Our lawyers are reviewing potential lawsuits for individuals who were diagnosed with pancreatic cancer or bullous pemphigoid after taking Kombiglyze XR (saxagliptin and metformin), a type 2 diabetes medication.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by Kombiglyze XR side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: Study Highlights Risks of Combining Kombiglyze XR with Other Diabetes Drugs
June 23, 2016 – A new study published in the British Medical Journal (BMJ) has found that combining DPP-4 inhibitors like Kombiglyze XR with “sulphonylureas” may increase the risk of hypoglycemia (low blood sugar), a potentially life-threatening condition.
What is Kombiglyze XR?
Kombiglyze XR contains a combination of metformin and saxagliptin, oral diabetes drugs that help maintain blood sugar levels in type 2 diabetics. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose in the intestinal tract. Saxagliptin works by regulating insulin levels the body produces after eating. Kombiglyze XR is manufactured by Bristol-Myers Squibb (BMS), and marketed in a joint partnership between BMS and AstraZeneca Pharmaceuticals LP.
Kombiglyze XR Side Effects
Kombiglyze XR is an incretin mimetic diabetes drug, and belongs to a class of medications which have recently been linked to the following serious side effects:
- Pancreatic Cancer
- Thyroid Cancer
- Acute Pancreatitis
- Hemorrhagic Pancreatitis
- Necrotizing Pancreatitis
- Kidney Complications
- Renal Failure
- Heart Failure
Kombiglyze XR and Pancreatic Cancer
In March 2013, the FDA launched an investigation into the link between incretin mimetics like Kombiglyze XR and pancreatic cancer. The investigation was initiated after the results of a recent study identified pre-cancerous cellular changes in pancreatic tissue taken from type 2 diabetics treated with this class of medications. European health authorities also recently launched a similar review investigating the association between incretin mimetics and pancreatic cancer.
According to an April 2013 report issued by the Institute for Safe Medication Practices (ISMP), more than 100 cases of pancreatic cancer in incretin mimetic users were reported to the FDA during the 12 month period ending in June 2012. However, it is commonly accepted that only 1 to 10% of all adverse reactions associated with prescription medications are ever actually reported to the FDA. Signs and symptoms of Kombiglyze pancreatic cancer may include:
- dark urine
- clay-colored stools
- loss of appetite
- weight loss
- pain or discomfort in the upper part of the belly or abdomen
- back pain
- blood clots
Another disease that has recently been associated with incretin mimetic diabetes drugs like Kombiglyze XR is thyroid cancer, a life-threatening condition that occurs in the thyroid gland. The disease occurs when abnormal cells in the thyroid gland mutate, multiply, and form cancerous tumors that affect the organ’s ability to function properly. In its early stages, the disease may not cause any significant identifiable symptoms. But as Kombiglyze XR thyroid cancer grows, symptoms may include:
- a lump in the front of the neck near the Adam’s apple
- hoarseness / difficulty speaking
- swollen lymph nodes
- problems with swallowing / breathing
- throat or neck pain
FDA Warns of Heart Failure Risk with Kombiglyze XR
April 5, 2016 – The U.S. Food & Drug Administration (FDA) announced today that saxagliptin and alogliptin-containing type 2 diabetes drugs may increase the risk of heart failure, especially in patients who have a history of heart or kidney disease. FDA will be adding new warnings to the labeling of affected drugs outlining this safety issue. The agency’s warning is based on 2 large clinical trials which found that saxagliptin and alogliptin users were hospitalized for heart failure more often than patients who received a placebo (inactive treatment).
Kombiglyze XR Linked to 27% Increased Risk of Heart Failure: Study
On February 11, 2014, FDA issued a Safety Communication announcing that it had launched an investigation in response to a New England Journal of Medicine (NEJM) study that linked Kombiglyze to a 27% increased risk of hospitalization for heart failure.
According to the FDA:
“Patients should not stop taking saxagliptin and should speak with their health care professionals about any questions or concerns. Health care professionals should continue to follow the prescribing recommendations in the drug labels.”
Heart Failure Symptoms
- Diminished exercise capacity
- Shortness of breath
- Swelling (edema)
FDA Warning: DPP-4 Inhibitor Diabetes Drugs Linked to Bullous Pemphigoid
Post-marketing cases of a rare skin disease called bullous pemphigoid (BP) have been reported with DPP-4 inhibitor use. In reported cases, patients typically recovered with
topical or systemic immunosuppressive treatment and discontinuation of the offending medication.
Bullous pemphigoid causes symptoms of blistering on the arms, legs, abdomen, and mucous membranes. Hives and itching are also common signs of the condition. The blisters have the following characteristics, regardless of where on the body they form:
- Red rash develops before the blisters
- Blisters are large and filled with fluid that is typically clear but may contain blood
- Blisters are thick and do not rupture easily
- Skin around the blisters may appear normal or slightly red or dark
- Ruptured blisters are usually sensitive and painful
Do I have a Kombiglyze XR Lawsuit?
The Product Liability & Defective Drug 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 pancreatic cancer cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one developed pancreatic cancer after taking Kombiglyze XR, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.