FDA Intensifies Warnings for Four Diabetes Drugs

The U.S. Food and Drug Administration is intensifying warnings for four diabetes drugs that the FDA claims can cause life-threatening kidney harm. “Canagliflozin, sold as Invokana and Invokamet by Janssen Pharmaceuticals, and dapagliflozin, sold as Farxiga and Xigduo XR by AstraZeneca,  can cause worse acute kidney injury than was previously thought,” the FDA said.
Between October 2014 and September 2015, 1.5 million prescriptions were written for either canagliflozin or dapagliflozin.
The FDA noticed that between March 2013 and October 2015, there were 101 individuals with confirmed kidney injury relating to the two drugs, one-fifth of which required hospitalization in intensive care. Four of the individuals died. “The revisions to the drugs’ labels will now include information about acute kidney injury and added recommendations to minimize this risk,” the FDA said. In an episode of acute kidney injury, the kidneys suddenly stop working. Still, patients should not stop taking the medicines if it happens, because that could wreak havoc on their blood sugar. They should simply seek immediate medical help. “Acute kidney injury can reveal itself through decreased urine or swelling in the legs or feet,” the FDA said.
For more than half of the cases of acute kidney injury, the problem occurred within a month after the patient started taking the diabetes drug. The FDA said that doctors who see patients with diabetes should think more seriously before prescribing these drugs and should also take into account any predisposal to kidney issues such as decreased blood volume, chronic kidney insufficiency, congestive heart failure, and other medications that may increase the risk through interaction.
Canagliflozin is the only active ingredient in Invokana and is combined with another active ingredient, metformin, in Invokamet. Invokana and Invokamet were approved in 2013 and 2014, respectively, and are used to control blood sugar levels in patients with Type 2 diabetes. Meanwhile, the FDA reported in May 2016 that patients in a clinical trial studying Invokana and Invokamet were roughly twice as likely to undergo amputations as patients taking a placebo.
In a safety alert, the agency said that five of every 1,000 patients taking a 300-milligram daily dose of the active ingredient canagliflozin needed amputations. In addition, the equivalent of seven out of 1,000 patients taking a 100-milligram daily dose needed amputations, compared with only three out of 1,000 patients taking a placebo. The amputations affected toes, feet, and legs. Agency officials said they are working to determine whether canagliflozin really does elevate the risk of amputation, and that patients should not stop taking the drug without first consulting a doctor.
“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 agency said.FDA Strengthens Kidney Warnings for Diabetes Medicines