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Invokana and Invokamet 43 articles

Farxiga lawsuits consolidated by Judicial Panel on Multidistrict Litigation

The U.S. Judiciary Panel on Multidistrict Litigation (JPML) created a new product liability MDL involving over kidney-related injuries with the type 2 diabetes drug Farxiga. The 18 actions consolidated in New York are currently pending in six federal district courts and share common questions of fact that would benefit from a centralized pre-trial MDL docket, the JPML concluded. The lawsuits, waged at the makers of Farxiga, as well as its so-called sister drug Xigduo XR, Bristol-Myers Squibb Co. and AstraZeneca, allege that use of the diabetes medications can cause acute kidney injury and diabetic ketoacidosis, a serious condition in which ... 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

New SGLT2 inhibitors in development despite serious side effects

Since the new class of type 2 diabetes drugs known as SGLT2 inhibitors hit the market in 2013, the drugs have been repeatedly called out by the Food and Drug Administration (FDA) for various but serious adverse events. Yet, drug makers continue to develop new versions of this drug hoping to cash in on the billions of dollars spent on diabetes treatments. SGLT2 inhibitors currently on the market include Invokana and Invokamet, Farxiga and Jardiance. The drugs work to lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Drug makers Merck and Pfizer ... Read More

Invokana heart benefits may not outweigh other risks for patients with diabetes

A newer class of type 2 diabetes drugs called SGLT2 inhibitors are being credited in recent studies for reducing the risk of hospitalization due to heart failure in diabetic patients, but the news doesn’t overshadow the drug’s laundry list of risks. Patients considering treatment with an SGLT2 inhibitors, such as Invokana and Invokamet, should first consider the potentially life threatening side effects. Invokana was the first SGLT2 inhibitor to hit the market in March 2013. Shortly thereafter, the Food and Drug Administration (FDA) issued a warning that the drugs had been linked to reports of ketoacidosis, a serious condition in ... Read More

Will the FDA add new amputation warning to popular diabetes drugs?

Last month, the European Medicines Agency (EMA) announced it was adding warnings to the safety labels of a popular class of type 2 diabetes drugs to caution about an increased risk for lower limb amputations, particularly of the foot and toe. U.S. drug regulators have yet to issue similar warnings. The label update stems from a review of data from two ongoing clinical trials involving type 2 diabetes drugs containing canagliflozin, which are known in the U.S. by the brand names Invokana and Invokamet. The data showed that patients who used these medications were more likely to undergo lower limb amputation ... Read More

FDA approves new type 2 diabetes treatment combining SGLT2, DPP-4 inhibitors

The Food and Drug Administration (FDA) approved Qtern, a new type 2 diabetes treatment that contains 5 mg of the DPP-4 inhibitor saxagliptin (known by the brand name Onglyza) and 10 mg of the SGLT2 inhibitor dapagliflozin (Farxiga). The medication is for patients who did not have adequate glycemic control with dapagliflozin alone or who were already taking dapagliflozin and saxagliptin. The FDA had rejected Qtern in late 2015 because reviewers didn’t think there was enough evidence to support its approval, despite giving clearance to a different DPP-4 inhibitor/SGLT2 inhibitor – Glyxambi – earlier that year. Qtern was approved by ... 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

Amputation warning to be added to type 2 diabetes drugs sold in Europe

Europe’s Committee for Medicinal Products for Human Use (CHMP) announced it is endorsing the European Medicine Agency (EMA) Pharmacovigiliance risk Assessment Committee (PRAC) recommendations to add new warnings to the labels to a class of type 2 diabetes drugs called SGLT2 inhibitors alerting users to an increased risk for lower limb amputations, mostly affecting the toes. The recommendations will be sent to the European Commission for a final legally binding decision that will stand for all drugs in the class sold throughout the European Union. The EMA issued a statement stating, “Patients taking these medicines are reminded to check their ... Read More

J&J remains mum about results of Invokana study data

Results from the CANVAS and CANVAS-R study investigating cardiovascular risks with the blockbuster type 2 diabetes drug Invokana are expected later this year. Invokana manufacturer Johnson & Johnson (J&J) and its subsidiary Janssen Pharmaceuticals are hoping for label-changing results like that of rival Jardiance, which showed the drug reduced the risk of cardiovascular death in diabetics with heart disease. But some analysts are skeptical. “While pure speculation on our part, it’s possible that J&J has seen more of the CANVAS/CANVAS-R data since the Q3 call and feels less confident in the outlook,” Wells Fargo Securities noted following the drug company’s ... Read More

FDA mum about whether amputation warning will be added to Invokana, Invokamet

The Food and Drug Administration (FDA) has not tipped its hand on whether it will require updating of the safety labels of the type 2 diabetes drugs Invokana and Invokamet to include new warnings of lower limb amputations following an announcement earlier this week that European drug authorities were ordering the updates on labels of Invokana and Invokamet as well as others in the same class. Invokana and Invokamet (marketed as Vokanamet in Europe) are in a class of type 2 diabetes medications known as sodium-glucose go-transporter 2 (SGLT2) inhibitors. Other drugs in this class include Forxiga and Jardiance. Both ... Read More