Onglyza (saxagliptin) is a product by AstraZeneca. It is an FDA-approved drug for the treatment of Type 2 diabetes. The drugs is part of a new class of diabetic drugs known as DPP-4 inhibitors and should lower glucose levels and diabetic difficulties in adults with Type 2 diabetes. Patients with type 2 diabetes know that they have an enhanced risk for cardiovascular problems. According to the American Heart Association, diabetes brings the risk of heart failures because people with this illness often have complications such as high blood pressure, cholesterol, and triglycerides, obesity, and lead a sedentary lifestyle. If blood sugar levels are not controlled, the risk is even higher. However, Onglyza has some potentially dangerous side effects of its own.
According to the Food and Drug Administration (FDA), this drug may cause a higher risk of congestive heart failure. FDA consulting committee recommended that Onglyza labeling must be updated because the users deserve to be warned against heart failure risk.
So far, a warning was not included on the medication’s label.
Potential Side Effects of Onglyza
Onglyza medicine has been linked to a potential risk of pancreatitis, pancreatic cancer, heart failure, and thyroid cancer. The side effects of this drug may even be fatal.
The patient may have hypersensitivity reactions such as exfoliative skin conditions, angioedema, and anaphylaxis.
Here are some of the most severe allergic reactions that can manifest as side effects of Onglyza:
- Swelling of the face, lips, or throat
- Problems with swallowing or breathing
- Swelling of the skin
- Hives, itching, fash flaking, or peeling
- Low blood sugar (hypoglycemia)
Low blood sugar (hypoglycemia) may become worse in people who already take another medication to regulate their blood sugar levels.
Should you be concerned if you use Onglyza?
Type 2 diabetes patients who take Onglyza have a higher risk for heart failure. Onglyza users are at risk of death as well.
These risks are based on a study published in 2013 in the New England Journal of Medicine (NEJM). The study found that saxagliptin raises the rate of patient hospitalization for heart failure for 27%. The study found that saxagliptin users had increased risk for all-cause mortality.
Based on the NEJM study findings, the FDA had a meeting of its Endocrinologic and Metabolic Drugs Advisory Committee in 2015. Almost all committee panelists voted for an updated Onglyza label that would warn the patients about the risk of heart failure. One of the panelists proposed that the drug should be withdrawn from the American market.
Why did the original Onglyza label not contain warnings about potential heart failure?
The FDA in 2008 announced new recommendations on evaluating the risks of new Type 2 diabetes drugs. They stated that companies must do a thorough examination of their drugs’ cardiovascular risks while they still develop the drug.
Onglyza reached the statistical criteria for cardiovascular events (heart attacks) provided by the 2008 FDA Guidance.
The FDA investigated the drug’s sufficiency of studies used to meet these criteria and was not convinced of the drug’s cardiovascular safety.
These same limitations provoked the FDA to require more rigorous post-approval Onglyza testing.
Lawsuits for Side Effects of Onglyza
There are thousands of pending Onglyza and similar lawsuits and wrongful death claims alleging that this drug was the main reason for the side effects or death of the patient that was taking it. Onglyza still has strong sales, and the manufacturer still hasn’t included any warnings about the potential risks of heart failures and death. Hundreds of people who are taking Onglyza and families who have lost a loved one because of this drug are filing lawsuits against the company, claiming that they were never warned about the potential risks and side effects of Onglyza.
Patients who take this drug are literally holding a ticking bomb; although it should help them with their diabetes, this drug is causing some other severe health damages and puts them at risk of sudden death.
Now that studies show that Onglyza is a risky drug, you can file a lawsuit against the company.
If your health was damaged or you have lost a loved one because of complications of this drug, you have the right to seek justice. You can file a lawsuit and seek compensation claim for your medical expenses for the wrongful death of your loved one.
Our law office handles mass tort cases, call today and let our team of attorneys help you with your Onglyza case. You are not alone, and we know how harsh it is to seek justice when you are facing such a harsh period in your life.
Schedule your consultation today.