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Invokana 112 articles

Invokana amputation risk does not apply to other drugs in class

The lower limb amputation risk with the type 2 diabetes drug canagliflozin, the active ingredient in the brand-name drugs Invokana, Invokamet and Invokamet XR, does not apply to other diabetes drugs in its class, according to an Advera Health analysis. Currently, only diabetes medications containing canagliflozin carry black box warnings regarding an increased risk of toe, foot or leg amputations. A boxed warning is the strongest warning issued by the Food and Drug Administration (FDA), and is designed to call attention to serious or life-threatening risks. The FDA’s warning was announced after the agency reviewed data from the CANVAS and ... Read More

New data confirms Invokana amputation risk

In May, after an extensive review of data, the Food and Drug Administration (FDA) ordered Johnson & Johnson’s Janssen Pharmaceuticals to add a black box warning to the labels of its Type 2 diabetes drugs containing the active ingredient canagliflozin to warn against an increased risk of amputations. The warning was added to the brand-name drugs Invokana, Invokamet and Invokamet XR. Since then, the FDA announced that new reports further support the link between canagliflozin and amputation risk. The new data comes from the FDA’s Adverse Event Reporting System (FAERS), which provides an analysis of safety signal reports that were ... Read More

J&J seeks to expand Invokana use despite added warnings

Johnson & Johnson has submitted a supplemental new drug application (sNDA) to the Food and Drug Administration (FDA) to expand the label of its type 2 diabetes medication Invokana to include a new cardiovascular indication. The request comes less than six months after the drug’s label was updated to include a boxed warning for a new disabling side effect – amputation. Invokana was approved by the FDA in 2013 as an adjunct to diet and exercise to improve glycemic control an adults with type 2 diabetes. The sNDA seeks the indication of risk reduction of cardiovascular events in type 2 ... Read More

Janssen hopes to expand Invokana indication

Johnson & Johnson’s Janssen Pharmaceuticals is hoping to gain a new indication for its Type 2 diabetes drug Invokana as a treatment to reduce major adverse cardiovascular events in at-risk patients with Type 2 diabetes. But will it be enough to balance the additional warnings added to its safety label since the drug launched in the U.S. in 2003? Janssen’s filing with the Food and Drug Administration (FDA) for the new indication is based on the results of the CANVAS trial, which showed its SGLT2 inhibitor Invokana could reduce the risk of cardiovascular death, heart attacks and strokes in at-risk, ... Read More

Diabetes drugs may increase risk of bladder cancer

A class of Type 2 diabetes drugs known as SGLT2 inhibitors come with a long list of warnings. A recent study suggests that the drugs may be linked to an increased risk of bladder cancer but not an increased risk of cancer overall. The study, conducted by scientists from Indiana University, consisted of a review of 46 clinical trials involving more than 34,000 participants. SGLT2 inhibitor medications that were reviewed as part of the study included Forxiga, Invokana, and Jardiance. Researchers looked at a variety of cancers including those affecting the skin, breast, bladder, prostate and renal system. A total of ... Read More

No DKA risk in type 1 diabetics taking Farxiga

The type 2 diabetes drug Farxiga helped patients with adequately controlled type 1 diabetes better manage their blood sugar and weight loss in the first phase 3 clinical trial testing a drug in the SGLT2 inhibitor class on type 1 diabetics. The study showed that Farxiga, as an oral adjunct to insulin, at both 5mg and 10mg doses, provided clinically relevant benefits to type 1 diabetics compared to similar patients treated with placebo. “The 24-week results are important as they represent the first phase 3 trial in type 1 diabetes of the newer selective SGLT-2 class of diabetes medicines as an ... Read More

Invokana risks may outweigh benefits

Doctors and their hospital-affiliated medical groups have become skittish about prescribing the type 2 diabetes drug Invokana after the Food and Drug Administration (FDA) slapped black box warning regarding a twofold risk of lower limb amputations among users on the drug. Since Invokana was approved in 2013 – the first in a new class of diabetes drugs called SGLT2 inhibitors – the agency has required new or strengthened warnings on Invokana’s safety label regarding adverse effects such as an increased risk for ketoacidosis, acute kidney injury, bone fractures, bone mineral density loss and serious urinary tract infections. When results from ... Read More

Invokana to be studied in children with type 2 diabetes

Children and adolescents ages 10 to 18 who have been diagnosed with Type 2 diabetes are currently being recruited to participate in a study assessing the overall safety and tolerability of treatment with the diabetes drug Invokana. Researchers aim to compare a group of pediatric patients with diabetes treated with Invokana to a group of similar patients treated with a placebo. Patients treated with Invokana will be given either 100 mg or 300 mg of Invokana. Effectiveness will be assessed after 26 weeks, and overall safety and tolerability will be assessed after 52 weeks. The study is a randomized, double-blind, ... Read More

Some doctors have stopped prescribing Invokana

New warnings regarding an increased risk of lower limb amputations with diabetes drugs containing canagliflozin have prompted some California doctors to transition patients off the medication, especially if they have key risk factors such as prior amputations. It is a “process that has been underway since the FDA warnings came out,” John Chomsky, a spokesman for Sharp HealthCare system in San Diego, California, told KPBS. Two large studies involving patients taking type 2 diabetes medications containing canagliflozin, which includes the brand-name drugs Invokana, Invokamet and Invokamet XR, showed that the medications doubled the risk of lower limb amputation compared to ... Read More

Invokana side effects continue to add up

Type 2 diabetics treated with a class of drugs called SGLT2 inhibitors are less likely to have or to die from cardiovascular events, according to new real-world data published in the journal Lancet Diabetes & Endocrinology. But adverse effects of drugs in this class continue to add up. Farxiga, which contains the active ingredient dapagliflozin, was the drug that served patients’ heart health the best, but other studies have shown a reduction in cardiovascular injury and death in patients treated with Jardiance, which contains empagliflozin, and Invokana, which contains canagliflozin. This has researchers speculating whether the cardiovascular benefits seen with ... Read More