The Food and Drug Administration is warning healthcare professionals to consider discontinuing the use of Type 2 diabetes medications containing saxagliptin and alogliptin, due to a higher risk of heart failure, especially in patients with existing heart or kidney disease.
Adults with Type 2 diabetes use these drugs to lower blood sugar, along with diet and exercise.
The FDA said patients should consult their doctors before discontinuing the medication and report heart failure symptoms: shortness of breath; trouble breathing; tiredness, weakness, or fatigue; weight gain; and swelling in their ankles, feet, legs, or stomach.
The FDA also said in its warning on Tuesday that doctors should consider prescribing other drugs for patients whose blood sugar is not well-controlled. It will require warning labels for drugs containing the two components.
Following are common brand names of medications containing saxagliptin and alogliptin:
• Onglyza (saxagliptin)
• Kombiglyze XR (saxagliptin and metformin extended release)
• Nesina (alogliptin)
• Kazano (alogliptin and metformin)
• Oseni (alogliptin and pioglitazone)
Warnings resulted from two large research trials showing higher rates of heart failure hospitalizations for patients taking medications with saxagliptin or alogliptin: 3.5 percent of saxagliptin patients compared to 2.8 percent on a placebo; and 3.9 percent of alogliptin patients versus 3.3 percent taking placebo.
Patients were at higher risk if they had a history of heart failure or kidney problems.
By AMERICAN HEART ASSOCIATION NEWS
April 6th, 2016