Federal drug regulators are warning that Glyxambi, a new medication for type-2 diabetes, may raise a user’s risk of many life-threatening side effects.
Need a Texas Glyxambi Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a severe side effect, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Glyxambi Side Effects
- Bile duct disease
- Bullous pemphigoid
- Gallbladder disease
- Joint pain
- Pancreatic cancer and pancreatitis
- Rhabdomyolysis
FDA Evaluating Rhabdomyolysis Risk
The FDA is evaluating a potential signals of a serious risk and new safety information linking DPP4 diabetes drugs and rhabdomyolysis. This potentially life-threatening kidney side effect was identified by the FDA Adverse Event Reporting System (FAERS) between April and June 2017.
UPDATE: Glyxambi Linked to Severe Joint Pain
August 28, 2015 — The FDA has issued a Safety Communication about the risk of severe, disabling joint pain from Glyxambi. Click here to read more.
What is Glyxambi?
Glyxambi is a prescription medication for the treatment of type-2 diabetes. It is manufactured by Boehringer Ingelheim and was approved by the FDA in February 2015. Glyxambi actually combines two medications that help control blood-sugar levels in different ways:
- Empagliflozin: Marketed alone under the brand-name Jardiance, it is the third member of a new class of diabetes drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. It helps the kidneys excrete sugar in the urine, which lowers blood-sugar levels.
- Linagliptin: Sold alone under the brand-name Tradjenta by Eli Lilly & Co. It is a dipeptidyl peptidase-4 (DPP4) inhibitor that works by increasing hormones that tell the body to produce insulin, which helps lower blood-sugar levels.
Glyxmabi Side Effects
- Diabetic ketoacidosis
- Kidney infections
- Pyelonephritis
- Urosepsis
- Kidney failure
- Urinary tract infections
Glyxambi and Kidney Failure
Having diabetes increases your risk of diabetic nephropathy and kidney failure. Therefore, the risks vs. benefits of any diabetes medication with kidney side effects must be carefully considered.
The FDA warns that Glyxambi can cause infections that spread to the bloodstream or kidneys (called “pyelonephritis“) and cause kidney failure. About 12% of Glyxambi patients developed urinary infections during clinical trials. Dehydration, another very common side effect of Glyxambi, can also cause kidney failure.
Glyxambi Linked to Diabetic Ketoacidosis
According to a Safety Communication issued in May 2015, Glyxambi and other SGLT2 inhibitors are associated with a life-threatening condition known as diabetic ketoacidosis.
SGLT2 inhibitors have only been on the market since March 2013. By June 2014, the FDA received 20 reports of diabetic ketoacidosis. More cases have been reported since then. All of the patients were hospitalized.
The FDA warned:
“Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.”
101 Cases of Ketoacidosis Linked to SGLT2 Inhibitor Diabetes Drugs
The European Medicines Agency (EMA) opened an investigation and warned that 101 cases of diabetic ketoacidosis had been linked to SGLT2 inhibitors as of May 19. All of the cases were serious, some patients had to be hospitalized, and in several cases patients had relatively normal blood-sugar levels:
“ Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports blood sugar levels were only moderately increased. These uncharacteristic blood levels could delay diagnosis and treatment.”
What is Ketoacidosis?
Diabetic ketoacidosis is an emergency medical condition that occurs when blood-sugar levels get very high and the body starts breaking down fat cells to use as fuel.
This releases acidic waste products known as ketones, which can build up in the body until life-threatening complications occur. Left untreated, ketosis can lead to cerebral edema, coma, and death.
Common Symptoms of Diabetic Ketoacidosis
- Decreased alertness
- Deep, rapid breathing
- Dry skin and mouth
- Flushed face
- Frequent urination or thirst that lasts a day or more
- Fruity-smelling breath
- Headache
- Muscle stiffness or aches
- Nausea and vomiting
- Stomach pain
Pancreatitis and Pancreatic Cancer
Glyxambi is associated with inflammation of the pancreas (pancreatitis), which can be severe and lead to death. In March 2013, the FDA is began investigating studies linking DPP-4 inhibitors (such as linagliptin, an ingredient in Glyxambi) with a possible risk of pancreatic cancer.
Texas Glyxambi Class Action Lawyer
The Clark Firm, LLP is a nationally-recognized team of trial attorneys in Texas. However, we are not filing a Glyxambi class action at this time. Instead, we are filing individual lawsuits and only accepting cases involving serious injuries
Need a Glyxambi Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Glyxambi lawyers for a free lawsuit review.