All too often, new drugs are rushed to market without proper evaluation and assessments of risks for potential side effects. Onglyza is the latest medication to catch the attention of the FDA after recent studies have exposed a possible link between Onglyza use and an increased likelihood of heart failure.

What is Onglyza?

Insulin is responsible for moving glucose from the blood into the cells; however, type-2 diabetics often suffer from a combination of insulin resistance and inhibited insulin production. Onglyza, also known as saxagliptin, is a medication prescribed for the treatment of symptoms of type-2 diabetes, helping to lower blood sugar by prompting the release of insulin from the pancreas and limiting the production of glucose by the liver.

By increasing insulin levels, more glucose reaches the cells than is required and forces the liver to hold onto glucose reserves to ensure that the body will use more of the glucose released into the blood stream following meals. The end result is sustained blood glucose at lower levels.

The primary advantage to prescribing Onglyza is that, unlike other diabetes medications, it does not cause weight gain or retention. AstraZeneca received FDA approval to bring it to market in 2009, but while the drug has shown to improve blood glucose levels in patients, others argue that AstraZeneca withheld important information regarding potential side effects and links to serious or life threatening conditions, including Onglyza heart failure.

It was in February 2014 that a study published in the New England Journal of Medicine prompted the FDA to issue a safety alert and begin its own investigation into whether Onglyza is linked to heart failure side effects that had not previously been disclosed.

Studies have shown that patients using Onglyza were 27 percent more likely to experience heart failure; however, no conclusive evidence directly linked the medication to heart attack, stroke, or other cardiovascular diseases. A trial of more than 16,000 patients, known as SAVOR, previously showed patients taking Onglyza had an increased risk of hospitalization due to heart failure.

FDA Issues Onglyza Heart Failure Warning

An FDA panel voted in April 2015 to require AstraZeneca to place a warning on Onglyza labeling that would caution patients of a possible increased risk of heart failure. This decision came after reviewing the data from the SAVOR study.

AstraZeneca was required to show that Onglyza would not increase the risk of heart failure or other cardiovascular conditions by more than 30 percent. While the manufacturer met the required threshold with 27 percent, the FDA panelists noted that more information was necessary in order to determine the actual risk of death from all causes associated with Onglyza.

If you were prescribed Onglyza for the treatment of diabetes and experienced severe side effects such as cardiovascular disease or heart failure, you may be entitled to compensation for the cost of medical care, pain and suffering and any additional financial losses you may be forced to incur in the present or the future.