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FDA Puts Stronger Warning on Invokana, Invokamet Due to Kidney Risks

Jun 20, 2016

The warning labels on four diabetes drugs are being strengthened due to the risk of acute kidney injury. The U.S. Food and Drug Administration (FDA) is strengthening warnings on canagliflozin, sold under the brand names Invokana and Invokamet by Janssen Pharmaceuticals, and dapagliflozin, sold under the brand names Farxiga and Xigduo XR by AstraZeneca. These drugs may present a greater risk of worsening acute kidney injury than previously thought, the FDA said.

The agency said the revised label will "include information about acute kidney injury and added recommendations to minimize this risk," There were 101 cases of acute kidney injury confirmed from the drugs between March 2013 to October 2015, the FDA said. Of these, four died and one-fifth required hospitalization in intensive case, Law 360 reports.

Patients taking these diabetes medications should not stop treatment without consulting their physician, as it may cause dangerous changes in their blood sugar.

Acute kidney injury can be characterized by "decreased urine or swelling in the legs or feet," according to the FDA. Episodes of acute kidney injury occur when the kidneys suddenly lose function.

The FDA advised health care professionals to take extra considerations when prescribing these diabetes medications. Greater caution is especially recommended if the patient has a history of kidney problems.

In May, the FDA warned that Invokana and Invokamet were linked to amputations in a clinical trial. Those taking these drugs were twice as likely to undergo amputation compared to those taking a placebo. "Patients taking [canagliflozin] should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet," The safety alert stated that the incidence of amputations in patients taking a 300-milligram daily dose of canagliflozin equated to five of every 1,000 patients. For patients taking a 100-milligram daily dose, the equivalent risk was seven of every 1,000 patients. Comparatively, the risk among those taking a placebo was three of every 1,000 patients. The amputations mostly affected the toes, feet and legs.

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