Diabetics Seek Compensation for Heart Failure After Taking Onglyza

By a vote of 14-1, an advisory committee recommended that the Food and Drug Administration (FDA) mandate new warnings on drug labels for medications containing saxagliptin. Those medications, marketed as Onglyza and Kombiglyze XR, are prescribed to patients with type 2 diabetes as part of a plan to control blood sugar levels. One committee member voted to withdraw the drugs from the market.

The committee’s recommendation followed its review of a study (known by the acronym SAVOR) that found a significant increase in the risk of hospitalization for heart failure in patients who took Onglyza. As a result of that study, the editor in chief of the Journal of the American College of Cardiology, Dr. Anthony DeMaria, has taken the position that type 2 diabetics with a history or a high risk of heart disease should avoid the use of Onglyza.

Understanding the risk

The FDA requested the SAVOR study in response to growing concerns about the link between Onglyza and heart disease. SAVOR was a double-blind study of more than 16,000 type 2 diabetics. All of the participants either had a history of heart disease or were at significant risk of developing heart disease due to smoking, high cholesterol levels, or hypertension.

Half of the participants were treated for diabetes with Onglyza. The other half were given a placebo. The study concluded that the risk of being hospitalized for heart failure was 27% higher for participants who took Onglyza than it was for those who took the placebo. Heart failure is a condition in which the heart no longer pumps an adequate supply of blood.

The SAVOR study did not find an increase in deaths by heart attack among the group that took Onglyza. A subsequent review of the data by the FDA, however, found that participants who took Onglyza had a higher risk of death from all sources than those who took the placebo.

Drug manufacturers spin the results

The generic drug saxagliptin was initially developed by the American pharmaceutical company Bristol-Myers Squibb. Together with British drug maker AstraZeneca, the drug companies asked the FDA for permission to market the drug using the trade name Onglyza. The FDA granted its approval in 2009. The FDA approved an extended-release version of the drug in 2010. That drug, marketed as Kombiglyze XR, combines saxagliptin with metformin.

When the drug companies initially marketed Onglyza, they expressed optimism that the drug would reduce heart attacks in patients who have type 2 diabetes. Since type 2 diabetics have an elevated risk of heart disease, risk-reduction would be an excellent benefit of taking Onglyza if it proved to be true. Unfortunately, as the spokesperson for the European Society of Cardiology points out, it is not logical to believe that saxagliptin would reduce heart attacks.

Attempting to put a positive spin on the results of the SAVOR study, AstraZeneca announced that the study “met the primary safety objective, demonstrating that ONGLYZA did not increase the risk for cardiovascular death.” The announcement made no mention of the finding that Onglyza does not reduce the risk of heart attacks, as the company initially predicted.

AstraZeneca acknowledged the advisory committee’s recommendation that it should be required to provide “important additional information” about the risk of taking Onglyza. A reader will need to read AstraZeneca’s announcement carefully and decode its medical jargon to discover that the “important additional information” concerns the increased risk of heart failure in patients who take Onglyza.

What the study means for diabetics who take Onglyza

More than 90% of the 29 million diabetics in the United States have type 2 diabetes. Type 2 diabetes occurs when the body does not process the insulin it manufactures in a way that helps blood sugar enter the body’s cells. That results in an overabundance of blood sugar, magnifying the risk of a heart attack or stroke. Diabetes can lead to other serious health problems, including kidney failure and blindness.

Exercise, weight loss, and a diet that minimizes blood sugar production (high fiber, low-fat foods and the avoidance of sugary foods) are recommended for the treatment and prevention of type 2 diabetes. If those measures do not reduce blood sugar to an acceptable level, doctors can choose among more than a half dozen classes of drugs to lower blood sugar levels.

Saxagliptin belongs to a class of drugs known as DPP-4 inhibitors. By blocking the release of the DPP-4 enzyme, saxagliptin leads to increased levels of insulin and decreased levels of blood sugar.

Saxagliptin is one of four DPP-4 inhibitors presently marketed in the United States. The FDA is studying the others to determine whether they carry the same risk as saxagliptin. Type 2 diabetics who have a history or a high risk of heart disease should ask their doctors whether it would make sense to choose an alternative treatment rather than taking Onglyza.

Compensation for heart failure after taking Onglyza

Patients who were hospitalized for heart failure after taking Onglyza or Kombiglyze XR may be entitled to compensation. Patients who received prescriptions for either of those drugs should have been warned that saxagliptin increases the risk of heart failure before deciding whether to take the drug.

Personal injury lawyers are developing evidence that Bristol-Myers Squibb and AstraZeneca knew about and withheld or deliberately disregarded information suggesting that saxagliptin is an unsafe drug when administered to type 2 diabetics who have a history or a high risk of heart disease. Their failure to warn consumers may entitle patients to compensation if they took the drug and were hospitalized for heart failure.

Compensation for patients who suffered from heart failure after taking Onglyza can include payment of their medical bills and lost income while hospitalized. In addition, patients may be entitled to compensation for their pain and suffering and emotional distress. Patients who are experiencing a long-term disability as a result of heart failure may be entitled to compensation that will help them cope with that disability.

Consult with a personal injury lawyer who handles cases against pharmaceutical companies if you were hospitalized for heart failure after taking Onglyza. A free case evaluation will help you determine whether you should seek compensation from the manufacturers of Onglyza. Be sure to act quickly, before the time for making a claim expires.