24-Hour Crisis Hotline: (877)SAFEGBC or (877)723-3422 Mental Health & Substance Abuse Issues

6502 Nursery Drive, Suite 100
Victoria, TX 77904
(361)575-0611
(800)421-8825

Diabetes
Resources
Basic InformationLatest News
Blame Diabetes: Rates of 2 Nerve Conditions on the RiseElectronic Messaging Intervention Cuts Cardiovascular Risk in T2DMHealth Tip: Preventing Diabetic Foot SoresEarly Menopause May Be Tied to Type 2 DiabetesMore Than 100 Million Americans Have Diabetes or Prediabetes: CDCNT-proBNP Improves Heart Failure Prediction in T2DMStem Cell Educator Therapy May Help Fight DiabetesResistance Training Improves Microvascular Blood Flow in T2DMNew Diabetes Treatment Teaches Rogue Immune Cells to BehaveIncreased Parental Anxiety With Increased Diabetes RiskIntensive Lifestyle Changes May Up Frailty Fracture Risk in DMExercising Safely With DiabetesHyperbaric Oxygen Therapy Increasingly Being UsedTherapeutic Inertia in 19 Percent With T2DM, HbA1c ≥8 PercentT1DM Patients With Active β-Cell Function Differ ImmunologicallyMany People With Type 1 Diabetes Still Make Some InsulinTryptophan May Be Marker for Diabetic NephropathyEstimated Prevalence of Diabetes 10.9 Percent in ChinaReview Spotlights Optimal Care of T2DM + OsteoporosissRAGE Linked to Risk of Incident Diabetic NephropathyDiabetic Ketoacidosis Poses Fetal Risk During/After EventFDA Warns Diabetics Against Use of Secondhand Test StripsRisk of Cardiovascular Events Similar With, Without DiabetesPCSK9 Increased in Females, Youth With Type 1 DiabetesText Messaging Intervention Can Up Glycemic Control in T2DMGood Results for Zone MPC-Based Artificial PancreasBroccoli Extract Shows Promise for Type 2 DiabetesSleep Apnea Linked to Diabetic Retinopathy in Type 2 DiabetesADA: Canagliflozin Tied to Lower Risk of Cardiovascular EventsKey Diabetes Test Gives Higher Blood Sugar Readings in Black PatientsFor Diabetics, Nasal Powder Fixed Severe Low Blood SugarADA: Glucose Self-Monitoring Often Lacks Benefit in T2DMCan Folks With Type 2 Diabetes Forgo the Finger Stick?Sitagliptin Stimulates Distal Tubular Natriuresis in T2DMStudy Confirms Link Between Diabetes Med and Rare But Dangerous ComplicationLower HbA1c Linked to Better Diabetes-Specific HRQoL in YouthHealth Tip: What's My Target Blood Glucose?Comorbid Celiac Disease Common Among Youth With T1DMDiabetic Foot Ulcers, Infections Significantly Up Burden of CareMapping IDs Geographic Access Barriers for Diabetic RetinopathyNormal Meal Tolerance Test Is Practical, Reliable in T2DMNo Link to Cognition in Diabetes Prevention Program StudySuicide by Insulin?Promising Start for National Diabetes Prevention ProgramDiabetes Drug Gets FDA Warning Due to Amputation RiskAngela Bassett Puts the Spotlight on Heart HealthAs Temps Rise, Risk of Pregnancy Complication May TooPharmacist-Involved Collaborative Care Benefits T2DMNever Breastfeeding Linked to Increased Risk of T1DMBioengineered Intraabdominal Endocrine Pancreas Feasible
Links
Related Topics

Medical Disorders

Diabetes Drug Gets FDA Warning Due to Amputation Risk

HealthDay News
by -- Robert Preidt
Updated: May 17th 2017

new article illustration

WEDNESDAY, May 17, 2017 (HealthDay News) -- The type 2 diabetes prescription drug canagliflozin (brand names Invokana, Invokamet, Invokamet XR) appears to increase the risk of leg and foot amputations, the U.S. Food and Drug Administration says.

The FDA is requiring the medications to carry new warnings about the risk. The required warnings on the drug's labeling include the most serious and prominent boxed warning.

The agency's decision is based on data from two large clinical trials showing that leg and foot amputations occurred about twice as often in patients taking canagliflozin as among those taking a placebo.

Amputations of the toe and middle of the foot were the most common, but leg amputations below and above the knee also occurred. Some patients had more than one amputation, some had amputations involving both limbs, according to the FDA.

Type 2 diabetes occurs when the body becomes resistant to insulin. Insulin is a hormone that helps to usher sugar from foods into the body's cells. When this process doesn't work correctly, blood sugar levels rise. Left untreated, high blood sugar levels can cause a number of possible complications, including heart disease, kidney problems and amputations, according to the American Diabetes Association.

Canagliflozin is meant to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. These drugs lower blood sugar levels by causing the kidneys to remove sugar from the body through the urine.

It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet.

Patients taking canagliflozin should immediately notify their health care providers if they develop new pain or tenderness, sores or ulcers, or infections in the legs or feet, the FDA said in a news release. Patients should not stop taking their medication without first talking to their health care provider.

Before prescribing canagliflozin to patients, doctors should consider factors that may predispose patients to the need for amputations, including a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers, the FDA said.

In addition, doctors should monitor patients taking canagliflozin for the above signs and symptoms, and discontinue canagliflozin if these complications occur.

In a statement, Janssen Pharmaceuticals, the maker of canagliflozin, said the company had already shared the findings on amputation risk with medical professionals prior to this warning.

"While the incidence was low, the highest incidence of amputations across all treatments was seen in patients with prior amputation," Janssen said. "At Janssen, patient safety is our highest priority. We are working with FDA to include this information in the prescribing information for canagliflozin."

More information

The American Diabetes Association has more on diabetes complications.