Recent studies have shown that many type-2 diabetes medications may actually increase risk of cardiovascular problems. The concern has grown significantly over the past several years.

Just recently, the Food and Drug Administration (FDA) raised red flags about Onglyza (saxagliptin), a type-2 diabetes medication on the market since 2009.

In April 2015, an FDA advisory committee recommended that this drug and other similar diabetes medications should carry warnings about the potential risk of heart failure.

What is Onglyza?

The FDA approved Onglyza in July 2009 for the treatment of type-2 diabetes.

The drug belongs to a class of diabetes medications known as “dipeptidyl peptidase-4 (DDP-4) inhibitors,” also called “incretin mimetics,” which stimulate the pancreas to make more insulin after a patient eats a meal. The extra insulin helps process the glucose to keep levels within a normal range.

The FDA based its approval on the results of eight clinical trials, supplied by manufacturer Bristol-Meyers Squibb and AstraZeneca.

Among these was a safety study meant to show that Onglyza was not linked to a significant risk of cardiovascular events.

Recently, however, FDA experts analyzed the findings of a clinical trial (the SAVOR study) on Onglyza and heart disease, and they found some concerning results.

The trial, sponsored by AstraZeneca, involved more than 16,000 participants, all of whom had a history or risk of cardiovascular disease. Some received Onglyza, and some a placebo.

Researchers followed the participants for about two years. Results showed that more patients in the Onglyza group than the placebo group were hospitalized for heart failure—a 27 percent increased risk, to be specific.

FDA Issues Warning For Certain Diabetes Medications

The FDA advisory panel determined that Onglyza and other similar diabetes medications should carry warnings about their potential to increase risk of heart failure.

They also concluded that the drugs did not increase the risk of cardiovascular death, stroke, or heart attack, and did not recommend any restrictions on prescriptions.

Fourteen out of fifteen of the FDA advisory panel members recommended that the FDA add new safety information to the labels on these products, with one member voting to withdraw Onglyza from the market because of safety concerns.

Onglyza Lawsuits

Many patients who took Onglyza were unaware of the potential increased risk of heart failure, and may have suffered serious side effects as a result.

Pharmaceutical companies are responsible for making sure their warnings are complete before releasing a product on the market, to protect the public from unnecessary health issues.

Those patients who took Onglyza and then suffered hospitalization for heart failure may be able to recover damages in court if the manufacturers failed to provide adequate warnings about this potential outcome.