The popular Type 2 diabetes drug Onglyza may be linked to an increased risk of potentially life-threatening side effects in users, including congestive heart failure, pancreatitis, pancreatic cancer, cardiac arrest and thyroid cancer, according to a growing body of research. This is despite claims by Onglyza makers AstraZeneca and Bristol-Myers Squibb that the prescription drug is a safe and effective means of treating Type 2 diabetes symptoms in adults. If you took Onglyza in the past, and you have since suffered a major adverse medical event, like congestive heart failure, you may be entitled to financial compensation for your injuries and medical expenses. Contact a reputable Onglyza attorney today to discuss filing an Onglyza injury claim against AstraZeneca and Bristol-Myers Squibb.
Patients with chronic medical conditions like Type 2 diabetes expect their prescription drugs to effectively treat their disease without putting them at risk for any additional complications. Unfortunately, research has shown that Onglyza and other DPP-4 inhibitor diabetes drugs may expose users to cardiovascular side effects and other potentially life-threatening injuries. In addition to making lifestyle changes related to diet and exercise, Type 2 diabetes patients who want to avoid taking Onglyza may try alternative treatment methods like:
Onglyza (saxagliptin) belongs to a class of prescription medications called dipeptidyl peptidase 4 (DPP-4) inhibitors, also known as incretin mimetic drugs, which are commonly prescribed in combination with diet and exercise to control high blood sugar in adults with Type 2 diabetes. Approved by the U.S. Food and Drug Administration (FDA) in 2009, Onglyza works by acting on a hormone called GLP-1, which stimulates the growth of cells in the pancreas that produce insulin. Since it first entered the market for consumer use, Onglyza has become a popular diabetes drug, because it can effectively control blood sugar without causing weight gain, like so many other diabetes medications on the market.
Millions of people with Type 2 diabetes have been prescribed DPP-4 inhibitors like Onglyza since the medications first entered the market, and only now are these patients being warned that their diabetes drugs may be exposing them to serious health risks. Among the side effects allegedly associated with Onglyza and other DPP-4 inhibitors are:
When DPP-4 drugs like Onglyza first became available for consumer use, they were “touted as the ‘new darlings of diabetes treatment’ – the biggest breakthrough since the discovery of insulin nearly a hundred years before,” according to British Medical Journal editor Deborah Cohen. However, doctors across the country are now coming forward and voicing their concerns about the potential for Onglyza treatment to cause heart failure, pancreatitis, pancreatic cancer, thyroid cancer and other side effects in users.
Because Onglyza is still a relatively new medication, the potential long-term risks of the diabetes drug are still not known. However, a growing number of studies have linked Onglyza use to a risk of potentially life-threatening injuries, with Onglyza side effect research dating back several years. In a study published in the medical journal Diabetes in March 2013, researchers found evidence of “eccentric” pre-cancerous cell growth in the pancreases of patients taking incretin mimetic drugs, including small benign tumors called adenomas. According to the researchers, “Since the standard of care of a pancreatic neuroendocrine tumor, because of the risk of conversion to malignancy, even if benign, is surgical resection [i.e. removal], patients exposed to incretin therapy would seem to be at increased risk of requiring pancreatic surgery.”
Shortly after this pancreatic cancer study was published, the FDA issued a drug safety communication indicating that the agency would be launching an investigation into the potential risk of pancreatic cancer from Onglyza use. In the years since, researchers have linked Onglyza treatment to other alleged complications, including heart failure, thyroid cancer, pancreatitis and wrongful death. In another study published in the New England Journal of Medicine in April 2015, a report that followed the publication of the SAVOR clinical trial, researchers found that Onglyza and other incretin mimetic drugs increased a patient’s risk of hospitalization for heart failure by 27%.
There are more than 29 million people in the United States who have diabetes, and Type 2 diabetes accounts for approximately 90% to 95% of all diagnosed cases of diabetes among Americans. Many of these diabetes patients are prescribed DPP-4 inhibitor medications like Onglyza, unaware that the prescription drugs may put them at risk for devastating side effects, like heart failure, cardiac arrest, pancreatic cancer, pancreatitis and wrongful death. As more information comes to light about the alleged risk of cardiovascular side effects from Onglyza, Onglyza attorneys across the country are investigating claims on behalf of patients who believe they have been harmed by the Type 2 diabetes medication.
December 2008 – The FDA issues an announcement requiring the makers of new Type 2 diabetes medications to provide evidence that their products are not associated with a significant increase in the risk of adverse cardiovascular events.
June 13, 2011 – A safety communication issued by the FDA indicates that Victoza, a diabetes drug similar to Onglyza, may cause thyroid cancer and acute pancreatitis in patients.
November 2011 – Information about the alleged risk of pancreatitis, a potentially life-threatening condition characterized by inflammation of the pancreas, is added to Onglyza’s warnings and precautions section.
March 14, 2013 – A safety alert is issued by the FDA, indicating that the agency would be evaluating “unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics”
February 11, 2014 – The FDA issues a drug safety communication announcing that it has requested clinical trial data from Onglyza’s manufacturing company, in order to investigate a possible link between the Type 2 diabetes drug and heart failure side effects.
April 13, 2015 – An FDA analysis of clinical trial data warns that Type 2 diabetes patients who use Onglyza may be considerably more likely to develop heart failure and more likely to die. The agency indicates that it will recommend changes to the Onglyza label to warn patients and doctors about this alleged risk.
March 2013 – In a study published in the journal Diabetes, researchers dissected the pancreases of three groups of deceased patients: diabetics who used an incretin mimetic drug, diabetics who used another medication, and non-diabetic patients. According to the report, the incretin mimetic group had 40% more massive pancreases, and researchers also found evidence of “eccentric” precancerous cell growth in this group.
September 2013 – Dr. Anthony DeMaria, editor in chief of the Journal of the American College of Cardiology, advises Type 2 diabetes patients at risk for heart failure to avoid using Onglyza.
April 2015 – The New England Journal of Medicine published a study indicating that incretin mimetic diabetes drugs like Onglyza appear to increase a patient’s risk of hospitalization for heart failure by 27%, according to the findings of the SAVOR clinical trial.
Onglyza has become a best-selling diabetes drug for AstraZeneca and Bristol-Myers Squibb, and the medication is expected to generate $2.47 billion in annual sales for the drug companies in 2018, as the controversial class of DPP-4 inhibitor medications achieve wider use. However, more and more consumers are becoming aware of the alleged link between Onglyza and severe side effects, and future product liability claims filed against the makers of Onglyza will likely allege the following:
Without treatment, Type 2 diabetes can lead to devastating medical complications, like blindness, kidney damage, loss of limbs, nerve problems and problems with sexual function. Unfortunately, the prescription drugs commonly prescribed to treat Type 2 diabetes, like Onglyza and other DPP-4 inhibitors, are believed to pose their own set of serious risks. If you believe you have been adversely affected by cardiovascular side effects of Onglyza, consult a knowledgeable Onglyza lawyer today for legal help. You may have grounds to file an Onglyza lawsuit against AstraZeneca and Bristol-Myers Squibb, in order to seek fair and timely reimbursement for your alleged Onglyza-related injuries.