Diabetics who were hospitalized for heart failure after taking Onglyza are asking whether they should receive compensation. Personal injury lawyers who represent clients in cases against pharmaceutical companies are basing lawsuits on the failure of drug manufacturers to warn diabetics that taking Onglyza could increase their risk of heart failure if they were already suffering from or prone to heart disease.
Onglyza and Diabetes
Type 2 diabetes is a disease that causes too much blood sugar to collect in the blood. While the body produces insulin to reduce blood sugar levels, people with type 2 diabetes do not absorb insulin efficiently into their body’s cells. About 90 percent of diabetics have type 2 diabetes.
Type 2 diabetes can be treated with a number of different medications, in addition to diet and exercise. Among the newer classes of medications, DPP-4 inhibitors are advertised as moderating blood sugar levels without causing hypoglycemia.
Saxagliptin is one of four DPP-4 inhibitors currently being marketed as a treatment for type 2 diabetes. It is manufactured and sold under the trade name Onglyza. An extended release medication that combines saxagliptin with metformin is marketed as Kombiglyze XR.
Onglyza and Kombiglyze XR are marketed jointly by the American pharmaceutical company Bristol-Myers Squibb and the British drug manufacturer AstraZeneca. The Food and Drug Administration (FDA) approved Onglyza for marketing in 2009 and approved Kombiglyze XR in 2010.
Heart Disease in Type 2 Diabetics
Heart disease is more common in diabetics than it is in the general population. Diabetics are twice as likely as individuals who do not have diabetes to suffer from cardiovascular disease. Heart attacks are the leading cause of death for type 2 diabetics.
On average, diabetics develop heart disease or have a stroke at an earlier age than people who do not suffer from diabetes. Heart attacks are more likely to be fatal when the person suffering the heart attack has diabetes.
Diabetes leads to heart disease because high glucose (blood sugar) levels cause plaque to be deposited on the interior walls of blood vessels. The buildup of plaque decreases blood flow and increases the chance that a diabetic will experience atherosclerosis.
Onglyza and Heart Failure
The FDA’s approval of Onglyza was based on studies that found no link between saxagliptin and an increased risk of heart disease. However, those studies (which included only 4,600 patients) did not focus on type 2 diabetics who had a history of heart disease. After the FCC became concerned about the impact of Onglyza on diabetics who have a high risk of developing (and those who have developed) heart disease, it ordered a further study of the impact that Onglyza has on those groups. The results of the study, known as SAVOR, validated the FDA’s concerns.
The SAVOR study compared health outcomes of type 2 diabetics who took Onglyza to those who took a placebo. The study involved more than 16,000 participants who either had a history of heart disease or were deemed to have a high risk for heart disease based on such factors as hypertension and smoking.
The study detected no difference in death rates from heart attacks in the two groups of patients. The study concluded, however, that the patients who took Onglyza were hospitalized for heart failure 27 percent more often than the patients who took the placebo. That critical finding establishes an enhanced risk of heart failure in type 2 diabetics who take Onglyza and who are already at risk of cardiovascular disease based on their histories or risk factors.
The study did not determine why Onglyza leads to heart failure. A potential explanation lies in the mechanism by which Onglyza operates. A condition known as cardiovascular autonomic neuropathy (CAN) is recognized as a serious complication of diabetes. The condition occurs when nerve fibers that stimulate the heart and blood vessels are damaged. Onglyza increases the body’s production of incretin, which leads to rising levels of insulin and decreasing levels of blood sugar. Studies have demonstrated that incretin pathways are involved in the development of type 2 diabetes. Since incretin pathways are closely linked to the autonomic nervous system, it may be that diabetics who suffer from CAN respond differently to Onglyza than other diabetics.
Regardless of the cause, the fact that Onglyza increases the risk that certain type 2 diabetics will be hospitalized for heart failure has been accepted by an FDA advisory committee. That committee recommended that Onglyza should be marketed with a warning that diabetics who take Onglyza face an increased risk of heart failure if they have a history of heart disease or have a good chance of developing heart disease. The committee made its recommendation despite AstraZeneca’s statement to the committee that saxagliptin “is not associated with an unacceptable increase” in cardiovascular risk.
The Consequences of Heart Failure
AstraZeneca apparently believes that the increased risk of heart failure is not “unacceptable” because heart failure does not result in immediate death. Type 2 diabetics who experienced heart failure because they took Onglyza would disagree.
In the words of the American Heart Association, heart failure means the heart “can’t keep up with its workload.” The heart does not stop, but it no longer pumps as much blood as it should. Consequences of heart failure may include:
- Constant fatigue
- Shortness of breath
- Persistent coughing
- Diminished ability to walk, climb stairs, carry groceries, or engage in other moderate exercise
- Swollen feet, ankles, legs, or abdomen
- Nausea or loss of appetite
- Confusion, impaired thinking, and memory loss
In most instances, heart failure cannot be cured. Whether symptoms of heart failure brought on by Onglyza can be improved with treatment has yet to be determined.
Compensation for Onglyza Consumers Who Experienced Heart Failure
Hospitalization for heart failure leads to expensive medical bills. It may also lead to lost wages. If you were hospitalized for heart failure after taking Onglyza, you may be able to recover those expenses.
In addition, diabetics who experienced heart failure after taking Onglyza may be entitled to compensation for their pain and suffering, their diminished life expectancy, any disability they must endure, and their emotional distress.
A personal injury lawyer who accepts cases against the makers of Onglyza can help you evaluate your potential claim for compensation. You should ask for a free consultation immediately if you were hospitalized for heart failure after taking Onglyza. If you wait too long, you may lose your right to receive compensation. The attorneys at Advocate Law Group have decades of experience handling product liability and personal injury claims. We work with leading product liability firms nationwide to help our clients obtain results. Contact us for a free case evaluation.