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Diabetes Drug Warning

Diabetes Drugs Cause Heart Failure And Pancreactic Cancer

Diabetes Drugs Cause Heart Failure And Pancreactic Cancer

Posted by: Allison Reed, staff writer in Drug Dangers August 16, 2015 0 (NaturalHealth365) According to the Centers for Disease Control, more than 29 million people are estimated to be living with diabetes in the United States, whether diagnosed or undiagnosed. That represents nearly 10 percent of the total population most of whom have the preventable form of type-2 diabetes . Of those, most take diabetes medications to help manage blood sugar levels. In fact, some take two or more medications to achieve adequate blood sugar control. While drugs have long been the go-to solution in Western medicine, they are not without their risks. Many patients and physicians put their faith in pills to achieve a health goal, only to find there are risks and adverse side effects associated with those medications . Not surprisingly, several types of diabetes drugs have been flagged for their potential dangers, which include a higher risk of heart failure and pancreatic cancer. The link between diabetes drugs, heart failure and pancreatitis There are several types of diabetes drugs used in the U.S. and around the world, some of the most common of which are GLP-1 agonists and SGLT2 and DPP-4 inhibitors. Keep this in mind, big pharma will manufacture these drugs under competing names, but nearly all have been linked to serious complications and risks. Heart disease , for example, is much more common in patients taking glucose-lowering medications than in those who do not. A study of more than 95,000 patients published in The Lancet Diabetes and Endocrinology found that nearly 10 percent of people taking these drugs eventually suffer a serious cardiovascular problem or event, while approximately 4 percent experience heart failure. Equally concerning is the increased risk for pancreatic ca 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 >>

Heart Failure Warning Added To The Dpp-4 Inhibitor Class Of Drugs

Heart Failure Warning Added To The Dpp-4 Inhibitor Class Of Drugs

Increased cardio risk of Saxagliptin found during trial prompts FDA decision. Sitagliptin (Januvia) is a DPP-4 antidiabetic oral agent for treating type 2 diabetes. A new warning label regarding the risk of developing heart failure in patients with cardiovascular disease was issued to this drug by the FDA in September 2017. Other drugs within the same class, Nesina and Tradjenta, were also issued this warning, suggesting the associated risk to be a “class-effect” of the DPP-4 inhibitors. To date, no direct studies have linked this drug with increasing risk of cardiovascular events, including heart failure. Saxagliptin (Onglyza), another DPP-4 inhibitor, was found to increase the risk of hospitalization for heart failure and the risk of hypoglycemic events. This study found that more patients in the Saxagliptin group than in the placebo group were hospitalized for heart failure.(1) This study happened to be the evidence and reason behind the FDA’s decision to correct Sitagliptin’s package insert. It appears that the FDA issued such warning in a conservative way without a solid controlled trial supporting the cardiovascular risk. From 2008 until 2015, a major randomized, double-blind, placebo-controlled, event-driven trial was conducted by Duke Clinical Research Institute (DCRI) and the University of Oxford Diabetes Trials Unit (DTU). It evaluated a total of 14,735 patients with established cardiovascular disease. They compared the sitagliptin group vs placebo. The primary endpoint was the risk of developing major cardiovascular events such as nonfatal MI, nonfatal stroke, cardiovascular death, or unstable angina. Mean follow-up was 3 years and included patients from 38 different countries. Baseline characteristics were well balanced for both groups and all cardio Continue reading >>

Diabetes Drug Injury Lawyers

Diabetes Drug Injury Lawyers

Prescription medications designed to treat Type 2 diabetes work by stimulating the release of certain chemicals in the brain, pancreas, and bloodstream to improve blood glucose levels in the body. These medications also reduce insulin resistance in the liver. Scientific studies have linked several Type 2 diabetes drugs to serious side effects, such as heart attacks, certain types of cancers, acute pancreatitis, and more. At Ferrer, Poirot & Wansbrough, were dedicated to helping the victims of prescription drugs get compensation for their medical bills, lost wages, and pain and suffering. If you or someone you love was injured by a Type 2 diabetes medication, our experienced diabetes drug injury lawyers want to help. Call us at (800) 210-8503 or fill out a free initial consultation form . An FDA advisory committee concluded that taking the prescription Type 2 diabetes drug Onglyza (saxagliptin) can increase the risk of heart failurea fatal condition. These medications can cause serious health complications that may leave you in the hospital, out of work, and facing expensive medical bills. Ferrer, Poirot & Wansbrough can help you get the money you deserve for your or your loved ones drug injuries. We have the experience to build a strong case for youcall today. Actos is a registered trademark of Takeda Pharmaceutical Company Limited. Invokana and Invokamet are registered trademarks of Janssen Pharmaceuticals, Inc. Onglyza is a registered trademark of AstraZeneca PLC. This law firm is not associated with, sponsored by, or affiliated with the U.S. Food and Drug Administration, Takeda Pharmaceutical Company, Janssen Pharmaceticals, Inc., or AstraZeneca PLC. Continue reading >>

Fda Warns Of Amputation Risk Linked To Newer Diabetes Drug

Fda Warns Of Amputation Risk Linked To Newer Diabetes Drug

agency officials have directed(www.fda.gov) that a new boxed warning be added to the package label of the medication canagliflozin (Invokana, Invokamet, Invokamet XR) to advise prescribers and patients of a heightened risk for leg and foot amputations associated with the drug. Canagliflozin is a member of the class of medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Marketed as single-ingredient products or in combination with other diabetes drugs such as metformin, SGLT2 inhibitors are FDA-approved for use in conjunction with diet and exercise to lower blood glucose in patients with type 2 diabetes -- specifically, by inhibiting renal glucose reabsorption. The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and these drugs are not approved for use in these patients. The MedWatch alert, issued on May 16, was based on results of two large clinical trials -- 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) -- which showed that leg and foot amputations occurred about twice as often in patients treated with the drug as in those who took a placebo. Specifically, according to a related FDA drug safety communication,(www.fda.gov) the CANVAS trial found the risks of amputation over a year's time were equivalent to 5.9 out of every 1,000 patients for canagliflozin compared with 2.8 out of every 1,000 patients for placebo. In the CANVAS-R trial, the comparative risks were equivalent to 7.5 per 1,000 patients for canagliflozin and 4.2 per 1,000 patients for placebo. Although amputations involving the toe or middle of the foot were the most common, amputations of the leg -- both Continue reading >>

Metformin, Oral Tablet

Metformin, Oral Tablet

Metformin oral tablet is available as both a generic and brand-name drug. Brand names: Glucophage, Glucophage XR, Fortamet, and Glumetza. Metformin is also available as an oral solution but only in the brand-name drug Riomet. Metformin is used to treat high blood sugar levels caused by type 2 diabetes. FDA warning: Lactic acidosis warning This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to potentially dangerous effects. Lactic acidosis is a rare but serious side effect of this drug. In this condition, lactic acid builds up in your blood. This is a medical emergency that requires treatment in the hospital. Lactic acidosis is fatal in about half of people who develop it. You should stop taking this drug and call your doctor right away or go to the emergency room if you have signs of lactic acidosis. Symptoms include tiredness, weakness, unusual muscle pain, trouble breathing, unusual sleepiness, stomach pains, nausea (or vomiting), dizziness (or lightheadedness), and slow or irregular heart rate. Alcohol use warning: You shouldn’t drink alcohol while taking this drug. Alcohol can affect your blood sugar levels unpredictably and increase your risk of lactic acidosis. Kidney problems warning: If you have moderate to severe kidney problems, you have a higher risk of lactic acidosis. You shouldn’t take this drug. Liver problems warning: Liver disease is a risk factor for lactic acidosis. You shouldn’t take this drug if you have liver problems. Metformin oral tablet is a prescription drug that’s available as the brand name drugs Glucophage, Glucophage XR, Fortamet, and Glumetza. Glucophage is an immediate-release tablet. All of the other brands are extended-r Continue reading >>

Feline Diabetes | Cornell University College Of Veterinary Medicine

Feline Diabetes | Cornell University College Of Veterinary Medicine

Avoiding inducing inappropriately low blood glucose levels with therapy Cats with diabetes are most often treated with injectable insulin. Oral drugs for humans (hypoglycemic medications) such as glipizide rarely work in controlling diabetes in cats. Insulin injection (see Figure 1) can be taught to most owners and, with a bit of experience, both owners and cats usually adapt to these injections very well. There are a variety of insulin preparations available, and each works for a different duration and has different effects on the ups and downs of blood glucose. Ideally, your veterinarian will perform a 12-24 hour glucose curve, during which insulin is administered intermittently and blood glucose is measured to establish the type of insulin and dosing frequency that best controls blood glucose while avoiding inappropriately low blood glucose levels (hypoglycemia). Your veterinarian may recommend feeding your cat a diet restricted in carbohydrates, which has been shown to improve control of blood glucose levels. When it comes to diet, its important to help your cat combat the weight loss that often occurs as a result of this disease. In diabetic cats that are underweight, this often means feeding multiple meals per day or allowing access to food at all times. If your cat is overweight, however, work with your veterinarian to institute a weight loss program, as managed weight loss in overweight diabetic cats will likely help the cat maintain steadier glucose levels. The optimal timing of meals for diabetic cats is controversial. Many veterinarians recommend feeding at the time of insulin injection to avoid a dangerous drop in blood glucose levels. However, there is no definitive evidence that the timing or frequency of meals in diabetic cats protects them from insulin- Continue reading >>

Why Trulicity Could Be A Truly Dreadful Diabetes Drug

Why Trulicity Could Be A Truly Dreadful Diabetes Drug

This is certainly turning out to be a bumper year for new diabetes drugs, which seem to be getting approved at an unprecedented rate. The latest one is called Trulicity, a once-a-week injection from Eli Lilly and Co, which has been fast-tracked onto both the American and European markets, despite serious concerns over its safety. Trulicity sounds like a character from a Julie Andrews musical and your brain will unconsciously associate the name with truth, simplicity and felicity (happiness). But a spoonful of sugar won’t make this very nasty medicine go down. It comes with an FDA ‘black box’ warning about its risks of medullary thyroid cancer and other thyroid tumours, while very similar drugs have previously been linked with acute pancreatitis and pancreatic cancer. Trulicity’s generic name is dulaglutide and it belongs to a class of drugs called GLP-1 receptor agonists that already includes exenatide (Byetta), liraglutide (Victoza) and albiglutide (Tanzeum). Also known as ‘incretin mimics’ – synthetic versions of a natural body chemical that inhibits the release of glucose from your liver into your blood stream – they work in the same way as another closely-related group of drugs called DPP-4 inhibitors. All of these drugs have a history of adverse side effects and serious health risks. As I wrote here, people taking Byetta or the DPP-4 inhibitor sitagliptin (Januvia) are twice as likely as those taking other kinds of diabetes medication to find themselves in hospital with acute pancreatitis, a condition that can lead to deadly pancreatic cancer. Tanzeum comes with warnings of thyroid C-cell tumours, acute pancreatitis and kidney damage, while Victoza also carries a warning of pancreatitis and has been associated with an increased risk of thyroid tumou Continue reading >>

Lilly Could Grab Diabetes Share From Dow's J&j On Amputation Woes

Lilly Could Grab Diabetes Share From Dow's J&j On Amputation Woes

Eli Lilly's (LLY) Jardiance will likely benefit most after the Food and Drug Administration required Dow component Johnson & Johnson (JNJ) to warn patients of leg and foot amputations associated with diabetes drug Invokana, an analyst said Tuesday. In a letter to physicians Tuesday, the FDA cited two large clinical trials and concluded that diabetes meds Invokana, Invokamet and Invokamet XR "causes an increased risk of leg and foot amputations." The FDA will now require Johnson & Johnson to add a boxed warning to its Invokana/Invokamet labels. The trials, dubbed Canvas and Canvas-R, showed that leg and foot amputations occurred twice as often in patients treated with Invokana vs. a placebo. "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," the FDA wrote. "Some patients had more than one amputation, some involving both limbs." Leerink analyst Seamus Fernandez expects Lilly to benefit from an influx of Invokana patients transitioning to one of its diabetes meds, Jardiance. Invokana and Jardiance belong to a class of drugs called SGLT2 inhibitors. SGLT2 — sodium-glucose co-transporter 2 — is a protein that facilitates glucose reabsorption in the kidneys. These drugs block the reabsorption of glucose in the kidneys, increase glucose excretion and lower blood glucose levels. "The increasingly differentiated labels and data to date suggest that Lilly's Jardiance likely will be a near-term beneficiary of further and perhaps accelerated market share losses for Invokana," Fernandez wrote in a note to clients. IBD'S TAKE: Stay on top of the biotech and drug industry by bookmarking IBD's Biotech And Pharma Industry And Stock News page. Whether physicians move their patients off 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 >>

The Ins And Outs Of Afrezza®, The Only Inhaled Insulin

The Ins And Outs Of Afrezza®, The Only Inhaled Insulin

AFREZZA is a man-made rapid-acting inhaled insulin breathed in through your lungs and is used to control high blood sugar in adults with diabetes. AFREZZA is available by prescription only. AFREZZA is not for use in place of long-acting insulin. AFREZZA must be used with long-acting insulin in people who have type 1 diabetes. AFREZZA is not for use to treat diabetic ketoacidosis. It is not known if AFREZZA is safe and effective for use in people who smoke. AFREZZA is not for use in people who smoke or have recently stopped smoking (less than 6 months). It is not known if AFREZZA is safe and effective in children under 18 years of age. What is the most important information I should know about AFREZZA? AFREZZA can cause serious side effects including: Sudden lung problems (bronchospasms). Do not use AFREZZA if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting AFREZZA, your healthcare provider will perform a detailed medical history, physical examination, and will give you a breathing test (called spirometry) to check how your lungs are working. Who should not use AFREZZA? Do not use AFREZZA: During episodes of low blood sugar (hypoglycemia). If you have chronic lung problems such as asthma or COPD. If you are allergic to regular human insulin or any of the ingredients of AFREZZA as this may cause a significant and severe allergic reaction. What should I tell my healthcare provider before using AFREZZA? Before using AFREZZA, tell your healthcare provider about all your medical conditions, including if you: Have lung problems such as asthma or COPD. Have or have had lung cancer. Are using any inhaled medications. Smoke or have recently stopped smoking. Have kidney or liver problems. Are pregnant, plan Continue reading >>

Type 2 Diabetes Drug Lawsuit – Risk Of Diabetic Ketoacidosis

Type 2 Diabetes Drug Lawsuit – Risk Of Diabetic Ketoacidosis

As more and more Type 2 diabetes drugs hit the market, managing the disease becomes less of a hassle for many. Unfortunately in some cases, the risks of taking these medications outweigh the reward and users are finding the serious side effects they experience are just not worth it. Though side effects can occur with any of the diabetes drugs available – or any drug for that matter – some of the most serious issues are related to sodium-glucose co-transporter (SGLT2) inhibitors, which are the newest class of type 2 diabetes medications. These drugs have been available for approximately two years and already, users have suffered numerous adverse reactions, many of which were life-threatening. There are several SGLT2 medications on the market. The first approved was Invokana, which made it to market despite five of the 15 members of the advistory panel voting against approval because of the drug’s potential link to heart attack. Farxiga, which had its original application denied by the FDA due to concerns of the drug’s effect on the liver, was later approved in the winter of 2014. Members of the FDA approval panels were not the only ones concerned about SGLT2 inhibitors. The advocacy group Public Citizen voiced its concern for the medications, stating they do not think the information available is adequate and that there is evidence the drugs cause harm. They have SGLT2 inhibitors on their list of “do not use” medications on their website. SGLT2 Inhibitors Cause Minor and Severe Side Effects Health officials have taken notice and following a number of adverse reactions to SGLT2 inhibitors, the FDA issued a warning to health care professionals in the spring of 2015 concerning a link to diabetic ketoacidosis. The agency had received 20 reports, but hundreds more Continue reading >>

Warning On 5 Diabetes Drugs That Increase Heart Failure

Warning On 5 Diabetes Drugs That Increase Heart Failure

People with diabetes are more likely to develop heart disease, and 68% of diabetics over age 65 will die from some form of heart disease. But new research shows that patients taking any of several type 2 diabetes medications are even more likely to develop heart failure, compared to patients on other diabetes medications. In April 2016, the FDA announced that patients taking any of five Type 2 diabetes medications containing saxagliptin or alogliptin are more likely to develop heart failure than if they took other diabetes medication, especially if they already have heart disease or kidney disease. This includes the following medications: AstraZeneca’s Onglyza (saxagliptin) AstraZeneca’s Kombiglyze (saxagliptin and metformin extended release) Takeda’s Nesina (alogliptin) Takeda’s Kazano (alogliptin and metformin) Takeda’s Oseni (alogliptin and pioglitazone) Saxagliptin and alogliptin lower blood sugar levels by blocking the breakdown of a hormone that stimulates insulin production. Warnings are for both medications even though studies showed saxagliptin is the more dangerous of the two. Since heart disease is the #1 killer of women and men, patients should avoid medications that contribute to heart failure. There are other types of diabetes drugs that may be better for patients, especially those who already have heart disease or kidney disease, such as sulfonylureas (Diabinese, Amaryl), biguanides (Glucophage, Metformin, Glumetza) and meglitinides (Prandin, Starlix). On the other hand, the type of diabetes drugs called thiazolidinediones (such as Avandia, Actos) also increase the risk of developing heart failure. And Farxiga has been found to increase the chances of being diagnosed with bladder cancer. For more information on the risks of various diabetes drug Continue reading >>

Fda Warns Of Amputation Risk For Diabetes Drug

Fda Warns Of Amputation Risk For Diabetes Drug

Canagliflozin (Invokana) may increase the risk of leg and foot amputations in patients with type 2 diabetes. The FDA recently issued a safety communication regarding canagliflozin (Invokana, Invokamet, Invokamet XR) due to an elevated risk of serious adverse events. Data from 2 clinical trials revealed that patients with type 2 diabetes taking canagliflozin may be at an increased risk of leg and foot amputations, according to a press release. This warning is an update to the safety communication issued on May 18, 2016. The FDA is now requiring a new warning for the drug – including a prominent boxed warning – to ensure that patients and providers are aware of the risks. Findings from the CANVAS and CANVAS-R clinical trials showed that amputations occurred at twice the rate among patients administered canagliflozin compared with those receiving placebo. Patients taking canagliflozin most commonly experienced amputations of the toe and the middle of the foot. However, the FDA reported that amputations below and above the knee also occurred, and some patients experienced more than 1 amputation, sometimes involving both limbs, according to the release. Canagliflozin is SGLT2 inhibitor indicated to lower blood glucose levels in patients with type 2 diabetes along with diet and exercise. The drug controls blood sugar by causing the kidneys to remove sugar through urination. Canagliflozin is available through prescription as a single-ingredient drug, or in combination with metformin, sold as Invokamet. The FDA advises that patients taking canagliflozin should alert their health care providers if they develop pain, tenderness, ulcers, or infections in the leg or feet. Despite the increased risk of amputation, patients should not stop treatment for type 2 diabetes without di Continue reading >>

Types Of Diabetes Medications

Types Of Diabetes Medications

Author's Perspective: Most people with diabetes start out taking oral medications (pills) such as metformin (Glucophage) when they are initially diagnosed with Type 2 diabetes. But, in my case, I was put on insulin immediately (in the hospital) because my diabetes was so bad. Because I had to inject myself with insulin 4 times a day (and, because I was afraid of needles), I never became comfortable with my insulin shots. Ironically, if I had started out taking a pill like most diabetics, I would have become comfortable taking the pills and I would not have been as motivated to want to get off the medication. In fact, I was so afraid of needles, that I considered getting an insulin pump so that I could avoid the insulin shots. Luckily, for me, my family doctor rejected the idea of me going on an insulin pump. Initially, I didn't see the advantage of taking insulin shots, but, it turned out that it was easier to gradually wean off the insulin because I was able to reduce my dosage one unit at a time from 60 units to 59 units to 58 units and so on. This would have been impossible to do with pills. So, in many ways, being on insulin, actually turned out to be advantageous to me because I was able to slowly reduce the dosage and safely wean off the insulin in 3.5 months. Oral Diabetes Medications Oral pills are the initial and primary type of diabetes medication given to people with Type 2 diabetes. These types of medications help to artificially lower and control blood sugar levels in people whose bodies still produce some insulin (which are the majority of people with Type 2 diabetes). Oral diabetes medications work in one of four ways: Stimulate the pancreas to release more insulin (causing you to gain weight) Stop the liver from releasing stored glycogen into the bloodst Continue reading >>

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