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FDA Issues Warning About Diabetes Drug

A new diabetes drug may cause a serious medical condition which raises the level of acid in the blood. The Food and Drug Administration (FDA) has warned that Invokana may lead to ketoacidosis, a health condition where the body produces high levels of blood acids called ketones, causing a severe accumulation of keto acids and decreasing PH of the blood. In more serious cases, ketoacidosis may require hospitalization – and can be fatal. The warning includes all medications in the class of prescription medicines – SGLT2 Inhibitors – including Farxiga, Invokamet, Glyxambi, Xigduo XR and Jardiance .

FDA Warning

Invokana is a popular drug by Johnson & Johnson, and part of a class of oral medicines (SGLT2 inhibitors) that are used, along with diet and exercise, to lower blood sugar in adults with type 2 diabetes. Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels.

The FDA said its Adverse Event Reporting System database identified 20 cases of  acidosis reported as diabetic ketoacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors between March 2013 to June 6, 2014. All the affected patients required emergency room visits or hospitalization to treat the condition. Government warns about new class of type 2 diabetes drugs

In March 2013, the U.S. Food and Drug Administration (FDA) approved Invokana to treat type 2 diabetes – it was the first in this new class of diabetes drugs to receive FDA approval. 

On May 15, 2015, the FDA issued a safety announcement advising patients using Invokana and other SGLT2 inhibitors to be aware of any signs of ketoacidosis and seek immediate medical attention if they experience possible Invokana side effects such as difficulty breathing, nausea, vomiting, abdominal pain, confusion and unusual fatigue or sleepiness.

Additionally, the FDA said health care professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.

“We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs,” the FDA said in its announcement.

Type 2 diabetes is the most common form of the disease, affecting about 24 million people and accounting for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.