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SGLT2 inhibitors 29 articles

‘Is there something wrong with Invokana?’

“Is there something wrong with Invokana?” The Motley Fool posed this question as part of a roundup of elements leading up to Johnson & Johnson’s quarterly report, which the media source says “often sets the tone for the pharmaceutical industry.” Johnson & Johnson is expected to produce $18.97 billion in sales – a growth of 2.6 percent over last year’s quarter. But, The Motley Fool says, “there is so much more to pay attention to than just a single sales and profit-per-share figure.” This includes the status of Johnson & Johnson’s top selling diabetes drug Invokana, which is manufactured by subsidiary ... Read More

Invokana may increase kidney stone risk

The Food and Drug Administration (FDA) has determined that no action is needed at this time regarding reports of kidney stones with a popular class of type 2 diabetes drugs called SGLT2 inhibitors, the agency announced in the newly released quarterly (January-March 2017) Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS). The agency had received reports of nephrolithiasis – or kidney stones – in patients taking SGLT2 inhibitors. Brand names include Invokana and Invokamet, as well as Farxiga, Jardiance, Synjardy, and Xigudo XR. When the FDA identifies a potential safety issue, as ... Read More

Study confirms ketoacidosis risk with diabetes drugs

A new study published in the New England Journal of Medicine confirms that a class of type 2 diabetes drugs increases the risk of a serious blood condition called ketoacidosis and “essentially confirms what doctors had already suspected,” said Dr. Stanislaw Klek, an endocrinologist at NYU Winthrop Hospital in Mineola, New York. “It is important to be aware of this potential complication and monitor for symptoms of diabetic ketoacidosis, particularly during periods of illness,” he added. The drugs in question are in a class of type 2 diabetes medications known as SGLT2 inhibitors. Invokana was the first in the class ... Read More

Invokana cases progress amid new warnings

The federal multidistrict litigation (MDL) involving nearly 300 lawsuits alleging the type 2 diabetes drug Invokana caused ketoacidosis or kidney damage continues to move forward in the U.S. district Court of New Jersey, as new concerns over the medication come to light. Within the past three weeks, the court has established an initial discovery plan that also covers how the selection of bellwether cases will be conducted, a well as scheduling and trial dates. The first bellwether is expected to begin in September 2018. The lawsuits name Invokana manufacturer Johnson & Johnson and its subsidiary Janssen Pharmaceuticals. The companies are ... Read More

Invokana linked to amputation risk

People taking the type 2 diabetes drug canagliflozin, the active ingredient in the brand name drugs Invokana, Invokamet and Invokamet XR, are at an increased risk of leg and foot amputations, the Food and Drug Administration (FDA) warned based on a safety review of two large clinical trials. As a result, the safety labels of the drug will also be updated to include the agency’s most prominent warning, called a Boxed Warning, regarding this risk. “Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcer, or infections in your ... Read More

Diabetics taking SGLT2 inhibitors should be aware of DKA symptoms

One of the recommended second-line therapies for patients with type 2 diabetes puts patients at risk for diabetic ketoacidosis (DKA) a serious condition in which too much acid builds up in the blood. The therapies, known as SGLT2 inhibitors, include the brand names Invokana and Invokamet. The drugs work by removing excess glucose from the blood and excreting it through the urine. The medications are only indicated for patients with type 2 diabetes, but they are being prescribed off-label as well as studied in some patients with type 1 diabetes. But the vast majority of patients taking SGLT2 inhibitors are ... Read More

Low carb diet shown to increase ketoacidosis risk in diabetics taking SGLT2 inhibitors

The alarming side effect ketoacidosis associated with a class of type 2 diabetes drugs known as SGLT2 inhibitors may be triggered by low-carbohydrate diets, according to a small, randomized trial published in the journal Diabetes, Obesity, and Metabolism. Head researcher Daisuke Yabe, MD, PhD, at Kyoto University Graduate School of Medicine in Japan, told Medscape Medical News that “We’re facing several concerns on adverse events of this drug class in clinical settings.” The study could help identify what causes these effects. SGLT2 inhibitors are a newer yet popular class of drugs that include Invokana and Invokamet. Both drugs are approved ... Read More

Doctors, patients should be aware of the link between diabetes meds and diabetic ketoacidosis

Physician and patient awareness of diabetic ketoacidosis (DKA) risk when using a drug in the SGLT2 Inhibitor class is important to quickly and accurately identify and treat the condition, and is key to improved outcomes for patients in the emergent setting of DKA, advised Deeply Dixit, Pharma, BCPS, in a column in Pharmacy Times. Dixit is a Clinical Assistant Professor at Ernest Mario School of Pharmacy and a Clinical Critical Care Pharmacist in the Medical Intensive Care Unit at Robert Wood Johnson University Hospital. In May 2015, the Food and Drug Administration (FDA) warned that SGLT2 inhibitors, such as the brand-name drugs Invokana, ... Read More

FDA strengthens boxed warning for diabetes drug Xigduo XR

The Food and Drug Administration (FDA) has approved safety label changes for the type 2 diabetes drug Xigduo XR that give more extensive updates to the boxed warning involving the risk for lactic acidosis. Lactic acidosis is a medical condition characterized by the buildup of lactate in the body. Lactic acidosis in patients taking Xigduo have reportedly resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. “The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain,” the updated warning states. Xigduo is a combination of the medications ... 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