Dangerous Complications from Onglyza®
Many type 2 diabetes patients have been prescribed Onglyza® to help maintain blood glucose levels within a healthy range, but there have been thousands of adverse events reported to the U.S Food and Drug Administration (FDA). Complications from Onglyza® may include heart failure, pancreatitis, and pancreatic cancer, and have prompted many patients to file claims against the manufacturer.
If you or a family member experienced an adverse health event while taking Onglyza®, you may be entitled to significant compensation for your injuries. Our legal team is currently offering complimentary case evaluations to victims of pharmaceutical negligence.
About Prescription Onglyza®
Onglyza® is a dipeptidyl peptidase-4 (DPP-4) inhibitor designed to help patients control their blood sugar levels. This type of medication works by stimulating the pancreas to secrete more insulin, which helps to reduce any spikes in blood sugar following meals. It also effectively inhibits the liver from producing an excessive amount of sugar, reducing the total amount that is released overnight and between meals.
The positive aspects about Onglyza® have been overshadowed by reports of serious complications in patients, as well as medical studies that have linked the drug to adverse outcomes.
Onglyza® was introduced to the market in 2009 as one of several drugs that use incretin-based therapy to treat patients. The manufacturer, AstraZeneca, promotes Onglyza® to patients as a way to help lower A1C test results, which would indicate successful blood sugar management. Taken orally once a day, Onglyza® offers patients a method of maintaining improved health and avoiding common, long-term diabetic complications.
This medication has been a popular choice among patients because it is considered effective without promoting weight gain, a common side effect among diabetes drugs. Additionally, AstraZeneca promoted Onglyza® heavily to physicians, spending $3.43 million on U.S. medical journal advertising in 2014. Global sales of the drug reached $786 million in 2015, and are projected to reach nearly $2.5 billion by 2018.
The positive aspects about Onglyza® have been overshadowed by reports of serious complications in patients, as well as medical studies that have linked the drug to adverse outcomes, including loss of life. Complications have been associated with saxagliptin, the active ingredient in Onglyza® and its sister drug, Kombiglyze XR®, an extended release tablet that combines the drug with metformin.
Heart failure is often thought to mean heart attack, but can be distinguished by the underlying cause and onset of the condition. A heart attack typically occurs suddenly, caused by a stoppage in blood flow from a clot surrounded by plaque build-up. Heart failure is more gradual, occurring as the cardiac muscle becomes weakened and loses the ability to pump blood effectively. Medical intervention, including surgery and other treatments, can be effective for some patients, but many cases ultimately prove fatal.
In April 2016, the FDA ordered the warning labels to be updated on Onglyza® packaging to advise patients about the risk of heart failure. Clinical studies reviewed by the FDA linked saxagliptin to heart complications, including findings of a 27 percent increase in hospitalization compared to patients taking a different medication.
The SAVOR study (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) was initially reported in 2013. In a randomized, double-blind, placebo-controlled study of over 16,000 patients, researchers found increased cases of heart failure and other major cardiac events, as well as “a potential increase in all-cause mortality with saxagliptin.” The study also found that 5.1 percent of patients using saxagliptin died compared to 4.6 percent of patients taking the placebo.
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In the fall of 2015, a lawsuit was filed alleging that Onglyza® lead to the death of a female patient. The case was filed by a Chicago woman who accused AstraZeneca of wrongful death after losing her mother to heart failure.
The FDA has also reported an association between patients undergoing incretin-based therapies and cases of acute pancreatitis. The SAVOR study found an increased incidence of pancreatitis in over 16,000 patients studied compared to those taking other medications. The FDA is currently studying the potential links between saxagliptin and other drugs in the incretin mimetic class with pancreatitis and pancreatic cancer.
The pancreas is a large gland located behind the stomach, which aids digestion and control of food energy in the body. Pancreatitis is an inflammation of the pancreas, a condition that can be acute or chronic. Acute cases range from minor to life-threatening; most patients will recover, but repeated episodes of acute pancreatitis can lead to chronic disease. Chronic pancreatitis can be painful and disabling, and it is considered a risk factor for pancreatic cancer.
Pancreatic cancer is known to be one of the most potentially deadly types of malignancies. Depending upon the type and stage, recommended treatments may include surgery, chemotherapy, and radiation, but the prognosis for long-term survival is often not favorable.
The study found the formation of abnormal beta cells in the pancreas as well as small growths that could become malignant.
DPP-4 inhibitors specifically target beta cells in the pancreas, which produce insulin, and a 2013 study raised fears of a potential connection between these medications and pancreatic cancer. The study found the formation of abnormal beta cells in the pancreas as well as small growths that could become malignant.
The SAVOR study also found increased “adverse events of special interest” among patients taking saxagliptin rather than a placebo. These adverse events included decreased lymphocyte count, renal abnormalities, and infections.
In addition, severe and persistent joint pain has been reported by Onglyza® patients. The FDA released an August 2015, safety alert after receiving many reports of severe joint pain in patients on DPP-4 inhibitor medications. Severe joint pain can be disabling, and has been found to persist for days to weeks after stopping the drug.
If you fear you may be suffering a serious complication and are still taking Onglyza® or Kombiglyze XR®, AstraZeneca advises you stop taking the medication and speak to your doctor immediately.
Legal Remedies for Patients and Families
Onglyza® and Kombiglyze XR® are just two of many type 2 diabetes medications that have been connected to serious and deadly complications, including cancer, cardiac events, kidney failure, and more. Civil lawsuits have sought and attained significant levels of compensation for victims and their families, including billions of dollars in settlements and jury verdicts for patients who took Actos® or Avandia. Many lawsuits are still pending for these medications, as well as thousands of claims resulting from complications of Invokana®, Invokamet® Januvia®, Janumet ®, Byetta® and Bydureon®.
Pharmaceutical product liability lawsuits frequently involved a multitude of plaintiffs with similar claims. In these cases, a class action may form or individual cases may be transferred to multidistrict litigation (MDL). It is often preferable for plaintiffs to file an individual lawsuit and participate in MDL. MDL is an efficient way to handle legal discovery, but still allows plaintiffs to receive individually tailored settlements or awards. Many Onglyza® claims have recently been consolidated in MDL.
Our legal team is highly experienced in personal injury, product liability, and wrongful death law, and is dedicated to maximizing compensation for injured victims of corporate wrongdoing. We believe pharmaceutical corporations should be held strictly liable for losses sustained by patients who trust in the safety of their products.
Speak with an Attorney
You are encouraged to reach out to our legal team if you or a loved one have suffered from an Onglyza® complication or adverse event related to any drug. Please schedule a complimentary case evaluation with an experienced pharmaceutical attorney.