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Diabetes Medication Amputation

Foot And Leg Amputations Risk Linked To Johnson & Johnson Diabetes Drug Invokana

Foot And Leg Amputations Risk Linked To Johnson & Johnson Diabetes Drug Invokana

No compatible source was found for this media. Health regulators have required Johnson & Johnson to add a new warning to its diabetes drug Invokana over increased risk for foot and leg amputations. Higher Incidence Of Leg And Foot Amputations In Diabetic Patients Who Use Invokana The U.S. Food and Drug Administration said on Tuesday that the final results from two clinical trials of the diabetes drug showed that leg and foot amputations were significantly higher in those who use it. The FDA said that the trials showed amputations occurred about twice as often in type 2 diabetes patients who were treated with the medication also called canagliflozin, as those who were given placebo. "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) - showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo," the FDA said in a statement. The most common amputations in patients as observed in the trials were of the toe and middle of the foot. Amputations of the leg, below and above the knee also happened and some patients required more than one amputation. The FDA said that the new warnings need to include a boxed warning, which is reserved for drugs with most serious possible adverse events. Invokana belongs to a new class of drugs for type 2 diabetes known as SGLT-2 inhibitors, which works by removing excess blood sugar through the patient's urine. It is recommended for use by diabetic adults along with diet and exercise to reduce levels of blood sugar. The federal health agency urged patients to inform their healthcare professionals if they develop sores or ulcers Continue reading >>

Diabetes Drug Gets Fda Warning Due To Amputation Risk

Diabetes Drug Gets Fda Warning Due To Amputation Risk

HealthDay Reporter WEDNESDAY, May 17, 2017 (HealthDay News) -- The type 2 diabetes prescription drug canagliflozin (brand names Invokana, Invokamet, Invokamet XR) appears to increase the risk of leg and foot amputations, the U.S. Food and Drug Administration says. The FDA is requiring the medications to carry new warnings about the risk. The required warnings on the drug's labeling include the most serious and prominent boxed warning. The agency's decision is based on data from two large clinical trials showing that leg and foot amputations occurred about twice as often in patients taking canagliflozin as among those taking a placebo. Amputations of the toe and middle of the foot were the most common, but leg amputations below and above the knee also occurred. Some patients had more than one amputation, some had amputations involving both limbs, according to the FDA. Type 2 diabetes occurs when the body becomes resistant to insulin. Insulin is a hormone that helps to usher sugar from foods into the body's cells. When this process doesn't work correctly, blood sugar levels rise. Left untreated, high blood sugar levels can cause a number of possible complications, including heart disease, kidney problems and amputations, according to the American Diabetes Association. Canagliflozin is meant to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. These drugs lower blood sugar levels by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet. Patients taking canagliflozin shoul Continue reading >>

Amputation Risk Linked To Diabetes Drug

Amputation Risk Linked To Diabetes Drug

The new drug warning EVERY diabetic needs to see There’s an urgent new warning EVERY diabetic needs to see — and it comes STRAIGHT from the FDA. One of the most commonly used new drugs given to diabetics — a medication that’s done BILLIONS in sales — can lead to a horrific side effect. I hope you haven’t eaten before I share the details, because this risk is pretty disturbing. In fact, it’s every diabetic’s nightmare: amputation. The new “black box” warning finds the drug canagliflozin (a.k.a. Invokana and Invokamet) can DOUBLE that risk. This drug can cause you to lose your toes, part of your foot, the entire foot, or even the leg itself. Some folks are in and out of the hospital for multiple operations, losing another piece of their body with every trip. And some folks lose all or part of BOTH legs… all because of the drug that was supposed to HELP them. One study the FDA looked at found that 7.5 people out of every 1,000 who take the drug end up with an amputation… or three amputations for every 400 patients. That’s a shockingly high number, especially since diabetic amputations have been on the decline over the years — and that’s what has me really concerned. While the headlines have focused on the horrific consequences, I’m worried about what’s happening BEFORE those limbs are removed, because it could be an indication that the drug is increasing the damage of the disease in other ways. Diabetics are prone to amputations — especially of the toes, feet, and legs — because of a combination nerve damage and poor circulation. That causes wounds to fester, often unnoticed — and by the time the damage is spotted, it could be much too late. The amputation risk could be a sign that this medication is causing or accelerating nerve dam Continue reading >>

Studies Show Diabetes Drug Invokana Increases Amputation Risk

Studies Show Diabetes Drug Invokana Increases Amputation Risk

People with diabetes who take a class of drugs known as sodium–glucose cotransporter 2 (SGLT2) inhibitors will now need to weigh benefits against risks after studies showed the medications significantly reduce heart problems in subjects, but, surprisingly, also increase the risk of amputation. The results of the studies on the Johnson & Johnson drug canagliflozin, marketed under the name Invokana, confirm cardiovascular benefits not only for that particular medication, but also for others in its class. Those same results, however, call into question whether other drugs in the class also contribute to increased amputation. “Drugs to treat diabetes have been undergoing a positive transformation in the last three or four years,” says Dr. Bruce Neal, lead investigator in the study and professor of medicine for University of New South Wales Sydney, and senior director, the George Institute for Global Health in Sydney, Australia. “It used to be we would test diabetes drugs to see if they lowered glucose levels and did not cause heart problems. Now, we test drugs and expect to see them not only lower glucose but improve cardiovascular health. It’s been extraordinary. But, now we might be finding out that there are glitches along the way.” Neal led a team of six other academic researchers combining data from two studies, the first a clinical trial before the drug was approved by the Food and Drug Administration in 2013 and the second a post-marketing study designed to detect any cardiovascular risks from the drug. Such studies are a recent requirement of the FDA to ensure safety of new medications across a wider population than may have been tested in clinical trials for the drug’s initial approval. The studies, one called Canagliflozin Cardiovascular Assessment S Continue reading >>

Fda Cites Increased Amputation Risk With Diabetes Drug Canagliflozin

Fda Cites Increased Amputation Risk With Diabetes Drug Canagliflozin

Based on new data from two large clinical trials, the FDA has concluded that the type-2 diabetes medicine canagliflozin (Janssen’s Invokana [canagliflozin], Invokamet [canagliflozin/metformin hydrochloride], and Invokamet XR [extended-release canagliflozin/metformin hydrochloride]) causes an increased risk of leg and foot amputations. The agency is requiring new warnings, including a prominent “boxed warning,” to be added to the canagliflozin drug labels to describe this risk. The FDA advised patients taking canagliflozin to notify their health care professionals right away if they develop new pain or tenderness, sores or ulcers, or infections in the legs or feet. Health care professionals should, before starting a patient on a canagliflozin regimen, consider factors that may predispose patients to the need for amputations, the agency wrote in a “Drug Safety Communication.” These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. The FDA advised health care providers to monitor patients receiving canagliflozin for the signs and symptoms described above and to discontinue canagliflozin if these complications occur. Untreated, type-2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type-2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. Final results from two clinical trials—the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal En Continue reading >>

Increased Amputation Risk Associated With Diabetes Drug Invokana

Increased Amputation Risk Associated With Diabetes Drug Invokana

The federal Food and Drug Administration (FDA) recently added new warnings – including a high-profile "black box" – to the packaging of a popular Type 2 diabetes medication. The drug, canagliflozin (sold under the brand names Invokamet, Invokamet XR and most commonly Invokana) should help manage insulin, blood sugar levels and A1C. It should also, in theory anyway, prevent internal diabetes-related damage. The medication went on the market in 2013, and soon became one of the most commonly prescribed diabetes drugs in America. Thousands upon thousands of patients have taken Invokana in the years since its introduction to: Control blood insulin and sugar levels Prevent damage to kidneys and other internal organs typically associated with Type 2 diabetes Reduce dependence on artificial insulin Supplement diet, exercise and lifestyle changes to help better manage symptoms Lower the amputation risks of diabetes (uncontrolled diabetes causes circulatory issues, which can lead to a lack of blood flow, slow-healing infections, damaged nerves and other symptoms, all of which can necessitate amputation) Lower A1C levels over time Tragic results for some patients Sadly, though many patients took Invokana to lower their amputation risk, the drug actually made it more likely that digit or limb loss would occur. A series of large-scale research trials that the FDA reviewed as part of its investigation into the drug revealed that those taking Invokana actually underwent amputations almost twice as often as those taking a placebo. The new FDA warnings indicate that medical professionals should carefully consider patients’ risk factors for amputation before prescribing Invokana. These risks include: A history of previous digit or limb amputation Neuropathy (painful peripheral nerv Continue reading >>

Diabetes Drug Linked With Increased Risk Of Amputations

Diabetes Drug Linked With Increased Risk Of Amputations

The FDA has issued a warning to patients and providers concerning a potential risk of leg and foot amputations associated with the use of the diabetes medication canagliflozin. This alert was based on results from an ongoing trial, which has found that patients treated with canagliflozin are more likely to require a leg or foot amputation. Toe amputation seemed particularly more likely among canagliflozin patients. Although the FDA acknowledged that further research is needed to determine whether the drug is responsible for this elevated risk, it has nevertheless encouraged patients to seek immediate medical attention if they experience symptoms such as pain or tenderness, sores or ulcers, or infections in their legs or feet. However, the agency added that patients should not stop or change their diabetes medicines without first consulting their prescriber, as doing so may lead to uncontrolled blood sugar levels, blindness, nerve and kidney damage, and heart disease. Canagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor indicated for the treatment of high blood sugar in patients with type 2 diabetes, is currently available under the brand names Invokana and Invokamet. The drug was among several SGLT2 inhibitors to receive a label update in December 2015 after the FDA discovered that the class was linked to increased risks of ketoacidosis and urinary tract infections. Any adverse events observed in patients who use canagliflozin should be to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. ◄ 2 Continue reading >>

Renewed U.s.-cuba Relations: Saving American Lives And Limbs?

Renewed U.s.-cuba Relations: Saving American Lives And Limbs?

Some 29.1 million Americans have diabetes, nearly 8 million unaware of their condition. Between 70,000 and 80,000 diabetics become amputees every year from one of the disease’s most nefarious complications: diabetic foot ulcers. As a result of the recent opening to Cuba, these amputees — over half of whom will otherwise die within five years of amputation — may be thrown a lifeline by Cuban innovation. Because of our estrangement from the Caribbean nation, most may be unaware that its biotech industry is booming, since the 1980s one of the ‘big three’ in the global South (with Brazil and India). Its latest R&D breakthrough is a medication called Heberprot-P, which has already treated 165,000 diabetic-foot patients in 26 countries, reducing relative risk for amputation by 75%. The treatment is in trials in 5 countries and in Europe, where it’s known as Epiprot.** Results on safety and effectiveness have been published in the International Wound Journal,Diabetes Careand MEDICC Review, among others, documenting ten years of clinical experience. Our California-based nonprofit MEDICC (Medical Education Cooperation with Cuba), took a bipartisan delegation to Havana to see diabetes care and Heberprot-P at work — as it happened, on the eve of the December 17 historic announcement by the U.S. and Cuban governments. The group included Rep. Diana DeGette (D-CO), chair of the Diabetes Caucus, the largest caucus in Congress with 345 members; more Caucus members; and diabetes experts and patient advocates. Among them, Rep. Karen Bass (D-CA), who said living with her mother’s diabetes brought the disease “up close and personal for me.” She also said her Los Angeles district has more than its share of diabetics: “Since the disease disproportionately hits low-incom Continue reading >>

Fda Orders Stronger Warning About Diabetes Drug Invokana And Amputations

Fda Orders Stronger Warning About Diabetes Drug Invokana And Amputations

The U.S. Food and Drug Adminstration is calling attention to the risk of amputation if you’re on the drug Canagliflozin (Invokana, Invokamet), a common type 2 diabetes medication. On May 16, 2017, the FDA concluded that the Type 2 diabetes medication Canagliflozin (Invokana, Invokamet and Invokamet XR) causes an increased risk of leg and foot amputations. The FDA will now require the most prominent black box warning to be added to the Canagliflozin drug labels. This new warning came at the conclusion of two large clinical trials, one of which showed that leg and foot amputations occurred about twice as often in patients treated with Canagliflozin versus a placebo. Clark Law Firm is currently investigationg these cases and committed to assisting in these cases on behalf of patients who have suffered an amputation. If you have been effected by this drug, the Clark Law Firm may be able to help you. Contact our office at 732-443-0333 or on our Contact Page. Continue reading >>

Type 2 Diabetes Drug Canagliflozin Shows Lower Heart Risk But Greater Amputations

Type 2 Diabetes Drug Canagliflozin Shows Lower Heart Risk But Greater Amputations

The type 2 diabetes drug canagliflozin (marketed as Invokana) is associated with a lower risk of heart attacks and stroke but increased risk of amputation, new research shows. The new data comes from two separate trials and was presented at the American Diabetes Association (ADA) 2017 Scientific Sessions. The Canagliflozin Cardiovascular Assessment Study (CANVAS) looked at effects of the drug on heart disease and stroke risks. The CANVAS renal-end-points trial (CANVAS-R) looked at the effects on kidney disease risks. The Australian study involved 10,000 people with type 2 diabetes who were randomly assigned to receive canagliflozin or placebo for an average of 188 weeks. The findings suggested canagliflozin reduced the risk of cardiovascular disease by 14 per cent and also lowered the risk of hospitalisation relating to heart failure by 33 per cent. Canagliflozin becomes the second SGLT2 inhibitor drug to show a benefit in heart disease risk. Last year, empagliflozin (marketed as Jardiance) became the first diabetes drug to demonstrate a benefit on heart health. Lead researcher Professor Bruce Neal, from the George Institute for Global Health, said: "Coronary heart disease is the biggest killer by far for people with type 2 diabetes. Our findings suggest that not only does canagliflozin significantly reduce the risk of heart disease, it also has many other benefits too. We found it also reduced blood pressure and led to weight loss." The results showed that users of canagliflozin had decreased risk related to kidney disease, however, the benefit was not enough to be judged statistically significant. Less positive was a doubling in risk of amputations associated with canagliflozin use. Prof. Neal added: "We don't know why there was an increased risk of amputation, and fu Continue reading >>

Toe, Foot Or Leg Amputation

Toe, Foot Or Leg Amputation

What To Do If You Suffered A While Taking Invokana® For Diabetes The law protects patients from dangerous drugs that can cause serious harm... If you (or a loved one) used Invokana® for diabetes and subsequently suffered an amputation, this may be the most important message you will ever read. Here is why... The popular diabetes medication Invokana® has been linked to these amputation risks... Toe amputations Foot amputations Leg amputations When Drug Manufacturers Fail To Properly Warn of Dangers, Innocent Patients Become Victims As a result of the manufacturer of Invokana® failing to properly warn patients and doctors of these amputation risks, you or your loved one likely suffered emotional and physical stress, along with unintended financial burdens -- such as surgeries and rehabilitation, time off work, costs of prosthetic fittings and more. Why should you suffer and be responsible for an amputation caused by a drug manufacturer's negligence? As a victim of a drug that potentially FAILED to properly warn you of such amputation risks with their medication, you may be entitled to what are called "money damages", which is a legal term for money awarded from individual lawsuits, settlements and class action lawsuits. All potential Invokana® lawsuits are currently being investigated on the grounds that Janssen Pharmaceutical® (maker of Invokana®)... failed to properly warn patients and doctors of known amputation risks How To Pursue Financial Compensation If You (Or A Loved One) Was Affected... Our legal team has reviewed the available evidence and our experience tells us that we are in prime position to represent victims who have suffered amputation due to the Invokana® prescription medication. We are currently accepting cases nationally from all 50 states. Get Continue reading >>

Free Case Review

Free Case Review

If you or a loved one have experienced an amputation after taking Invokana or another qualifying type 2 diabetes drug, contact the experienced attorneys at The Law Offices of Foster & Houston today. Our team of lawyers has more than 30 years of combined experience obtaining financial compensation for cases just like yours. A relatively new class of diabetes drugs, known as SGLT-2 inhibitors, have been linked to a higher risk of leg and foot amputations. Intended to lower blood sugar in adults with type 2 diabetes, Invokana first hit the market in 2013. However, it wasn’t until 2017 that the FDA required the manufacturer of Invokana to carry a boxed warning of the associated risk for leg amputations and foot amputations. Other risks associated with these type 2 diabetes medications include diabetic ketoacidosis, kidney disease, kidney failure, and in some cases, stroke and even death. If you or a loved one is taking a qualifying glucose-controlling medication such as Invokana and suffered an amputation, please contact the experienced lawyers at Foster & Houston today at 1-800-943-3071.* FDA WARNS OF AMPUTATIONS CONNECTED TO DIABETES DRUGS Based on data from two clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (such as Invokana) can lead to an increased risk of leg amputation, foot amputation, and other amputations. This safety announcement comes after an earlier warning about SGLT-2 inhibitors where the FDA found an increased risk of ketoacidosis and acute kidney injury in those taking Invokana. Common type 2 diabetes medications include: Invokana, Invokamet, Invokamet XR, Farixga, Xigduo XR, Jardiance, Glyxambi, and Synjardy. If you or a loved has taken a type 2 diabetes drug, the FDA suggests watching for the following symptoms*: Continue reading >>

Invokana Lawsuit

Invokana Lawsuit

Did you see an Invokana lawsuit commercial and have questions about your legal rights? Our diabetic drug amputation lawyers are here to answer your Invokana questions. The diabetes medication Invokana has been the subject of lawsuits before. However, only recently has new evidence emerged that links the drug to amputation. In fact, research has shown that Invokana patients are twice as likely to undergo lower-limb amputation as diabetes sufferers who aren’t taking the drug. If your Invokana problems included the loss of your toe, foot, or leg, you need to act fast. You have the right to file an Invokamet personal injury lawsuit – but that right won’t last forever. Don’t wait to take action. Compensation For Your Amputation An Expert In Your Corner: Your lawyer is someone who is an expert in medical liability cases. We Handle Everything: We’ll handle all the paperwork associated with your claim so you can focus on your recovery. You Never Pay Out Of Pocket: Our No-Fee promise means we don’t get paid until you win. There are no fees to worry about, and no bills that will surprise you. You Deserve Compensation: If you experienced a serious medical side effect, such as an amputation, after taking Invokana, Johnson & Johnson should pay for the damage they caused. We’ll help make sure they do. When you suffer from diabetes, you know that lower-limb amputations are common. What you might not know is that the medications you take to manage your diabetes could raise your risk of an amputation – by quite a lot. In fact, patients across the U.S. are pursuing diabetic drug amputation lawsuits. So can you. If you take Invokana for diabetes and have lost a toe, foot, or leg, the drug could be to blame. You have legal rights – the right to find out if the medication Continue reading >>

Toe Amputation Lawsuit

Toe Amputation Lawsuit

Invokana is a diabetes drug that may double the risk of toe amputations, according to a recent study. Patients should seek medical attention for any infections, sores, ulcers, or abnormal pain in their legs and feet. What You Can Do & How We Can Help The Schmidt Firm, PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or somebody you know had a toe amputation, 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. FDA Orders “Black Box” Warning for Amputations May 2017 — The FDA has confirmed that patients on Invokana are twice as likely to require a toe, foot, or leg amputation. The drug-labels will now carry a “Black Box” warning about the risk. According to the agency: “Amputations to the toe and middle of the foot were the most common, however, amputations involving the leg, below and above the knee also occurred. Some patients had more than one amputation, some involving both limbs.” FDA Warning for Invokana Toe Amputation Risk May 2016 — The FDA issued a warning about the risk of toe amputations from Invokana and Invokamet. The FDA was concerned about preliminary data from the CANVAS clinical trial, which estimated that 7 in 1,000 patients on Invokana (100-mg) would need an amputation after taking the medication for a year. In comparison, 3 in 1,000 patients on a placebo needed an amputation. Click here to read more. What is the problem? Invokana and Invokamet control diabetes by increasing the amount of sugar in urine. This can cause dehydration and reduce the amount of blood that circulates into the toes. Less circulation increases the risk of foot problems, ulcers, and infe Continue reading >>

Fda Adds Boxed Warning To Type 2 Diabetes Drug Invokana Over Amputation Risk

Fda Adds Boxed Warning To Type 2 Diabetes Drug Invokana Over Amputation Risk

The US Food and Drug Administration (FDA) has announced that a new warning must be added to the label of Invokana (canagliflozin), a type 2 diabetes drug. Data from two large clinical trials found that Invokana was associated with an increased risk of leg and foot amputations compared to placebo. This led the FDA to post a statement on its website insisting that Invokana now carries a boxed warning, reserved for the most serious possible adverse events. Invokana, an SGLT2 inhibitor, was approved in the EU in 2013 to lower blood glucose levels in people with type 2 diabetes. The drug works by helping to remove excess sugar through urine. But the increased risk of lower limb amputation has heightened in recent years. In May 2016 the FDA noted a correlation between Invokana and amputation risk, but required more evidence to prove causality. The European Medicines Agency has also warned healthcare professionals of this risk while Janssen Pharmaceuticals, the drug's manufacturers, wrote to doctors in 2016 detailing these observations. This new FDA warning was made following the findings of two trials: CANVAS and CANVAS-R, which found leg and foot amputations were twice as common in patients treated with canagliflozin compared to placebo. In the CANVAS trial the risk of amputation among Invokana-treated patients was equivalent to 5.9 out of 1,000, compared to 2.8 out of 1,000 among those given placebo. The CANVAS-R trial found the amputation risk was equivalent to 7.5 out of every 1,000 Invokana patients compared to 4.2 out of every 100 placebo patients. "Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs," sai Continue reading >>

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