FDA Launches Investigation of Saxagliptin due to Heart Concerns
The U.S. Food and Drug Administration has launched an investigation into the diabetes drug saxagliptin after determining that the drug may result in patients’ risk of suffering serious cardiovascular events.
- Patients with diabetes usually have problems making the hormone, insulin, and therefore their blood sugar remains abnormally high.
- Saxagliptin, marketed as Onglyza and Kombiglyze XR, works by producing more insulin to break down the sugar in the blood.
- However, data suggests that saxagliptin may also increase cardiovascular risks among a population already prone to heart problems.
FDA Launches Investigation into Saxagliptin
- The Food and Drug Administration (FDA) is investigating the effects of the drug because of a recent research study published in the New England Journal of Medicine revealed that patients taking this medicine have a higher risk of heart failure.
- Researchers analyzed data from 16,500 patients diagnosed with Type II Diabetes from 26 different nations around the world.
- They saw that those using saxagliptin was associated with increased risk of hospitalization due to heart failure.
- The heart failure problem occurs when heart cannot pump blood properly.
- Health officials say patients should not stop their use of the drug, but urge patients to speak to their healthcare providers over any concerns with the drug.
Side Effects of Saxagliptin
Adverse events reported in patients taking saxagliptin include:
- Renal failure
- Chest pain
- Pulmonary edema
- Bladder cancer
- Atrial fibrillation
- Pulmonary congestion
- Sudden cardiac death