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Invokana Dka Mechanism

Euglycemic Dka: It’s Not A Myth

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 >>

Canagliflozin-induced Diabetic Ketoacidosis

Canagliflozin-induced Diabetic Ketoacidosis

Go to: Case Report A 62-year-old woman with type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease, and depression presented with 4 days of nausea, vomiting, and generalized weakness. Her symptoms became progressively worse such that by the day of admission she had decreased appetite, polydipsia, polyuria, and could not walk. The patient denied fever, chills, abdominal pain, diarrhea, or sick contacts. Home medications were atorvastatin, metformin, sucralfate, pioglitazone, canagliflozin, exenatide, omeprazole, fluoxetine, ranitidine, lisinopril, and alprazolam. On physical examination, the patient’s vital signs included a temperature of 38.3°C, blood pressure 134/61, heart rate 107, respiratory rate 24, and oxygen saturation of 100% on 2 liters nasal cannula oxygen. The patient appeared ill and distressed. She had dry mucous membranes, clear lung sounds bilaterally, and her heart was regular without murmurs, gallops, or rubs. Her abdomen was soft and nontender with present bowel sounds. Extremities showed no edema, and she had no focal neurological findings. Laboratory revealed a metabolic acidosis with a pH of 7.08 and anion gap >17. Chemistry panel indicated sodium 134 mEq/L, potassium 5.2 mEq/L, chloride 112 mEq/L, CO2 <5 mEq/L, blood urea nitrogen 22 mg/dL, and creatinine 1.3 mg/dL. Blood glucose was 213 mg/dL, and urinalysis revealed glucose 2+ and ketones 3+. Serum ketones were present at 1:8 dilution, with a lactic acid of 0.8 mmol/L. The patient’s hemoglobin A1C (HbA1c) was 11.1. The patient was admitted to the intensive care unit for severe metabolic acidosis secondary to DKA. Aggressive fluid resuscitation was undertaken and an insulin drip initiated. Within 6 hours, the anion gap metabolic acidosis improved. On further review of her med Continue reading >>

Sglt2 Inhibitors: Updated Advice On The Risk Of Diabetic Ketoacidosis

Sglt2 Inhibitors: Updated Advice On The Risk Of Diabetic Ketoacidosis

Advice for healthcare professionals: When treating patients who are taking a sodium-glucose co-transporter 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin, or empagliflozin): inform them of the signs and symptoms of diabetic ketoacidosis (DKA) – see below – and advise them to seek immediate medical advice if they develop any of these discuss the risk factors for DKA with patients (see below) discontinue treatment with the SGLT2 inhibitor immediately if DKA is suspected or diagnosed do not restart treatment with any SGLT2 inhibitor in patients who experienced DKA during use, unless another cause for DKA was identified and resolved interrupt treatment with the SGLT2 inhibitor in patients who are hospitalised for major surgery or acute serious illnesses; treatment may be restarted once the patient’s condition has stabilised Reports of diabetic acidosis EU medicines regulators have completed a review of DKA associated with SGLT2 inhibitor treatment; this article summarises the review’s recommendations. We published preliminary advice on this in June 2015. SGLT2 inhibitors are licensed for use in adults with type 2 diabetes to improve glycaemic control. Serious, life-threatening, and fatal cases of DKA have been reported in patients taking an SGLT2 inhibitor (canagliflozin, dapagliflozin, or empagliflozin). The EU review concluded that this side effect is rare (affecting between 1 in 1000 and 1 in 10,000 patients). Up to 26 February 2016, we had received 118 Yellow Card reports of DKA and associated reactions in patients taking an SGLT2 inhibitor in the UK. In several cases, blood glucose levels were only moderately elevated (eg <14mmol/L)—representing an atypical presentation for DKA, which could delay diagnosis and treatment. Therefore inform patients of the si Continue reading >>

Get Unlimited Access On Medscape.

Get Unlimited Access On Medscape.

You’ve become the New York Times and the Wall Street Journal of medicine. A must-read every morning. ” Continue reading >>

Euglycemic Diabetic Ketoacidosis: A Predictable, Detectable, And Preventable Safety Concern With Sglt2 Inhibitors

Euglycemic Diabetic Ketoacidosis: A Predictable, Detectable, And Preventable Safety Concern With Sglt2 Inhibitors

The Case At Hand Recently, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication that warns of an increased risk of diabetic ketoacidosis (DKA) with uncharacteristically mild to moderate glucose elevations (euglycemic DKA [euDKA]) associated with the use of all the approved sodium–glucose cotransporter 2 (SGLT2) inhibitors (1). This Communication was based on 20 clinical cases requiring hospitalization captured between March 2013 and June 2014 in the FDA Adverse Event Reporting System database. The scarce clinical data provided suggested that most of the DKA cases were reported in patients with type 2 diabetes (T2D), for whom this class of agents is indicated; most likely, however, they were insulin-treated patients, some with type 1 diabetes (T1D). The FDA also identified potential triggering factors such as intercurrent illness, reduced food and fluid intake, reduced insulin doses, and history of alcohol intake. The following month, at the request of the European Commission, the European Medicines Agency (EMA) announced on 12 June 2015 that the Pharmacovigilance Risk Assessment Committee has started a review of all of the three approved SGLT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) to evaluate the risk of DKA in T2D (2). The EMA announcement claimed that as of May 2015 a total of 101 cases of DKA have been reported worldwide in EudraVigilance in T2D patients treated with SGLT2 inhibitors, with an estimated exposure over 0.5 million patient-years. No clinical details were provided except for the mention that “all cases were serious and some required hospitalisation. Although [DKA] is usually accompanied by high blood sugar levels, in a number of these reports blood sugar levels were only moderately increased” (2). Wit Continue reading >>

Can Invokana Trigger Diabetic Ketoacidosis?

Can Invokana Trigger Diabetic Ketoacidosis?

Invokana Research has shown that taking the diabetes drug Invokana (canagliflozin) can trigger diabetic ketoacidosis, a potentially fatal condition. Invokana is used to treat Type 2 diabetes. There are more than 450,000 Invokana prescriptions filled every three months in the United States. The drug is made and marketed by Janssen, a partner of Johnson & Johnson. It was the first drug of its kind to treat Type 2 diabetes and drug makers were hopeful it would help patients who did not respond to other diabetes drugs. Sadly, it has been linked to many medical risks, including potentially deadly diabetic ketoacidosis. Type 2 Diabetes Type 2 diabetes is a disease that affects the body’s ability to process insulin. The disease affects about nine million Americans. Over time, it can lead to high blood pressure, heart disease, blindness, kidney disease, damage to the feet and hands, and other health problems. In order for the body to manage sugar and turn it into energy, insulin must help cells absorb it. When this does not happen because of problems with insulin, sugar remains in the blood system, causing blood glucose levels to raise to unhealthy levels. This is why diabetics must pay attention to their blood sugar. About Invokana Invokana is part of a group of drugs known as SGLT2 anti-diabetics. It works by preventing glucose from being reabsorbed by the kidneys. It also allows excess sugar to be let out in urine. Studies have shown Invokana users excrete up to 450 calories of extra sugar in urine. Despite Invokana working for some users, it comes with a variety of side effects. Most are mild and might be a problem with all diabetes medications, including: Yeast infection Urinary tract infection Nausea Fatigue Photosensitivity Increased LDL (bad) cholesterol One of the bi Continue reading >>

Sglt2 Inhibitors May Predispose To Ketoacidosis

Sglt2 Inhibitors May Predispose To Ketoacidosis

SGLT2 Inhibitors May Predispose to Ketoacidosis Diabetes, Endocrinology, and Obesity Branch (S.I.T., J.E.B., K.I.R.), National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland 20892; Division of Diabetes, Endocrinology, and Nutrition (S.I.T.), Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland 21201 Address all correspondence and requests for reprints to: Simeon I. Taylor, MD, PhD, Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Mail Stop 1453, 9000 Rockville Pike, Bethesda, MD 20892. Search for other works by this author on: Diabetes, Endocrinology, and Obesity Branch (S.I.T., J.E.B., K.I.R.), National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland 20892; Search for other works by this author on: Diabetes, Endocrinology, and Obesity Branch (S.I.T., J.E.B., K.I.R.), National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland 20892; Search for other works by this author on: The Journal of Clinical Endocrinology & Metabolism, Volume 100, Issue 8, 1 August 2015, Pages 28492852, Simeon I. Taylor, Jenny E. Blau, Kristina I. Rother; SGLT2 Inhibitors May Predispose to Ketoacidosis, The Journal of Clinical Endocrinology & Metabolism, Volume 100, Issue 8, 1 August 2015, Pages 28492852, Sodium glucose cotransporter 2 (SGLT2) inhibitors are antidiabetic drugs that increase urinary excretion of glucose, thereby improving glycemic control and promoting weight loss. Since approval of the first-in-class drug in 2013, data have emerged suggesting that these drugs increase the risk of di Continue reading >>

Sodium Glucose Co-transporter 2 Inhibitors - Used To Treat Type 2 Diabetes

Sodium Glucose Co-transporter 2 Inhibitors - Used To Treat Type 2 Diabetes

Australian Government Department of Health Sodium glucose co-transporter 2 inhibitors - used to treat type 2 diabetes Safety advisory - risk of diabetic ketoacidosis Consumers and health professionals are advised that serious cases of diabetic ketoacidosis (DKA) have been reported in patients taking prescription medicines that are inhibitors of sodium glucose co-transporter 2 (SGLT2). These medicines include canagliflozin, dapagliflozin or empagliflozin, which are used to help lower blood sugar levels in patients with type 2 diabetes. Early signs and symptoms of DKA include abdominal pain, nausea, vomiting, anorexia, excessive thirst, difficult breathing, unusual fatigue and sleepiness. If DKA is not diagnosed early and treatment initiated, more serious signs and symptoms including dehydration, deep gasping breathing, confusion and coma can potentially develop. DKA occurs most commonly in patients with type 1 diabetes, although it can occur in type 2 diabetes. It is usually accompanied by high blood glucose levels. However, in a number of the cases of DKA associated with SGLT2 inhibitors, patients demonstrated only a moderately increased blood glucose level. This could lead to delayed diagnosis and treatment. Invokana (canagliflozin) tablets 100mg and 300mg Xigduo XR (dapagliflozin and metformin hydrochloride XR) tablets 5mg/1000mg, 10mg/1000mg and 10mg/500mg Jardiance (empagliflozin) tablets 10mg and 25mg. The sponsors of these medicines have jointly written to health professionals to provide further information about this issue, including recommendations for patient management. The above information relates to a potential risk associated with these medicines. If you or someone you care for takes one of the affected products, you should continue taking your medicine u Continue reading >>

Risk Of Diabetic Ketoacidosis After Initiation Of An Sglt2 Inhibitor

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 >>

Canagliflozin

Canagliflozin

Canagliflozin (trade name Invokana or Sulisent) is a medication used for the treatment of type 2 diabetes.[1][2] It is of the gliflozin class or subtype 2 sodium-glucose transport (SGLT-2) inhibitors class. This mechanism is associated with a low risk of hypoglycaemia (too low blood glucose) compared to sulfonylurea derivatives and insulin.[3] In 2017, the FDA concluded that canagliflozin causes an increased risk of leg and foot amputations.[4] The FDA began requiring a Boxed Warning to be added to the canagliflozin drug labels to describe this risk.[5] Canagliflozin is an inhibitor of subtype 2 sodium-glucose transport proteins (SGLT2), which is responsible for at least 90% of renal glucose reabsorption (SGLT1 being responsible for the remaining 10%). Blocking this transporter causes up to 119 grams of blood glucose per day to be eliminated through the urine.[6] It was developed by Mitsubishi Tanabe Pharma and is marketed under license by Janssen, a division of Johnson & Johnson.[7] Medical use[edit] Canagliflozin is an anti-diabetic drug used to improve glycemic control in people with type 2 diabetes. In extensive clinical trials, canagliflozin produced a consistent dose-dependent decrease in HbA1c levels of 0.77% to 1.16% when administered either as monotherapy, in combination with metformin, in combination with metformin and a sulfonylurea, in combination with metformin and pioglitazone, or in combination with insulin, from initial HbA1c levels of 7.8% to 8.1%. When added to metformin, canagliflozin daily was shown to be non-inferior to both sitagliptin 100 mg daily and glimepiride in reducing HbA1c levels at one year, whilst canagliflozin 300 mg successfully demonstrated statistical superiority over both sitagliptin and glimiperide in decreasing HbA1c levels. Secon Continue reading >>

Adverse Effects Of Canagliflozin, An Sglt2 Inhibitor

Adverse Effects Of Canagliflozin, An Sglt2 Inhibitor

Adverse Effects of Canagliflozin, an SGLT2 Inhibitor Allan S. Brett, MD reviewing Peters AL et al. Diabetes Care 2015 Sep . The FDA has expressed concern about diabetic ketoacidosis and fractures in users of sodiumglucose cotransporter 2 inhibitors. The sodiumglucose cotransporter 2 (SGLT2) inhibitors (canagliflozin [Invokana], empagliflozin [Jardiance], and dapagliflozin [Farxiga]) increase urinary excretion of glucose. These drugs are approved for use in type 2 diabetes, but anecdotal reports suggest that off-label prescribing to type 1 diabetic patients is increasing. In May 2015, the FDA noted a possible association between SGLT2 inhibitors and diabetic ketoacidosis (DKA) . Now, several endocrinologists describe 13 cases of euglycemic DKA in 9 diabetic patients (7 patients with type 1, and 2 patients with type 2) who were taking canagliflozin in addition to insulin. The designation euglycemic DKA refers to presentations with anion-gap acidosis and ketosis but serum glucose levels only in the 100 to 200 mg/dL range. The absence of substantial hyperglycemia tended to delay recognition and treatment. Some of the cases were preceded by moderate alcohol intake or low intake of food and insulin. Presumably, in patients who are developing DKA for varying reasons, the glycosuric effect of canagliflozin lowers serum glucose and signals patients to reduce not increase their insulin doses. This sequence facilitates progression to full-blown DKA. The FDA also recently strengthened a previous warning about canagliflozin's association with excess risk for fractures in clinical trials . A proposed mechanism is a decrease in serum parathyroid hormone and 1,25-dihydroxyvitamin D levels in some patients who take SGLT2 inhibitors ( Lancet Diabetes Endocrinol 2015 3:8 ). The SGLT2 inh Continue reading >>

Euglycemic Diabetic Ketoacidosis With Canagliflozin

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 >>

Sglt2 Inhibitors And Diabetic Ketoacidosis: What's Behind The Fda Warning

Sglt2 Inhibitors And Diabetic Ketoacidosis: What's Behind The Fda Warning

With commentary by Yehuda Handelsman, MD, FACP, FACE, FNLA, an endocrinologist in private practice in Tarzana, CA, Medical Director and Principal Investigator of the Metabolic Institute of America and President of the American College of Endocrinology People with diabetes who take blood sugar-lowering drugs called SGLT2 inhibitors were recently warned by the U.S. Food and Drug Administration (FDA) that they should watch for signs of a life-threatening condition called diabetic ketoacidosis. canagliflozin (Invokana) dapagliflozin (Farxiga) empagliflozin (Jardiance) as well as the combination pills: canagliflozin plus metformin (Invokamet) dapagliflozin plus metformin extended-release (Xigduo XR) empagliflozin plus linagliptin (Glyxambi). “Diabetic ketoacidosis (DKA) can be deadly,” says Amy Hess-Fischl, MS, RD, LDN, BC-ADM, CDE, an advanced practice dietitian at the University of Chicago Kovler Diabetes Center and a member of EndocrineWeb’s advisory board. “DKA is usually more of a concern for people with type 1 diabetes, but this warning is for people with type 2 diabetes who are taking the SGLT2 inhibitors, as well as people with type 1 diabetes who take these medications off label. DKA — dangerously high acid levels in the bloodstream — happens when your body breaks down fat instead of glucose for energy, releasing acidic compounds called ketones. Early symptoms include thirst, frequent urination and sweet, fruity breath, Hess-Fischl says. You may feel tired and confused, and develop nausea, stomach pain, vomiting and difficulty breathing. “If you notice symptoms, call your doctor immediately. But if you’re vomiting, can’t catch your breath or are concerned, go to the emergency room,” she says. Putting the Risk in Perspective The FDA warning, relea Continue reading >>

Understanding Sglt2 Inhibitors' Diabetic Ketoacidosis Risk

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 >>

Sglt2 Inhibitor Diabetes Drugs May Cause Ketoacidosis: Fda

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 >>

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