If you, loved one, or a friend are looking into filing claims against the diabetes drug Onglyza (saxagliptin) for causing health complications that include heart failure or death, then Dalimonte Rueb Stoller Stoller is more than happy to offer you the legal assistance needs for your case.
AstraZeneca is the company that makes Onglyza, an FDA-approved drug meant to treat type 2 diabetes. Onglyza is a DPP-4 inhibitor, the kind of medications designed to lower glucose levels and inhibit diabetic complications in adults that have type 2 diabetes.
The FDA (Food and Drug Administration) says that Onglyza users can have a significant risk of developing congestive heart failure. In a recent FDA advisory committee meeting, it was passed that the labeling used on Onglyza be updated with clear warnings about the risk of developing heart failure. It was a warning that was not included the drug’s labels previously.
If you, loved one, or relative took Onglyza and suffered heart failure, or your loved one died, you might have grounds for asking for compensation against the manufactures of Onglyza. Understand that AstraZeneca is a huge company and has a team of trusted Mass Tort lawyers representing its interests when the company is slapped with lawsuits.
Get in touch with Dalimonte Rueb Stoller Stoller for a free consultation, case review, and to know more about your rights.
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What Is Onglyza?
Onglyza got the nod from the FDA in July 2009 as medication that can be used to treat type 2 diabetes. As a DDP-4 (dipeptidyl peptidase-4) inhibitor, a type of drug also known as an incretin mimetic, Onglyza has elements that stimulate the pancreas to increase insulin production after the user eats a meal. Januvia is another drug, like Onglyza, that is used to treat type 2 diabetes. With the increase in insulin levels, the body can process glucose (sugars) and ensure they are maintained within the normal range.
FDA approved the use of Onglyza after reviewing the results of eight clinical trials done by manufacturers AstraZeneca Pharmaceuticals LP. and Bristol-Meyers Squibb Co. The trial included safety research meant to prove that Onglyza was not associated with any significant risk of cardiovascular complications.
However, recent analyses of the results of a clinical trial on Onglyza done by FDA experts discovered that concerning issues that linked the medication to heart disease risks. The trial (the SAVOR study), which was sponsored by AstraZeneca, had more than 16,000 participants. The participants either had a history or prone to developing cardiovascular disease. Some of them were given Onglyza, and others received Placebo.
The researchers monitored the participants’ health progress for about two years. The results showed many of the patients that used Onglyza were hospitalized for heart failure than those who got Placebo. The Onglyza users have a 27% increased risk of heart disease, heart failure, or related complications.
The results necessitated more stringent scrutiny on the drug by the FDA.
Why And How Is Onglyza Linked To Heart Failure?
Cardiovascular disease is one of the leading health problems that lead to the death of both men and women in America. The CDC says that there are nearly 610,000 fatalities attributed to heart disease annually. If you do the math, that amounts to 1 in every 4 deaths in the United States each year.
Heart failure occurs when the heart fails to pump as much blood as is needed throughout the body. It is a type of cardiovascular disease where the body gets an inadequate supply of blood. Therefore, less oxygen to its organs, thereby crippling their collective function. When not treated, heart failure progresses and leads to deadly health complications with fatal consequences.
For people that have type 2 diabetes and are using Onglyza, the link between their health issues and the medication is alarming. The FDA started an investigation process into the drug and how it increases the risk of heart failure; this is after grown concerns across the United States. The investigation unearthed worrying issues that led to additional warnings of heart failure risk linked with the use of Onglyza as well as Kombiglyze XR.
Is There A Link Between Onglyza And Pancreatic Cancer?
Because of how Onglyza stimulates the pancreas to release more insulin, that is why the medication has been linked to the users facing a potential increase in the risk of pancreatitis and pancreatic cancer.
A study was done in 2013 that focused on how DDP-4 inhibitors affected the pancreas found that participants who had type 2 diabetes and were using Onglyza have a higher chance of having an enlarged pancreas. They also have an increased risk of having precancerous cellular changes in their pancreas, suggesting a significant possibility of developing pancreatic cancer. According to the research, it was also discovered that tumors (precancerous growths) are highly likely to require surgical interventions and that the patients using drugs such as Onglyza showed a higher risk of need pancreatic surgery.
The FDA communicated another drug safety alert in March of 2013, saying it was examining findings of a research that suggested the significant probability of pancreatitis and precancerous cellular changes people that were using incretin mimetic to treat their type 2 diabetes. Among the drugs listed as incretin mimetics were Nesina, Januvia, Onglyza, and Byetta.
A later study conducted in 2014 in which researchers analyzed data from a major clinical trial on Onglyza found no signs of pancreatic cancer or the risk of pancreatitis. They, however, recommended further research to ensure they get conclusive findings that suggest pancreatic safety regarding the use of incretin mimetics.
Is Onglyza Linked To Thyroid Cancer?
Victoza, an incretin mimetic that shares similarities with Onglyza, was found to cause malignant thyroid cancer as well as acute pancreatitis in rodents that were given the drug in “clinically relevant” dosages. In June 2011, the FDA issued a safety warning stating the risk of thyroid cancer from the use of Victoza. Furthermore, the FDA has received many reports of people diagnosed with thyroid cancer after using prescribed incretin mimetics such as Byetta (exenatide) and Januvia (sitagliptin).
Has There Been A Recall Of Onglyza Or Other Incretin Mimetics?
No recall has been announced, and it is unlikely for one to be issued any time soon. The recalls seem unforthcoming, yet the reality of heart failure, cancers, and other potentially fatal health issues cannot be overlooked or swept under the rug. Vioxx was a medication that was recalled due to causing strokes and heart attacks, among other cardiovascular concerns. The same fate is expected of Onglyza and other incretin mimetics found to increase the risk of heart failure. However, it seems that the only significant measure taken for these medications with such severe side effects is to demand that the manufacturers include additional safety warnings on their products’ labels. You may come across a “black box” warning on the top of the drug’s labeling.
Are There Any Ongoing Class Action Lawsuits Involving Kombiglyze, Onglyza Or Any Other Incretin Mimetic?
Drug injury lawsuits are rarely filed as “class action,” whereby a few plaintiffs will represent the others that have cases against a drug company. Instead, you will fill such a matter individually.
In January 2018, the U.S Judicial Panel on Multidistrict Litigation ordered the “consolidation” of existing lawsuits filed against Kombiglyze and Onglyza in the U.S District Court for the Eastern District of Kentucky. By May 2018, there were around 100 of these cases that formed consolidated litigation called the MDL 2809. Other lawsuits are still pending the California State Court.
What Are Some Of The Injuries Associated With Onglyza?
Some of the most notable adverse health issues associated with the use of Onglyza include:
- Heart failure
- Kidney problems
- Thyroid cancer
- Pancreatic cancer
Aside from the severe side effects mentioned above, Onglyza is also linked to the following mild to moderate health risk:
- Urinary tract infections
- Rashes and hives
- Upper respiratory tract infections
Can Lawsuit Against Onglyza Be Filed Despite No FDA Recall?
The FDA panel recommends the inclusion of clear warnings about the increased risk of heart failure on the labels of Onglyza. But this directive has many asking why the warning was never included when the product was released ten years ago.
And if this is the current state of affairs, then it means many of the patients that took Onglyza over the past decade were unaware of the potential health risk. They, therefore, might have suffered serious side effects, not knowing the cause.
The law stipulates that drug manufacturers should be responsible for ensuring the public is duly informed before they release a product into the market. It makes them accountable for any adverse outcomes and serves to protect the public from unnecessary health problems.
And as per the law, patients that took Onglyza and suffered heart failure can seek compensation because the pharmaceutical companies making the drug fail to provide the public with adequate safety warnings about such a likely outcome.
Get Legal Help From An Onglyza Attorney At Dalimonte Rueb Stoller Stoller
If you or a loved one used Onglyza and suffered heart failure, hospitalization, or your relative died due to using the drug, the dedicated class action attorneys at Dalimonte Rueb Stoller Stoller is here to help. We have represented different people from across the country. Therefore, we have a deep understanding o how pharmaceuticals such as Bristol Meyers Squibb and AstraZeneca are expected, by law, to ensure doctors and patients are fully aware of the risk associated with the use of their drugs. Failure to do this means that these manufacturers are liable for damages that people who use their medications suffer.
At Dalimonte Rueb Stoller Stoller, we have dealt with cases related to Onglyza and have a deep understanding of its flaws. Therefore, we are your best bet if you want to face the makers of Onglyza and win. Contact our law offices today at (833) 44-DRLAW a free consultation, case review, and learn more about your rights.