Warnings

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If you are taking SGLT2 inhibitor to control diabetes or treat schizophrenia, it is important to exercise caution. The FDA has issued these warnings:

  • In May 2015, the the FDA issued a drug safety alert stating that SGLT2 inhibitors may lead to diabetic ketoacidosis. Approximately 20 problem reports, from patients going a an emergency room or hospital, were filed. If left untreated, the condition may result in death.
  • In September 2015, the FDA issued a warning about bone fractures resulting from the use of Invokana and Invokamet. The agency announced the ongoing evaluation of this risk related to other drugs in the SGLT2 inhibitor class.
  • In December 2015, the FDA ordered manufacturers of SGLT2 inhibitors to place notices of health risks on these drug labels. The FDA also issued new INVOKAMET warnings, alerting patients to get prompt medical assistance if they have a urinary tract infection. This symptom may signal a more dangerous blood or kidney infection, which could lead to kidney failure and even death. The FDA received at least 73 reports about ketoacidosis resulting from INVOKAMET or similar diabetes drugs.

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