If you are considering filing a San Diego Onglyza lawsuit, Class Action Lawyer Coalition is more than happy to offer you a free consultation and discuss your legal options.
AstraZeneca is the business that makes Onglyza (saxagliptin), an FDA-approved medication meant to treat type 2 diabetes.
The FDA (Food and Drug Administration) says that Onglyza users can have a substantial risk of developing congestive heart failure. In a recent FDA advisory committee meeting, it was passed that the labeling used on Onglyza be updated together with clear warnings about the chance of developing heart failure. It was a warning which was not contained the drug’s labels previously.
If you or a loved one suffered heart failure or other complications after taking Onglyza, or your loved one died, you may have grounds to sue the manufactures of Onglyza. Understand that AstraZeneca is a massive company and has a team of trusted attorneys representing its own interests once the company is slapped with lawsuits.
What Is Onglyza?
Onglyza got the nod from the FDA in July 2009 as a medication that may be used in the treatment of type 2 diabetes. As a DDP-4 (dipeptidyl peptidase-4) inhibitor, a sort of drug also called an incretin mimetic, Onglyza has components that stimulate the pancreas to increase insulin production following the user eats a meal. Januvia is another medication, like Onglyza, that’s used as a treatment for type 2 diabetes. With the rise in insulin levels, the body is able to process glucose (sugars) and ensure they are kept within the normal range.
FDA approved using Onglyza after reviewing the outcomes of eight clinical trials done by manufacturers AstraZeneca Pharmaceuticals LP. The trial included research meant to demonstrate that Onglyza was not associated with any significant risk of cardiovascular disease.
However, recent analyses of the outcomes of a clinical trial on Onglyza done by FDA experts discovered concerning data that linked the medicine to heart disease risks. The trial (the SAVOR study), which was sponsored by AstraZeneca, had over 16,000 participants. The participants either had a background of cardiovascular disease or were prone to developing it. Some of them took Onglyza, and others received Placebo.
The researchers monitored the participants’ health progress for about two years. The results showed a number of the patients who utilized Onglyza were hospitalized for heart failure compared to those who obtained Placebo. The Onglyza users have a 27% increased risk of cardiovascular disease, heart failure, or related complications.
The outcomes necessitated more stringent scrutiny on the medication by the FDA.
Heart Failure and Onglyza
Cardiovascular disease is one of the top health problems that lead to the passing of both men and women in America. The CDC claims there are nearly 610,000 deaths attributed to cardiovascular disease yearly. Should you do the math, that amounts to 1 in every 4 deaths in the USA annually.
Heart failure happens when the heart fails to pump as much blood as is required throughout the entire body. It’s a sort of cardiovascular disease in which the body receives an insufficient supply of blood. Thus, less oxygen to its organs, thereby crippling their collective purpose. If not treated, heart failure grows and leads to deadly health issues with fatal consequences.
For people that have type 2 diabetes and are utilizing Onglyza, the connection between their health issues and the drug is alarming. The FDA began an investigation process into the drug and how it increases the risk of heart failure; that is after increased concerns across the United States. The investigation found stressing issues that resulted in additional warnings of heart failure risk linked with the use of Onglyza in addition to Kombiglyze XR.
Cancer and Onglyza
Onglyza has been linked to cancer, including:
Because of how Onglyza stimulates the pancreas to release more insulin, that is why the medication has been associated with the consumers facing a potential increase in the chance of pancreatitis and pancreatic cancer.
A study was performed in 2013 that focused on how DDP-4 inhibitors affected the pancreas discovered that participants who had type 2 diabetes and have been utilizing Onglyza have a higher probability of having an enlarged pancreas. They also have an increased risk of getting precancerous cellular changes in their own pancreas, suggesting a significant probability of developing pancreatic cancer. According to the research, it was also found that tumors (precancerous growths) are prone to require surgical interventions also that the patients using drugs such as Onglyza showed a greater chance of desire pancreatic surgery.
The FDA communicated another medication safety awake in March of 2013, saying it was examining findings of a study that suggested the significant likelihood of pancreatitis and precancerous cellular changes in people who were utilizing incretin mimetic to treat their type 2 diabetes.
A later study conducted in 2014 where researchers analyzed data from a major clinical trial on Onglyza discovered no signs of pancreatic cancer or the risk of pancreatitis. They, however, recommended further research to make certain they get conclusive findings that suggest pancreatic safety regarding the use of incretin mimetics.
Victoza, an incretin mimetic that shares similarities with Onglyza, was discovered to induce malignant thyroid gland in addition to severe pancreatitis in rodents that were given the drug in”clinically relevant” dosages. Back in June 2011, the FDA issued a security warning stating the probability of thyroid cancer from the use of Victoza. Furthermore, the FDA has received many reports of people diagnosed with thyroid cancer following having prescribed incretin mimetics such as Byetta (exenatide) and Januvia (sitagliptin).
Has There Been a Recall of Onglyza or Other Incretin Mimetics?
No recall was announced, and it is unlikely for one to be issued any time soon. However, the fact of coronary failure, cancers, and other possibly deadly health issues can’t be overlooked or swept under the carpet.
Vioxx was a medication that was recalled due to causing strokes and heart attacks, among other cardiovascular problems. The same fate is expected of Onglyza and other incretin mimetics found to increase the risk of heart failure.
But it appears that the only significant step taken for these drugs with such serious side effects would be to require that the manufacturers incorporate extra safety warnings in their products’ labels.
Are There Any Class Action Lawsuits Involving Kombiglyze, Onglyza, or Any Incretin Mimetic?
Drug injury lawsuits are rarely filed as”class action,” whereby a few plaintiffs will signify the others that have cases against a drug company. Alternatively, you will file this kind of claim separately.
In January 2018, the U.S Judicial Panel on Multidistrict Litigation ordered the”consolidation” of present lawsuits filed against Kombiglyze and Onglyza from the U.S District Court for the Eastern District of Kentucky. From May 2018, there were approximately 100 of these cases that shaped consolidated litigation called the MDL 2809.
What Are Some Of The Injuries Associated With Onglyza?
Onglyza is linked to a number of complications, such as:
- Heart failure
- Kidney problems
- Thyroid cancer
- Pancreatic cancer
Aside from the severe side effects Mentioned Previously, Onglyza is also linked to the next mild to moderate health risk:
- Urinary tract infections
- Rashes and hives
- Upper respiratory tract infections
Can a Lawsuit Against Onglyza Be Filed Despite No FDA Recall?
The FDA called for clear warnings about the risk of heart failure from Onglyza. This has many asking why the warning was never included when the product was released ten years ago. And when this is the current state of affairs, then it means many of the patients who took Onglyza within the past decade were oblivious of the possible health risk.
The law stipulates that drug makers should be accountable for ensuring the public is duly informed before they release a product into the market. It makes them accountable for any negative outcomes and functions to safeguard the general public from unnecessary health problems.
And in accordance with the law, patients that took Onglyza and suffered heart failure can seek reimbursement since the pharmaceutical companies making the medication fail to give the public adequate security warnings about such a probable outcome.
Choose Experienced Attorneys for Your San Diego Onglyza Lawsuit
If you or a loved one used Onglyza and endured heart failure or hospitalization, or your relative died because of using the drug, our committed class action lawyers are here to help. We have represented different individuals from across the nation. Therefore, we’ve got a profound understanding of how pharmaceuticals like Bristol Meyers Squibb and AstraZeneca are anticipated, by law, to ensure doctors and patients are fully aware of the risk associated with the use of their drugs. Failure to do so means that these manufacturers are liable for damages that people using their medications suffer.
We have dealt with cases related to Onglyza and possess a profound comprehension of its flaws. Therefore, we are your best option if you would like to face the makers of Onglyza and triumph. Contact our law offices now at 855-938-0980 for a free consultation, have your case reviewed, and learn more about your rights.