Tagged Articles

Jardiance 18 articles

Safety label updates made to diabetes medication Gylxambi

New warnings have been added to the safety labels of the type 2 diabetes drug Gylxambi, the Food and Drug Administration (FDA) announced. Gylxambi is a combination of the diabetes drugs empagliflozin and linagliptin. Emphagliflozin is the active ingredient in the diabetes treatment Jardiance, which is in a class called SGLT2 inhibitors. Other drugs in this class include Invokana and Invokamet. Last year, the FDA required all SGLT2 inhibitors to include new warnings for serious urinary tract infections in patients taking the drugs, as well as an increased risk of ketoacidosis, a condition in which too much acid builds up ... Read More

Benefits of SGLT2 diabetes drugs should be weighed against side effects

The Food and Drug Administration (FDA) has signed off on a new indication for the type 2 diabetes drug Jardiance, allowing its manufacturers Eli Lily and Boehringer Ingelheim to advertise that the medication can reduce the risk of cardiovascular death in type 2 diabetics. The new indication is expected not only to boost sales of Jardiance, but also sales of other diabetes treatments in its class. Jardiance is in a newer class of drugs called SGLT2 inhibitors. Johnson & Johnson and Janssen Pharmaceuticals’ Invokana was the first in the class to be approved and enjoys the largest sales among its direct ... Read More

FDA panel questions study to expand indication for type 2 diabetes drug Jardiance

A Food and Drug Administration (FDA) advisory panel gave a half-hearted recommendation to expand the indication of the type 2 diabetes drug Jardiance (empagliflozin) to include prevention of cardiovascular events, and raised important questions involving a key study used to make those claims. Since 2008, developers of approved type 2 diabetes drugs are required to collect data to rule out an increase in cardiovascular risk. Such was the case with Jardiance, which was approved in August 2014. But developer Boehringer Ingelheim opted to take its EMPA-REG  study a step forward, using a broader sample of patients with type 2 diabetes and an ... 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

Kardashian star diagnosed with ketoacidosis

Television personality and businessman Rob Kardashian, best known for his role on Keeping Up with the Kardashians and its spin-offs, as well as a stint on Dancing with the Stars, was diagnosed with life threatening diabetic ketoacidosis, according to TMZ. Ketoacidosis is a serious condition that affects diabetics. Kardashian, 28, said he didn’t know he had diabetes. The condition occurs when too much acid builds up in the blood. Patients usually experience symptoms such as nausea, vomiting, abdominal pain, tiredness and trouble breathing. If left untreated, it can lead to diabetic coma and death. Ketoacidosis is most often seen in ... Read More

Diabetics should know warning signs of ketoacidosis

Ketoacidosis is a serious condition that affects diabetics and can lead to diabetic coma and death. The condition occurs when cells do not get the glucose they need for energy, causing the body to burn fat for energy, which produces ketones. When ketones build up in the blood, the blood becomes more acidic. High levels of ketones can poison the body and cause serious health complications. Ketoacidosis often develops slowly with early symptoms including very dry mouth, frequent urination, elevated blood sugar levels and high levels of ketones in the body. As the condition progresses, patients may begin feeling tired, ... 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