The latest announcement follows a February 2014 announcement that the FDA was investigating a potential association between the Type-2 diabetes drug and Onglyza heart failure.

After the FDA analyzed injury reports, the agency confirmed that there was an increased risk of heart failure in conjunction with Onglyza use. The agency recommended that Onglyza and similar drugs should include the risk of heart failure in the medication side effects section on the drug’s label.

In evaluating two large clinical trials, FDA scientists found that subjects taking saxagliptin products had higher rates of heart failure as compared to patients taking a placebo. 3.5 percent of subjects taking saxagliptin were hospitalized for heart failure, versus 2.8 percent of subjects taking the placebo.

The evaluation found that subjects who already had a history of kidney problems and heart failure were at the highest risk.

Overview of Onglyza Heart Failure

Onglyza is a member of the DPP-4 inhibitor family of drugs. These medications, also known as incretin mimetics, work by stimulating the pancreas to produce more insulin. By signaling the body to make more insulin, the body’s blood sugar levels are controlled and thereby prevent diabetic attacks.

The FDA approved Onglyza on July 31, 2009, as a new treatment option for type-2 diabetes patients.

At the time of its release, Onglyza was hailed as a great innovation and addition to the lineup of diabetes treatment options. However, the FDA has been receiving adverse event reports that Onglyza patients have reportedly been suffering from heart failure, pancreatitis, and other severe medication side effects after taking Onglyza.

Even though heart failure is now a known risk associated with Onglyza, the FDA’s latest warning came too late for patients who have already suffered from adverse Onglyza side effects.