FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 1, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

SGLT2 inhibitors can slow progression of chronic kidney disease
(ERA-EDTA) The CREDENCE trial [3] provided evidence that the SGLT2 inhibitor Canagliflozin slows the progression of CKD in individuals with type 2 diabetes (T2D) and CKD with albuminuria. The Phase III DAPA-CKD trial [1] has now shown that the SGLT2 inhibitor Dapagliflozin can significantly slow CKD progression in all CKD patients, not only in those with diabetes. This breakthrough in kidney disease treatment goes back to an incidental study finding of Professor Christoph Wanner, President of the ERA-EDTA. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - August 31, 2020 Category: International Medicine & Public Health Source Type: news

FDA Pulls Amputation Boxed Warning Off Canagliflozin Label FDA Pulls Amputation Boxed Warning Off Canagliflozin Label
New safety information suggests the risk of amputation, while still increased with canagliflozin, is lower than previously described, particularly when appropriately monitored, the FDA said.News Alerts (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - August 26, 2020 Category: Cardiology Tags: Cardiology News Alert Source Type: news

Invokana, Invokamet, Invokamet XR (canagliflozin): MedWatch Safety Alert - Boxed Warning about Risk of Leg and Foot Amputations Removed
Based on FDA's review of new data from three clinical trials, the Boxed Warning about amputation risk from the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) prescribing information was removed. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 26, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
Based on new data from two large clinical trials, FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk. Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your healthcare professional if you have questions or concerns. Do not stop taking your diabete...
Source: FDA Center for Drug Evaluation and Research - What's New - August 26, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 26, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Removes Boxed Warning About Risk of Leg and Foot Amputations for the Diabetes Medicine Canagliflozin (Invokana, Invokamet, Invokamet XR)
August 26, 2020 -  Based on a U.S. Food and Drug Administration (FDA) review of new data from three clinical trials, we have removed the Boxed Warning about amputation risk from the diabetes medicine canagliflozin (Invokana,... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - August 26, 2020 Category: General Medicine Source Type: news

Unexpected Rosuvastatin-Canagliflozin Adverse Effect Reported Unexpected Rosuvastatin-Canagliflozin Adverse Effect Reported
Canadian clinicians report the rare case of a 76-year-old woman who had a sharp spike in plasma levels of rosuvastatin within days of starting the SGLT2 inhibitor.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - August 5, 2020 Category: Cardiology Tags: Diabetes & Endocrinology News Source Type: news

In Rare Cases, Diabetes & Cholesterol Drug Combo Could Be Toxic
MONDAY, Aug. 3, 2020 -- Taking the statin Crestor in combination with the diabetes drug canagliflozin (Invokana) may have the potential to trigger statin toxicity, a new case report suggests. Although this report details the problem in just one... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - August 3, 2020 Category: General Medicine Source Type: news

EU Green Light for Canagliflozin to Slow Diabetic Kidney Disease EU Green Light for Canagliflozin to Slow Diabetic Kidney Disease
The CHMP has recommended approval for the SGLT2 inhibitor canagliflozin (Invokana) be extended to include diabetic kidney disease.International Approvals (Source: Medscape Transplantation Headlines)
Source: Medscape Transplantation Headlines - June 1, 2020 Category: Transplant Surgery Tags: Diabetes & Endocrinology News Alert Source Type: news

Janssen Highlights Continued Commitment to Cardiovascular & Metabolic Healthcare Solutions with Late-Breaking Data at the First Fully Virtual American College of Cardiology Scientific Session
RARITAN, N.J., March 20, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the virtual American College of Cardiology’s 69th Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC) on March 28-30, 2020. Notably, four late-breaking abstracts for XARELTO® (rivaroxaban) will be presented, including data from the Phase 3 VOYAGER PAD study in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization.Click to...
Source: Johnson and Johnson - March 20, 2020 Category: Pharmaceuticals Source Type: news

Canagliflozin Helps Heart, Kidneys in'Well-Controlled' Diabetes Canagliflozin Helps Heart, Kidneys in'Well-Controlled' Diabetes
A subanalysis of CREDENCE suggests that SGLT2 inhibitor use should be based on clinical benefit, not solely glycemic control, say researchers. Another study hints that these drugs up EPO levels.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - December 10, 2019 Category: Cardiology Tags: Cardiology News Source Type: news

Highlights From ASN Kidney Week 2019 Highlights From ASN Kidney Week 2019
Highlights from ASN's Kidney Week 2019 include results from the CREDENCE trial showing benefit from the SGLT2 inhibitor canagliflozin for patients with established diabetic nephropathy.Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 3, 2019 Category: Consumer Health News Tags: Nephrology ReCAP Source Type: news

New Analysis from Landmark CREDENCE Study Shows the Efficacy and Safety Profiles of INVOKANA ® (canagliflozin) are Consistent Across Various Levels of Kidney Function
Analysis shows consistent renal and cardiovascular benefit when treated with INVOKANA ® even when patients had moderate to severe renal deficiency INVOKANA® is the only diabetes medicine indicated to slow the progression of diabetic nephropathy (also known as DKD) and reduce the risk of hospitalization for heart failure in patients with type 2 diabetes (T2D) and DKDData announcemen t comes after recent news of the company’s commercial partnership with Vifor Pharma, leader in nephrology, to jointly commercialize the INVOKANA® DKD indication in the United States (Source: Johnson and Johnson)
Source: Johnson and Johnson - November 12, 2019 Category: Pharmaceuticals Source Type: news

FDA Approves Invokana (canagliflozin) to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes and DKD
RARITAN, N.J., Sept. 30, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for Invokana (canagliflozin) to reduce the risk of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 30, 2019 Category: Drugs & Pharmacology Source Type: news

FDA OKs Canagliflozin to Curtail Diabetic Kidney Disease FDA OKs Canagliflozin to Curtail Diabetic Kidney Disease
Results of CREDENCE lead to FDA approval for canagliflozin to slow kidney disease progression and reduce the risk of heart failure hospitalization in adults with type 2 diabetes.FDA Approvals (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - September 30, 2019 Category: Cardiology Tags: Diabetes & Endocrinology News Alert Source Type: news

U.S. FDA Approves INVOKANA ® (canagliflozin) to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in Patients with Type 2 Diabetes (T2D) and DKD
INVOKANA ® is the only diabetes medicine indicated to slow the progression of diabetic nephropathy (also known as DKD) and reduce the risk of hospitalization for heart failure in patients with T2D and DKDApproval is based on the landmark Phase 3 CREDENCE renal outcomes study – the only completed renal out comes study of a diabetes medicine (Source: Johnson and Johnson)
Source: Johnson and Johnson - September 30, 2019 Category: Pharmaceuticals Source Type: news

SUSTAIN-8: Semaglutide vs Canagliflozin After Metformin in T2D SUSTAIN-8: Semaglutide vs Canagliflozin After Metformin in T2D
Reduction in HbA1c and weight loss are superior with SC semaglutide compared with canagliflozin, but treatment decisions should also consider patient comorbidities, patient preference, tolerance, and cost.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - September 23, 2019 Category: Cardiology Tags: Diabetes & Endocrinology News Source Type: news

canagliflozin (Invokana)
Title: canagliflozin (Invokana)Category: MedicationsCreated: 4/10/2013 12:00:00 AMLast Editorial Review: 7/19/2019 12:00:00 AM (Source: MedicineNet Diabetes General)
Source: MedicineNet Diabetes General - July 19, 2019 Category: Endocrinology Source Type: news

No Fracture Risk for New Diabetes Drugs in Real-World Study No Fracture Risk for New Diabetes Drugs in Real-World Study
Link between SGLT2 inhibitors for type 2 diabetes and fractures has been controversial. Canagliflozin has an FDA warning about the risk, but some studies have found no link.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - July 17, 2019 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density
[9-10-2015] The U.S. Food and Drug Administration (FDA) has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures and added new information about decreased bone mineral density. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - June 19, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CREDENCE'Knocks Your Socks Off'; New Analysis Reported at ADA CREDENCE'Knocks Your Socks Off'; New Analysis Reported at ADA
Latest analysis of CREDENCE with SGLT2 inhibitor canagliflozin shows the agent has a cardio- and renal-protective effect in both primary and secondary CV prevention populations.Medscape Medical News (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - June 17, 2019 Category: Internal Medicine Tags: Diabetes & Endocrinology News Source Type: news

INVOKANA ® (canagliflozin) Significantly Reduced Major Cardiovascular Events and Kidney Failure in Patients with Type 2 Diabetes and Chronic Kidney Disease in New CREDENCE Analysis
(Source: Johnson and Johnson)
Source: Johnson and Johnson - June 11, 2019 Category: Pharmaceuticals Source Type: news

ADA Standards Updated With Renal Guidance Based on CREDENCE ADA Standards Updated With Renal Guidance Based on CREDENCE
New renal management guidance is based on data from the recently reported Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy (CREDENCE) trial.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - June 4, 2019 Category: Cardiology Tags: Diabetes & Endocrinology News Source Type: news

U.S. FDA Grants Priority Review of INVOKANA ® (canagliflozin) sNDA for the Treatment of Chronic Kidney Disease in Patients with Type 2 Diabetes
(Source: Johnson and Johnson)
Source: Johnson and Johnson - May 22, 2019 Category: Pharmaceuticals Source Type: news

Old Malaria Drug as Good as Blockbuster Type 2 Diabetes Agent Old Malaria Drug as Good as Blockbuster Type 2 Diabetes Agent
When added to metformin and vildagliptin, hydroxychloroquine lowered HbA1c as well as canagliflozin and also reduced weight and inflammation.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - May 3, 2019 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

Novel therapies slow CKD progression in patients with diabetes
(ERA-EDTA) The recently published CREDENCE study showed that SGLT2 inhibitors can slow progression of chronic kidney disease (CKD) in diabetes patients in addition to the effects seen with RAAS blockade. Canagliflozin was associated with a 34% risk reduction of the renal end point. The SONAR study had shown that the selective endothelin A receptor antagonist, atrasentan, reduced the risk of renal events in a specially selected CKD cohort with diabetes to a similar extent (35%). (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 26, 2019 Category: International Medicine & Public Health Source Type: news

Teprotumumab, Canagliflozin, and Kevin Pho Top AACE Agenda Teprotumumab, Canagliflozin, and Kevin Pho Top AACE Agenda
Graves'ophthalmopathy, type 2 diabetes treatment, social media matters, and much more to be featured at Los Angeles conference.Medscape Medical News (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - April 16, 2019 Category: Endocrinology Tags: Diabetes & Endocrinology News Source Type: news

Common Diabetes Drug May Also Help Kidneys, Heart
Those who took Invokana had a 30% lower risk of developing kidney failure, a 30% lower risk of dying from kidney failure or heart disease, the researchers reported. (Source: WebMD Health)
Source: WebMD Health - April 16, 2019 Category: Consumer Health News Source Type: news

Treatment success for diabetic kidney disease
Clinical trial findings inThe New England Journal of Medicine report that canagliflozin can reduce the risk of kidney and cardiac failure in patients with diabetes.iNews (Source: Society for Endocrinology)
Source: Society for Endocrinology - April 16, 2019 Category: Endocrinology Source Type: news

Canagliflozin Seems Effective for Patients With T2DM, Kidney Disease
MONDAY, April 15, 2019 -- Canagliflozin is associated with a reduced risk for renal and cardiovascular events for patients with type 2 diabetes and kidney disease, according to a study published online April 14 in the New England Journal of Medicine... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 15, 2019 Category: Pharmaceuticals Source Type: news

Diabetes Drug'Home Run' Curtailing Kidney Failure Risk Diabetes Drug'Home Run' Curtailing Kidney Failure Risk
Canagliflozin also showed cardiovascular benefits in the CREDENCE multicenter trial, with no imbalance in adverse events, investigators shared here at the nephrology world congress.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - April 15, 2019 Category: Cardiology Tags: Nephrology News Source Type: news

Common Diabetes Drug Invokana (canagliflozin) May Also Shield Kidneys, Heart
MONDAY, April 15, 2019 -- A common diabetes drug may also greatly reduce the odds for death from kidney failure and heart disease in diabetes patients with kidney disease, a new study finds. The news on Invokana (canagliflozin) is important,... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 15, 2019 Category: General Medicine Source Type: news

INVOKANA ® (canagliflozin) Significantly Reduces the Risk of Renal Failure in Patients with Type 2 Diabetes and Chronic Kidney Disease in the Landmark Phase 3 CREDENCE Study
(Source: Johnson and Johnson)
Source: Johnson and Johnson - April 15, 2019 Category: Pharmaceuticals Source Type: news

A Diabetes Drug Called Invokana May Prevent or Slow Kidney Disease, a New Study Says
A drug that’s used to help control blood sugar in people with diabetes has now been shown to help prevent or slow kidney disease, which causes millions of deaths each year and requires hundreds of thousands of people to use dialysis to stay alive. Doctors say it’s hard to overstate the importance of this study, and what it means for curbing this problem, which is growing because of the obesity epidemic. The study tested Janssen Pharmaceuticals’ drug Invokana. Results were discussed Sunday at a medical meeting in Australia and published by the New England Journal of Medicine. About 30 million Americans and...
Source: TIME: Health - April 15, 2019 Category: Consumer Health News Authors: MARILYNN MARCHIONE / AP Tags: Uncategorized medicine onetime overnight Source Type: news

Janssen Submits Supplemental New Drug Application to U.S. FDA for INVOKANA ® (canagliflozin) for the Treatment of Chronic Kidney Disease in Patients with Type 2 Diabetes
(Source: Johnson and Johnson)
Source: Johnson and Johnson - March 28, 2019 Category: Pharmaceuticals Source Type: news

Diabetes drug alters vitamin D levels, possibly explaining increased bone fracture risk
Scientists found that the diabetes drug canagliflozin reduces vitamin D levels and calcium uptake, which may explain why this drug can increase the risk of bone fractures.  (Source: NIDDK News)
Source: NIDDK News - March 22, 2019 Category: Endocrinology Source Type: news

CANVAS: Reassuring Data on Stroke With Canagliflozin CANVAS: Reassuring Data on Stroke With Canagliflozin
More detailed data from the CANVAS program have been reported showing reassuring results on all stroke types and a significant reduction in hemorrhagic stroke.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 9, 2019 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

Type 2 Diabetes Med Might Not Harm Bones After All
Canagliflozin (Invokana, Invokamet) is in a class of medications called SGLT-2 inhibitors. These drugs cause the kidneys to remove excess sugar from the blood and excrete it through urine, which lowers blood sugar levels. This class of drugs has been linked to a number of complications, including kidney injury and serious genital infections. (Source: WebMD Health)
Source: WebMD Health - January 3, 2019 Category: Consumer Health News Source Type: news

Study Eases Concern That Common Diabetes Med, Canagliflozin (Invokana, Invokamet), Might Harm Bones
THURSDAY, Jan. 3, 2019 -- If you have type 2 diabetes and you're taking canagliflozin to help control your blood sugar, a new study has some good news for you: The drug doesn't appear to raise the risk of bone fractures. Previously, research had... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - January 3, 2019 Category: General Medicine Source Type: news

Study Eases Concern That Common Diabetes Drug Canagliflozin (Invokana, Invokamet) Might Harm Bones
THURSDAY, Jan. 3, 2019 -- If you have type 2 diabetes and you're taking canagliflozin to help control your blood sugar, a new study has some good news for you: The drug doesn't appear to raise the risk of bone fractures. Previously, research had... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - January 3, 2019 Category: General Medicine Source Type: news

No Increased Fracture Risk With Canagliflozin in Type 2 Diabetes
WEDNESDAY, Jan. 2, 2019 -- Canagliflozin is not associated with increased fracture risk versus glucagon-like peptide-1 (GLP-1) agonists for middle-aged patients with type 2 diabetes, according to a study published online Jan. 1 in the Annals of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - January 2, 2019 Category: Pharmaceuticals Source Type: news

Canagliflozin does not increase fracture risk in diabetes patients
Canagliflozin treatment does not increase the risk of fractures in type-2 diabetes patients, according to research published inAnnals of Internal Medicine.MedicalXpress (Source: Society for Endocrinology)
Source: Society for Endocrinology - January 2, 2019 Category: Endocrinology Source Type: news

Canagliflozin Not Linked to Fractures in Large Database Study Canagliflozin Not Linked to Fractures in Large Database Study
Risk associated with SGLT2 inhibitor may be limited to patients with type 2 diabetes who have additional fracture risk.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 31, 2018 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

Canagliflozin not associated with increased risk for fracture
(American College of Physicians) Compared with a glucagon-line peptide-1 (GLP-1) agonist, canagliflozin was not associated with an increased risk for fracture in patients with type 2 diabetes at relatively low risk for fracture. Findings from a multidatabase cohort study are published in Annals of Internal Medicine. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 31, 2018 Category: International Medicine & Public Health Source Type: news

Take this FDA-approved diabetes drug, and you might have to amputate your leg, warns the FDA
(Natural News) The U.S. Food and Drug Administration (FDA) has recently issued a black box warning against Johnson & Johnson’s Type 2 diabetes drug Invokana as the medication was found to increase the risk of amputation in patients. Data from two clinical trials showed that patients taking canagliflozin, the drug’s generic name, had higher incidence of amputations than... (Source: NaturalNews.com)
Source: NaturalNews.com - December 2, 2018 Category: Consumer Health News Source Type: news

Nov 2, 2018 This Week in Cardiology Nov 2, 2018 This Week in Cardiology
CV outcomes in patients with type 2 diabetes, canagliflozin, cardiorespiratory fitness, the value of randomized trials, and the most important paper of 2018 are reviewed in this week ’ s podcast.theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 2, 2018 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news

Questions Raised About Invokana Label Expansion For CV Risk Reduction
Experts are raising questions about FDA's decision to expand the label of the diabetes drug Invokana to reduce the risk of cardiovascular events. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - November 1, 2018 Category: Pharmaceuticals Authors: Larry Husten, Contributor Tags: NYSE:LLY NYSE:JNJ Source Type: news

Canagliflozin (Invokana) Gets FDA Nod for CV Protection Canagliflozin (Invokana) Gets FDA Nod for CV Protection
The SGLT2 inhibitor is the first oral diabetes medication approved to reduce the risk of cardiovascular events in patients with type 2 diabetes and heart disease.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 31, 2018 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news