The U.S. Food and Drug Administration has issued a warning that the type 2 diabetes drug Invokana may cause ketoacidosis, a serious condition that occurs when the body produces too many ketones. Symptoms of ketoacidosis include:
- Difficulty breathing
- Abdominal pain
- Unusual sleepiness
As of May 15th, 2015 the FDA reported receiving information about approximately 20 cases of ketoacidosis, in which all the stricken patients required emergency room visits or hospitalization to treat the condition. Most of these patients took Invokana for about two weeks before the symptoms began to appear.
What is Invokana?
Invokana, approved by the FDA in 2013, is part of a new class of type 2 diabetes drugs known as sodium-glucose-cotransporter-2 (SGLT2) inhibitors, along with Invokamet, Farixga, Jardiance, Glyxambi, and Xigduo.
SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. These medicines are available as single-ingredient products and also in combination with other diabetes medicines such as metformin (see Table 1 below). The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and FDA has not approved them for use in these patients.
Besides ketoacidosis, other potentially dangerous side effects the FDA associates with Invokana use include:
- Brain swelling
- Kidney failure
- Heart attack
Patients experiencing any of these side effects should consult with their doctors before discontinuing use of Invokana, as serious health problems may result if the medication is stopped suddenly.