Pittsburgh Onglyza Injury Attorneys
According to the Pennsylvania Department of Health, an estimated 872,000 residents in the state including in the greater Pittsburgh area were diagnosed with diabetes in 2008. Additional surveys showed that 13 percent of African Americans and 7 percent of Hispanics, as well as 8 percent of non-Hispanic whites, were affected by diabetes between 2006 and 2008.
The Ohio Department of Health estimates that 10.1 percent of Ohio adults have been diagnosed with diabetes, which adds up to more than 895,000 people. And the Division of Health Promotion and Chronic Disease of West Virginia estimates that 12 percent of the population—about 240,626 people—were diagnosed with diabetes in 2011.
There’s no doubt that diabetes is a serious health issue plaguing millions of Americans, and the Ohio Valley is by no means exempt from the concerns. Doctors continue to look for new medications that can help reduce blood glucose levels while minimizing side effects. It’s concerning, however, to find after the fact that some of these medications may themselves increase the risks of health complications—in ways that patients and doctors were unaware of.
An FDA advisory panel recently suggested that the FDA require manufacturers of Onglyza, a newer type 2 diabetes medication, to add warnings to the label that the drug could increase the risk of heart failure in some patients. This was in response to recent studies that indicate the drug is potentially dangerous for some patients.
Onglyza Linked with Heart Failure
The FDA approved the use of Onglyza (saxagliptin) for the treatment of type 2 diabetes in July 2009. Onglyza belongs to a class of drugs known as “dipeptidyl peptidase-4 (DDP-4) inhibitors,” also called “incretin mimetics.” These drugs block the DDP-4 enzyme, which usually breaks down the incretin hormone called GLP-1. The body releases GLP-1 in response to eating, as it signals the pancreas to make more insulin, which then processes the glucose to keep blood sugar levels steady.
Type 2 diabetes patients, who have high blood glucose levels, either can’t use the insulin their bodies produce effectively, or they don’t produce enough of it to keep blood sugar levels in check. DDP-4 inhibitors, or incretin mimetics, stop DDP-4 from breaking down GLP-1, so that the pancreas keeps producing insulin after a meal. This gives the body more insulin to work with, increasing its ability to process glucose and keep levels within the normal range.
These drugs also help stop the liver from making too much glucose.
When drugs like Onglyza first hit the market, they were advertised as being the latest-greatest options, and sales skyrocketed within just a few years. Later studies, however, raised red flags as to the potential serious side effects associated with these drugs.
FDA Investigates Onglyza and the Risk of Heart Failure
In 2013, the New England Journal of Medicine published a study on Onglyza (saxagliptin) and cardiovascular outcomes in nearly 16,500 patients (referred to as the “SAVOR” study). Researchers gave some patients saxagliptin and others a placebo, and then followed them for about two years. They were looking specifically for events like heart attack, stroke, and death from cardiovascular disease.
Results showed no significant difference between the groups when it came to heart attacks and strokes, but there was a significant difference between those taking the medication and those on placebo as far as how many were hospitalized for heart failure. More specifically, 27 percent more of the study participants who were taking Onglyza were hospitalized than those who were not taking it.
This study raised concerns for the FDA, who initiated further analysis of the results. In February 2014, the FDA issued a drug safety communication stating that they had requested additional clinical trial data from the manufacturers of Onglyza, “to investigate a possible association between the use of the type 2 diabetes drug and heart failure.”
The analysis showed that the FDA’s concerns about heart failure were valid, and also indicated that people taking saxagliptin could be at an increased risk of death from all causes. Considering these results, the FDA called for an advisory panel meeting to more closely examine the safety questions.
The meeting took place on April 14, 2015. The advisory panel examined data from several sources—including from the not-for-profit group Public Citizen.
Public Citizen Suggests FDA Recall Onglyza
Public Citizen expressed their concerns about Onglyza back in 2011, when it published an article in their “Worst Pills Best Pills” newsletter. Public Citizen noted that the drug was too new to be trusted, and that there was already there some evidence of a potential increased risk of heart failure, as well as other potentially serious side effects.
The group stepped forward again in 2014 when their director of health research, Dr. Sydney Wolfe, addressed the FDA advisory panel. Dr. Wolfe stated that the drug had no unique benefits over other type 2 diabetes drugs, yet it did have potentially unique and devastating side effects. He urged the panel to recommend that the drug be withdrawn from the market.
In the end, the advisory panel voted 14-1 to increase warnings on Onglyza and other DDP-4 drugs, to indicate that they may increase the risk of heart failure. The Panel did not recommend any restrictions on the drug’s prescriptions, and overall the Panel agreed that the drug did not increase risk of cardiovascular death, stroke, or heart attack.
Onglyza Linked to Increased Risk of Pancreatic Cancer
Drugs like Onglyza work by acting on the pancreas to increase production of insulin. This has been found to potentially increase the risk of health problems in the pancreas, including inflammation (pancreatitis) and pancreatic cancer.
A 2013 study published in Diabetes examined the effects of drugs like Onglyza on the pancreas. Researchers actually examined the pancreases from organ donors who had type 2 diabetes and had been treated by incretin memetics. They found that those who took the drugs were more likely to have enlarged pancreases, as well as pre-cancerous cells in the pancreas. Researchers also found small tumors that had the potential to become malignant.
As a result of studies like these, the FDA released another safety communication in March 2013. It announced that the FDA was evaluating evidence indicating an increased risk of pancreatitis and pre-cancerous cellular changes in patients with type 2 diabetes who were treated with these drugs. The FDA noted that it hadn’t made any new conclusions about the safety of the drugs, but that it simply wanted to inform the public and healthcare professionals that it was investigating.
Later studies showed conflicting results concerning the drugs’ effects on the pancreas, and the researchers suggested additional trials were necessary to reach more definitive results.
Types of Injuries Associated with Onglyza
According to studies and clinical reports, Onglyza may be associated with the following health effects:
• Heart failure
• Pancreatic cancer
• Thyroid cancer
• Kidney problems
The drugs are also associated with less severe side effects like upper respiratory infections, urinary tract infections, headaches, rashes, and hives.
An Onglyza Lawyer Can Help
Patients who took Onglyza and then suffered heart failure may understandably be upset that the manufacturers, Bristol-Meyers and AstraZeneca, failed to provide adequate warnings about this risk. Though the drug did contain warnings about effects on the pancreas, there were not warnings indicating the seriousness of the potential cardiovascular risks.
Lawsuits have already been filed against these companies because of side effects associated with other type 2 diabetes drugs like Januvia and Byetta. If you or a loved one suffered heart failure or hospitalization for cardiovascular problems because of Onglyza, the Pittsburgh attorneys at Chaffin Luhana LLP may be able to help.
Pharmaceutical companies are responsible for making sure doctors and patients completely understand the risks of taking any particular drug. Those who knowingly or unknowingly conceal certain potential side effects should be held liable for the damages.
At Chaffin Luhana, we understand how the manufacturers of Onglyza may have misled consumers. If you feel you have suffered as a result, call today for a free and confidential case evaluation at 1-888-316-2311. We have offices in Pittsburgh, West Virginia, New York City and our attorneys handle Onglyza case victims nationwide.