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FDA strengthens Invokana, Farxiga kidney risk warning

  On June 14, 2016, FDA issued a drug safety newsletter to modify the SGLT2 inhibitor Invokana / Invokamet and Farxiga / Xigduo XR label warnings to add information on acute kidney injury and how to minimize the risk of kidney damage.

  According to a press release from the FDA, 101 cases of Invokana / Invokamet and Farxiga / Xigduo XR have been received from March 2013 to October 2015, SLE) -related acute renal injury reported that some patients need hospitalization and dialysis treatment.

  The drug safety advisory advises health care professionals to "fully consider increasing risk factors for acute kidney injury before prescribing canagliflozin or dapagliflozin," including reduced blood volume, chronic renal insufficiency, congestive heart failure, diuretics, ACE Inhibitors, angiotensin receptor blockers and non-steroidal anti-inflammatory drugs and other drugs.

  The FDA also recommends that patients take renal function before taking any of the two drugs, and should monitor renal function during medication. If patients with acute kidney injury, should be immediately discontinued and given treatment.

  FDA suggested that acute renal injury symptoms - decreased urine output, lower limb swelling - patients should promptly seek medical treatment, after the guidance of professional medical personnel before withdrawal.

  Source: FDA strengthens kidney warnings on Invokana, Farxiga labels.Healio.June 14, 2016.


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