What’s the Problem?
In response to the recent problems with Onglyza, the FDA has requested that drugmaker Bristol-Myers Squibb provide data from the SAVOR trial, which found a 27% increased risk of hospitalization for heart failure among patients taking the drug. The findings were reported in August 2013 at the European Society of Cardiology Meeting, and later published in the New England Journal of Medicine.
“Hospitalizations for heart failure are something we need to take seriously,” said Naveed Sattar, MD, PhD, of the University of Glasgow in Scotland. “The findings from SAVOR might be a new signal for heart failure, and we cannot exclude that this may be a class effect.” Sattar also stated that he would be “reluctant to give this (Onglyza) to patients with heart failure at this time.”
FDA said it expects Bristol-Myers Squibb to submit the data for review by March 2014. Additionally, the administration noted that their investigation into Onglyza is part of a broader look at the potential heart risks of all type 2 diabetes drugs, which was prompted by cardiovascular side effects linked to Avandia (rosiglitazone). FDA said patients shouldn’t stop using Onglyza on their own, and should consult their physicians if they have any questions or concerns.
What is Heart Failure?
Heart failure occurs when the heart is unable to pump an adequate supply of blood to meet the body’s needs. In some cases, the heart can’t fill with enough blood. In others, the heart is unable to pump oxygenated (red) blood to the rest of the body with enough force. Some patients have both problems.
Heart Failure Symptoms
Signs and symptoms of heart failure may include:
- Shortness of breath (dyspnea)
- Swelling (edema) in the legs, ankles and feet
- Rapid or irregular heartbeat
- Reduced ability to exercise
- Persistent cough or wheezing
- Increased need to urinate
- Swelling of the abdomen
- Sudden weight gain
- Lack of appetite
- Difficulty concentrating
- Sudden, severe shortness of breath
- Elevated blood pressure
- Chest pain
Heart Failure Stages
- Stage A – Presence of heart failure risk factors without heart disease and no symptoms
- Stage B – Heart disease present without symptoms (structural changes in heart before symptoms occur)
- Stage C – Structural heart disease with symptoms
- Stage D – Presence of advanced heart disease with continued heart failure symptoms requiring aggressive medical therapy
Prompt diagnosis and effective medical treatment can do wonders to help people who have heart failure. Treatment will depend on the type of heart failure and severity of the condition. The goals of treatment include:
- Treating the condition’s underlying cause, such as coronary heart disease, high blood pressure, or type 2 diabetes
- Reducing symptoms
- Stopping the condition from getting worse
- Increasing the patient’s lifespan and overall quality of life
Treatments typically include a combination of lifestyle changes, prescription drugs, and ongoing care. If you have severe heart failure, you also may need medical procedures or surgical intervention.
Kentucky Man Alleges Heart Attack from Onglyza
August 30, 2016 – A man from Kentucky who claims he had a heart attack after using Onglyza to treat his diabetes for just 2 months has filed a lawsuit against the manufacturers. Plaintiff alleges that his doctor would not have prescribed him Onglyza had they been adequately warned of the drug’s health risks, including the potential for heart failure and associated complications.
FDA Updates Onglyza Labels with Heart Failure Warning
April 6, 2016 – Type 2 diabetes drugs containing saxagliptin and alogliptin may increase the risk of heart failure, according to an FDA safety review published today. The agency is adding new warnings to the drug labels about this safety issue.
Woman Sues AstraZeneca, Blames Onglyza for Mother’s Heart Failure Death
October 29, 2015 – A Chicago woman filed a lawsuit today in Clark County Circuit Court alleging that Onglyza caused her mother’s death from heart failure. According to the complaint, Lillie Ree Gibson began taking the medication per her doctor’s orders in 2010, was diagnosed with heart failure in June 2011, and died from the condition on October 31, 2013.
Do I Have an Onglyza Heart Failure Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Onglyza lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
If you or a loved one developed heart failure after taking Onglyza, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.