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FDA Adds Cases of Patient Injury in New Invokana Warnings

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Patients taking Invokana for diabetes may already be aware of potentially harmful side effects. However, the U.S. Food and Drug Two Medication Bottles Filled With White PillsAdministration (FDA) has released in a new warning about the drug only six months after patients were placed on high alert—and this time, they know just how many patients have suffered due to the medication.

FDA Increases Warnings About Invokana Due to High Injury Rates

On December 4, 2015, the FDA released results of a safety review of type-2 diabetes medications called sodium-glucose cotransporter-2 (SGLT2) inhibitors. These medications include Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance, Glyxambi, and Synjardy, all of which will see additional warnings on their labels due to increased risk of life-threatening conditions.

According to the FDA, patients taking SGLT2 inhibitors should be wary of:

  • Ketoacidosis. Over 70 patients were reported as hospitalized with ketoacidosis while taking SGLT2 inhibitors between March 2013 to May 2015, although the FDA suspects that the actual number is much higher. Ketoacidosis is a potentially fatal condition that is caused by high levels of blood acids (ketones). These patients either required hospitalization, emergency room treatment, or both, and in many cases the condition was not immediately recognized due to lower than average glucose levels.
  • Kidney infections. The study also discovered 19 cases of serious kidney infections reported between March 2013 through October 2014 in patients taking SGLT2 inhibitors. These injuries began as urinary tract infections and spread throughout the patients’ systems—requiring hospitalization, stays in intensive care units, and in some cases, dialysis for kidney failure.
  • Marketing testing. In order to reduce the risks to patients, the USDA has mandated that all manufacturers of SGLT2 inhibitors must conduct enhanced pharmacovigilance studies on their products. Drug makers are required to analyze all post marketing reports of ketoacidosis in patients talking SGLT2 inhibitors, and perform reasonable and dedicated follow-up for a period of five years.

What Should I Do If I am Taking SGLT2 Inhibitors for Diabetes?

Both patients and health care providers should be extremely careful when considering treatment with SGLT2 inhibitors. Patients should be aware of the warning signs of ketoacidosis, including nausea, vomiting, shortness of breath, fatigue, and abdominal pain. Patients could be suffering from ketoacidosis even if their blood sugar levels are not excessively high. Patients should also seek treatment at the first sign of a urinary tract infection, such as pain, burning, or bleeding, while urinating and an increase in urination frequency.

If you were hospitalized for any of these symptoms while taking an SGLT2 inhibitor, you may be owed compensation for your suffering. Call us today at 800-237-3334 to discuss the details of your dangerous drug injury at no cost to you.


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