FDA Investigating Link Between DPP-4 Inhibitors & Rhabdomyolysis
December 1, 2017 – FDA has received reports of rhabdomyolysis, a syndrome caused by injury to skeletal muscle, in patients with type 2 diabetes who have taken Jantadueto and other DPP-4 inhibitors. The agency has not yet offered any formal recommendations, and patients should talk to their doctor before switching medications or discontinuing use.
What’s the Problem?
Approved in January 2012, Jentadueto joined a group of widely-prescribed type 2 diabetes medications called incretin mimetics. Unfortunately, concerns have been raised about these drugs’ potential to cause a number of adverse side effects, including pancreatitis and pancreatic cancer. Lawsuits are currently being reviewed for diabetes patients who were injured after taking Tradjenta.
What is Jentadueto?
Jentadueto combines linagliptin and metformin to control blood glucose levels in patients with type 2 diabetes. Linagliptin works by increasing the amount of incretin (a hormone that raises insulin levels when blood sugar is high and decreases the amount of sugar made by the body) that is released by the intestines. Metformin works by reducing the amount of glucose made by the liver and by making it easier for glucose to enter into the tissues of the body.
Incretin Mimetics and Pancreatitis
Recent studies have identified a link between incretin mimetics like Jentadueto and an increased risk for pancreatitis. Although most people with pancreatitis never develop pancreatic cancer, chronic pancreatitis may lead to the disease over time. An Italian study published in 2014 confirmed the link between incretin mimetics and pancreatitis, and recommended caution in prescribing the drugs and close monitoring of exposed patients.
Pancreatic Cancer Symptoms
According to the Cancer Treatment Centers of America (CTA), signs and symptoms of pancreatic cancer include:
- Jaundice (yellowing of the skin and whites of the eyes)
- Digestive problems, including abnormal stools, nausea or vomiting
- Pain in the upper abdomen which can extend to your back
- Loss of appetite
- Sudden weight loss
- Swollen gallbladder (usually found by your doctor during a physical exam)
- Blood clots
Black Box Warning
The labeling of Jentadueto includes a black box warning alerting consumers about the risk of lactic acidosis attributed to the metformin contained in the drug. Lactic acidosis is a potentially fatal condition that occurs when lactic acid builds up in the bloodstream. If you feel you may be experiencing lactic acidosis, you should go to the hospital immediately.
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 Jentadueto 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 Jentadueto lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by Jentadueto side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.