April 8, 2016 — The FDA has issued a Safety Communication after finding that diabetes drugs containing alogliptin or saxagliptin can increase the risk of heart failure, especially in patients with pre-existing heart or kidney disease.
Diabetes drugs linked to heart failure:
- Onglyza (saxagliptin)
- Kombiglyze XR (saxagliptin and metformin extended release)
- Nesina (alogliptin)
- Kazano (alogliptin and metformin)
- Oseni (alogliptin and pioglitazone)
The FDA will add new warnings to drug labels about these safety concerns. The agency has been investigating the risk since February 2014, when the SAVOR clinical trial showed a 27% increase in hospitalizations for heart failure among patients on saxagliptin compared to a placebo.
Data from two large clinical trials indicated that 3.5% of patients on saxagliptin were hospitalized with heart failure compared to 2.8% on a placebo, and risk-factors included a history of heart failure or kidney impairment. In clinical trials of alogliptin, 3.9% of patients were hospitalized with heart failure compared to 3.3% on a placebo.
Heart failure is when the heart is too weak to pump enough blood into the body. It is a very common condition that often occurs as a complication of uncontrolled diabetes, high blood pressure, or coronary heart disease.
According to the FDA, patients on these medications should seek emergency medical attention if they develop symptoms of heart failure, such as unusual tiredness, weakness, fatigue, shortness of breath during daily activities, trouble breathing when lying down, and weight gain with swelling in the legs or stomach.
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