FDA Onglyza Warning
Full Regulatory and FDA Onglyza Warning Information
The risk of heart failure from Onglyza has been the subject of an ongoing FDA investigation. In April of 2015, the FDA convened a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to examine the link between heart failure and Onglyza. The FDA Onglyza heart failure warning, released in April of 2016, cautions patients and doctors of the heightened risk of heart disease from taking Onglyza. This page contains full information on the FDA Onglyza warning, including signs and symptoms of Onglyza heart failure and recommendations to patients from the FDA Onglyza warning.
FDA Heart Failure Warning for Onglyza
On April 5, 2016, the first official FDA Onglyza heart attack warning was issued, entitled “FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin”. Saxagliptin is the active ingredient in Onglyza.
The FDA Onglyza warning announced the addition of a heart disease and heart failure warning to the drug’s label. According to the warning, following a safety review of DPP-4 inhibitor drugs, the FDA has determined Onglyza and other similar diabetes drugs can increase the risk of heart attack:
A U.S. Food and Drug Administration (FDA) safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. Heart failure can result in the heart not being able to pump enough blood to meet the body’s needs. As a result, we are adding new warnings to the drug labels about this safety issue.
Heart failure, according to the Onglyza FDA warning, can lead to a circumstance where the heart is incapable of pumping adequate blood for the body. Heart failure can lead to worse conditions, such as heart disease, heart attack kidney damage or kidney failure, heart valve problems, heart rhythm problems, and liver damage. Heart failure is a life-threatening condition that may require hospitalization. Some heart failure patients require a heart transplant or the use of a ventricular assistance device. Patients taking Onglyza have a 1.27 times higher rate of being hospitalized for heart failure than other diabetics not taking the drug.
FDA Onglyza Warning – Heart Failure Symptoms
The FDA Onglyza heart attack warning recommends that patients experiencing symptoms of heart failure seek medical help immediately. Symptoms of Onglyza heart disease include:
- shortness of breath, trouble breathing while lying down
- tiredness, fatigue, weakness
- heart palpitations, faster heartbeat than normal
- dizziness, faintness, lightheadedness
- weight gain with swelling in the ankles, feet, legs, or stomach
Any patient taking Onglyza who experiences these or other unusual symptoms should contact their doctor to be seen immediately. The FDA Onglyza warning recommends that health care providers consider an alternate treatment if a patient has developed heart failure while taking Onglyza, due to the risk of serious complications resulting from heart disease such as heart attack.
FDA Onglyza Safety Investigation
Onglyza has been the subject of an ongoing safety investigation by the U.S. Food and Drug Administration. In April of 2015, a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee was held to closely examine the risks posed by Onglyza and to make recommendations for regulatory action. Specifically, the group of federal regulators, medical experts, and pharmaceutical representatives examined the danger of heart failure from Onglyza.
After examining the results of the SAVOR-TIMI study (published in the New England Journal of Medicine in 2013) which stated Onglyza increases the rate of heart failure in diabetics taking the drug, 14 of the 15 member advisory team voted to add a heart failure warning to the Onglyza label. One panel member voted to recommend the drug be withdrawn from the U.S. market based on its tendency to increase rates of heart problems. The panel determined that more information was required in order to determine whether Onglyza increases the chance of premature death.
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