FOOD AND DRUG ADMINISTRATION WARNS OF HEART FAILURE WITH DIABETES DRUGS

April 13, 2016

Here’s an important alert for patients taking prescriptions containing either of the two diabetes medications saxagliptin (ONGLYZA, KOMBIGLYZE XR) or alogliptin (KAZANO, NESINA, OSENI). These drugs are known as dipeptidyl peptidase-4 inhibitors, or gliptins, all of which we designate as Do Not Use.

On April 5, the Food and Drug Administration (FDA) released a warning that saxagliptin- and alogliptin-containing medications can increase the risk of heart failure, which can involve the heart not being able to pump enough blood to the rest of the body. This adds yet another reason not to use these two drugs.

The FDA based its alert on two large clinical trials that together involved a total of 22,000 patients with heart disease. The patients were followed for an average of two years in the saxagliptin trial and one and a half years in the alogliptin trial. Both trials showed that subjects taking saxagliptin- or alogliptin-containing medicines were more likely to be hospitalized with heart failure than those not given the medications. Saxagliptin- and alogliptin-containing medicines resulted in the hospitalization of six to seven more subjects for heart failure for every 1,000 subjects given the medicines in the trials. In the saxagliptin trial, the risk was especially apparent in subjects with a history of heart failure or abnormal kidney function.

The agency has updated the product labels for saxagliptin- and alogliptin-containing medications to carry a warning of heart failure, which is especially likely to occur in patients with a history of heart failure or abnormal kidney function. However, the warning is not prominent (as a black-box warning would be) and may be missed by both physicians and patients.

The agency also advised that patients showing symptoms or signs of heart failure see their doctor immediately. Symptoms include shortness of breath during daily activities, trouble breathing when lying down, weakness or fatigue, and signs include weight gain with swelling in the feet, ankles, legs, or stomach.

What You Can Do

Do not use any of the gliptins. Public Citizen’s Health Research Group classifies all of these drugs as Do Not Use because their risks of acute pancreatitis, severe skin allergic reactions, possible kidney injury (with sitagliptin) and possible liver toxicity (with alogliptin) outweigh their limited benefits in reducing blood sugar levels. If you are currently taking any of these medications, see your doctor immediately to discuss switching to another, safer diabetes drug. Do not stop taking any drug before seeing your doctor.

To see the FDA’s safety alert, visit http://www.fda.gov/Drugs/DrugSafety/ucm486096.htm.

Gliptins Approved in the U.S.

References

[1] Food and Drug Administration. Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin. April 5, 2016. http://www.fda.gov/Drugs/DrugSafety/ucm486096.htm. Accessed April 8, 2016.

[2] A review of the 'gliptin' diabetes drugs. Worst Pills, Best Pills News. March 2012. https://www.worstpills.org/member/newsletter.cfm?n_id=784. Accessed September 1, 2015.

[3] Type 2 diabetes drug alogliptin causes liver toxicity. Worst Pills, Best Pills News. August 2014. https://www.worstpills.org/member/newsletter.cfm?n_id=915. Accessed September 1, 2015.