Onglyza lawsuits allege the type-2 diabetes medication has caused heart failure.

The FDA approved Onglyza (saxagliptin) in 2009 as a medication to control blood sugar in patient diagnosed with type 2 diabetes. Astra Zeneca partnered with Bristol Myers Squibb to make the drug, which received a great reception from patients because Onglyza didn’t cause weight gain like other glycemic drugs.

Some patients, however, have since filed Onglyza lawsuits, alleging they should have gotten a better warning about this heart failure risk.

The FDA issued a Drug Safety Communication in February 2014 warning that Onglyza might increase the risk of heart failure, especially among patients who already have heart disease or kidney disease. When the heart muscle is too weak to pump enough blood throughout the body, the result is heart failure. The body becomes deficient in oxygen and nutrients, leading to tiredness. Fluid retention eventually leads to congestive heart failure.

Onglyza lawsuits allege the drug’s makers should have known of the increased risk of heart failure before they placed it on the market in 2009.

Heart failure symptoms can include shortness of breath during normal daily movements; breathing problems upon lying down; extreme fatigue; and weight gain with swelling in the ankles, feet, legs or stomach.

Indications of heart failure usually appear gradually. Advanced congestive heart failure often is accompanied by the following:

• a rapid or irregular heartbeat
• a nagging cough or wheezing with white or blood-tinged phlegm
• Increased need to urinate, especially at night
• Lack of appetite, nausea
• Reduced tolerance for exercise

The FDA has instructed patients who feel they are experiencing any signs of heart failure to consult their doctor before stopping any prescription medications.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee examined two clinical trials of patients experiencing heart disease. Both trials indicated more patients who received Onglyza were hospitalized for heart failure compared with a control group who received an inert drug called a placebo.

Of those taking Onglyza, 35 out of every 1,000 patients were admitted to the hospital for heart failure compared with 28 of every 1,000 patients who took the placebo. Patients with impaired kidney function were more likely to suffer from heart failure.

Related combination drug Kombiglyze XR, which contains both saxagliptin and metformin, may also be linked to an increased risk of heart failure.

Other Onglyza Adverse Effects

Onglyza also can cause a rare and severe skin reaction known as bullous pemphigoid. Large fluid-filled blisters develop over areas of the skin that flex often, such as the lower abdomen, upper thighs, and armpits.

Onglyza also has been known to cause pancreatitis, an inflammation of the pancreas that can be severe and life-threatening. Pancreatitis is marked by severe abdominal pain that might be felt from the stomach to the back.

Patients, Families File Onglyza Lawsuits

Patients who have experienced heart failure from Onglyza or Kombiglyze XR may be eligible to file Onglyza lawsuits to seek compensation for medical expenses, lost wages, pain and suffering, and other unexpected expenses.

Loved ones of patients who have died after taking the diabetes medication may be eligible to file wrongful death Onglyza lawsuits.