause some side effects, patients have claimed that Onglyza can cause adverse side effects that range from mild to extremely severe. Some of the more common side effects that may arise as a result of taking Onglyza include:
- Diarrhea
- Nausea and vomiting
- Sore throat
- Urinary tract infection
- Swelling or fluid retention
- Low blood sugar
Onglyza has also been linked to other side effects, including:
- Pancreatitis
- Pancreatic cancer
- Heart failure
- Thyroid cancer
- Death
- Other side effects
Pancreatitis and Thyroid & Pancreatic Cancer Risks
In a 2013 safety communication, the FDA stated that there have been reports of acute pancreatitis in patients taking Onglyza. Pancreatitis is the inflammation of the pancreas. Pancreatic damage happens when the digestive enzymes are activated before they are released into the small intestine and begin attacking the pancreas. Although mild cases often subside without treatment, more severe ones can cause complications that are life-threatening.
Studies have also linked diabetes drugs in the incretin mimetic class, including Onglyza, to the possible risk of thyroid cancer. In 2011, the FDA issued a safety communication indicating that Victoza, a diabetes drug very similar to Onglyza, may cause thyroid cancer in patients.
Another serious complication that may be linked to DPP-4 drugs, including Onglyza, is the possibility of an increase in the risk of pancreatic cancer, a cancer that is difficult to treat because it is often not diagnosed until later stages. In 2013, the FDA issued a report stating that the agency was investigating reports of a possible increased risk of pancreatic cancer from incretin mimetic drugs for type 2 diabetes. Additionally, in March of 2013, a study was published in the medical journal Diabetes, which suggests pancreatic tissue from the use of DPP-4 medications can increase precancerous cellular changes and pancreatic mass.
Onglyza and Heart Failure
As the American Diabetes Association (ADA) changes its definition of what constitutes as diabetes, an increasing number of people are being labeled as having the condition. For example, in 1997, the ADA changed its blood sugar threshold, and more than 1.9 million people in the U.S. were deemed to have diabetes. In 2003, a similar situation occurred when 25 million people were deemed to have a condition known as pre-diabetes.
Due to these altered requirements, more and more diabetes drugs like Onglyza have entered the marketplace. Despite the introduction of these new drugs, of the 30 that were introduced between the years 2004 and 2013, none of them were designed to reduce blindness, heart attacks, strokes and other conditions associated with having diabetes. This may be due to the fact that the FDA reportedly approved these medications simply on the basis that they could lower blood sugar.
In order to meet the growing demand for diabetes drugs, such as Onglyza, the FDA often relies on surrogate measures while approving new medications. This form of approval is attractive because it does not require extensive clinical trials, which can take years to complete.
As a result of the concerns that developed over Onglyza and cardiovascular issues, the FDA began to require companies that did not do extensive clinical testing, and instead used surrogate activities, to conduct follow-up testing. One example of this was a study, which was published in the New England Journal of Medicine, set out to prove that Onglyza could effectively reduce strokes, heart attacks and other cardiovascular issues.
Despite this purpose, it was discovered that even though taking Onglyza does not necessarily increase or decrease the ischemic events (a restriction of blood supply to tissues), the rate of hospitalization for heart failure does increase when this type of medication is taken. In the 2013 study, 16,492 patients with diabetes who either were at risk for cardiovascular problems or who had a history of them were given a placebo or Onglyza. The participants were then studied for a median of 2.1 years. The goal of the study was to see if Onglyza could provide heart benefits in addition to controlling blood sugar.
Onglyza Studies
Following the study published in the New England Journal of Medicine, the FDA requested that the manufacturers of Onglyza submit clinical data to determine if there was a link between taking this type 2 diabetes drug and heart failure. When the agency issued the safety warning, they considered the study as preliminary and encouraged patients taking Onglyza to speak with their health care provider if they had concerns. Medical professionals were also urged to continue prescribing Onglyza, based on the recommendations included on the drug’s labels.
After this warning was issued, the FDA conducted an advisory committee meeting to determine if the information contained on diabetes medications, such as Onglyza, should include information about cardiovascular risks. During this meeting, 14 of the 15 panelists from the Endocrinologic and Metabolic Drugs Advisory Committee were in favor of updating the labeling on Onglyza to include information about the medication’s potential risk for heart failure. The remaining member of the panel voted in favor of removing this type of medication from the U.S. market completely.
The main reason why the panel’s majority voted to alter this medication’s labelling, instead of pulling it from the market altogether, was because taking this medication does not increase the risk of cardiovascular disease by more than 30 percent.
FDA Warning
An Onglyza lawsuit attorney notes that, as a result of the FDA’s evaluation of two large clinical trials conducted in patients with heart disease, the agency added updated information in April 2016 as well as new warnings to the labels of medicines that contain saxagliptin (Onglyza) to inform of the potential increased risk of heart failure.
Clinical trials showed that more patients who received saxagliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment. Patients how already suffer from heart or kidney disease are particularly at risk.
Joint Pain May Lead Patients to Contact an Onglyza Lawsuit Attorney
While taking Onglyza has been linked to a higher risk of cardiovascular issues, the FDA released an additional safety warning in August 2015, stating that DPP-4 inhibitors, including Onglyza, could be linked to joint pain that is severe and disabling.
In addition to issuing this warning, the agency announced that it would add information about this potential risk to any diabetes medications classified as a DPP-4 inhibitor. However, the FDA stated that patients should not immediately stop taking Onglyza. Rather, it recommended that patients should consult with their health care provider, especially if they experience severe symptoms, to determine if discontinuing use of this drug would be appropriate.
The safety warning was released after an analysis revealed that severe joint point could be a potential side effect of taking DPP-4 inhibitors. Patients who claimed that they experienced severe joint pain after taking this type of medication developed symptoms anywhere from one day to several years after this drug was initially prescribed.
Once patients stopped taking a DPP-4 inhibitor, most patients found relief from their symptoms in less than a month, and some of these patients experienced serious joint paint once they started taking the same medication or a different type of DPP-4 inhibitor later on.
Onglyza Lawsuit News
- July 2016Onglyza lawsuit filed in U.S. District Court for the Eastern District of Kentucky claims that the plaintiff suffered myocardial infarction after taking the medication to treat type 2 diabetes.
- April 2016FDA issues a safety review stating that the agency had found that type 2 diabetes medicines containing saxagliptin (Onglyza) and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.
- April 2016FDA issues an updated safety communication stating that there have been postmarketing reports of acute pancreatitis taking Onglyza.
- February 2014Folllowing a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure, the FDA issued an announcement stating that the agency had requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure.
- March 2013In an article published in the journal Diabetes, researchers concluded that incretin therapy in humans resulted in a marked expansion of the exocrine and endocrine pancreatic compartments, potentially evolving into cancerous neuroendocrine tumors.
How an Onglyza Lawsuit Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by Onglyza may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.
