Diabetes drugs may be linked to heart failure, FDA warns

Type 2 diabetes drugs containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease, according to FDA’s new Drug Safety Communication.

FDA is adding new warnings to labels of the drugs in question, including: Onglyza, Kombiglyze XR, Nesina, Kazano and Oseni.

In addiiton, FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally.

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"FDA concluded, from the review of studies published in the medical literature, that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function," the agency said in a statement. However, "FDA is requiring changes to the metformin labeling to reflect this new information and provide specific recommendations on the drug’s use in patients with mild to moderate kidney impairment."

FDA made the decision on the heart failure warning after evaluating 2 large clinical trials, which showed that more patients who received saxagliptin- or alogliptin-containing drugs were hospitalized for heart failure compared to patients who received a placebo.

In the saxagliptin trial, 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8% of patients who received a placebo. Risk factors included a history of heart failure or kidney impairment. In the alogliptin trial, 3.9% of alogliptin-treated patients were hospitalized for heart failure versus 3.3% in the placebo group.

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Patients taking saxagliptin- or alogliptin-containing drugs should contact their healthcare professionals right away if they develop signs and symptoms of heart failure, according to FDA, Symptoms include unusual shortness of breath during daily activities; trouble breathing when lying down; tiredness, weakness or fatigue; and weight gain with swelling in the ankles, feet, legs, or stomach.

However, patients should not stop taking their medicine without first talking to their healthcare professionals. FDA is also urging healthcare professionals and patients to report side effects involving saxagliptin, alogliptin, or other drugs to the FDA MedWatch program.

FDA is also requiring manufacturers to revise the labeling to recommend that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of renal function (i.e., glomerular filtration rate estimating equation (eGFR)). "This is because, in addition to blood creatinine concentration, the glomerular filtration rate takes into account additional parameters that are important, such as the patient’s age, gender, race and/or weight," FDA said in a statement.

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