The diabetes medication Glyxambi (generic: empagliflozin and linagliptin) has been linked to diabetic ketoacidosis, urinary tract infections, bullous pemphigoid and other adverse effects, according to a warning by the U.S. Food & Drug Administration (FDA).
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by Glyxambi, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: SGLT2 Inhibitor Drugs Linked to Flesh-Eating Genital Infections
August 29, 2018 - FDA is warning that type-2 diabetes drugs from the SGLT2 inhibitor class have recently been linked to a gruesome type of genital infection called necrotizing fasciitis of the perineum, also known as Fournier’s gangrene. The condition has been conclusively diagnosed in at least a dozen patients, all of whom required hospitalization and surgery, including one who died from complications resulting from the condition.
What is Glyxambi?
Glyxambi is a sodium-glucose cotransporter-2 (SGLT2) diabetes medication that contains two active ingredients, empagliflozin and linagliptin. The drug works by decreasing the amount of sugar the body absorbs and increasing the amount of sugar removed through the body in the urine. Glyxambi is made by Boehringer Ingelheim, and was approved by the FDA in February 2015.
Type 2 Diabetes Medications Linked to Ketoacidosis
From March 2013 to June 6, 2014, FDA received at least 20 reports of diabetic ketoacidosis (also known as DKA, diabetic acidosis, metabolic acidosis or ketoacidosis) in patients who took SGLT2 inhibitor diabetes medications. The condition occurs when levels of blood acids called ketones are too high. If left untreated, ketoacidosis can lead to a diabetic coma or even death, according to the American Diabetes Association (ADA).
According to the FDA, all 20 patients required hospitalization or a trip to the emergency room to treat the condition. As a result of these problems, on Dec. 4, 2015, the agency issued a Drug Safety Communication stating that it was requiring the labels of all SGLT2 inhibitors to be updated with information about the diabetic ketoacidosis risk.
Which Diabetes Drugs are SGLT2 Inhibitors
In addition to Glyxambi, other SGLT2 inhibitors include:
- Invokana (canagliflozin)
- Invokamet (canagliflozin and metformin)
- Jardiance (empagliflozin)
- Farxiga (dapagliflozin)
- Xigduo XR (dapagliflozin and metformin extended-release)
DKA (Ketoacidosis) & Ketones
When cells don't get enough glucose, the body begins to burn fat for energy, which produces ketones. When ketones accumulate in the blood, they make it more acidic. Elevated ketone levels are a warning sign that a diabetic’s blood sugar levels are out of control or that a person is getting sick. When levels get too high, a person can develop diabetic ketoacidosis (DKA).
Ketoacidosis Warning Signs
- Difficulty breathing
- Abdominal pain
FDA to Investigate Glyxambi / Rhabdomyolysis Link
December 1, 2017 - The U.S. Food & Drug Administration (FDA) is evaluating the need for regulatory action over Glyxambi and other DPP-4 inhibitor diabetes medications after finding an increased risk of rhabdomyolysis with the drugs, according to a surveillance report issued October 6. Rhabdomyolysis is a severe medical condition characterized by the rapid destruction of skeletal muscle, which causes leakage into the urine of the muscle protein myoglobin.
Diabetes Drugs Can Cause Severe Joint Pain, FDA Says
August 28, 2015 - The entire class of DPP-4 diabetes medications can cause severe joint pain in some users, the FDA warned today. "The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling," the agency said.
Glyxambi Side Effects
- Diabetic ketoacidosis (DKA, diabetic acidosis, metabolic acidosis, ketoacidosis)
- Heart attack (myocardial infarction or MI)
- Kidney failure
- Urinary tract infections (UTIs)
- Yeast infections of the vagina or penis
- Changes in urination, including urgent need to urinate more often, in larger amounts, or at night
- Low blood sugar (hypoglycemia)
- Joint pain
- Increased fats in your blood (bad cholesterol or LDL)
DPP-4 Inhibitors Linked to Rare Skin Disorder
In October 2016, the FDA asked manufacturers of DPP-4 inhibitor diabetes drugs to add a label change to their products regarding an increased risk of bullous pemphigoid, a rare skin disorder that causes symptoms of blistering on the arms, legs, abdomen, and mucous membranes. All patients who developed the disease had severe outcomes, including one person who died. As a result of these problems, FDA required a class-wide label change to reflect the risk of bullous pemphigoid with DPP-4 inhibitors.
Has There Been a Recall?
At this time, neither Glyxambi nor any other drug from the SGLT2 inhibitor class has been recalled. However, the FDA warnings have highlighted potential health risks of the medications, and it is anticipated that lawsuits will allege that drugmakers failed to adequately warn of the dangers associated with their use.
Do I Have a Glyxambi 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 Glyxambi lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by the side effects of Glyxambi, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.