Has the FDA Taken any Action Against the Makers of Invokana?

Has the FDA taken any action against the makers of Invokana?So far, the Food and Drug Administration has not issued a formal recall of Invokana or any other SGLT2 inhibitor. However, this should not come as any surprise. The FDA moves very slowly and is extraordinarily cautious in issuing a recall of any pharmaceutical product. The agency normally takes many years and conducts exhaustive investigations before reaching this decision. However, it has issued a warning for drugs containing canagliflozin (the active ingredient in Invokana), dapagliflozin, and empagliflozin as well as SGLT2 inhibitors generally because they may lead to "A serious condition where the body produces high levels of blood acids called ketones that may require hospitalization." In its warning (which you can read here: http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm), the FDA advised patients to keep an eye out for the following symptoms and tell their doctor if they appear:

  • Difficulty breathing
  • Nausea
  • Vomiting
  • Abdominal pain
  • Confusion
  • Unusual fatigue or sleepiness

Of course, the agency urged patients to continue taking their medication until they have spoken with a doctor but wanted them to also alert the FDA to any side effects in the following SGLT2 inhibitors:



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