Update: DPP-4 Inhibitors Linked to Rhabdomyolysis
December 1, 2017 – Diabetes patients who took DPP-4 inhibitors like Kombiglyze XR have been diagnosed with a rare muscular disease called rhabdomyolysis, according to the FDA Adverse Event Reporting System (FAERS). Rhabdomyolysis occurs when damaged skeletal muscle breaks down rapidly. Symptoms may include muscle pains, weakness, vomiting, and confusion.
What is Kombiglyze?
Kombiglyze XR combines saxagliptin and metformin for the treatment of type 2 diabetes. The drug is classified as an incretin mimetic, and works by mimicking metabolic hormones (incretins) and increasing GLP-1, a hormone that stimulates the pancreas to secrete more insulin. Kombiglyze XR is jointly manufactured by Bristol-Myers Squibb and AstraZeneca, and was approved by the U.S. Food & Drug Administration (FDA) in November 2010.
Kombiglyze Side Effects
The problem with any new drug is that sometimes there are unanticipated side effects that were not identified during pre-approval clinical trials. Kombiglyze belongs to a relatively new class of type 2 diabetes medications that have been increasingly linked to reports of the following serious side effects:
- Acute pancreatitis (pancreas inflammation)
- Pancreatic cancer
- Thyroid cancer
- Heart failure
- Lactic acidosis
- Impaired liver function
- Kidney problems
- And more
Kombiglyze and Cancer
Kombiglyze XR has been linked to reports of:
- Pancreatic Cancer – Studies have linked Kombiglyze to pancreatitis, a major risk factor for pancreatic cancer. Other incretin mimetics have been associated with dozens of reports of pancreatic cancer in the FDA adverse event database, and the agency has warned about “pre-cancerous cellular changes” in the pancreas of patients taking these types of diabetes medications.
- Thyroid Cancer – Victoza, another incretin mimetic, has been shown to cause malignant thyroid cancer in laboratory rats at clinically relevant doses. An FDA Safety Alert was issued as a result of these findings.
Kombiglyze Linked to 27% Increased Risk of Heart Failure
In February 2014, the FDA issued a Drug Safety Communication after the New England Journal of Medicine (NEJM) published a study linking saxagliptin (one of the main active ingredients in Kombiglyze XR) to a 27% increased risk of heart failure. As a result of these problems, FDA conducted an analysis from the SAVOR clinical trial, which was performed by AstraZeneca and Bristol Myers-Squibb. These actions are part of a broader investigation into the heart risks associated with type 2 diabetes medications.
Heart Failure Symptoms
- Congested lungs
- Fluid / water retention
- Dizziness / fatigue / weakness
- Rapid / irregular heartbeats (arrythmias)
A rare skin disease called bullous pemphigoid that causes severe skin blistering has been linked to Jentadueto and all other diabetes drugs from the DPP-4 inhibitor class. In October 2016, FDA asked manufacturers of DPP-4 inhibitors to add a bullous pemphigoid warning to their products’ labeling after the agency received multiple reports of the condition associated with the drugs. Each case had severe health outcomes, half of them required hospitalization and one died.
MDL Proposed for Kombiglyze Heart Failure Lawsuits
Nov. 1, 2017 – A man alleging to have developed heart failure from the use of Onglyza has requested multidistrict litigation (MDL) status for claims involving Onglyza and Kombiglyze XR. Plaintiff suggested the Northern District of California as the venue for the proposed litigation, noting that several cases have already been filed there, and that at least one plaintiff is based in San Francisco.
Bristol-Myers Squibb, AstraZeneca Sued for Kombiglyze Heart Failure
July 24, 2017 – A New Jersey man who claims that he developed coronary artery disease and congestive heart failure after taking saxagliptin has filed a products liability lawsuit against Bristol-Myers Squibb and AstraZeneca Pharmaceuticals. Plaintiff Earl Binns alleges that the drugmakers are responsible for his injuries because they had known for years that the diabetes drug could increase the risk of catastrophic heart damage.
Kombiglyze XR May Increase Risk of Heart Failure, FDA Warns
April 5, 2016 – Type 2 diabetes medications containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease, according to an FDA Warning issued today. As a result of these problems, the agency is requiring that the drugs’ labeling be updated to include information about the heart failure risk.
Do I Have a Kombiglyze XR Class Action Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Kombiglyze XR lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Confidential Case Evaluation: Again, if you got pancreatic cancer from Kombiglyze, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.