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Diabetes Drugs and Heart Failure Lawsuit

FDA ALERT:

Onglyza and Kombiglyze XR May Cause Increased Risk of Heart Failure

  • Onglyza (saxagliptin)
  • Kombiglyze XR (saxagliptin and metformin extended release)
  • Nesina (alogliptin)
  • Kazano (alogliptin and metformin)
  • Oseni (alogliptin and pioglitazone)

History of Onglyza and Kombiglyze XR

  • July  2008  Onglyza Approved by the FDA
  • Nov. 2010  Kombiglyze XR Approved by FDA
  • Oct. 2013  New England Journal Of Medicine Article warns of Heart Failure
  • Feb. 2014  FDA issues Drug Safety Communication of Heart Failure Risks

As mentioned above this FDA announcement updated an earlier 2014 FDA Drug Safety Communication in which suspected heart failure issues were being studied in these dipeptidyl peptidase-4 (DPP-4) inhibitor drugs.

In reaching this 2016 conclusion the FDA evaluated two large clinical trials conducted in patients with heart disease. These Type 2 clinical trials showed that more patients who received saxagliptin- or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo (see Data Summary in the FDA Drug Safety Communication for additional information). In the saxagliptin trial, 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8% of patients who received a placebo. This is the same as 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. In the alogliptin trial, 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.

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FDA reccomends that health care professionals consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control. If a patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.

Patients taking these medicines should contact their health care professionals right away if they develop signs and symptoms of heart failure such as:

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

** FDA warns that patients should not stop taking their medicine without first talking to their health care professionals.

Onglyza & Kombiglyze XR Heart Failure Lawsuit

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