FDA adds stronger kidney warnings for SGLT2 inhibitor drugs

Benedict Jephcote
Mon, 04 Jul 2016
FDA adds stronger kidney warnings for SGLT2 inhibitor drugs
The US Food and Drug Administration (FDA) have strengthened warnings relating to risks of acute kidney injury associated with dapagliflozin (Forxiga) and canagliflozin (Invokana).

The medications are type 2 diabetes drugs in the sodium-glucose co-transporter 2 (SGLT2) inhibitors drug class. The medications work by decreasing blood glucose levels by getting the kidneys to remove sugar through urine.

The new package labelling on the drugs will warn people of acute kidney injury risks, including risk-minimizing recommendations.

Doctors and nurse prescribers are now being urged to look at factors which further the risk of acute kidney injury before administering the drug, including chronic kidney insufficiency, decreased blood volume and congestive heart failure.

Healthcare professionals are also being asked to take care giving the medications alongside diuretics, ACE inhibitors, angiotensin II receptor blockers or non-steroidal anti-inflammatory drugs.

Between March 2013 and October 2015, 101 cases of acute kidney injury were confirmed and reported to the FDA. 73 of the reports related to canagliflozin and 28 with either canagliflozin or dapagliflozin use. A total of 96 people were admitted to hospitals and four died, while 15 people were given dialysis.

About half of reported acute kidney injury cases happened one month of first taking the drugs.

Within the UK, NICE guidelines state that canagliflozin and dapagliflozin should not be prescribed to people with low kidney function and that patients taking either of these drugs should have their kidney function regularly monitored to decrease the risk of adverse effects.
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