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Jardiance Ketoacidosis

Jardiance, Invokana, And Farxiga Double Risk Of Diabetic Ketoacidosis

Jardiance, Invokana, And Farxiga Double Risk Of Diabetic Ketoacidosis

Jardiance, Invokana, And Farxiga Double Risk Of Diabetic Ketoacidosis The June 8, 2017 edition of The New England Journal of Medicine (NEJM) has a To the Editor letter, titled Risk of Diabetic Ketoacidosis after Initiation of an SGLT2 Inhibitor, which is likely causing some concerns among doctors and type 2 diabetes (T2D) patients. It is about the safety of Jardiance, Invokana, Farxiga, and other diabetes medicines in the SGLT2 inhibitor class of diabetes drugs. A June 7, 2017 MedPage Today article, Study Warns of Diabetic Ketoacidosis With SGLT2 Inhibitors in T2D, provides a summary and some commentary about the recent medical study which is described in this June 2017 NEJM letter to the editor: The newest class of drugs for treating type 2 diabetes carries a greater risk for diabetic ketoacidosis compared to other classes of drugs, a new study suggests. Newly initiated use of an SGLT2 inhibitor was associated with a roughly twofold greater risk of diabetic ketoacidosis versus new initiation of a DPP4 inhibitor (HR 2.2, 95% CI 1.4 to 3.6), according to Michael Fralick, MD, of Brigham and Womens Hospital, and colleagues. It is important to know that if diabetic ketoacidosis (DKA) is not treated, it can lead to severe illness or death. In more detail, possible complications of DKA include these medical conditions: Cerebral Edema (fluid buildup in the brain) Bowel Necrosis (death of bowel tissue due to low blood pressure) All of these newer diabetes medicines are part of the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class of drugs: Invokamet XR (canagliflozin and metformin extended-release) Xigduo XR (dapagliflozin and metformin extended-release) Continue reading >>

In Brief: Ketoacidosis With Sglt2 Inhibitors

In Brief: Ketoacidosis With Sglt2 Inhibitors

The FDA has warned that use of an SGLT2 (sodium-glucose co-transporter 2) inhibitor for treatment of type 2 diabetes may lead to ketoacidosis.1 Three SGLT2 inhibitors, canagliflozin (Invokana, Invokamet), dapagliflozin (Farxiga, Xigduo XR), and empagliflozin (Jardiance, Glyxambi), are approved for treatment of type 2 diabetes in the US. Between March 2013 and June 2014, 20 cases of ketoacidosis requiring emergency room visits or hospitalization were reported in patients who had recently started taking an SGLT2 inhibitor; the median time to onset of symptoms after initiation of therapy was 2 weeks (range 1-175 days). SGLT2 inhibitors decrease renal glucose reabsorption and increase urinary glucose excretion, resulting in a reduction in blood glucose levels. The mechanism by which these drugs could cause ketoacidosis has not been established. Diabetic ketoacidosis (DKA) occurs primarily in patients with type 1 diabetes; it is characterized by elevated blood glucose levels (usually ≥250 mg/dL), a high anion gap, glucosuria, and ketonuria.2 Unlike typical cases of DKA, most ketoacidosis cases associated with SGLT2 inhibitors have occurred in patients with type 2 diabetes, and in some patients glucose levels were <200 mg/dL. Only half of the 20 cases were associated with a recognizable DKA-precipitating factor, such as infection, reduced caloric intake, or reduced insulin dose. Other factors that may contribute to the development of high anion gap metabolic acidosis, such as hypovolemia, hypoxemia, reduced oral intake, acute renal impairment, and a history of alcohol use, were identified in some patients.1 Continue reading >>

Diabetes Drugs Linked To Higher Risk For Rare But Deadly Complication

Diabetes Drugs Linked To Higher Risk For Rare But Deadly Complication

A new class of type 2 diabetes drugs called SGLT2 inhibitors could increase the risk of a rare, life-threatening complication of the disease called ketoacidosis, a new study warns. SGLT2 inhibitors include prescription medications such as canagliflozin, dapagliflozin and empagliflozin. Brand names are Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi. These drugs first became available in 2013, but in 2015 the U.S. Food and Drug Administration issued a warning about an increased risk for diabetic ketoacidosis when SGLT2 inhibitors are used. The condition typically occurs in people with type 1 diabetes. And while it is uncommon in people with type 2 diabetes, case reports have shown it can occur with type 2 disease, according to the study authors. Ketoacidosis can cause vomiting, abdominal pain, shortness of breath and swelling in the brain. Left untreated, the condition can be fatal, the researchers said. The new study "essentially confirms what doctors had already suspected," said diabetes expert Dr. Stanislaw Klek, an endocrinologist at NYU Winthrop Hospital in Mineola, N.Y. "Fortunately, the rate of diabetic ketoacidosis is still very low and should not prevent the usage of this medication class," he added. "It is important to be aware of this potential complication and monitor for symptoms of diabetic ketoacidosis, particularly during periods of illness." In the new study, researchers at Brigham and Women's Hospital in Boston analyzed data from 40,000 people with type 2 diabetes. They found that those taking SGLT2 inhibitors were twice as likely to develop diabetic ketoacidosis than those taking another class of diabetes drugs called DPP4 inhibitors (drugs such as Januvia and Onglyza). Still, the risk to any one patient remains very slim, the researche Continue reading >>

Jardiance Ketoacidosis Is Potential Risk Of Popular Diabetes Drug

Jardiance Ketoacidosis Is Potential Risk Of Popular Diabetes Drug

Jardiance Ketoacidosis is Potential Risk of Popular Diabetes Drug The diabetes drug Jardiance has been linked with a number of serious complications, including an increased risk of Jardiance ketoacidosis. Jardiance (also known by its generic name, empagliflozin) is a diabetes drug jointly manufactured by Eli Lilly and Boehringer Ingelheim Pharmaceuticals. The diabetes medication, along with other diabetes drugs belonging to its class, has recently been accused of increasing a patients risk of developing Jardiance ketoacidosis . Jardiance, Invokana, and Farxiga are all members of a new class of diabetes medications approved to treat type-2 diabetes. These drugs are known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. SGLT2 inhibitors include the following diabetes drugs: Unfortunately, despite the popularity of SGLT2 inhibitor drugs like Jardiance, these medications have been linked with ketoacidosis complications. In response to reports of Jardiance ketoacidosis and ketoacidosis associated with other SGLT2 inhibitor drugs, the U.S. Food and Drug Administration (FDA) has issued a warning for drugs in the SGLT2 inhibitor class. Jardiance ketoacidosis can be a serious complication. Essentially, ketoacidosis is the buildup of high levels of ketones, or blood acids, in the blood. This can lead to a number of symptoms, including the following: In the drugs first fifteen months on the market, the FDA reports having received over twenty adverse events reports linking SGLT2 inhibitors like Jardiance with ketoacidosis problems. These patients required emergency room treatment and/or hospitalization due to diabetic ketoacidosis, ketosis, acidosis, or other similar conditions. Diabetic ketoacidosis is generally associated with type-1 diabetes. Type-1 diabetes is a condition Continue reading >>

Jardiance Lawsuits: Kidney Failure & Diabetic Ketoacidosis

Jardiance Lawsuits: Kidney Failure & Diabetic Ketoacidosis

Jardiance Lawsuits: Kidney Failure & Diabetic Ketoacidosis Commonly asked questions about Jardiance (empagliflozin): What makes me eligible for a Jardiance lawsuit? Jardiance (empagliflozin) is a drug of the gliflozin class used to treat Type 2 diabetes . It was developed by Boehringer Ingelheim. The U.S. Food and Drug Administration approved dapagliflozin in 2014 for glycemic control, along with diet and exercise, in adults with Type 2 diabetes . Common side effects of Jardiance may include: Are There Any Jardiance Lawsuits or Recalls? As Jardiance is a new drug, there are no recalls or lawsuits yet. However, The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines, which include Jardiance, may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. The FDA says that patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Jardiance is an SGLT2 inhibitor , which is a class of prescription medicines for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. What Makes Me Eligible for an Jardiance Lawsuit? The manufacturers of SGLT2 Inhibitors have been the subject of litigation because of the side effects caused by their drugs. The national Invokana lawsuit alleges that the manufacturers and marketers of SGLT2 Inhibitors failed to warn patients and physicians of the increased risks of kidney failure, myocardial infarction (heart attacks), o Continue reading >>

Jardiance Lawsuit Over Ketoacidosis Claim Cleared To Proceed By Judge

Jardiance Lawsuit Over Ketoacidosis Claim Cleared To Proceed By Judge

Jardiance Lawsuit Over Ketoacidosis Claim Cleared To Proceed By Judge Have A Potential Case Reviewed By An Attorney This field is for validation purposes and should be left unchanged. A federal judge recently cleared the way for a lawsuit to move forward involving allegations that side effects of Jardiance , a popular diabetes drug, caused a woman to experience diabetic ketoacidosis (DKA), which led to her hospitalization. In a court order (PDF) issued on November 21, U.S. Chief District Judge S. Thomas Anderson partially granted and partially denied a request for summary judgment filed by the drug makers Eli Lilly and Boehringer Ingelheim, in a lawsuit brought by Melissa Mitchell. Mitchell filed a complaint (PDF) against the drug makers in June 2016, after she suffered diabetic ketoacidosis in June 2015, indicating that she had been using Jardiance for the treatment of type 2 diabetes since February of that year. Her lawsuit alleges that the drug makers failed to warn the medical community and patients of the risks of diabetic ketoacidosis. Jardiance (empagliflozin) belongs to a class of diabetes drugs known as sodium glucose cotransporter-2 (SGLT-2) inhibitors. The class also includes Invokana, Invokamet, Farxiga and Xigduo. The FDA approved Jardiance on August 1, 2014. However, the agency issued a safety alert linking Jardiance and similar drugs to an increased risk of diabetic ketoacidosis, a dangerous build up of acid in the blood, in May 2015 based on adverse event reports that were submitted from March 2013 to June 2014; before Jardiance was approved for sale. The defendants sought to have the lawsuit dismissed entirely, arguing that Mitchells failure to warn claims were based on adverse events reported before the FDA approved Jardiance for sale. Since the FDA a 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-linked Diabetic Ketoacidosis Is Rare, But Severe

Sglt2 Inhibitor-linked Diabetic Ketoacidosis Is Rare, But Severe

SGLT2 Inhibitor-Linked Diabetic Ketoacidosis Is Rare, but Severe Many cases of sodium-glucose cotransporter-2 (SGLT2) inhibitor-associated diabetic ketoacidosis (DKA) are preventable, new research suggests. But physicians and patients are missing the signs and symptoms of this rare side effect or not even aware of the link and as a result, any cases are severe and one was fatal, according to this latest audit of Australian databases, published online February 13 in Diabetes Care by Emily J Meyer, MBBS, of the Royal Adelaide Hospital and University of Adelaide, Australia, and colleagues. As DKA was initially missed by both patients and physicians, likely due in part to relative euglycemia, this led to delayed treatment, say the researchers. However, "identifiable precipitants were often present, suggesting the potential for risk mitigation," Meyer and colleagues write. Stop SGLT2 Inhibitors for Acute Illness, Surgery The US Food and Drug Administration (FDA) first warned about the risk for DKA with SGLT2 inhibitors, a relatively new class of oral agents for type 2 diabetes, in 2015, and the European Medicines Agency followed suit in 2016. The phenomenon has also been reported several times in the literature, including in the New England Journal of Medicine in 2017. The advice has been, and the Australian authors agree, that SGLT2 inhibitors should be temporarily stoppedduring acute illness or surgery. The possibility of DKA should be considered in any patient taking one of the agents who presents with malaise, nausea, and/or vomiting, they add. The drug should be stopped and, if caught early, the patient given hydration, carbohydrates, and insulin to prevent progression to DKA. Also, Meyers and colleagues suggest excluding a diagnosis of autoimmune diabetes (type 1 or l Continue reading >>

Jardiance Might Become The Next Blockbuster Diabetes Drug Despite Ketoacidosis And Acute Kidney Injury Side Effects - Drug Injury Watch

Jardiance Might Become The Next Blockbuster Diabetes Drug Despite Ketoacidosis And Acute Kidney Injury Side Effects - Drug Injury Watch

Jardiance Might Become The Next Blockbuster Diabetes Drug Despite Ketoacidosis And Acute Kidney Injury Side Effects December 2016 FDA Determination About Cardiovascular Benefits Also Includes Increased Drug Safety Warnings Label Change For Jardiance (Posted by Tom Lamb at DrugInjuryWatch.com ) After the December 2, 2016 decision by the FDA to expand the health benefits for the relatively new diabetes medicine Jardiance (empagliflozin) to include preventing fatal heart attacks and strokes in type 2 diabetes patients, we saw news reports about its expected effect on Jardiance sales in the U.S. From this December 9, 2016 Reuters article, " New diabetes guidelines imminent, Jardiance sales may surge ", we get this information: Two leading U.S. medical societies are poised in the coming weeks to issue new diabetes treatment guidelines reflecting the lifesaving cardiovascular effects of Eli Lilly's Jardiance in a move expected to drive up the drug's sales. The forthcoming guidelines from the American Diabetes Association and the American Association of Clinical Endocrinologists.... Ashtyn Evans, analyst with the Edward Jones investment company, expects annual Jardiance sales to approach $4 billion by the early 2020s, up from $200 million now, split with privately held German partner Boehringer Ingelheim. Evans predicted that doctors would now favor Jardiance for new patients over other similar drugs called SGLT-2 inhibitors, including Johnson & Johnson's Invokana and AstraZeneca's Farxiga, until they complete their own heart-protection studies in the next two years. What did not get this same type of media coverage was the other part of the FDA's December determination, a "Revised: December 2016" Jardiance Prescribing Information document -- also called the package insert or Continue reading >>

Fda: Diabetes Drug Jardiance May Cause Ketoacidosis

Fda: Diabetes Drug Jardiance May Cause Ketoacidosis

FDA: Type 2 diabetes medicine Jardiance may cause ketoacidosis Food and Drug Administration warns SGLT2 inhibitors may lead to serious health problems You are here: Home SGLT2 Inhibitor Injuries FDA: Type 2 diabetes medicine Jardiance may cause ketoacidosis On May 15 2015, the Food and Drug Administration (FDA) issued a Drug Safety Communication warning Jardiance (empagliflozin) users about possible links between the type 2 diabetes medication and developing serious medical conditions. Jardiance may be linked to ketoacidosis, a serious medical condition which may require hospitalization. Individuals who suffered severe side effects may be eligible to file a Jardiance lawsuit in order to receive compensation for damages. Jardiance is in a class of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. The FDA approved SGLT2 inhibitors to treat diabetes along with changes in diet and exercise. The FDAs May 2015 Drug Safety Communication also included the SGLT2 inhibitors Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin extended-release), and Glyxambi (empagliflozin and linagliptin). Possible links between taking SGLT2 inhibitors and developing serious health problems are being evaluated by the FDA, Health Canada, and the European Medicines Agency. SGLT2 inhibitors are being evaluated by independent health organizations for possible links to increased risk of heart attack and stroke. Jardiance is a once-daily pill taken to treat type 2 diabetes developed and marketed by Boehringer Ingelheim and Eli Lilly and Company. The FDA first approved Jardiance for use by adults with type 2 diabetes in August 2014. Jardiance is and other SGLT2 inhibitors treat type 2 diabetes by making the ki Continue reading >>

Jardiance Ketoacidosis Lawsuit | Lawyer, Attorney

Jardiance Ketoacidosis Lawsuit | Lawyer, Attorney

Diabetic patients who use Jardiance can develop ketoacidosis (too much acid in the blood), a life-threatening complication that can occur even when blood-sugar levels are normal. The Schmidt Firm, PLLC is currently accepting Jardiance induced injury cases in all 50 states. If you or somebody you know has been diagnosed with ketoacidosis, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753. Jardiance (empagliflozin) treats type-2 diabetes by forcing the kidneys to excrete more sugar from the body in urine, which lowers blood-sugar levels. It belongs to a class of drugs called SGLT2 inhibitors . The FDA warned about the risk of ketoacidosis from Jardiance and other SGLT2 inhibitors in December 2015. The agency ordered drug-makers to update the label on Jardiance. Between March 2013 and May 2015, the FDA received 73 reports of ketoacidosis from all SGLT2 inhibitors. Jardiance was linked to 12 reports of ketoacidosis in 2015, according to a report by the Institute for Safe Medication Practices (ISMP). Clinical trials indicate that ketoacidosis occurs in less than 1% of patients on SGLT2 inhibitors. However, the chances are higher for people with certain risk-factors uncontrolled diabetes, a recent illness (cold, flu, etc.) or infection, emotional stress, physical injury, recent surgery, eating less, or drinking a lot of alcohol. Patients on Jardiance should use urine test strips to check ketone levels. It is also a good idea to check blood-sugar levels, though ketoacidosis can occur even when blood-sugar levels are only slightly higher than usual. You should also stop taking Jardiance and seek emergency medical attention if you de Continue reading >>

Fda Issues Safety Statement That Sglt-2 Inhibitors May Cause Diabetic Ketoacidosis

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 In Type 2 Diabetes Treated With A Sodium-glucose Cotransporter-2 Inhibitor

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 >>

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 >>

Three Diabetes Drugs Linked To Ketoacidosis, Fda Warns

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 >>

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