The FDA issued a statement earlier this month that it was adding a new warning to the labels of diabetes drugs like Onglyza that contain the saxagliptin and alogliptin.

The FDA said the drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.”

They issued this warning as an update to their February 2014 drug safety communication that stated that they were investigating a possible association between type 2 diabetes drug Onglyza and heart failure.

The panel analyzed results from two large cardiovascular outcomes trials: SAVOR studied saxagliptin (Onglyza), and EXAMINE studied alogliptin (Nesina). The two drugs are members of the dipeptidyl peptidase-4 (DPP-4) inhibitor class used to lower glucose.

After further analysis, they confirmed that the drug did increase risk of hospitalization for heart attack risk and heart failure, and an advisory panel subsequently determined that Onglyza and other similar drugs should carry warnings about their potential to increase risk of heart failure.

Now, the FDA is recommending that health care professionals consider discontinuing the drugs in patients who develop heart failure. They should continue to monitor their glucose and consider other drugs if glucose levels are not properly controlled.

Onglyza Heart Failure, Other Risks

Onglyza and other similar oral diabetes drugs belong to a class of medications called “dipeptidyl peptidase-4 (DPP-4) inhibitor” drugs, also called “incretin mimetics.” These drugs stimulate the pancreas to make more insulin after a patient eats a meal. The extra insulin helps to control blood sugar levels so they don’t get too high.

However, in the clinical trials conducted in patients with heart disease, scientists found that more patients taking these types of drugs were hospitalized for heart failure compared to patients who received a placebo. In the Onglyza trial, specifically, 3.5 percent of patients suffered this fate, compared to 2.8 percent taking the placebo.

As a result, the FDA has added new warnings and precautions to the label so that both doctors and patients are aware of the risk.

The FDA adds that other risks associated with the medication include pancreatitis (inflammation of the pancreas), severe joint pain, allergic reactions, and low blood sugar when combined with other diabetes medications.

Onglyza Lawsuits

Because of the lack of prior warning of the risk of heart attack or heart failure with regard to diabetes medications like Onglyza, there are a growing number of Onglyza lawsuits being filed in courts nationwide by individuals who took the drug and then suffered a heart attack or heart failure.

These patients claim that the drug maker should have been aware of the risks before putting the drug on the market, rather than exposing so many people to potential life-threatening complications.

If you or a loved one experienced a heart attack or suffered heart failure after taking Onglyza, you may be eligible to file an Onglyza lawsuit.  An experienced dangerous drug attorney can provide you with a free case consultation and advise you on your legal options.