FDA Adds Heart Failure Warning to 2 Diabetes Drugs
The FDA has issued a new warning concerning heart failure risk associated with the use of type 2 diabetes medicines containing saxagliptin and alogliptin.
The risk is particularly directed toward patients taking these dipeptidyl peptidase-4 (DDP4) inhibitors who already have heart or kidney disease.
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The warning comes in response to an evaluation of 2 large clinical trials of patients with heart disease. The results of this evaluation indicated that more patients who received medicines containing either saxagliptin or alogliptin were hospitalized for heart failure than those who received placebo.
In the trial examining saxagliptin, 3.5% of patients receiving the drug were hospitalized vs 2.8% of those who received placebo. In the alogliptin trial, 3.9% of those receiving the drug were hospitalized compared with 3.3% of those taking a placebo.
“Health care professionals should 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,” the FDA wrote.
The FDA recommends that any patients taking these medications who experience unusual shortness of breath, trouble breathing when lying down, fatigue, or weight gain with swelling in the ankles, feet, legs, or stomach contact their health care provider immediately.
—Michael Potts
Reference:
FDA. Diabetes medications containing saxagliptin and alogliptin: drug safety communication - risk of heart failure [press release]. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494252.htm. Accessed April 6, 2016.