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Farxiga 21 articles

FDA monitoring severe dehydration risk with diabetes drug Farxiga

The Food and Drug Administration (FDA) is monitoring reports of severe dehydration in patients taking the type 2 diabetes drug Farxiga and has updated the “Warnings and Precautions” section on the safety label about the risk of acute kidney injury (AKI), according to the FDA’s April 1, 2016 to June 30, 2016, review of postmarket drug safety evaluations. The agency’s website provides summary information about ongoing and completed postmarket safety evaluations of adverse experience reports made to the FDA to determine if there are any new serious adverse events not previously identified during product development, known side effects reported in ... Read More

Some diabetes meds linked to increased risk for serious kidney injury

A growing number of cases of acute kidney injury in patients taking one of the type 2 diabetes medications canagliflozin (Invokana, Invokamet) or dapagliflozin (Farxiga, Xigudo XR) have prompted the Food and Drug Administration (FDA) to strengthen the current warnings on the drugs. Canagliflozin and dapagliflozin are in a class of type 2 diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. They are used along with diet and exercise to lower blood sugar levels in adults with type 2 diabetes. The drugs work by causing the kidneys to remove sugar from the body and excrete it through the urine. ... Read More

FDA strengthens kidney injury warnings on type 2 diabetes drugs

Stronger warnings about acute kidney injury will be added to the safety labels of a class of type 2 diabetes treatments, which includes the prescription medications Invokana, Invokamet, Farxiga, and Xigduo XR, the Food and Drug Administration (FDA) announced in a Drug Safety communication. The medications, which include the active drug ingredient canagliflozin or dapagliflozin, are prescription medicines that belong to a class of diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. They work by lowering blood sugar by causing the kidneys to remove the sugar from the body through the urine. Since Invokana became the first drug in the ... Read More

Type 1 diabetics treated with Farxiga at risk for ketoacidosis

The type 2 diabetes drugs Farxiga and Victoza, when used together, are an effective treatment for managing blood sugar levels in patients with type 1 diabetes, but patients were at an increased risk of developing ketoacidosis, a serious condition in which too much acid builds up in the blood. The findings were noted by researchers with the State University of New York in Buffalo, who tested 30 patients already taking insulin and Victoza, known chemically as liraglutide, and randomly gave them either Farxiga, known chemically as dapagliflozin, or a placebo as an add-on for 12 weeks. HbA1c levels fell by ... Read More

Sales of Invokana climb despite safety concerns

Medications in a class of type 2 diabetes drugs are raking in millions of prescriptions offering effective blood sugar control, but the risks continue to raise concerns. SGLT2 inhibitors, which include the brand name drugs Invokana, Invokamet, Farxiga and Jardiance, were first introduced in the U.S. in 2013. Invokana was the first to win Food and Drug Administration (FDA) approval despite concerns about cardiovascular and bone density risks. The following year, Farxiga was approved despite bladder cancer risks. In 2014, the FDA issued its first warning that SGLT2 inhibitors had been linked to an increased risk of ketoacidosis, a life-threatening ... Read More

FDA adds new warnings to class of type 2 diabetes drugs

New warnings for serious and life threatening side effects have been placed on the safety labels of a new class of type 2 diabetes medications, which includes the brand names Invokana, Invokamet, Jardiance, and Farxiga. The drugs, known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, work on the main site of filtered glucose reabsorption in the kidneys, resulting in the reduction of glucose reabsorption and increasing urinary excretion of glucose, thus lowering blood sugar levels in the body. A recent review by the Food and Drug Administration (FDA) into growing adverse event reports found that between March 2013 to May 2015, 73 ... Read More

FDA warns of serious urinary tract infections, ketoacidosis with SGLT2 diabetes drugs

New warnings have been added to the safety labels of some type 2 diabetes drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors about side effects of too much acid in the blood and serious urinary tract infections, both of which may require hospitalization, the Food and Drug Administration (FDA) announced in a Safety Alert. In May 2015, the FDA launched an investigation into the risk of ketoacidosis with SGLT2 inhibitors after a review of the agency’s adverse event data revealed 73 cases of ketoacidosis from March 2013 to May 2015 in patients with type 1 or type 2 diabetes treated with ... Read More

Diabetes drugs including Invokana linked to ketoacidosis

Three type 2 diabetes drugs have been linked to ketoacidosis, a serious metabolic state that can lead to diabetic coma or even death, the Food and Drug Administration (FDA) warned. The drugs include the brand names Invokana (canagliflozin), Farxiga (dapagliflozin) and Jardiance (empagliflozin), which all belong to a class called sodium-glucose co-transporter-2 (SGLT2) inhibitors. At least two studies have found an increased risk of ketoacidosis, or diabetic ketoacidosis (DKA), in patients who take an SGLT2 inhibitor. The warning is based on a search of reports of ketoacidosis reported to the FDA Adverse Event Reporting System, which revealed 20 cases of ... Read More

Type 2 diabetes drug class shares risk/benefit profiles

Johnson & Johnson is arguing that its type 2 diabetes treatment Invokana should have the same life-saving capabilities as its rival drug Jardiance showed in a new, large clinical trial. Jardiance, made by Eli Lilly and Co., announced last month results from a three-year study that showed Jardiance cut death risk by 32 percent in patients with type 2 diabetes at risk of heart attack and stroke. The news sent prescriptions for the drug skyrocketing, nearly doubling for the quarter to $340 million. Johnson & Johnson, whose drug Invokana shares the same class as Jardiance, wants in on that action. ... Read More

Alarming number of pancreatitis, pancreatic cancer cases with diabetes drugs

Pancreatitis is a painful inflammation of the pancreas that can increase the likelihood of a patient developing pancreatic cancer, a health problem that type 2 diabetics are already at greater risk of developing. Interestingly, a study of drug adverse event reports reveals that common type 2 diabetes drugs have been associated with side effects that include acute pancreatitis and pancreatic cancer. Health informatics firm AdverseEvents scoured through post-marketing reports filed with the Food and Drug Administration (FDA) and found 1,900 cases of pancreatitis with AstraZeneca’s Byetta injection, 1,284 cases in patients taking Novo Nordisk’s Victoza, and 1,296 cases in patients ... Read More