US FDA warns diabetes drugs SGLT2 inhibitors might cause ketoacidosis
18 May 2015
The US Food and Drug Administration (FDA) issued a warning Friday regarding a widely used newer class of type 2 diabetes drugs sold by AstraZeneca, Johnson & Johnson and Eli Lilly in partnership with Boehringer Ingleheim.
The FDA said the drugs might cause dangerously high levels of blood acids that could require hospitalisation.
The oral drugs which belong to a class known as SGLT2 inhibitors, work by causing blood sugar to be secreted in the urine. These include AstraZeneca's Farxiga (dapagliflozin), J&J's Invokana (canagliflozin) and Jardiance (embagliflozin) from Lilly and Boehringer.
The FDA warned on its website, that the medicines might lead to ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones.
According to the FDA, 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 6 June 2014. It added all the affected patients required emergency room visits or hospitalisation for treatment of the condition.
The agency further said, it had continued to receive additional adverse event reports of diabetic ketoacidosis and ketoacidosis in patients treated with SGLT2 inhibitors.
The FDA now advises, ''Healthcare 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.''
According to the FDA the signs and symptoms associated with these complications now listed with these drugs include - nausea, confusion, difficulty breathing, vomiting, abdominal pain, and unusual fatigue or sleepiness.
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