FDA Warns of Serious Kidney Infections Associated with Type 2 Diabetes Drugs

The US Food and Drug Administration (FDA) has updated the labels for sodium-glucose cotransporter 2 (SGLT2) inhibitors—a class of type 2 diabetes drugs—to include the risks for ketoacidosis and serious urinary tract infections.

Drugs in the SGLT2 inhibitor class include Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin). In May 2015, the FDA issued a drug safety communication cautioning about the risk for ketoacidosis with SGLT2 inhibitors, Medscape reports. The FDA said it would continue to study this issue.

The FDA Adverse Event Reporting System received reports of 19 cases of potentially fatal urosepsis (infection that spreads from the urinary tract into the bloodstream) and pyelonephritis (kidney infection) that began as urinary tract infections in patients taking SGLT2 inhibitors from March 2013 through October 2014. Those 19 patients all required hospitalization, and some required intensive care unit admission or dialysis to treat kidney failure.

From March 2013 to May 2015, the FDA received reports of 73 cases of ketoacidosis—a build-up of acids in the blood—in patients with type 1 or type 2 diabetes who were treated with SGLT2 inhibitors. Ketoacidosis symptoms include nausea, vomiting, abdominal pain, fatigue, and difficulty breathing.

SGLT2 inhibitors, a new class of type 2 diabetes drugs, are used, in conjunction with diet and exercise, to help control blood sugar in adults with type 2 diabetes. SGLT2 inhibitors work by turning off the SGLT2 protein, which blocks the excretion of glucose by the kidneys. If blood sugar is not well controlled, this can lead to serious health consequences including heart disease, blindness, and nerve and kidney damage.

The new safety warnings and precautions in the labels of all SGLT2 inhibitors will address these safety issues and make prescribing and monitoring recommendations. The FDA is also directing manufacturers of SGLT2 inhibitors to conduct a postmarketing study to analyze spontaneous postmarketing reports of ketoacidosis in patients using SGLT2 inhibitors. The study will include the collection of follow-up data for five years.

Patients who develop symptoms of ketoacidosis should stop taking their SGLT2 inhibitor and seek medical attention immediately, the agency said.

Health care providers should assess patients taking SGLT2 inhibitors for ketoacidosis and urinary tract infections if they present with suggestive symptoms, the FDA advised. Patients who take SGLT2 inhibitors can develop ketoacidosis even if their blood glucose is not excessively high. Patients in whom ketoacidosis is suspected should have their SGLT2 inhibitor use stopped and receive treatment promptly.

The SGLT2 inhibitors Invokana and Invokamet also carry warnings about the risk for bone fractures in those who take these drugs. A clinical trial in elderly patients showed that those who took canagliflozin for more than two years had reduced bone mineral density in their hips and lower spines, which puts them at greater risk for fracture, according to the FDA.

The FDA encourages clinicians to promptly report adverse events with SGLT2 inhibitors to MedWatch, the FDA’s safety information and adverse event reporting program.

 

from Parker Waichman http://www.yourlawyer.com/blog/fda-warns-of-serious-kidney-infections-associated-with-type-2-diabetes-drugs/