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Diabetes Drug Invokana

Doctors Debate Danger Of Popular Diabetes Drug After Fda Amputation Warning

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 >>

Fda Orders Stronger Warning About Canagliflozin (invokana) & Amputation Risk

Fda Orders Stronger Warning About Canagliflozin (invokana) & Amputation Risk

The U.S. Food and Drug Adminstration is calling attention to the risk of amputation if you're on the drug canagliflozin (Invokana, Invokamet). It is requiring the drug to carry stronger warnings about the risk. The drug's label will have the so-called ''black box'' warning, designed to call attention to serious or life-threatening risks.1,2 The decision, announced May 16, was not unexpected, says J. Michael Gonzalez-Campoy, MD, PhD, FACE, medical director and CEO of the Minnesota Center for Obesity, Metabolism and Endocrinology and a member of the editorial board for EndocrineWeb. The recent decision was issued as an update to a 2016 safety alert. "In May, 2016, the FDA called attention to one trial (CANVAS, or CANagliflozin cardioVascular Assessment Study) in which the incidence of amputations was higher among people taking the medication compared to people taking placebo," Dr. Gonzalez-Campoy says.3 The risks were twice as high in those treated with the drug. Over a year's time, the amputation risks were evaluated to be 7 of every 1,000 treated with 100 milligrams of the drug, versus 3 of every 1,000 on placebo.3 A second trial also identified a higher risk of amputation with the drug's use.3,4 "It therefore came as no surprise" when the FDA strengthened the warnings, Dr. Gonzalez-Campoy says. What the FDA Says In its statement, the FDA says that ''Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canaglifozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk." The risk is about two-fold, the FDA concludes, and most often affects the Continue reading >>

Diabetes Drug Invokana Must Warn Patients About Increased Risk Of Foot, Leg Amputation

Diabetes Drug Invokana Must Warn Patients About Increased Risk Of Foot, Leg Amputation

A new class of diabetes medicines is heavily advertised on TV and shows great promise in getting patients’ blood sugar levels down, but a safety announcement from the Food and Drug Administration warns that one of the drugs, Johnson & Johnson’s Invokana, doubles those patients’ chance of needing parts of their legs or feet amputated. People with diabetes are already at risk of having lower limbs amputated because of circulatory and nerve damage that the disease does over time. However, in two clinical trials of the drug canagliflozin, marketed as Invokana, Invokamet, and Invokamet XR, patients taking the drug were twice as likely to need amputations. Most of the amputations were of toes or the middle of the foot, but some patients needed their entire foot or leg removed, sometimes even above the knee. The two studies lasted a year. In one, which had 4,330 patients enrolled, 5.9 out of 1,000 patients treated with the drug needed amputations, compared to 2.8 out of 1,000 patients receiving a placebo. In the other, which enrolled 5,814 patients, 7.5 out of 1,000 patients receiving canagliflozin had a foot or leg amputation that year, compared to 4.2 out of 1,000 of the patients receiving a placebo. Due to these results, the FDA will require new warnings on Invokana, including the attention-getting boxed warning. It will alert patients to be watchful and notify health care providers about ulcers, infections, or any new pain or tenderness in their legs and feet. Physicians will be warned to consider an individual patient’s risk when deciding whether to prescribe the medication, including their past foot or toe amputations and history of diabetic ulcers, vascular disease, or nerve damage. Discovering serious risks from taking a drug after it’s been on the market isn Continue reading >>

Invokana (canagliflozin)

Invokana (canagliflozin)

Tweet Invokana is an oral medication for type 2 diabetes that helps to lower blood glucose levels by encouraging the body to filter out more glucose from the blood and excrete it via the urine. The drug helps patients to reduce blood sugars without increasing the likelihood of gaining weight as long as a healthy, balanced diet is followed and regular exercise taken. Invokana is a relatively new drug and the effects on patients taking the drug for several years are not yet known. About Invokana Trade name: Invokana Generic name: Canagliflozin Drug class: SGLT2 inhibitors Manufacturer: Janssen Pharmaceuticals How does Invokana help in diabetes? Invokana is effective in reducing blood glucose levels and has lowered blood glucose levels more significantly than DPP-4 inhibitors in clinical trials. The antidiabetic drug causes the body to pass out glucose from the blood via the urine, which means that calories in the glucose are excreted. This action helps support weight loss when the drug is used in combination with a healthy diet and regular physical activity. Invokana has also been shown to help lower blood pressure levels. Mechanism of action Invokana is in a class of drugs called sodium-glucose transport protein 2 (or SGLT2) inhibitors, which drugs work by increasing the amount of glucose that gets passed out in the urine. When blood passes through the kidneys, the kidneys filter glucose out of the blood and the SGLT proteins then help reabsorb glucose back into the blood. SGLT2 proteins are responsible for 90% of the glucose that is reabsorbed, so by blocking the action these proteins, less glucose is reabsorbed and so more glucose is excreted via the urine. Who is canagliflozin suitable for? Canagliflozin is suitable for adults with type 2 diabetes. Invokana was launch Continue reading >>

Diabetes Drug Invokana Problems And Side Effects

Diabetes Drug Invokana Problems And Side Effects

ATTENTION: HEALTH WARNING This is an important health alert for anyone being treated for Type 2 Diabetes. If you have type 2 diabetes and take Invokana, please read this for very important information about serious health risks: Invokana – How It Works The drug Invokana was launched in the spring of 2013, and by early 2015 annual sales were projected to exceed $1.2 billion. designed to work with the patient’s kidneys to help remove sugar from the body through the process of urination. By design it allows high levels of glucose to enter the kidneys. It triggers the body’s emergency process to jettison the excess sugar via urinary excretion. Invokana – What Happens To Your Body Normal bodies produce insulin which metabolizes sugar so it can be used as an energy for the body. When there isn’t enough insulin to complete this task, the body cannibalizes fat as an alternative energy source. When that happens, it produces a high level of blood acids called ketones, and this buildup causes a condition called diabetic ketoacidosis (DKA). Type 1 diabetics take insulin to prevent DKA, a condition which has a very high risk of causing a heart attack. Invokana – The Problem By allowing the buildup of sugar in the kidneys without the introduction of additional insulin (either naturally produced by the body or taken as medication), Invokana actually decreases urinary excretion of ketones. DKA is now appearing in Invokana patients with normal or near normal glucose counts. While Invokana is working as predicted in terms of glucose, it is also causing a very dangerous elevation of ketones levels in the blood: DKA, a serious condition which may require either hospitalization or emergency room care. Invokana – The Risk: Heart Attack Studies have shown in the first 30 days of Continue reading >>

What’s Invokana? 10 Things You Need To Know

What’s Invokana? 10 Things You Need To Know

Invokana (canagliflozin) is one of the new oral medications for adult onset diabetes. It’s expensive but has many upsides. Taken usually in combination with metformin it is a rising star in the treatment of diabetes. Here is what you need to know to help you decide: worth it or not? Invokana is taken as a 100 mg tablet once daily before breakfast, increasing to a 300 mg tablet once a day if you have normal kidney function. Invokana can be taken with or without food. Invokana is not yet recommended for use alone in the treatment of diabetes; it should be given as a second agent in addition to metformin or as a third-line treatment. Invokana works on the kidneys and tells the proximal tubule to resorb approximately 90 percent of the filtered glucose load. So, Invokana promotes dumping of glucose from the kidneys to the urine. Invokana used alone doesn’t lower blood sugars (measured by the A1C blood test) enough to make it effective as a single agent for diabetes. In studies it lowers A1C by 0.5 to 0.7 percentage points, making it a relatively weak glucose lowering agent. When should Invokana be added? It has been shown to be effective in lowering A1C when metformin alone is not achieving the goal A1C of < 7.0. Invokana 300 mg compared to Januvia 100 mg mixed with metformin was better at lowering blood sugar and helped with weight loss. Will I lose weight on Invokana? Yes, in most studies Invokana (used with metformin) resulted in a 6.5 pound weight loss at 12 weeks and an almost 10 pound weight loss at the end of a year. That’s quite a plus. The huge downside of Invokana is the frequency of genital fungal infections, which are almost sixfold higher. This means there is an increased risk of genital yeast infections: vulvovaginal candidiasis (vaginal yeast infections) Continue reading >>

Invokana Side Effects

Invokana Side Effects

Generic Name: canagliflozin (KAN a gli FLOE zin) Brand Names: Invokana What is Invokana? Invokana (canagliflozin) is an oral diabetes medicine that helps control blood sugar levels. Canagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Invokana is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Invokana is not for treating type 1 diabetes. Important information You should not use Invokana if you have severe kidney disease (or if you are on dialysis). Invokana is not for treating type 1 diabetes. Before taking this medicine You should not use Invokana if you are allergic to canagliflozin, or if you have: severe kidney disease or if you are on dialysis. To make sure Invokana is safe for you, tell your doctor if you have ever had: kidney disease; liver disease; bladder infections or other urination problems; blood circulation problems; nerve problems caused by diabetes; a diabetic foot ulcer or amputation; an electrolyte imbalance (such as high levels of potassium in your blood); high cholesterol levels; diabetic ketoacidosis (call your doctor for treatment with insulin); if you are on a low salt diet; or if you use insulin or other oral diabetes medicines. It is not known whether Invokana will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether canagliflozin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine. Invokana is not approved for use by anyone younger than 18 years old. How should I take Invokana? Invokana is usually taken once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the 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 Drug Safety Communication: Fda Confirms Increased Risk Of Leg And Foot Amputations With The Diabetes Medicine Canagliflozin (invokana, Invokamet, Invokamet Xr)

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 >>

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

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 Wearable insulin delivery device improves HbA1c levels in type 2 diabetes 10 May 2017 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 Continue reading >>

Lawsuits Blame Diabetes Drug Invokana For Amputations

Lawsuits Blame Diabetes Drug Invokana For Amputations

Lawsuits Blame Diabetes Drug Invokana for Amputations News Lawsuits Blame Diabetes Drug Invokana for Amputations People who say they had to undergo amputations below the knee after taking the Type 2 diabetes drug Invokana are filing lawsuits against Johnson & Johnsons Janssen Pharmaceuticals. Injured parties have filed Invokana lawsuits in state court in New Jersey, where Johnson & Johnson is based, and in federal multidistrict litigation, which is also being managed in New Jersey. Multidistrict litigation (MDL) is a way for federal courts to streamline the management of large numbers of lawsuits filed around the country involving the same issues. When MDLs are created, all the cases are transferred to a single judge, who presides over the initial trials. Injured by complications related to Invokana? We can help. A federal court panel created the Invokana MDL on Dec. 7, 2016. The link to amputations was highlighted in May 2017 when the U.S. Food and Drug Administration required the manufacturer to include a black box warning the most serious kind regarding amputations. The FDAs decision followed two large clinical trials that showed people who took the drug having twice as many leg and foot amputations as people given a placebo. Drugwatch legal partner Weitz & Luxenberg began accepting Invokana amputation cases in June 2017. The most recent federal lawsuit linking Invokana to amputations involves Gadsden, Tenn., resident Bonnie Hamm , who filed a lawsuit Dec. 26, 2017. Hamm began using Invokana after it was prescribed to treat her diabetes in May 2016, according to the complaint. Invokana is a sodium-glucose cotransporter 2 (SGLT2) inhibitor drug. It works by stopping the kidneys from reabsorbing glucose to control blood sugar levels. A month after prescribing her Invo Continue reading >>

Invokana

Invokana

Invokana (canagliflozin) is one of several drugs that belong to a class of Type 2 diabetes medications called sodium-glucose cotransporter 2 (SGLT2) inhibitors. Invokana and SGLT2s control blood sugar by causing excess sugar to leave the body in urine. In March 2013, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s (J&J) Invokana as the first drug in its class. Then, in 2014, the FDA approved Invokamet (canagliflozin and metformin) and, in 2016, Invokamet XR (canagliflozin and metformin extended release). The Invokana family of medications made more than $1.4 billion for J&J in 2016, according to annual reports. Studies show the drug is effective at controlling blood sugar, but since the FDA approved the drug it has also released several safety communications and warnings. Serious side effects of Invokana include diabetic ketoacidosis, kidney injury, urinary tract infections and cardiovascular problems. How Invokana Works While many drugs treat Type 2 diabetes by increasing insulin or insulin sensitivity, Invokana works by stopping the kidneys from reabsorbing glucose. It acts by inhibiting a special protein in the kidney called SGLT2 that is responsible for reabsorbing 90 percent of the glucose in the kidneys. Instead of reabsorbing the sugar, the kidneys secrete it, and it leaves the body during urination. This results in lowered levels of glucose in the blood. Side Effects of Invokana In clinical studies, people who took Invokana suffered a number of common side effects. Researchers gathered data from 1,667 patients with Type 2 diabetes who took Invokana for about 24 weeks. The average age was 56 years and about 2 percent were older than 75. About half of the participants were male and 72 percent of all participants were white. Certain side Continue reading >>

Invokana: Diabetes Drug Gets Black Box Warning For Amputation Risks

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 >>

Invokana Side Effects Center

Invokana Side Effects Center

Invokana (canagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor used to control blood sugar in people with type 2 diabetes mellitus, in addition to diet and exercise. Common side effects of Invokana include: urinary tract infections, increased urination, yeast infections, vaginal itching, thirst, constipation, nausea, fatigue, weakness, skin sensitivity to sunlight, hypersensitivity reactions (including skin redness, rash, itching, hives, and swelling), bone fractures, and kidney problems. The recommended starting dose of Invokana is 100 mg once daily, taken before the first meal of the day. Doses may be increased to 300 mg in patients who are able to tolerate Invokana at 100 mg doses. Invokana may interact with rifampin or digoxin. Tell your doctor all medications you use. Invokana should only be given to a pregnant woman if the benefit of the drug justifies the risk of harm to the fetus. Breastfeeding women should decide with their doctors whether to breastfeed or to discontinue taking Invokana. Our Invokana (canagliflozin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Continue reading >>

Canagliflozin, Invokana

Canagliflozin, Invokana

Is canagliflozin safe to take if I'm pregnant or breastfeeding? What is canagliflozin, and how does it work (mechanism of action)? Canagliflozin is an oral drug that reduces blood sugar (glucose) levels in patients with type 2 diabetes. It is a new type of diabetes medication in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. Under normal conditions, glucose is filtered out of the blood and into the kidney tubules as blood passes through the kidneys. The glucose then as absorbed from the tubules back into the blood so that glucose is not lost in the urine. SGLT2 is an enzyme in the kidney tubule that causes glucose to be reabsorbed from urine. Canagliflozin blocks the action of SGLT2. Therefore, canagliflozin reduces the reabsorption of glucose from renal tubules, leading to more excretion of glucose in urine. Canagliflozin was approved by the FDA in March 2013. What are the side effects of canagliflozin? AND PRECAUTIONSThe most common side effects of canagliflozin are: Other side effects of canagliflozin include: Diabetes Diet: Healthy Meal Plans for Diabetes-Friendly Eating What is the dosage for canagliflozin? Canagliflozin should be taken before the first meal of the day. The recommended starting dose is 100 mg once daily and the maximum dose is 300 mg once daily. Renal function should be assessed prior to starting canagliflozin and periodically during treatment, and the dose of canagliflozin should be modified based on renal function. Which drugs or supplements interact with canagliflozin? : Canagliflozin may slightly increase the concentration of digoxin (Lanoxin) in the body when both drugs are being taken. Digoxin concentrations should be monitored appropriately. Rifampin, phenytoin (Dilantin, Dilantin-125, phenobarbital, and ri Continue reading >>

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