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canagliflozin 35 articles

FDA approves boxed warning on Invokana label

The labels of the type 2 diabetes drugs Invokana, Invokana and Invokamet XR have been updated to include a new boxed warning regarding an increased risk of leg and foot amputations, the Food and Drug Administration (FDA) announced. The approved safety label update comes two months after the FDA issued a Safety Communication alerting the public that after a review of clinical trial data, the agency has determined that its strongest warning should be added to the labels of all drugs that contain the active ingredient canagliflozin regarding the amputation risk. Invokana, Invokamet and Invokamet XR all contain canagliflozin. The ... Read More

Diabetes drug linked to amputations

EndocrineWeb, an ezine for people with endocrine disorders, cautioned readers about the latest warning added to the safety labels of the type 2 diabetes medications Invokana and Invokamet, which involves an increased risk for lower limb amputations. Both Invokana and Invokamet contain the active drug ingredient canagliflozin. Invokamet combines canagliflozin with metformin. The medications were approved in 2013 and 2014, respectively. They belong to a new class of type 2 diabetes medications called SGLT2 inhibitors. The May 16 warning was not unexpected, said J. Michael Gonzalez-Campoy, MD, PhD, FACE, who serves as medical director and CEO of the Minnesota Center ... 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

SGLT2 inhibitor benefits come at a risk

A new class of diabetes drugs called SGLT2 inhibitors launched in the U.S. in 2013 are demonstrating they can effectively drive down blood sugar levels and even help users lose weight. But those benefits come at a risk, according to a speaker at the Cardiometabolic Health Congress. SGLT2 inhibitors, or sodium-glucose cotransporter 2 inhibitors, include the brand name drugs Invokana and Invokana (which contain the active ingredient canagliflozin); Farxiga and Xigduo XR (which contain the active ingredient dapagliflozin); and Jardiance (which contains the active ingredient empagliflozin). SGLT2 inhibitors lower blood sugar by causing the kidneys to remove the sugar from ... 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

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

Study shows increased leg and foot amputations with Invokana, Invokamet

A clinical trial assessing heart risk with the newer type 2 diabetes drug canagliflozin, found in the brand-name drugs Invokana and Invokamet, found that patients who used the medication were at an increased risk of leg and foot amputations. The ongoing CANVAS (Canagliflozin Cardiovascluar Assessment Study) was launched four and a half years ago and continues to be evaluated by an independent data monitoring committee. Seven out of every 1,000 patients were treated with 100 mg of canagliflozin daily, five out of every 1,000 were treated with 300 mg daily, and three out of every 1,000 were given a placebo. A one-year ... Read More

UK, US launch investigations into lower limb amputation risk with Invokana

A clinical trial showing that patients taking the newer type 2 diabetes drugs Invokana or Invokamet are at twice the risk of lower limb amputations, primarily of the toe, has prompted the European Medicines Agency (EMA), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and U.S. Food and Drug Administration (FDA) to launch an investigation into whether new warnings should be placed on the drug’s safety label. Amputation is already a health risk for diabetic patients due to neuropathy, or nerve damage, particularly in the toes, feet and legs. According to the study, the risk of lower limb ... Read More

Diabetics should be screened for kidney problems before starting Invokana

Health care providers are advised to consider factors that may predispose patients to acute kidney injury before prescribing them the type 2 diabetes drugs Invokana and Farxiga following an announcement by the Food and Drug Administration (FDA) that it was strengthening the current warning about acute kidney injury on the drugs’ safety labels. The strengthened warnings apply to the brand name diabetes drugs Invokana and Invokamet (which include the active drug ingredient canagliflozin), and Farxiga and Xigduo XR (which contain the drug dapagliflozin). The drugs are in a class known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. They are used with ... Read More

Increased risk of kidney injury, renal impairment with Invokana, Invokamet

The type 2 diabetes treatments Invokana and Invokamet have been updated to include new warnings for acute kidney injury and impaired renal function. Invokana contains the drug ingredient canagliflozin. Invokamet contains canagliflozin in combination with the first-line diabetes treatment metformin. The medications were approved by the Food and Drug Administration (FDA) in 2013 and 2014, respectively. Invokana and Invokamet work by inhibiting sodium glucose co-transporter 2, a carrier that aids in the reabsorption of glucose into the bloodstream through the kidneys, and eliminated through the urine. The new warning states: Invokana and Invokamet cause intravascular volume contraction and can cause renal ... Read More