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FDA Provides Additional Warnings for SGLT2 Inhibitors

On Behalf of | Dec 7, 2015 | Pharmaceutical Liability

In May, the United States Food and Drug Administration released information advising physicians and patients to be cautious about the risks related to SGLT2 inhibitors. Now, the FDA has updated the warning label for the drugs to include the risk of ketoacidosis and severe urinary tract infection.

SGLT2 inhibitors, like the drug Invokana, work to improve glycemic control in patients with Type II Diabetes. SGLT2 medications were released after studies showed that they successfully helped to lower blood sugar levels in patients with the disease. However, the drugs prompt the kidneys to remove glucose from the body at rapid rates through an individual’s urine. This very process can lead to the diminishment of all glucose within the blood, generating the necessity for the body to burn fat for energy, and in some cases causing ketoacidosis—a highly dangerous condition that occurs when the body produces high levels of blood acids.

Between March, 2013, and May, 2015, the FDA has received 92 adverse event reports regarding the class of drugs. 73 of those reports detailed cases of ketoacidosis in patients, and 19 dealt with patients who had been hospitalized due to potentially fatal urosepsis and pyelonephritis that began as urinary tract infections. The FDA has stated that patients who develop any of the following symptoms should stop taking the medication and consult with their physician immediately:

  • Difficulty breathing
  • Vomiting
  • Nausea
  • Confusion
  • Unusual Fatigue
  • Abdominal Pain

The FDA has also required that SGLT2 manufacturers conduct post-marketing studies assessing the reported incidences of ketoacidosis in patients who are taking, or have previously taken, the medication.

If you, a patient or a loved one has been prescribed an SGLT2 inhibitor and have suffered ketoacidosis or a urinary tract infection, the FDA has requested that you file an adverse event report here.