April 8, 2016 — The FDA is warning that Onglyza and similar diabetes drugs increase the risk of heart failure, especially for patients who already have heart disease or kidney problems.
The FDA opened an investigation in February 2014, soon after the SAVOR clinical trial concluded that patients on Onglyza were 27% more likely to be hospitalized with heart failure.
According to data from two large clinical trials, 3.5% of patients on saxagliptin were diagnosed with heart failure vs. 2.8% on a placebo. For patients on alogliptin, 3.9% were diagnosed with heart failure vs. 3.3% on a placebo.
The agency ordered label updates to warn about heart failure from the following medications:
- Onglyza (saxagliptin)
- Kombiglyze XR (saxagliptin and metformin extended release)
- Nesina (alogliptin)
- Kazano (alogliptin and metformin)
- Oseni (alogliptin and pioglitazone)
The FDA recommends that patients on these medications should seek emergency medical attention if they experience symptoms of heart failure, such as unusual shortness of breath, breathing problems, weight gain due to swelling, and unusual tiredness, weakness, or fatigue.
Diabetes is a major risk-factor for heart failure, in which the heart progressively weakens and is unable to pump enough blood into the body. The condition is exacerbated by high blood pressure and coronary artery disease, which commonly afflict people with diabetes.
Do I have an Onglyza Lawsuit?
The Schmidt Firm, PLLC is currently accepting Onglyza induced injury cases in all 50 states. If you or somebody you know has been diagnosed with heart failure, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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