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FDA Investigating Ongoing Reports of Dangerous Ketoacidosis in SGLT2 Inhibitor Patients

In the wake of renewed government investigations, The Bongiorno Law Firm is investigating adverse events relating to Invokana and other SGLT2 inhibitors linked to diabetic ketoacidosis and kidney failures. This newer class of drugs used to treat type 2 diabetes (Sodium-glucose cotransporter-2 or SGLT2 inhibitors) has been connected with dangerously high levels of blood acids that can poison the body.

The Food and Drug Administration (FDA) is currently investigating numerous reports of ketoacidosis in patients taking these drugs. Symptoms of diabetic ketoacidosis may include difficulty breathing, nausea, vomiting, abdominal pain, confusion, or unusual fatigue or sleepiness.

These new drugs are prescribed for lowering an individual’s blood sugar. In television and other advertisements, pharmaceutical companies advertise that SGLT2 inhibitors work by removing the sugar through the kidneys and then out of the body through urination.
The most common SGLT2 inhibitor brands include:

  • Invokana® (Approved March 2013)
  • Farxiga® (Approved January 2014)
  • Jardiance® (Approved August 2014)

Other drugs in the class include Invokamet™, Xigduo XR™ and Glyxambi®, combination type 2 diabetes treatments that include an SGLT2 inhibitor drug as one of its two components.

SGLT2 Inhibitors also Linked to Kidney Injuries

The Institute for Safe Medication Practices (ISMP) stated in May 2015 that the FDA had received 457 adverse event reports for Invokana in a 12-month period since the drug launched. Among the reports, 54 involved kidney failure or renal injury. Additionally, some patient safety advocates feel that other red flags may point to increased risk of cardiovascular problems such as heart attack or stroke.

Contact The Bongiorno Law Firm for a free consultation.
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