The FDA recently issued a Black Box Warning for users of diabetes medication, Invokana®. The new safety alert states that Invokana® has been shown to increase the risk of leg, foot and toe amputations. The notification is based on final results of clinical trials which show that Invokana® users may have a risk that is twice as high as normal.
In May of 2015, the FDA announced that a new class of type 2 diabetes medication, SGLT2 inhibitors may lead to “ketoacidosis”, a condition in which the body produces abnormally elevated amounts of blood acid. When this is left untreated, ketoacidosis can lead to diabetic comas and even death.
Symptoms of ketoacidosis include:
- Disorientation/ confusion
- Excessive fatigue/ drowsiness
- Nausea and vomiting
- Abdominal pain
- Difficulty breathing
A diabetic ketoacidosis is a form of ketoacidosis that is common among type 1 diabetics but rare among patients with type 2 diabetes. The FDA continued to monitor reports after receiving a great amount of adverse event reports in which patients prescribed SGLT2 inhibitors like INVOKANA® suffered near-fatal cases of the condition.
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