Since February 2014, the Food and Drug Administration (FDA) has been scrutinizing the diabetes drug Onglyza over concerns about heart failure.

On Feb. 11, 2014, the FDA issued a Drug Safety Communication stating that a recent article in the New England Journal of Medicine had raised concerns that Onglyza and related diabetes drugs could increase the risk of heart problems.

The NEJM article found that patients taking the drug had an increased risk of heart failure, a condition where the heart cannot pump enough blood.

The NEJM study found a very specific increase of the risk of heart failure, though curiously not heart attacks, for patients taking Onglyza and other type-2 diabetes drugs.

The FDA considered the research by the NEJM study to be preliminary, and not yet conclusive enough to warrant banning or restricting the drug, but definitely warranting further investigation.

In the past, FDA investigations against other drugs have resulted in anything from ruling that the concerns are unfounded, to mandating changes to a drugs labeling, all the way to an outright ban of certain drugs due to safety concerns.

The specific study dates back to October of 2013. In this study researchers randomly assigned a group of 16,492 type-2 diabetes patients into two groups: one took Onglyza and related drugs and one did not.

Patients the control group (the group that did not take Onglyza) could be prescribed any other diabetes drug. The patients were followed for 2.1 years.

Since diabetics naturally have a higher rate of heart attack and heart disease, this approach helped to distinguish an actual increase in the risk of heart problems from the “background noise” of diabetics’ increased rate of heart problems.

Researchers in the Onglyza study found very specific results. They found that the Onglyza group had no increase in the rate of heart attacks, defined here as a myocardial infarction, stroke, or other heart problems. These problems are all related to blockages of critical blood vessels. However, the patients taking Onglyza did have a higher rate of hospitalization due to heart failure.

Often, specificity in results is a sign that there is a significant process going on in a research study. The researchers concluded that Onglyza and related drugs were not a safe way to decrease the risk of heart problems in diabetics due to concerns about heart failure.

An Onglyza class action lawsuit investigation has been launched to explore the possibility of legal action against the makers of Onglyza. Under U.S. law, drugmakers have a legal obligation to thoroughly test their drugs for safety and efficacy, and to perform postmarket surveillance.

Postmarket surveillance involves monitoring research journals and FDA reporting tools to look for signs that their drugs are having side effects that didn’t show up in clinical trials.

An Onglyza lawsuit could allege that drugmakers did not do enough to test and monitor their drug for side effects, leading to Onglyza side effects like life-threatening heart failure.

Such an Onglyza lawsuit could seek to recoup costs related to heart failure and other alleged Onglyza side effects, as well as lost wages and lost income potential. Large group litigation against drugmakers in the past has also recouped legal fees and punitive damages.