Reports suggesting that Onglyza linked to heart failure could give diabetes patients reason to reconsider treatment with that particular drug.

Onglyza is a brand name that refers to the generic drug saxagliptin. It was first approved by the FDA on July 31, 2009. It is part of a drug class called incretin mimetics. This class of drugs promotes insulin production in the pancreas and helps regulate diabetic patients’ sugar levels.

Onglyza is manufactured by AstraZeneca and became popular when incretin mimetics hit the market. But after-market reports have since called into question whether Onglyza linked to heart failure could make the drug worth the risks it presents.

Onglyza Linked to Heart Failure in Post-Market Studies

Concerns over Onglyza linked to heart failure were spurred in part by a study published in the New England Journal of Medicine in 2013. This study, known as the SAVOR study, examined the histories of 16,492 patients with type-2 diabetes.

Researchers found that patients who were prescribed Onglyza were slightly more likely to be hospitalized for heart failure than those who took other diabetes drugs. Patients who took Onglyza were found to have a 27 percent greater risk of hospitalization for heart failure than those in the control group.

Based in part on the results of the SAVOR study, the U.S. Food and Drug administration issued a safety communication regarding Onglyza linked to heart failure in April 2015. In that communication, the agency warned that saxagliptin (Onglyza) was associated with an increased frequency of hospitalization for heart failure, particularly in patients who already have heart or kidney disease.

Because of the possibility of Onglyza linked to heart failure, at least one reviewer on an FDA panel suggested that the drug should be removed from the U.S. market.

But as a whole, the panel declined to take Onglyza off the market, based on evidence that the rate of cardiovascular events associated with saxagliptin was lower than the maximum allowable threshold of 30 percent. Instead, the panel recommended the inclusion of a warning in Onglyza’s prescribing information.

Even though AstraZeneca narrowly met the needed margin, the FDA panel noted that more information was needed to determine the actual risk of Onglyza linked to heart failure.

Heart failure is not to be confused with a heart attack. Heart failure occurs when the heart muscle is too weak to pump blood throughout the body efficiently. Over time, medical problems such as high blood pressure or coronary artery disease can weaken the heart and contribute to heart failure.

Heart failure patients can work to reverse the condition by exercising, eating healthier, reducing sodium intake, losing weight and managing stressful situations.

If you or someone you love has experienced Onglyza linked to heart failure or any other adverse side effects of Onglyza, you may be entitled to legal compensation.