The U.S. Food & Drug Administration (FDA) has issued a new warning about an increased risk of heart failure in patients who use dipeptidyl peptidase–4 (DPP-4) inhibitor diabetes medications.
Free Confidential Lawsuit Evaluation: If you or a loved one developed heart failure after taking a type 2 diabetes drug, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
April 5, 2016 – DPP-4 inhibitors will have their labeling updated with a warning indicating the drugs may increase the risk of heart failure, particularly in patients who have a history of cardiovascular or kidney disease.
“Healthcare professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control,” FDA said. “If a patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.”
Affected medications include:
- Onglyza (saxagliptin)
- Nesina (alogliptin)
- Kombiglyze XR (saxagliptin and metformin)
- Oseni (alogliptin and pioglitazone)
- Kazano (alogliptin and metformin)
The warning follows an internal safety review of 2 large trials of patients with cardiovascular disease, and a recommendation for the labeling update by FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.
The committee expressed greater concern about heart failure with saxagliptin than for alogliptin, but because the mechanism of action is not clearly understood and the 2 drugs belong to the same class, they decided to recommend the warning on both medications.
A third large cardiovascular trial with another DPP-4 inhibitor, sitagliptin (Januvia), showed no indication of heart failure in type 2 diabetes patients who took the drug.
SAVOR and EXAMINE
Results of the 2 studies that prompted the heart failure warning — Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Moderate or Severe Renal Impairment (SAVOR-TIMI 53) and Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome (EXAMINE) — were initially presented at the European Society of Cardiology (ESC) meeting in 2013 and subsequently published in the New England Journal of Medicine (NEJM).
SAVOR-TIMI 53 involved 16,492 type 2 diabetics with a history of cardiovascular disease, or who were at risk for cardiovascular disease, and found no overall risk for cardiovascular events. However, there was a 27% increase (3.5% vs 2.8%) in hospitalization for heart failure and a potential increased risk for all-cause mortality. Risk factors included a pre-existing history of heart failure or renal impairment.
In EXAMINE, which included 5380 test subjects, 3.9% of patients treated with alogliptin were hospitalized for heart failure vs 3.3% of patients receiving placebo. Although the difference was not statistically significant (hazard ratio, 1.19), heart failure was not determined to be an end point of the study.
Do I Have a Diabetes Drug Heart Failure Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in diabetes drug lawsuits. We are handling individual litigation nationwide and currently accepting new heart failure cases in all 50 states.
Free Confidential Case Evaluation: Again, if you got heart failure from a type 2 diabetes medication, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.