SGLT2 Inhibitors (Invokana, Invokamet, Farixga, Xigduo XR, Jardiance, Glyxambi, Synjardy)
In June 2016, FDA required manufacturers of Invokana®, Invokamet®, Farxiga®, and Xigduo XR® to strengthen warnings on their drug labels to include an association with kidney failure soon after beginning to take the drug. FDA reports that some patients’ kidneys suddenly stopped working within one month of use, among other possible ailments. While many received dialysis after being hospitalized, some cases tragically resulted in death.
Motley Rice Diabetes Attorneys
Experiencing complications from a prescription can be scary and confusing when you are diabetic. Motley Rice attorneys Kimberly Barone Baden, Fred Thompson and Ann E. Rice Ervin, along with our staff, have worked with hundreds of diabetic patients, helping them navigate drug lawsuits, including Actos® and Duetact®, which have been linked to an increased risk of developing bladder cancer, as well as incretin mimetics Januvia®, Victoza®, Janumet® and Byetta® which are linked to pancreatic cancer.
What are SGLT2 Inhibitors?
Medications affected by FDA’s June 2016 ruling fall into a class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors that are approved for use in adults with type 2 diabetes for lowering blood sugar. This class includes drugs such as:
- Invokana® (canagliflozin)
- Invokamet® (canagliflozin and metformin)
- Farxiga® (dapagliflozin)
- Xigduo XR® (dapagliflozin and metformin extended-release)
- Jardiance® (empagliflozin)
- Glyxambi® (empagliflozin and linagliptin)
- Synjardy® (empagliflozin and metformin).
Invokana and other SGLT2 Inhibitor Side Effects
Symptoms of kidney failure:
- A reduced amount of urine
- Drowsiness or fatigue
- Pain in your chest
- Swelling of your legs, ankles, and feet caused by fluid retention
- Unexplained shortness of breath
Symptoms of ketoacidosis:
- Abdominal pain
- Difficulty breathing
- Unusual fatigue or sleepiness
And can lead to severe complications such as:
- Abnormal weight loss
- Angioedema (rapid swelling of tissues, often around the eyes and lips)
- Heart attack
- Kidney failure or impairment
- Kidney stones
FDA Warnings Related to Some Diabetes Medicines
In 2015 FDA forced manufacturers to strengthen side effect warnings on Invokana and other SGLT2 inhibitors after linking these drugs to a serious complication called ketoacidosis, also known as diabetic ketoacidosis (DKA) or ketosis. DKA can lead to severe kidney complications, heart attack, stroke or even death.
Ketoacidosis, or an excess of blood acids, occurs when the body is unable to regulate the natural production of ketones and the pH balance of the blood drops significantly. For type 1 diabetics, this is often accompanied by a spike in blood sugar levels. For type 2 diabetics, however, blood sugar levels may only increase slightly and symptoms may not be evident until they become severe.
While Invokana is only approved for use with type 2 diabetics, it has been known to be prescribed to type 1 diabetics as well as being off-label marketed as a weight loss drug.
Motley Rice LLC, a South Carolina Limited Liability Company, is engaged in the New Jersey practice of law through Motley Rice New Jersey LLC. Esther Berezofsky attorney responsible for New Jersey practice.