
Many people take drugs to control their type-2 diabetes. However, some patients are concerned about the adverse effects of Ongylza.
Type-2 Diabetes is a serious illness affecting 29 million people in the U.S. alone. Of those 29 million, roughly 7.25 million individuals remain undiagnosed and unaware of their condition.
For known type-2 Diabetes cases, physicians have sought out medicines that will help control blood sugar levels while not putting undo strain on the heart muscle and other major organs.
The adverse effects of Onglyza and other medications containing saxagliptin and alogliptin have recently been of concern for patients and the medical community alike.
The Adverse Effects of Onglyza and Related Diabetic Drugs
On April 5, 2016, the Food and Drug Administration’s (FDA) safety review board released information indicating that diabetic drugs containing saxagliptin and alogliptin have the potential to increase the risk of experiencing heart failure during drug treatment.
Heart failure is term used to describe a situation in which the cardiac muscle weakens to such a degree as to be unable to adequately pump oxygenated blood to the body’s tissues. Sometimes heart failure can be treated, but often it becomes so critical as to lead to death.
Other diabetic drugs that have adverse effects similar to the adverse effects of Onglyza – just one of the medications containing saxagliptin or alogliptin – are as follows:
- Kombiglyze XR
- Nesina
- Kazano
- Oseni
FDA Adds New Label Warnings About the Adverse Effects of Onglyza
The FDA approved Onglyza and Kombiglyze XR, both saxagliptin-containing pharmaceutical products, for the market in July 2009 and November 2011, respectively. Bristol Myers-Squibb and AstraZeneca collaborated jointly on their development.
Two years later, The New England Journal of Medicine published results of a study known as SAVOR. In this study, type-2 diabetes patients were treated with several current medications to determine which drugs were the most effective.
After reviewing records of medication reactions from the 163,492 participants, it was concluded that there was just under a 30% increase in heart failure risk among diabetics taking Onglyza and related treatment drugs. The risk was further exacerbated by a pre-existing diagnosis of heart or kidney disease.
The FDA opened an investigation into diabetic drugs containing saxagliptin and alogliptin in early 2014, shortly after release of the SAVOR study. This investigation concluded with the FDA determining that additional warnings were needed on the drug’s label.
The precautions listed the possible symptoms of heart failure as being:
- Swelling in the ankles, feet, legs, or stomach
- Shortness of breath during routine activities (in the absence of exercise)
- Unusual weakness, fatigue, exhaustion
- Trouble getting a breath while lying fully horizontal
The warnings encouraged patients to seek immediate medical treatment if they experienced any of the above symptoms while taking Onglyza or a related drug.
The new label also addressed health care professionals by encouraging them to discontinue this drug in patients experiencing symptoms of heart failure. Re-evaluation for other potential blood-sugar controlling treatment regimens in combination with diet and exercise were further encouraged.
In general, Onglyza lawsuits and Kombiglyze XR lawsuits are filed individually by each plaintiff and are not class actions.
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