Onglyza Lawsuits Will Look At Recent FDA Warnings for Onglyza and Kombiglyze XR Labels after Clinical Trial Links Saxagliptin to An Increased Risk of Heart Failure
Wright & Schulte LLC, an experienced law firm that represents plaintiffs in Onglyza lawsuits, reports that the U.S. Food & Drug Administration (FDA) has issued a new Drug Safety Communication to inform the public that a number of Type 2 diabetes drugs, including Onglyza (saxagliptin), may be associated with an increased risk of heart failure. New warnings and precautions outlining this risk are now being added to the labels of Onglyza. Similar modifications will also be made to the label of Kombiglyze XR, a combination medicine that contains saxagliptin and metformin.
[fda.gov/Drugs/DrugSafety/ucm486096.htm, FDA, April 5, 2016]
The attorneys at Wright & Schulte LLC are currently investigating Onglyza lawsuits on behalf of patients who allegedly experienced heart failure or other complications related to its use. If you or a loved were diagnosed with heart failure after using either Onglyza or Kombiglyze XR to control Type 2 diabetes, please contact our Firm at 1-800-399-0795 to learn whether or not you qualify to file a legal claim.
Both Onglyza and Kombiglyze XR are manufactured by AstraZeneca. They are categorized as dipeptidyl peptidase-4 (DPP-4) inhibitors, and lower blood glucose levels by blocking an enzyme that reduces insulin production. The FDA approved Onglyza in 2009, while Kombiglyze XR was approved in 2010. The agency has been investigating a possible association between saxagliptin and an increased risk of heart failure since February 2014.
According to an FDA alert issued on April 5th, a large clinical trial recently found that 3.5% of patients taking saxagliptin were hospitalized with heart failure compared to 2.8% of patients on a placebo. This is equal to 35 out of every 1,000 patients compared to 28 out of every 1,000 patients. Risk factors included a history of heart failure or kidney impairment, according to the FDA.
The alert also noted that a second clinical trial had found a potential link between the use of alogliptin and heart failure. In that study, 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group. This is the same as 39 out of every 1,000 patients compared to 33 out of every 1,000 patients, the FDA said. Alogliptin containing medications include Nesina (alogliptin), Kazano (alogliptin and metformin) and Oseni (alogliptin and pioglitazone).
Heart failure can result in the heart not being able to pump enough blood to meet the body’s needs.
Signs and symptoms of the condition include:
- Shortness of breath during normal daily activities
- Trouble breathing when lying down
- Tiredness, weakness, or fatigue
- Weight gain with swelling in the ankles, feet, legs, or stomach
Patients using Onglyza or other Type 2 diabetes drugs cited in the FDA communication should not stop taking their medicine without first talking to their health care professionals. However, they should contact their doctor right away if they experience any of the above symptoms.
About Wright & Schulte LLC and Filing an Onglyza Lawsuit:
Wright & Schulte LLC is an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright Schulte LLC stand up for the rights of people who have been injured or wronged, and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, do not hesitate to contact Wright & Schulte LLC today. Free Onglyza Lawsuit and Kombiglyze XR Lawsuit case evaluations are available through yourlegalhelp.com, or call 1-888-399-0795.
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