The personal injury attorneys at Parker Waichman LLP are investigating the association between SGLT2 Type 2 diabetes medications and heart attack, stroke, renal failure, diabetic ketoacidosis, or the need for amputations and are also investigating potential lawsuits. If you or someone you know suffered adverse reactions following treatment with these medications, our personal injury attorneys would like to hear from you.
FDA Updates Canagliflozin Warning Following Two Recent Studies Revealing Increased Amputation Risks
In an update to the FDA’s “Drug Safety Communication” entitled “Interim Clinical Trial Results Find Increased Risk of Leg and Foot Amputations, Mostly Affecting the Toes, with the Diabetes Medicine Canagliflozin (Invokana, Invokamet); FDA to Investigate” that was issued on May 18, 2016, the agency issued a new FDA “Drug Safety Communication” entitled “FDA Confirms Increased Risk Of Leg And Foot Amputations With The Diabetes Medicine Canagliflozin (Invokana, Invokamet, Invokamet XR).
According to the May 2017 announcement, the FDA indicated that, based on new data from two large clinical trials, it concluded that Invokana, Invokamet, and Invokamet XR do cause an increased risk of leg and foot amputations. The FDA is mandating new warnings, including its most prominent Boxed Warning, to be added to all canagliflozin drug labels to describe this risk. This is expected to take place in the near future.
Patients taking these drugs are advised by the FDA to advise their health care provider immediately if new pain, tenderness, sores, ulcers, or infections develop in the legs and feet. Health care professionals should consider factors that may predispose patients for amputations before prescribing canagliflozin. Risk factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
The FDA noted that the final results from two clinical trials, which are, essentially, post-marketing studies—the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus)—revealed that leg and foot amputations took place approximately twice as often in patients who were treated with canagliflozin, when compared to patients who were treated with a placebo. The study was conducted in this way to eliminate confounding factors that may have been introduced by other drugs. The fact that patients diagnosed with Type 2 diabetes and treated with Invokana have an approximately doubled risk of amputation compared with patients treated with placebo strongly suggests that the amputations may be directly attributed to Invokana given that the expectation should be the opposite. For example, the placebo-treated patients should be expected to experience increased amputation risks compared to patients taking a canagliflozin medication, such as Invokana..
The journal, Diabetes, Obesity and Metabolism, noted that the two large cardiovascular outcome trials will complete in early 2017. The research collected data for drugs in the SGLT2 inhibitor class or drugs and has “identified questions and opportunities that were not apparent when the trials were designed.” Because of this, modifications have been made to the planned analyses to ensure the data from the CANVAS Program will increase advances in both scientific knowledge and patient care. The researchers noted that the CANVAS Program is expected to “significantly advance our understanding of the effects of canagliflozin, and the broader SGLT2 inhibitor class, on a range of important efficacy and safety outcomes.”
The studies were a response to high profile cases of diabetes drugs causing serious adverse events in real world use such as Avandia and Rezulin. Janssen Pharmaceuticals, a unit of Johnson & Johnson, recruited over 10,000 subjects between December 2009 and May 2015. The researchers sought to find potential adverse events in patients diagnosed with diabetes who were treated with Invokana and were/had been also diagnosed with vascular death, total mortality, heart failure, and kidney disease as the highest priorities.
The CANVAS trial revealed that, over one year, the risk of amputation for patients in the trial was equivalent to:
- 9 out of every 1,000 patients treated with canagliflozin
- 8 out of every 1,000 patients treated with placebo
The CANVAS-R trial revealed that, over one year, the risk of amputation for patients in the trial was equivalent to:
- 5 out of every 1,000 patients treated with canagliflozin
- 2 out of every 1,000 patients treated with placebo
The most common amputations were of the toe and middle of the foot; amputations involving the leg, below and above the knee, were also seen. Also, some patients had more than one amputation and some involved both limbs.
MedPage Today pointed out that the studies were both randomized, placebo-controlled trials that involved close to 6,000 patients taking canagliflozin, pointing out that lower extremity amputations were doubled in the active drug groups, regardless of dosage. The statistics were deemed statistically significant, especially given that this type of study provides the highest level of evidence on a drug’s safety and efficacy.
The CANVAS study was mandated by the FDA and reviewed cardiovascular outcomes. The CANVAS-R reviewed renal endpoints, noted MedPage Today. The research revealed that lower-limb infections, gangrene, diabetic foot ulcers, and ischemia were the most common factors for amputations in the studies, according to the FDA.
Patients in the study were only included if they had cardiovascular disease or risk factors for cardiovascular disease in addition to Type 2 diabetes; however, the boxed warning applies to all patients whether or not they have increased risks for cardiovascular disease, according to MedPage Today. Although the FDA has not mentioned that other SGLT-2 inhibitors may carry similar amputation risks, in February 2017, the European Medicines Agency pointed out that the amputation risk may be an effect of the entire drug class, including Farxiga and Jardiance.
The exact mechanism by which Invokana/Invokamet may lead to an increased rate of amputations in patients diagnosed with Type 2 diabetes remains unknown and may take some time to determine. It is possible that the mechanism may relate Invokana; however, the mechanism may involve the entire class of SGLT-2 inhibitors.
In the European Union, the European Medicines Agency (EMA), which is a similar regulatory body to the United States’ FDA, warned in February 2017 of the increased risk of amputation for three SGLT-2 inhibitors—canagliflozin, dapagliflozin, and empagliflozin. The EMA warning only derives from the CANVAS and CANVAS-R studies with no specific data on the risk of amputation in patients taking Farxiga or Jardiance. It is possible that the EMA may suspect a class effect, given that it issued such a broad warning for all SGLT-2 inhibitors.
PulseHeadlines.com noted that canagliflozin may also cause other adverse events, including hypotension, ketoacidosis, kidney problems, excess blood potassium levels, urinary infections, high cholesterol, yeast infections, bone fractures, and low blood sugar if combined with other drugs for treating diabetes.
New Transfer Order For Invokana/Invokamet MDL
The United States Judicial Panel on the multidistrict litigation (MDL) for In Re: Invokana (Canagliflozin) Products Liability Litigation MDL No. 2750 issued a transfer order concerning Invokana and Invokamet with injuries that include diabetic ketoacidosis and kidney damage. Before the Panel are plaintiffs in 29 actions that are pending in the District of Jersey to be centralized in that district. The litigation is comprised of 55 actions and the Panel has been advised of another 44 related federal actions.
The 55 actions similarly allege Invokana may cause a variety of injuries, including diabetic ketoacidosis and kidney damage, and that defendant, Janssen Pharmaceuticals, Inc. neglected to sufficiently test the drug and warn of the risks. One of the actions, currently in the Western District of Kentucky House, is what is known as a “combination case,” which is an action that involves Invokana/Invokamet and Farxiga.
The centralization concern involves if the proposed MDL should include only Invokana/Invokamet cases or if cases involving other SGLT2 inhibitors such as Farxiga and Jardiance should be included. Although moving plaintiffs and plaintiffs in certain other actions does support centralization of only Invokana/Invokamet cases, there is concern regarding choice of a transferee district.
Janssen supports centralization of only Invokana/Invokamet in the District of New Jersey or, if necessary, the Northern District of Illinois. The Farxiga defendants oppose inclusion of any Farxiga claims or cases in this proposed MDL, as do the Jardiance defendants.
The Panel indicated that, on the basis of papers filed and the hearing session held, it found that the “Invokana/Invokamet actions involve common questions of fact, and that centralization of these cases will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. The actions share factual questions arising from allegations that taking Invokana or Invokamet may result in patients suffering various injuries, including diabetic ketoacidosis and kidney damage.” The panel also indicated that, “The actions thus implicate numerous common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs.” The panel indicated that, “centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings … and other pretrial matters, and conserve the resources of the parties, their counsel, and the judiciary.”
The Panel also noted that it is not convinced that the MDL should include claims involving Farxiga, Jardiance, or other SLGT2 inhibitors, including any such claims in “combination cases,” noting that it is “typically hesitant to centralize litigation against multiple, competing defendants which marketed, manufactured and sold similar products.” The Panel pointed out that the centralization of competing defendants in the same MDL may complicate case management, because of the need to protect trade secret and confidential information and a multi-defendant MDL may extend pretrial proceedings due to the potential need for separate discovery, motion tracks, and the need for additional bellwether trials.
The Panel concluded that class-wide centralization is not warranted at the present time and selected the District of New Jersey as transferee district for this litigation for Invokana/Invokamet. Janssen is headquartered in that district; many witnesses and relevant documents are expected to be found there; and 37 of the constituent actions are pending in that district, as are multiple tag-along actions. Centralization in the District of New Jersey allows the Panel to assign the litigation to Judge Brian R. Martinotti, described as an “able and experienced jurist who has not had the opportunity to preside over an MDL. Judge Martinotti already is presiding over the constituent and tag-along actions pending in the district, and we are confident that he will steer this litigation on a prudent course.
Federal Regulators Warn About Serious Adverse Reactions Associated with Type 2 Diabetes Drugs
According to a U.S. Food and Drug Administration (FDA) “Safety Alert,” issued in June 2016, the agency indicated that about five of every 1,000 patients taking a 300-milligram daily dose of canagliflozin—the active ingredient in Invokana and other Type 2 diabetes medicines—required amputations. Seven of every 1,000 patients taking a 100-milligram daily dose also required amputations.
Amputations involved toes, feet, and legs. Agency officials noted that they are looking into if canagliflozin elevates amputation risks. “Patients taking [canagliflozin] should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet,” the agency wrote.
The FDA issued a prior “Safety Announcement” on May 15, 2015 over Type 2 diabetes medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, also known as SGLT2 inhibitors. These drugs may lead to a serious condition known as ketoacidosis, which causes the body to produce high levels of blood acids known as ketones. Ketoacidosis may lead to severe reactions that may require hospitalization.
SGLT2 Inhibitors: Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance, Glyxambi
SGLT2 inhibitors received FDA approval for use in diabetes care and are prescribed along with improved nutrition such as a low carbohydrate diet, as well as exercise to help control a patient’s diabetes by leading to lower blood sugar levels in adults diagnosed with Type 2 diabetes (diabetes mellitus).
Type 2 diabetes is typically associated with weight gain, an increased body mass index (BMI), glucose control issues, and an obese body type. Metabolic syndrome describes a cluster of conditions that includes increased blood pressure, high blood sugar levels, excess body fat in the waist area, and abnormal cholesterol levels, all of which occur together and increase risks for serious diseases, including diabetes, stroke, and heart disease.
SGLT2 inhibitors lower blood sugar levels by causing the kidneys to remove sugar from the body and cause blood sugar to be secreted in the urine. SGLT2 inhibitors are prepared as single-ingredient and combination drugs with other diabetes drugs, including metformin. Canagliflozin is the only active ingredient in Invokana. Invokana with the active ingredient, metformin, is known as Invokamet.
SGLT2 inhibitors are not approved for the treatment of Type 1 diabetes. SGLT2 inhibitors are made with the following active ingredients: canagliflozin, dapagliflozin, and empagliflozin. The Type 2 diabetes drugs are sold by AstraZeneca, Johnson & Johnson, and Eli Lilly in partnership with Boehringer Ingleheim and are sold in the following combinations and brand names:
- Invokana: canagliflozin (Johnson & Johnson)
- Invokamet: canagliflozin and metformin
- Farxiga: dapagliflozin (AstraZeneca)
- Xigduo XR: dapagliflozin and metformin extended-release
- Jardiance: empagliflozin (Lilly and Boehringer)
- Glyxambi: empagliflozin and linagliptin
Effective June 2016, the FDA strengthened the existing warning about the risk of acute kidney injury for the Type 2 diabetes medicines Invokana and Invokamet (canagliflozin) and Farxiga, and Xigduo XR (dapagliflozin). Recent reports led to the revised warnings on the drugs’ labeling, according to the FDA, and now include information about acute kidney injury, as well as additional recommendations to minimize this risk.
The drugs involved in the Farxiga (dapagliflozin) multidistrict litigation (MDL) also include Xigduo XR. Both drugs are the brand versions of the drug dapagliflozin and are used to lower blood glucose levels in patients diagnosed with Type 2 diabetes. Farxiga and Xigudo XR have both been associated with increased risks of ketoacidosis. In 2015, the FDA mandated that the makers of Farxiga and Xigudo XR change the drug warning labels to indicate this increased risk of ketoacidosis.
Farxiga is a Sodium Glucose Cotransporter 2 (SGTL2) inhibitor and is manufactured by Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, AstraZeneca PLC, and AstraZeneca AB and was released in 2014.
Farxiga is meant to be used in addition to a healthy diet and exercise program to improve glycemic control in adults who are diagnosed with Type 2 diabetes mellitus. Common side effects of Farxiga include:
- Back pain
- Changes in urination, including an urgent need to urinate more often, discomfort when urinating, urinating in larger amounts, urinating at night
- Elevated cholesterol or fat in the blood
- Pain in the extremities
- Runny, stuffy nose
- Sore throat
- Urinary tract infections (UTIs)
- Yeast infections of the vagina or penis
SGLT2 inhibitors block the pathways in the body that are used by glucose to enter the bloodstream. This lowers patients’ blood sugar levels by causing glucose to be excreted through the process of urination. When SGLT2 inhibitors are overly effective in blocking these glucose pathways, the glucose reduction may lead to ketoacidosis and kidney injury. Other SGLT2 inhibitors include Invokana and Jardiance and have also been associated with increased risks of ketoacidosis.
When patients develop ketoacidosis, the body stops breaking down glucose for use as energy. When there is insufficient glucose for the body to metabolize, the body, instead, breaks down fat, which releases acid into the blood. This leads to dangerously high levels of blood acids or ketones, a very serious condition known as ketoacidosis.
The FDA released safety communications concerning Farxiga, including reporting on 73 adverse events between 2013 and 2015. The first communication warned about the symptoms and dangers of ketoacidosis. This communication was accompanied by a label change requirement. The second safety announcement involved a mandate by the FDA that mandated a stronger safety warning about kidney injury on Farxiga and Xigduo XR labels.
As of August 2017, there are 18 cases currently involved in the Farxiga litigation that have been consolidated under MDL No. 2776 entitled In Re: Farxiga (Dapagliflozin) Products Liability Litigation. The MDL was organized in the Southern District of New York and was assigned to the Honorable Judge Lorna G. Schofield in New York. The Farxiga MDL was created In April 2017. On April 6, 2017 the United States Judicial Panel On Multidistrict Litigation (JPML) issued “In Re: Farxiga (dapagliflozin) Products Liability Litigation Transfer Order—MD: No 2776.
Allegations include that taking Farxiga may cause a variety of injuries, including diabetic ketoacidosis and kidney damage, and that the defendants—Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca PLC, and AstraZeneca AB— (Bristol-Myers/AstraZeneca), which developed, manufactured, and marketed the drugs, neglected to sufficiently test the drugs and warn of the drugs’ risks.
Based on court documents and a hearing session that was held, the actions involve common questions of fact. Because of this, centralization of the cases will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. The actions also share factual questions arising from allegations that treatment with Farxiga or Xigduo XR may lead to patients suffering from kidney-related injuries, including diabetic ketoacidosis and kidney damage. The actions implicate various common issues about the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs.
The FDA indicates that it continues to investigate a tie between Farxiga and Xigduo XR (along with the other SGLT2 inhibitors Invokana, Invokamet, Jardiance, Glyxambi, Synjardy, and Qtern) that have been allegedly associated with the following potential medical complications:
- Acute kidney injury
- Amputation of the leg, foot, toes
- Deep Vein Thrombosis (DVT)
- Diabetic ketoacidosis (DKA)
- Heart Failure
- Ischemic Stroke/Cerebral Vascular Accident (CVA)
- Myocardial Infarctions (MI) (heart attack)
- Pulmonary Embolism (PE)
- Pyelonephritis (kidney infection)
- Renal (kidney) damage, failure
- Urinary Tract Infection (UTI)
- Urosepsis (blood infection)
AstraZeneca continues to heavily market Farxiga with what some have described as a general disregard for the detrimental side effects that users of the drug must manage in their daily lives.
In 2014, the FDA approved Farxiga to minimize medical problems such as kidney damage and heart disease; however, research conducted on behalf of the FDA revealed that there was no evidence that Farxiga improved health. FDA reports found that the most common Farxiga side effects are urinary tract infections (UTIs) and genital fungal infections; however, more serious side effects included renal failure in patients diagnosed with moderate or severe kidney damage, which is not uncommon in individuals diagnosed with Type 2 diabetes.
FDA studies also revealed that Farxiga was associated with a five-fold increased risk for developing bladder cancer and FDA scientists concluded that the drug may stimulate bladder cancer in patients already at risk. Bladder cancer may be fatal. Studies conducted by the drug makers and provided to the FDA revealed that patients taking Farxiga experienced a two-fold increased risk of developing breast cancer. The FDA initially rejected Farxiga over these cancer concerns; however, the federal regulator reversed its decision and approved the drug in early 2014.
FDA Increases Warnings on Janssen Pharmaceuticals’ Invokana, Invokamet and Kidney Damage
The FDA received 101 confirmable cases of acute kidney injury which, in some cases, involved hospitalization and dialysis from March 2013, when Invokana and Invokamet were approved, to October 2015. This amount only involves those reports submitted to the FDA; therefore, according to federal regulators, there are likely more cases about which the agency is not aware.
More than half of the cases of acute kidney injury—a total of 58 percent—occurred within one month after the patient began taking the diabetes drug, wrote Law360. Some cases occurred in patients who were younger than 65 years of age and some were dehydrated, suffered from low blood pressure, or were taking other medicines that can affect the kidneys, according to the FDA.
The agency recommends that health care professionals consider those factors that may predispose patients to acute kidney injury before prescribing them Invokana, Invokamet, Farxiga, and Xigfuo XR. Such factors include, “decreased blood volume; chronic kidney insufficiency; congestive heart failure”; as well as taking other drugs “that may increase the risk through interaction.” These other drugs include diuretics; blood pressure medicines known as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs); and nonsteroidal anti-inflammatory drugs (NSAIDs). Physicians should assess patient kidney function prior to starting these medications and should continue with periodic monitoring. Should acute kidney injury occur, the FDA advises prompt discontinuation of the medication and treatment of the kidney impairment. Patients should also seek immediate medical attention should they experience symptoms of acute kidney injury (see symptom list below), a serious condition in which the kidneys suddenly stop working. This may lead to dangerous levels of wastes building in the body. Patients should not stop taking their medicine without first talking to their health care professionals as this may lead to uncontrolled blood sugar levels that may be harmful.
FDA Warns that Janssen Pharmaceuticals’ Invokana, Invokamet Linked to Amputations in Clinical Trial
On May 18, 2016, the FDA issued a “Drug Safety Communication” warning that the diabetes medicine canagliflozin may be linked to a higher risk of leg and foot amputations. The alert was based on the interim safety results of an ongoing clinical trial. Canagliflozin is sold under the brand names Invokana (canagliflozin) and Invokamet (canagliflozin and metformin) and is manufactured by Janssen Pharmaceuticals, a unit of the healthcare giant, Johnson & Johnson.
According to the interim data, patients were twice as likely to suffer amputations while using Invokana and Invokamet compared to patients taking a placebo. The FDA alert states that the risk equated to five of every 1,000 patients taking 300-milligrams daily. In patients taking a 100-milligram daily dose, the risk equated to seven of every 1,000 patients. Patients suffered amputations of the toes, feet, and legs.
The FDA indicated that it was working to further investigate the link between canagliflozin and the occurrence of an amputation. Patients were advised against stopping their medication without consulting their physicians first. “Patients taking [canagliflozin] should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet,” the FDA wrote.
The FDA approved canagliflozin in March 2013 to treat patients with Type 2 diabetes. Along with its approval, FDA mandated several post-marketing studies to evaluate the risk of certain adverse events, including:
- Cardiovascular events
- Severe hypersensitivity reactions
- Photosensitivity reactions
- Liver abnormalities
- Adverse pregnancy outcomes
- Bone safety
Additionally, the FDA required two pediatric studies under the Pediatric Research Equity Act (PREA) to evaluate whether Invokana/Invokamet is safe and effective in children. Based on trial findings, the FDA warned of increased risk of bone fracture associated with canagliflozin in 2015.
FDA Strengthens Warning on Invokana and Invokamet Due to Bone Fracture Risk
In September 2015, the FDA strengthened the warning on Invokana (canagliflozin) and Invokamet (canagliflozin and metformin), Type 2 diabetes drugs in the SGLT2 class, to include information about the increased risk of bone fractures. The agency also added additional information about reduced bone mineral density. In light of this information, the FDA advised health care professionals to consider whether patients are already at increased risk for bone fractures before prescribing Invokana or Invokamet.
The warning label indicates that bone fractures have been reported in patients taking canagliflozin, occurring as early as 12 weeks after starting treatment. Invokana has been linked to reduced bone mineral density at the hip and lower spine.
Health care professionals should discuss risk factors for bone fractures, the FDA notes. The agency also indicated that it, “is continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class,” including Farxiga and Xigduo XR (dapagliflozin), Jardiance, Glyxambi, and Synjardy (empaglifozin), to determine if additional label changes or studies are needed.
Ketoacidosis and Other Possible Side Effects of SGLT2 Inhibitors
Acidosis occurs when there is an excess of acid in the body. Ketoacidosis associated with SGLT2 inhibitors may be present even if the blood sugar is not very high. The agency advises patients to be aware of the signs of ketoacidosis, a serious side effect, and to seek immediate medical attention if any of these symptoms occur:
- Difficulty breathing
- Abdominal pain
- Unusual fatigue or sleepiness.
In addition to ketoacidosis, SGLT2 inhibitors may also lead to the following potential side effects:
- Kidney problems
- Low blood sugar (when this class of medicines is combined with other prescription medicines used to treat diabetes)
- Increased blood cholesterol
- Yeast infections
The FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis from March 2013 to June 6, 2014 that were reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients who were being treated with SGLT2 inhibitors.
The FDA indicates that, since June 2014, it has received additional FAERS reports for DKA and ketoacidosis in patients receiving treatment with SGLT2 inhibitors. DKA is considered a sub-set of ketoacidosis or ketosis in patients diagnosed with diabetes and is a type of acidosis that typically occurs when insulin levels are too low or during periods of prolonged fasting. DKA is usually seen in patients diagnosed with Type 1 diabetes and is most typically associated with high blood sugar levels.
According to the FDA, the FAERS cases reported are not typical for DKA as most of the patients involved were diagnosed with Type 2 diabetes and their blood sugar levels, when reported, were only slightly increased when compared to typical DKA cases. In every case, a diagnosis of DKA or ketoacidosis was made by a health care professional and hospitalization was required. A temporal (time-based) tie with SGLT2 inhibitor initiation was seen in every case with a median onset time of an average of two weeks; however, the range was anywhere from one to 175 days.
According to the agency, post-marketing cases reveal an association between sodium-glucose cotransporter-2 (SGLT2) inhibitor use and the development of a high anion gap metabolic acidosis with elevated urine or serum ketones and was not associated with the very high glucose levels that are normally seen in diabetic ketoacidosis. In other words, it appeared as if the SGLT2 inhibitor drug was associated with the acidosis.
Complications of Diabetic Ketoacidosis without prompt and appropriate treatment, DKA complications may occur and include:
- Cerebral edema (swelling of the brain)
- Acute kidney failure
- Adult respiratory distress syndrome
- Heart Attack
Brain swelling occurs when too much water accumulates in the brain. Cerebral edema is seen in one of every 150 cases of diabetic ketoacidosis; one in four cases may be fatal. The condition is serious, typically requires intensive care unit (ICU) treatment in a hospital, and may lead to severe brain damage. The reason for the water build-up remains unknown. Symptoms include:
Acute Kidney Failure
Severe dehydration may lead to acute kidney failure, which may lead to the following symptoms and may require dialysis to filter waste products from the blood until the dehydration is resolved and the kidneys begin working properly:
- Decreased urine
- Edema (swelling) in the arms, legs, and/or feet
- Feeling tired
Adult Respiratory Distress Syndrome
Diabetic ketoacidosis may lead to fluid level changes that may be both rapid and unpredictable and may lead to the lungs becoming filled with fluid. This condition is known as adult respiratory distress syndrome and may lead to significant breathing difficulties. Treatment typically involves assistance with a ventilator until the condition stabilizes.
Legal Help for Victims of the SGLT2 inhibitor-Related DKA, Stroke, Heart Attack, or Renal Failure
If you or someone you know suffered adverse reactions including DKA, Stroke, Heart Attack, Renal Failure, or amputation following use of a SGLT2 Type 2 diabetes drug, you may have valuable legal rights, including filing a Ketoacidosis lawsuit. For a free lawsuit evaluation with a personal injury attorney, please fill complete our online form or call 1-800-YOURLAWYER (1-800-968-7529) today.>
New York City, Long Island, New Jersey, and Florida
Our personal injury attorneys in NYC are here to help you when you need it the most.