Onglyza has been linked to an increased risk of heart failure and even death, and Lawsuits are now being filed against the drug’s manufacturer (AstraZeneca) on behalf of those injured.
If you or a loved one has taken the drug Onglyza and have experienced heart failure, you may be entitled to compensation for your pain, suffering and medical costs.
Onglyza Lawsuit Information
AstraZeneca won the approval of the US Food and Drug Administration (FDA) for Onglyza (Saxagliptin) as a treatment for type 2 diabetes in 2009. But recently, the drug has been associated with an increased rate of death due to heart failure. Onglyza belongs to a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. These drugs can affect the body’s production of glucose as a form of diabetes management.
Unfortunately, along with improved glycemic control, Onglyza also carries a higher risk of heart failure. A clinical trial commissioned by the manufacturer and a study involving more than 16,000 patients linked Onglyza to this risk. According the study, which was published in the New England Journal of Medicine, patients who took Onglyza were at a greater risk of hospitalization due to heart failure along with an increased risk for all causes of death.
Pharmaceutical manufacturers such as AstraZeneca have a legal duty to warn the public of any risks associated with the use of their medical products. Experienced pharmaceutical attorneys can perform a no-cost, no obligation evaluation of your case to determine your legal options. You will incur no legal fees unless you are awarded a settlement or judgment. The law limits the amount of time you have to file a claim, so contact us now to discuss your case.
The FDA Requires Manufacturers to Provide Evidence Of Drug Safety
The FDA began to require drug manufacturers to provide evidence that their type 2 diabetes drugs don’t increase the patient’s chance of developing cardiovascular disease.
Onglyza won FDA approval
AstraZeneca won the approval of the US Food and Drug Administration (FDA) for Onglyza (Saxagliptin) as a treatment for type 2 diabetes.
Savor Study Suggests Higher Risk of Heart Disease
A study referred to as SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus – Thrombolysis in Myocardial Infarction 53) indicates that those who already had cardiovascular disease or an increased risk of cardiovascular disease experienced an increased risk of hospitalization due to heart failure.
FDA Reviews The Savor Findings
An FDA advisory panel is convened to discuss the safety of Onglyza and a similar drug.
The FDA analysis showed the heart failure risk to be valid and also identified a possible increased risk of death from all causes. The FDA also announces that as a result of its findings, it will require new warnings to the labels on all products containing Saxagliptin, the active ingredient in Onglyza.
A Lawsuit is Filed Against AstraZeneca
A lawsuit is filed in Cook County, IL. by Rochelle Gibson and against AstraZeneca, maker of Onglyza, alleging that the drug is linked to the death of her mother Lillie Ree Gibson.
FDA Publishes a New Safety Announcement Regarding Saxagliptin
The FDA recommends that healthcare professionals discontinue medications containing Saxagliptin for patients who develop heart failure.
Onglyza and Heart failure
Onglyza, manufactured by AstraZeneca, belongs to a class of drugs that stimulate the pancreas to create more insulin after eating. According to an FDA review of data on the drug, patients who were given Onglyza appeared to have almost a 30% increase in hospitalization due to heart failure and a higher risk of dying from all causes.
The analysis of the drug did not indicate the cause of the overall trend and also note that individual patients often had morbid events days or weeks before they died. Still the FDA wrote that it was not reassured and that it did not view “this pattern of variable causes as evidence that the mortality signal was due to chance”.
Onglyza and Heart Failure Symptoms Bullets/List:
Patients on Onglyza should contact their doctor if they develop any of the following symptoms of heart failure:
- Shortness of breath while performing usual activities
- Difficulty breathing when lying down
- Unexplained Fatigue
- Unexplained Weight gain
- Swelling of the ankles, feet, legs or stomach
Let’s Find the Right Attorney
Drug manufacturers have a legal duty to warn doctors and their patients of the risks associated with their prescription drugs. When they do not, they may be held liable to you for any harm you suffer as a result of using their products.
Quality lawyers have recovered millions of dollars for victims and the families of those who have suffered injuries or lost their lives due to the negligence of big pharmaceutical companies that put profits over the safety of patients.
To learn how easy it is to submit your claim, fill out our law firm’s form or call today before it’s too late to file a lawsuit and hold those responsible accountable for your injuries and losses.