Fda Drug Safety Communication: Fda Revises Labels Of Sglt2 Inhibitors For Diabetes To Include Warnings About Too Much Acid In The Blood And Serious Urinary Tract Infections
[12-4-2015] A U.S. Food and Drug Administration (FDA) safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization. Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing. Patients should also be alert for signs and symptoms of a urinary tract infection, such as a feeling of burning when urinating or the need to urinate often or right away; pain in the lower part of the stomach area or pelvis; fever; or blood in the urine. Contact a health care professional if you experience any of these symptoms. Health care professionals should assess for ketoacidosis and urinary tract infections in patients taking SGLT2 inhibitors who present with suggestive symptoms. Ketoacidosis associated with the use of SGLT2 inhibitors can occur even if the blood sugar level is not very high. If ketoacidosis is suspected, the SGLT2 inhibitor should be discontinued and treatment instituted promptly. SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin (see section on List of FD Continue reading >>
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Sglt2 Inhibitor Diabetes Drugs May Cause Ketoacidosis: Fda
SGLT2 Inhibitor Diabetes Drugs May Cause Ketoacidosis: FDA The US Food and Drug Administration (FDA) warned today that sodium-glucose cotransporter-2 (SGLT2) inhibitors used to treat type 2 diabetes may lead to ketoacidosis requiring hospitalization. The warning includes the SGLT2 inhibitors canagliflozin (Invokana, Johnson & Johnson), dapagliflozin (Farxiga, AstraZeneca), and empagliflozin (Jardiance, Lilly/Boehringer), as well as three combination products that include an SGLT2 inhibitor: canagliflozin plus metformin (Invokamet, Johnson & Johnson), dapagliflozin plus metformin extended release (Xigduo XR, AstraZeneca), and empagliflozin plus linagliptin (Glyxambi, Lilly/Boehringer). A search of the FDA Adverse Event Reporting System database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014, the FDA said . Ketoacidosis is not typically observed in patients with type 2 diabetes, the FDA notes, and the DKA case presentations were "atypical in that glucose levels were only mildly elevated at less than 200 mg/dL in some reports, while patients with type 1 diabetes who have DKA typically have glucose levels greater than 250 mg/dL." Signs of ketoacidosis include difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue and sleepiness. "Healthcare professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels," the FDA advises. In Half of Cases, No Triggering Factor for DKA In all cases, a diagnosis of DKA or ketoacidosis wa Continue reading >>
Three Diabetes Drugs Linked To Ketoacidosis, Fda Warns
NASHVILLE -- Three type 2 diabetes drugs -- canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance) -- may lead to ketoacidosis, the FDA warned today. The sodium-glucose co-transporter-2 (SGLT2) inhibitors are designed to lower blood sugar in patients with diabetes, but the FDA is investigating a connection between the drugs and dangerously high acid levels in the blood. They are also looking at whether changes will need to be made to the prescribing information, they said in the warning, which is posted online. At least two studies presented here at the annual meeting of the American Association of Clinical Endocrinologists have found a connection between the SGLT2 inhibitors and diabetic ketoacidosis (DKA). "Healthcare professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms," the FDA said. "Discontinue SGLT2 inhibitors if acidosis is confirmed, and take appropriate measures to correct the acidosis and monitor sugar levels." The signs and symptoms listed included difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. The FDA is issuing the warning after they searched their database of adverse event complaints, they said in an announcement. From March 2013 to June 2014 there were 20 cases of DKA reported, most of them with type 2 diabetes as the indication. Hospitalization was required in all of the cases, and the median time to onset was 2 weeks after starting the drug. "I would encourage that these cases be studied so we can learn the scenarios behind them so they can be broadcast," said Farhad Zangeneh, MD, medical director of Endocrine, Diabetes and Osteoporosis Clinic, in an interview with MedPage Today. "The important Continue reading >>
Euglycemic Dka: It’s Not A Myth
Background: Diabetic ketoacidosis (DKA) is traditionally defined as a triad of hyperglycemia (>250mg/dL), anion gap acidosis, and increased plasma ketones. There is another entity that providers must be aware of known as euglycemic DKA (euDKA), which is essentially DKA without the hyperglycemia (Serum glucose <200 mg/dL). Euglycemic DKA is a rare entity that mostly occurs in patients with type 1 diabetes, but can possibly occur in type 2 diabetes as well. The exact mechanism of euDKA is not entirely known, but has been associated with partial treatment of diabetes, carbohydrate food restriction, alcohol intake, and inhibition of gluconeogenesis. euDKA, can also be associated with sodium-glucose cotransporter 2 (SGLT-2) inhibitor medications. These medications first came onto the market in 2013 and are FDA approved for the treatment of type 2 diabetes, however many physicians use them off-label for type I diabetes due to their ability to improve average glucose levels, reduce glycemic variability without increasing hypoglycemia, and finally promote weight loss. Does euDKA Exist even in Patients not Using SGLT-2 Inhibitors? The short answer is YES. Munro JF et al [5] reviewed a case series of 37 episodes of euDKA in a publication from 1973. Although, dated and not robust evidence some take home messages can be derived: All but one episode was in insulin dependent diabetics Vomiting was the most frequent symptom of euDKA in 32% of patients Management in most cases consisted of: Intravenous fluids and electrolyte replacement. No deaths occurred in this case series What are the Names of the SGLT-2 Inhibitors? Ipragliflozin (Suglat) – Approved in Japan Dapagliflozin (Farxiga) – 1st SGLT2 Inhibitor Approved; Approved in US Luseogliflozin (Lusefi) – Approved in Japan Tofo Continue reading >>
Euglycemic Diabetic Ketoacidosis In Type 2 Diabetes Treated With A Sodium-glucose Cotransporter-2 Inhibitor
Go to: Case A 51-year-old man with a known history of T2DM and hypertension presented to the emergency department with a 1-week history of malaise, cough, and intermittent shortness of breath. Over the preceding 2 days, he admitted to a history of decreased oral intake and fever, and he had abstained from taking his antihyperglycemic medications (canagliflozin and linagliptin-metformin). He reported 3 episodes of clear emesis the day of his presentation in the emergency department. He denied any other symptoms, sick contacts, or travel history. He reported no substance use, alcohol consumption, or other ingestions. He was not vaccinated against the flu. He was not taking insulin. Vital signs at triage were within normal limits except for a heart rate of 122 beats/min. The patient looked well and was in no acute distress. The only relevant physical examination findings were mild inspiratory crackles at the left lower lobe on auscultation of the lungs. A 12-lead electrocardiogram showed sinus tachycardia at 101 beats/min. Initial bloodwork revealed a hemoglobin level of 159 g/L (normal range 130 to 170 g/L); a white blood cell count of 12.1 × 109/L (normal range 4.8 × 109/L to 10.8 × 109/L); a neutrophil count of 11.0 × 109/L (normal range 2.0 × 109/L to 7.0 × 109/L); a platelet count of 405 × 109/L (normal range 130 × 109/L to 400 × 109/L); a random blood glucose level of 11.9 mmol/L (normal range 3.9 to 11.2 mmol/L); a sodium concentration of 139 mmol/L (normal range 136 to 144 mmol/L); a potassium level of 5.0 mmol/L (normal range 3.5 to 5.5 mmol/L); a chloride level of 93 mmol/L (normal range 98 to 109 mmol/L); a total CO2 level of 8 mmol/L (normal range 22 to 29 mmol/L); an anion gap of 38 mmol/L (normal range 4 to 12 mmol/L); a urea level of 9.3 mmol/L (nor Continue reading >>
The Dka That Wasn't: A Case Of Euglycemic Diabetic Ketoacidosis Due To Empagliflozin
The DKA that wasn't: a case of euglycemic diabetic ketoacidosis due to empagliflozin Nellowe Candelario * and Jedrzej Wykretowicz Department of Internal Medicine, Einstein Healthcare Network, Philadelphia, USA *Correspondence address. Department of Internal Medicine, Einstein Healthcare Network, 5501 Old York Road, Philadelphia, PA 19141, USA. Tel: +267-858-5508; E-mail: ude.nietsnie@nalednac Received 2016 May 14; Revised 2016 Jun 14; Accepted 2016 Jun 16. Copyright The Author 2016. Published by Oxford University Press. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( ), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact [email protected] This article has been cited by other articles in PMC. Sodium glucose co-transporter (SGLT-2) inhibitor is a relatively new medication used to treat diabetes. At present, the Food and Drug Administration (FDA) has only approved three medications (canagliflozin, dapagliflozin and empagliflozin) in this drug class for the management of Type 2 diabetes. In May 2015, the FDA issued a warning of ketoacidosis with use of this drug class. Risk factors for the development of ketoacidosis among patients who take SGLT-2 inhibitors include decrease carbohydrate intake/starvation, acute illness and decrease in insulin dose. When identified, immediate cessation of the medication and administration of glucose must be done, and in some instances, starting an insulin drip might be necessary. We present a case of a patient with diabetes mellitus being on empagliflozin (SGLT-2 antagonist) who was admitted for acute cholecystitis. The hospital course was compl Continue reading >>
Euglycemic Diabetic Ketoacidosis: A Diagnostic And Therapeutic Dilemma
Euglycemic diabetic ketoacidosis: a diagnostic and therapeutic dilemma 1Department of Internal Medicine, Memorial Hospital of Martinsville and Henry County, Martinsville, Virginia, USA, 2Texas Tech University Health Sciences Center, El Paso, Texas, USA, 3Senior Research Associate, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA, 4Department of Pharmacology, St Johns Medical College, Bangalore, India, Received 2017 Jul 18; Accepted 2017 Aug 4. This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported License . Euglycemic diabetic ketoacidosis (EDKA) is a clinical triad comprising increased anion gap metabolic acidosis, ketonemia or ketonuria and normal blood glucose levels <200 mg/dL. This condition is a diagnostic challenge as euglycemia masquerades the underlying diabetic ketoacidosis. Thus, a high clinical suspicion is warranted, and other diagnosis ruled out. Here, we present two patients on regular insulin treatment who were admitted with a diagnosis of EDKA. The first patient had insulin pump failure and the second patient had urinary tract infection and nausea, thereby resulting in starvation. Both of them were aggressively treated with intravenous fluids and insulin drip as per the protocol for the blood glucose levels till the anion gap normalized, and the metabolic acidosis reversed. This case series summarizes, in brief, the etiology, pathophysiology and treatment of EDKA. Euglycemic diabetic ketoacidosis is rare. Consider ketosis in patients with DKA even if their serum glucose levels are normal. High clinical suspicion is required to diagnose EDKA as normal blood sugar levels masquerade the underlying DKA and cause a diagnostic and therapeutic dilemma. Blood pH and blood or urine Continue reading >>
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A Case Of Euglycemic Diabetic Ketoacidosis Due To Canagliflozin Complicated By Takotsubo Cardiomyopathy
A Case of Euglycemic Diabetic Ketoacidosis due to Canagliflozin Complicated by Takotsubo Cardiomyopathy Muzammil Khan , Shaza Khalid, Asghar Marwat, Hassan Mehmood American Journal of Medical Case Reports. 2018, 6(1), 1-3. DOI: 10.12691/ajmcr-6-1-1 Sodium-glucose co-transporter-2 (SGLT-2) inhibitor is the latest class of anti diabetic medication that improves glycemic control in insulin independent fashion by increasing urinary loss of filtered glucose. Since its introduction in 2013, several cases of euglycemic DKA have been reported in patients being treated with SGLT-2 inhibitors. Blood glucose levels in range lower than expected for DKA makes the diagnosis challenging if clinical suspicion for euglycemic DKA is not high. We report a case of a patient being treated with canagliflozin who presented with DKA, AKI and mild hyperglycemia that was complicated by stress-induced cardiomyopathy. Keywords: sodium-glucose co-transporter-2 (SGLT-2) inhibitor euglycemic DKA In March 2013, first Sodium-glucose co-transporter-2 (SGLT-2) inhibitor, canagliflozin, was approved for the treatment of type 2 diabetes mellitus by the US food and drug agency (FDA) (1). SGLT-2 inhibitors reversibly inhibit the SGLT-2 located in the proximal convoluted tubule of the kidney where 90% of filtered sodium and glucose is reabsorbed. By increasing urinary loss of glucose, SGLT-2 improves glycemic control 3 . Major adverse effect of SGLT-2 inhibitors is to increase the propensity towards ketoacidosis with lower than anticipated blood glucose level although the incidence of DKA has not found to be greater than the general diabetes population 6 . It has been proposed that acute illness, starvation, deficiency of insulin or oral secretagouges increases the release of counter regulatory hormones that Continue reading >>
Invokana Lawsuit: Diabetic Ketoacidosis
Basis of Invokana Lawsuit The Invokana lawsuit is against the drug manufacturer for failure to warn about the risk of Invokana causing diabetic ketoacidosis (DKA). The Invokana lawsuits allege that Johnson & Johnson and their subsidiary Janssen Pharmaceuticals, Inc. failed to warn both prescribing doctors and patients of the potential risk of Invokana causing diabetic ketoacidosis. If identified and treated properly, diabetic ketoacidosis can usually be reversed quickly and easily. Unfortunately, most patients that have experience Invokana-induced diabetic ketoacidosis are not being properly diagnosed and treated. Failure to treat diabetic ketoacidosis in a timely fashion can result in extended hospitalization, organ damage, and even death. Our Invokana lawyers believe that if Johnson & Johnson would have provided adequate warnings on Invokana, then many physicians would not have prescribed Invokana, patients would not have consented to taking Invokana, and the signs and symptoms for Invokana-induced diabetic ketoacidosis would have been monitored closer. All Invokana lawsuits filed in Federal court have been consolidated into a Multi-District Litigation (MDL) in the United States District Court for the District of New Jersey under Judge Brian R. Martinotti. There Invokana lawsuits consolidated in New Jersey state court, where Johnson & Johnson is located. Invokana remains on the market in the United States, even as the lawsuits continue to pile up. About Invokana Invokana, also known by its chemical name canagliflozin, came to the market in the United States in 2013. Invokana was approved by the United States Food and Drug Administration for the treatment of adults with Type 2 diabetes. Invokana was the first of a new class of medications called sodium glucose co-trans Continue reading >>
Understanding Sglt2 Inhibitors' Diabetic Ketoacidosis Risk
Deepali Dixit, PharmD, BCPS, is a Clinical Assistant Professor at Ernest Mario School of Pharmacy and a Clinical Critical Care Pharmacist in the Medical Intensive Care Unit at Robert Wood Johnson University Hospital. Dr. Dixit has been involved in multiple committees and in leadership positions in regional and national pharmacy and organizations. Dr. Dixit's research interests include sedation and delirium in the critically ill, infectious disease, alcohol withdrawal syndrome, chronic obstructive pulmonary disease, and patient safety. This article was collaboratively written with Shannon Anthony, PharmD Candidate. In May 2015, the FDA issued a warning about the risk of developing diabetic ketoacidosis while using SGLT2 inhibitors. That December, the FDA updated the drugs’ labels to include warnings about developing ketoacidosis even with near-normal blood glucose levels.1 SGLT2 inhibitors lower blood glucose levels by decreasing renal glucose reabsorption, which increases urinary glucose excretion.2 Three drugs in this class are currently available in the United States: canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance).1 These medications are approved for managing type 2 diabetes, although they’re increasingly used off-label to treat type 1 diabetes (T1D), and trials are currently being conducted to evaluate their efficacy for this potential indication.3 Diabetic ketoacidosis (DKA) develops most frequently in T1D patients secondary to omission or decreased dosage of insulin, acute illness, or a recent surgical procedure.4 The typical clinical presentation includes hyperglycemia (>250mg/dL), anion-gap acidosis, and elevated plasma and urine ketones.3 Early diagnosis and management of ketoacidosis is vital. The cornerstone DKA treatment Continue reading >>
Fda Issues Safety Statement That Sglt-2 Inhibitors May Cause Diabetic Ketoacidosis
Twitter Summary: @US_FDA warns SGLT-2 inhibitors may cause DKA in some patients w/out #hyperglycemia. Get the inside scoop from Dr. Anne Peters. Essential news for patients, caregivers, and health care providers: the FDA recently issued a drug safety warning on the possibility of diabetic ketoacidosis (DKA) in all people taking SGLT-2 inhibitor pills. Diabetic ketoacidosis is a complication of diabetes that occurs when the body produces elevated levels of acidic compounds called ketones, often due to a lack of effective insulin action, which can lead to hospitalization, coma, and even death if left untreated. Typically, diabetic ketoacidosis is associated with extremely high blood glucose levels (hyperglycemia), but the reports of diabetic ketoacidosis associated with SGLT-2 inhibitors come without these elevations in blood glucose – this is called “euglycemic diabetic ketoacidosis” or “euDKA.” It is considered an acute complication of type 1 diabetes and does not generally occur in people with type 2 diabetes. The FDA’s safety warning is currently based on 20 reported cases of euglycemic ketoacidosis when using SGLT-2 inhibitors in people who had mostly been diagnosed with type 2 diabetes, although some (using the drug off-label) were diagnosed with type 1 diabetes. As we understand it, the risk of euDKA is rare with these drugs, but when it occurs it is quite serious. Part of the problem is that euDKA can often be misdiagnosed when health care providers aren’t aware of the need to check for elevated ketone levels in the absence of hyperglycemia, or when someone is diagnosed with type 2 diabetes. If diagnosed correctly, though, the treatment for euDKA is relatively simple and primarily requires the administrations of intravenous (IV) insulin, fluids, and Continue reading >>
Euglycemic Diabetic Ketoacidosis With Canagliflozin
Euglycemic diabetic ketoacidosis with canagliflozin Not-so-sweet but avoidable complication of sodium-glucose cotransporter-2 inhibitor use Clinical Assistant Professor at the University of British Columbia in Vancouver, a family physician with a consulting practice in diabetes in the interior of British Columbia, and Medical Lead for the Interior Health Authority Diabetes Strategy. Professor, Director of the Division of Endocrinology and Metabolism, and Medical Director of the Clinical Islet Transplant Program at the University of Alberta in Edmonton. Correspondence : Dr Maureen Clement; e-mail [email protected] Cet article est disponible en franais. Voyez " Lacidoctose diabtique euglycmique due la canagliflozine ". This article has been cited by other articles in PMC. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have been approved in Canada for use in the management of type 2 diabetes (T2DM) since May 2014. Three agents from this class are licensed in Canada (canagliflozin, dapagliflozin, and empagliflozin). These agents are likely to be used commonly in family practice because they are once-daily oral medications that lower blood glucose levels and they are associated with weight loss, lower blood pressure, and a low risk of hypoglycemia. Furthermore, recent evidence showed reduced cardiovascular mortality with empagliflozin. 1 The Canadian Diabetes Association clinical practice guidelines were updated in 2015 to include this class. They note a risk of rare diabetic ketoacidosis [DKA] (may occur with no hyperglycemia), 2 a potentially life-threatening condition that has been observed in some postmarketing reports. Here we present a case of euglycemic DKA associated with use of an SGLT2 inhibitor, with discussion of the potential mechanism of pro Continue reading >>
Risk Of Diabetic Ketoacidosis After Initiation Of An Sglt2 Inhibitor
To the Editor: Inhibitors of sodium–glucose cotransporter 2 (SGLT2) decrease plasma glucose by blocking the reabsorption of glucose at the proximal tubule.1,2 Case reports have suggested that SGLT2 inhibitors may be associated with an increased risk of diabetic ketoacidosis, which led to a warning from the Food and Drug Administration (FDA) in May 2015.3,4 The objective of our study was to assess the risk of diabetic ketoacidosis after the initiation of an SGLT2 inhibitor. Using a large claims database of commercially insured patients in the United States (Truven MarketScan), we identified a cohort of adult patients (≥18 years of age) who had newly started treatment with either an SGLT2 inhibitor or a dipeptidyl peptidase-4 (DPP4) inhibitor between April 1, 2013, and December 31, 2014 (before the FDA warning). DPP4 inhibitors were chosen as the comparator medication because they are similarly used as a second-line treatment for diabetes but have no known association with diabetic ketoacidosis. We excluded patients with human immunodeficiency virus infection, end-stage renal disease, cancer, type 1 diabetes, or past diabetic ketoacidosis. Our primary outcome was hospitalization for diabetic ketoacidosis (using the primary position code of the International Classification of Diseases, Ninth Revision) within 180 days after the initiation of an SGLT2 inhibitor or a DPP4 inhibitor. We censored data for patients at the time that they discontinued the initial medication, had the outcome, lost insurance coverage, or died. We used 1:1 propensity-score matching to balance 46 characteristics of the patients and Cox regression to estimate hazard ratios and 95% confidence intervals for diabetic ketoacidosis within 180 days after treatment initiation. Predefined sensitivity analy Continue reading >>
Euglycemic Diabetic Ketoacidosis With Prolonged Glucosuria Associated With The Sodium-glucose Cotransporter-2 Canagliflozin
Euglycemic Diabetic Ketoacidosis With Prolonged Glucosuria Associated With the Sodium-Glucose Cotransporter-2 Canagliflozin Neda Rasouli, MD, University of Colorado Denver, Mail Stop 8106, 12631 East 17th Avenue, Aurora, CO 80045, USA. Email: [email protected] Received 2017 Mar 15; Revised 2017 May 5; Accepted 2017 May 9. Copyright 2017 American Federation for Medical Research This article is distributed under the terms of the Creative Commons Attribution 4.0 License ( ) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( ). Sodium-glucose cotransporter-2 (SGLT2) inhibitors improve glycemic control by a reversible inhibition of the sodium-glucose cotransporters in the renal proximal tubules resulting in increased urinary glucose. This unique mechanism, independent of insulin secretion and beta cell function, has made this class of medication desirable in patients with type 2 diabetes. However in May 2015, the US Food and Drug Administration issued a safety warning pertaining to the development of diabetic ketoacidosis (DKA) with the use of SGLT2 inhibitors. DKA associated with SGLT2 inhibitors frequently develops in the absence of hyperglycemia, which makes the diagnosis more challenging. Due to the reversible inhibition of SGLT2 by this class of medication, a quick recovery of glucosuria after cessation of medication is expected. In this article, we present a case of a 50-year-old woman with type 2 diabetes who developed euglycemic DKA after initiating therapy with canagliflozin. This case of DKA associated with SGLT2 inhibitor use was unique due to her hypoglycemic presentation and persistent glucosuria. SGLT2 inhibitors such as ca Continue reading >>
