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FDA warns users of Onglyza and Kombliglyze XR of an increased risk of heart failure

 

Onglyza Lawsuit

FDA warns users of Onglyza and Kombliglyze XR of an increased risk of heart failure

The U.S Food and Drug Administration (FDA) has announced that taking medications containing saxagliptin or alogliptin, such as ONGLYZA or KOMBIGLYZE XR, may increase your risk of heart failure, especially if you already have heart or kidney disease. The announcement came at the end of the FDA’s Safety Review in which it analyzed the results of two large clinical trials that evaluated the risks of heart disease in those taking such medications. The announcement was particularly alarming, given that ONGLYZA and KOMBIGLYZE XR are marketed to diabetics to help control their blood sugar, and those with diabetes are already at a greater risk of developing heart disease.

The FDA’s safety review included its evaluation of two large clinical trials conducted on patients with heart disease. Some of the patients were given medications containing saxagliptin or alogliptin, such as ONGLYZA or KOMBIGLYZE XR, while other received a placebo. The results of these trials were discussed during the agency’s Endocrinologic and Metabolic Drugs Advisory Committee meeting in April 2015.
Both trials showed that more patients who received ONGLYZA or KOMBIGLYZE XR, or another saxagliptin or alogliptin medication, were hospitalized for heart failure compared to patients who received a placebo. More information on these trials can be found here.

As a result of the FDA’s Safety Review, the agency advised patients taking ONGLYZA or KOMBIGLYZE XR, and other saxagliptin or alogliptin medications to immediately contact their health care providers if they develop signs or symptoms of heart failure such as:

  • Unusual shortness of breath during daily activities
  • Trouble breathing when lying down
  • Tiredness, weakness, or fatigue
  • Weight gain with swelling in the ankles, feet, legs, or stomach

The FDA also warned health care professionals to consider discontinuing ONGLYZA or KOMBIGLYZE XR, and other saxagliptin or alogliptin medications in patients who develop heart failure and to monitor their diabetes control.

According to the FDA, in 2015, approximately 386,000 patients received a dispensed prescription for saxagliptin-containing products, such as ONGLYZA or KOMBIGLYZE XR, from the U.S. outpatient retail pharmacy setting.

New Warning Labels

As a result of its safety review the FDA mandated that new warnings be placed on drug labels for ONGLYZA, KOMBIGLYZE XR and other saxagliptin or alogliptin medications.

The new labels now specifically warn patients and doctors about the increased risks associated with heart disease and taking ONGLYZA or KOMBIGLYZE XR. For example, each new ONGLYZA label now states:

Heart Failure: Consider the risks and benefits of ONGLYZA in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. (5.2)

5.2 Heart Failure
In a cardiovascular outcomes trial enrolling participants with established ASCVD or multiple risk factors for ASCVD (SAVOR trial), more patients randomized to ONGLYZA (289/8280, 3.5%) were hospitalized for heart failure compared to patients randomized to placebo (228/8212, 2.8%). In a time-to-first-event analysis the risk of hospitalization for heart failure was higher in the ONGLYZA group (estimate Hazard Ratio: 1.27; 95% Cl: 1,07, 1.51). Subjects with a prior history of heart failure and subjects with renal impairment had a higher risk for hospitalization for heart failure, irrespective of treatment assignment.

Consider the risks and benefits of ONGLYZA prior to initiating treatment in patients at a higher risk for heart failure. Observe patients for signs and symptoms of heart failure during therapy. Advise patients of the characteristic symptoms of heart failure and to immediately report such symptoms. If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of ONGLYZA.

Protect Your Rights

If you or a loved one have suffered heart failure, congestive heart failure, cardiac complications or death while taking ONGLYZA or KOMBIGLYZE XR to treat type 2 diabetes you may be entitled to compensation. Please contact us today.

There are time limits by which you need to file a product liability lawsuit. Those limits could time bar your case if it is not filed in a timely manner. Your state of residence, when you ingested the drug and when you experienced injuries could all affect how much time you have to file.

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Securities Lawyer Melissa_Hague

Melissa Fry Hague

If you believe you or a loved one may have an Onglyza claim, contact us today. One of our attorneys will contact you within 24 hours to conduct a free and confidential evaluation of your case.

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In our legal system, every person is innocent until and unless found guilty by a court of law or a tribunal. Whenever we reference “allegations” or charges that are “alleged,” such allegations or charges have not been proven, and are merely accusations, not findings of fault, as of the date of the blog. We do not have, nor do we undertake, a duty to continue to monitor or follow cases about which we report, and/or to publish subsequent updates regarding various developments that may occur in such cases. Readers are encouraged to conduct their own research regarding any such cases and any developments that may or may not have occurred in such cases. Also, the brokercheck report linked to some of our blogs is the up-to-date version as of the date of posting. Visitors may check the most recent version of each brokercheck report at www.finra.org.

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