Invokana: Diabetes Drug Gets Black Box Warning For Amputation Risks
Invokana (canagliflozin), an SGLT-2 drug for use in type 2 diabetes and off-label in those with type 1 diabetes has been required by the FDA to carry the prominent boxed warning due to a higher risk for leg and foot amputations. This new requirement is a result of two clinical trials whose data revealed these elevated risks. Canagliflozin is the drug present in the marketed products: Invokana, Invokamet, and Invokamet XR. The clinical trials called 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 happened about twice as often in those taking canagliflozin compared to those taking a placebo. Over the span of a year the amputation risk for CANVAS trial patients was equal to 5.9 out of every 1,000 patients taking canagliflozin and 2.8 out of every 1,000 patients taking a placebo. Over the span of a year the amputation risk for CANVAS-R trial patients was equal to 7.5 out of every 1,000 patients taking canagliflozin and 4.2 out of every 1,000 patients taking a placebo. Most common was toe and middle the foot amputations but below and above the knee leg amputations were also observed. Some patients needed multiple amputations, “some involving both limbs.” This warning is in addition to last year’s FDA strengthened warning to users of canagliflozin for an increased risk of acute kidney injury and in 2015 the strengthened “warning for canagliflozin related to the increased risk of bone fractures,” Symptoms to Watch For The FDA warns that if you take Invokana (canagliflozin) you should be sure to call your healthcare provider immediately if you “develop new pain or tenderness, sores or ulcers, or i Continue reading >>
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 Possible With Diabetes Drugs, Fda Warns
Based on new data from 2 large clinical trials, FDA is warning that the blockbuster type 2 diabetes medications Invokana, Invokamet, Invokamet XR (canagliflozin, Janssen) cause an increased risk of leg and foot amputations. Read: Diabetic patients challeng insulin makers FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the drugs’ labels to describe the risk. “Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations,” FDA said in its Drug Safety Communication. “These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.” In addition, healthcare professionals should monitor patients on canagliflozin for symptoms described above and discontinue the drug if the complications occur, FDA said. Patients taking canagliflozin should notify their healthcare professionals right away if they develop new pain or tenderness, sores or ulcers, or infections in their legs or feet, FDA said in the Drug Safety Communication. “Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.” Final results from 2 clinical trials—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, according to FDA. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below an Continue reading >>
Diabetes Drug Raises Risk Of Foot And Leg Amputation
Consumers who are taking canagliflozin to treat their type 2 diabetes are being warned that the drug carries an increased risk of leg and foot amputations. The U.S. Food and Drug Administration is requiring a prominent boxed warning for the drug, which is sold under the brand names Invokana, Invokamet and Invokamet XR. Final results from two clinical trials showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. 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. If you are taking canagliflozin, you should notify your doctor right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your physician. Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. "Canagliflozin is an important treatment option for people with type 2 diabetes," said the drug's manufacturer, Janssen Continue reading >>
Doctors Debate Danger Of Popular Diabetes Drug After Fda Amputation Warning
Many San Diego doctors are taking their patients off of Invokana, a widely used diabetes drug, after a large industry-sponsored trial found it doubled the risk of lower limb amputations compared with those taking a placebo. With 23.1 million people in the U.S. diagnosed with diabetes, many of them are taking newer drugs to control glucose. But new research involving one of those drugs, Invokana, shows a doubled rate of leg, foot and toe amputations. Patients are being switched to other medications even though the study’s authors say the drug’s benefits — a reduced risk of cardiovascular events including death, non-fatal heart attacks and non-fatal strokes — outweigh its risk of amputations. The drug is prescribed for people with Type 2 diabetes. The patients in the trial were already at high risk for heart disease and other diabetes complications including amputations. While a number of physicians interviewed said they still prescribe the drug to lower their patients’ glucose levels, attitudes among others began to change after the U.S. Food and Drug Administration on May 16 issued what’s called a black box warning about amputations. It urges patients taking canagliflozin, sold under the brand name Invokana, Invokamet and Invokamet XR, to contact their doctors “right away” if they notice pain or tenderness, sores, ulcers or infections in their legs or feet. About half of the amputations occurring among patients in the trial were of toes, while the rest were across the foot, at the ankle, below the knee and above the knee. The FDA warning suggests physicians should consider factors that predispose patients to amputations, such as prior amputations, peripheral vascular disease, neuropathy and diabetic foot ulcers, before prescribing the drug. Physicians sh Continue reading >>
Janssen Diabetes Drugs Linked To Amputations, Fda Says
Law360, New York (May 18, 2016, 3:36 PM EDT) -- Patients in a clinical trial studying Janssen Pharmaceuticals’ diabetes drugs Invokana and Invokamet were roughly twice as likely to undergo amputations as patients taking a placebo, the U.S. Food and Drug Administration reported Wednesday. In a safety alert, the FDA said that the equivalent of five of every 1,000 patients taking a 300-milligram daily dose of the active ingredient canagliflozin needed amputations. In addition, the equivalent of seven of every 1,000 patients taking a 100-milligram daily dose needed amputations, compared with only three of every 1,000... Continue reading >>
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 >>
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 >>
Why Does Invokana Cause Amputations?
When a diabetic gets a small cut, its a serious concern. For diabetics, a simple blister, cut, crack or sore can become a dangerous ulcer that could leadto a life-changing amputation. In the past 20 years, the rate of lower limb amputations caused by diabetes complications has decreased by 50 percent. But most diabetics dont know that the popular diabetes medication Invokana(canagliflozin) can actually worsen their risk. When the diabetes drug Invokana first hit the market in 2013, it was heralded as a breakthrough for patients who wanted to lower their blood sugar and possibly lose some weight, too. But now, many of those hopeful patients are also wondering The Centers for Disease Control and Prevention (CDC) estimates 23.6 million Americans currently have diabetes. In the past decade, the number of Americans with diabetes has increased heavily from 18.2 million in 2003. Amputations are a serious concern for people with diabetes. Most amputations are performed on the lower extremities, primarily of the toes and feet. Though its less common, some diabetics require amputations below the knee. Nearly 67 percent of U.S. amputations are linked to diabetes and related complications. According to the CDC, about 73,000 non-traumatic lower-limb amputations were performed in adults aged 20 years or older with diagnosed diabetes in 2010. An amputation is the surgical removal of a limb or other body part to extract diseased or dead tissue. Depending on the severity and location, an amputation can severely alter personal identity and limit the ability to participate in daily activities. Theres no doubt that people who experience amputations deal with a lot of pain and suffering. The amputation rate for people with diabetes is 28 times higher than for people without diabetes. Amput Continue reading >>
Amputation Risk Leads To Boxed Warning On Diabetes Drugs
Law360, New York (May 16, 2017, 6:29 PM EDT) -- The U.S. Food and Drug Administration on Tuesday said it has confirmed that Janssen Pharmaceuticals’ diabetes medications Invokana and Invokamet can increase the risk of patients needing to have their legs or feet amputated and said the drugs will now require black-box warnings. The agency had first sent out an alert a year ago that patients in clinical trials for the drugs were twice as likely to need amputations as those on a placebo, and the FDA on Tuesday issued the final results from two clinical trials.... Continue reading >>
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 >>
J&j’s Diabetes Drug Cuts Heart Risk But Amputations Are Hazard
Heart attack, stroke, death 14 percent lower with Invokana Higher rate of amputations and fractures could limit use Johnson & Johnson’s pill Invokana reduced the risk of cardiovascular complications in diabetic patients, making it the second medication of its kind to help the heart, but the benefit came with an increased risk of amputations and perhaps broken bones, researchers said. Patients given Invokana were 14 percent less likely to suffer a heart attack, stroke or die from heart disease than those given a placebo, according to the combined data from two studies presented at the American Diabetes Association’s annual meeting. The improvement was similar to the results seen with Eli Lilly & Co.’s Jardiance, which was the first diabetes drug shown to protect the heart in 2015. The findings from the study known as Canvas may boost use of the medicines known as SGLT-2 inhibitors, which make up about 6 percent of the $40 billion spent annually to control diabetics’ blood sugar levels. The rate of amputations seen with Invokana, which doubled compared to the placebo to 6.3 per 1,000 patients treated, and the increase in fractures seen in one of the two studies released on Monday could limit the drug’s use. The study results are “good for the SGLT-2 class overall, in that it reconfirms the utility of this class of drugs in lowering cardiovascular risk,” said Tim Anderson, an analyst at Sanford C. Bernstein & Co. “But Invokana’s unique amputation risk leaves Jardiance looking better overall.” Lilly’s shares fell less than 1 percent to $80.63 at 9:48 a.m. in New York. Johnson & Johnson was down less than 1 percent to $131.66. Amputations, Fractures Diabetics are already at increased risk for amputations and fractures, and it’s unclear why Invokana se Continue reading >>
Fda Warns Of Foot, Leg Amputations With J&j Diabetes Drug
(Reuters) - Johnson & Johnson (JNJ.N) is required to add new warnings to its diabetes drug, Invokana, about the risk of foot and leg amputations, the U.S. Food and Drug Administration said on Tuesday. Final results from two clinical trials showed leg and foot amputations occurred about twice as often in patients with type 2 diabetes treated with Invokana, known also as canagliflozin, as those given a placebo, the FDA said in an announcement posted on its website. The warnings include a boxed warning, reserved for the most serious possible adverse events, the FDA said. Invokana belongs to a relatively new class of type 2 diabetes drugs called SGLT-2 inhibitors, which help remove excess blood sugar through urine. Others in the class include Eli Lilly and Co’s (LLY.N) Jardiance and AstraZeneca Plc’s (AZN.L) Farxiga. The FDA noted that results of one clinical trial showed that over the course of a year the risk of amputation in patients treated with Invokana was equivalent to 5.9 out of 1,000, compared with 2.8 out of 1,000 for patients given a placebo. A second trial showed the risk of amputation was equivalent to 7.5 out of every 1,000 patients treated with Invokana compared with 4.2 out of every 1,000 patients given a placebo. The agency said amputations of the toe and middle of the foot were the most common but that amputations involving the leg, below and above the knee, also occurred. Untreated type 2 diabetes can cause blindness, nerve and kidney damage and heart disease. Continue reading >>
Fda Drug Safety Communication: Fda Confirms Increased Risk Of Leg And Foot Amputations With The Diabetes Medicine Canagliflozin (invokana, Invokamet, Invokamet Xr)
[ 5-16-2017 ] Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk. Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional. Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and 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 (SGLT2) 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 Endpoints in Adult Participants With Type Continue reading >>
Diabetes And Amputation
Tweet Diabetes, when present in the body over many years, can give rise to all sorts of complications. These include heart disease, kidney disease, retinopathy and neuropathy. If left untreated, some of these complications can become extremely damaging to the body. Diabetes is a leading cause of amputation The NHS reports that people who have diabetes are 15 times more likely to undergo amputations than other people without the condition. Diabetes is one of the leading causes of amputation of the lower limbs throughout the world. Charity Diabetes UK notes that problems of the foot are the most frequent reasons for hospitalisation amongst patients who have diabetes. Many hospital visits due to diabetes-related foot problems are preventable through simple foot care routines. All people who have diabetes should have foot check-ups as a part of their regular care routine. What factors lead to amputation? Several key factors usually predispose ulceration and ultimately amputation. These include: Circulation problems Other damage to the foot How are these factors assessed? Diabetic foot complications are more common amongst the elderly, and amputation rates do increase with age. For people over 75 years old, the risk does increase considerably. All people who have diabetes should have a basic education in foot care, and beyond this they should have regular foot examinations. The risk for the development of ulceration can be assessed by basic clinical examination of the foot. What are major and minor amputations? Amputations in general, not just diabetes-related amputations, are classed as major and minor. Minor amputation regards removal of toes or feet. Major amputation refers to the above or below the knee amputation. How should I identify a foot at risk from amputation? Lo Continue reading >>
