Glyxambi may be Linked to Rhabdomyolysis, FDA Warns
December 1, 2017 – The U.S. Food & Drug Administration (FDA) is investigating a potential link between Glyxambi and other type 2 diabetes medications in its class and a severe muscular condition known as rhabdomyolysis, according to a surveillance report issued October 6. Signs and symptoms of rhabdomyolysis include dark, reddish urine, a decreased amount of urine, weakness, and muscle aches.
What is Glyxambi?
Glyxambi is a diabetes drug that contains empagliflozin and linagliptin. Empagliflozin is a Sodium Glucose Transporter inhibitor type 2, and linagliptin is a DPP-4 inhibitor. Approved in February 2015, Glyxambi is the first prescription drug in the U.S. to combine the dual mechanisms of action of SGLT2 and DPP-4 inhibitors.
Ketoacidosis Risk with New Diabetes Drugs: FDA Warning
On May 5, 2015, the FDA issued a Drug Safety Communication stating that Glyxambi and other SGLT2 medications had been linked to ketoacidosis (also known as DKA, diabetic acidosis, metabolic acidosis or ketoacidosis), a complication of uncontrolled diabetes mellitus characterized by a combination of ketosis and acidosis. Ketosis is the accumulation of substances called ketones and ketone bodies in the blood, and acidosis is increased acidity of the blood.
Between March 2013 and June 6, 2014, FDA received at least 20 reports of the condition in patients who took SGLT2 diabetes drugs. In all cases, patients required either hospitalization or emergency room treatment. Since 2014, the agency has continued to receive reports of ketoacidosis associated with diabetes medications. As a result of these problems, on Dec. 4, 2015, FDA announced that it was requiring the labels of all SGLT2 inhibitors to be updated with information about the ketoacidosis risk.
SGLT2 Inhibitor List
- Glyxambi (empagliflozin and linagliptin)
- Farxiga (dapagliflozin)
- Invokana (canagliflozin)
- Invokamet (canagliflozin/metformin)
- Jardiance (empagliflozin)
- Xigduo XR (dapagliflozin/metformin HCl extended-release)
Signs of Ketoacidosis
DKA symptoms may include:
- Decreased alertness
- Rapid breathing
- Dry skin and mouth
- Flushed face
- Frequent urination
- Fruity-smelling breath
- Muscle stiffness or aches
- Nausea / vomiting
- Stomach pain
Treatment & Prognosis (Outlook)
Ketoacidosis is a medical emergency and should be treated in a hospital setting. Treatment includes administering intravenous fluids, insulin, glucose and dietary changes.
The overall mortality rate for ketoacidosis is 2% or less. The presence of diabetic coma at the time of diagnosis, hypothermia, and oliguria are signs of poor prognosis. However, the long-term outlook for properly treated patients is generally excellent, especially in younger patients. Unfavorable prognosis is typically observed in older patients with severe intercurrent illnesses, especially when these patients are treated outside an intensive care unit.
Glyxambi Side Effects
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Acidosis, Ketoacidosis)
- Heart Attack
- Kidney Failure (Renal Failure)
- Kidney Cancer
- Kidney Stones
- Bone Fractures
- Bone Abnormalities
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
DPP-4 Inhibitors Linked to Severe Joint Pain
August 28, 2015 – The FDA warned today that Tradjenta and other DPP-4 inhibitor diabetes medications may cause joint pain that can be severe and disabling. The agency stated that it has added a new warning about the risk to the labels of all products in the DPP-4 inhibitor class.
Tradjenta and Bullous Pemphigoid
A study published in the journal Dermatology in 2016 looked at 3 cases of DPP-4 inhibitor use associated with bullous pemphigoid, a rare skin disorder that causes symptoms of blistering on the arms, legs, abdomen, and mucous membranes. All 3 patients showed a clear temporal relationship between DPP-4 inhibitor therapy and the onset of BP. One case was due to Tradjenta use, while the other 2 cases were linked to a combination of vildagliptin-metformin.
Is There a Recall?
Despite being linked to numerous reports of adverse effects, Glyxambi has not been recalled in the U.S. or any other country. From a legal standpoint, the investigation into the drug’s effects is still in its early stages. However, the FDA’s warning on SGLT2 inhibitors has highlighted some of the potential health risks associated with the medications, which may lead to a nationwide recall at some point in the future.
Do I Have a Glyxambi 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 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 has been injured by the side effects of Glyxambi, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.