The FDA has added a new warning to the labels of diabetes drugs like Onglyza that contain the saxagliptin and alogliptin.

According to the agency, these drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.”

They issued this Onglyxa and heart failure warning as an update to their February 2014 drug safety communication that stated that they were investigating a possible association between the type 2 diabetes drug 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 an increased risk of Onglyza and heart failure, specifically, hospitalization for heart attack risk and heart failure. Moreover, an advisory panel subsequently determined that, along with other diabetes drugs, the labels should provide warnings about the possibility of Onglyza and 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.

What is Onglyza?

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 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, two large 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 placebo.

New FDA Warning About Onglyza and Heart Failure

According to the FDA, patients who already had other risk factors such as a history of heart failure or kidney impairment were more likely to experience Onglyza and heart failure. 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 of Onglyza and heart failure.

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 Onlgyza and heart failure or heart attack with regard to the diabetes medication, 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 of Onglyza and heart failure 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.