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Statins And Diabetes Warning

Statins | Lipitor | Diabetes | Lawsuit

Statins | Lipitor | Diabetes | Lawsuit

Studies Link Lipitor to an Increased Risk of Diabetes A number of studies have linked statins including Lipitor (atorvastatin), Crestor (rosuvastatin), as well as Zocor (simvastatin, produced by Merck) to an increased risk of diabetes. In fact, an FDA warning was required to be included on the Lipitor label following a safety announcement on February 28, 2012, that warned of the diabetes risk as well as other side effects. A study published in BMJ on May 23, 2013 confirmed the FDA warning and earlier research when it concluded that statins, such as Lipitor, had a higher incident of diabetes risk than pravastatin. The study analyzed patients in Ontario, Canada were treated with Lipitor, Crestor and Zocor. The team of researchers examined the healthcare records of more than 1.5 million patients aged 66 or older without diabetes who started statin treatment between August 1997 and March 2010. Overall, a 10-22% increased risk of diabetes was found. The BMJ study follows a Women’s Health Initiative study published on January 23, 2012, which found a nearly 50% increase in new onset diabetes for postmenopausal women with statins compared with a placebo. In addition to the risk of diabetes, a BMJ research paper published on March 19, 2013, noted that users of “high potency statins” (including Lipitor) were 34% more likely to be hospitalized with acute kidney injury within 120 days after starting treatment, again confirming the need for the FDA warning. Lipitor Diabetes Litigation Moves Forward On March 25, 2013, a South Carolina woman spoke to a Lipitor diabetes lawyer and filed a complaint against Pfizer claiming that Pfizer promoted and marketed Lipitor as safe and effective. (U.S. District Court of South Carolina Civil Action No. 2:13-cv-796-CWH). Evalina Smalls, the p Continue reading >>

Could Statins Raise Diabetes Risk?

Could Statins Raise Diabetes Risk?

THURSDAY, May 23 (HealthDay News) -- Certain statins -- the widely used cholesterol-lowering drugs -- may increase your chances of developing type 2 diabetes, a new study suggests. The risk was greatest for patients taking atorvastatin (brand name Lipitor), rosuvastatin (Crestor) and simvastatin (Zocor), the study said. Focusing on almost 500,000 Ontario residents, researchers in Canada found that the overall odds of developing diabetes were low in patients prescribed statins. Still, people taking Lipitor had a 22 percent higher risk of new-onset diabetes, Crestor users had an 18 percent increased risk and people taking Zocor had a 10 percent increased risk, relative to those taking pravastatin (Pravachol), which appears to have a favorable effect on diabetes. Physicians should weigh the risks and benefits when prescribing these medications, the researchers said in the study, which was published online May 23 in the journal BMJ. This does not, however, mean that patients should stop taking their statins, the experts said. The study also showed only an association between statin use and higher risk of diabetes; it did not prove a cause-and-effect relationship. "While this is an important study evaluating the relationship between statins and the risk of diabetes, the study has several flaws that make it difficult to generalize the results," said Dr. Dara Cohen, a professor of medicine in the department of endocrinology, diabetes and bone disease at the Icahn School of Medicine at Mount Sinai in New York City. "There was no data regarding weight, ethnicity and family history -- all important risk factors for the development of diabetes." Cohen added that there was no information on the patients' cholesterol and blood sugar levels, and that higher-risk patients might automa Continue reading >>

Warning! Read These Before Taking Cholesterol Drugs

Warning! Read These Before Taking Cholesterol Drugs

Statins are the most popular cholesterol drugs and the second most commonly prescribed drug class in the US. Yet their benefits are in question and there are strong concerns about their side effects. Even the FDA recognizes these side effects and mandates certain warnings on the labels of statin drugs. Which statin side effects are so serious to warrant repeated FDA warnings? Who benefits from statins? Read on to find out the answers to these questions and also why Big Pharma’s next moves should warn you off statins. Statins are the most popular drugs used to lower blood cholesterol levels. They are still commonly prescribed for people with hypercholesterolemia even though the first statin drugs were released over 20 years ago. The sales of statin drugs is quite huge. Lipitor, the most popular statin drug, earned Pfizer over $12 billion in 2008 and has been determined to be the best-selling drug in history. Since the release of Lipitor (atorvastatin), newer generations of statins have been introduced as well as combinations with other cholesterol-lowering agents. As cholesterol-lowering agents, statins inhibit the liver enzyme known as HMG-CoA reductase. This enzyme is involved in the early stages of the mevalonate pathway. This is the synthetic pathway used for synthesizing cholesterol in the liver. Statins are effective cholesterol-lowering drugs. They are especially effective for lowering LDL (low-density lipoprotein or “bad”) cholesterol levels. However, they are not as effective for reducing triglyceride levels or raising HDL (high-density lipoprotein or “good”) cholesterol as supplements such as niacin (vitamin B3). Although they are commonly prescribed, statins are also controversial drugs with serious adverse effects and questionable benefits for reduc Continue reading >>

New Diabetes Warning To Be Added To Statin Drug Labels

New Diabetes Warning To Be Added To Statin Drug Labels

February 28, 2012 – The U.S. Food & Drug Administration (FDA) issued a press release today stating that it will be requiring all statin drugs to carry a new warning about the increased risk of elevated blood sugar and possible transient memory and cognition problems. The label changes will apply to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), lovastatin extended-release (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor). In addition to being linked to increased blood sugar levels and cognitive problems, statin drugs have also recently been associated with muscle damage, myopathy, rhabdomyolysis and kidney failure. Free Statin Drug Lawsuit Evaluation: If you or a loved one has suffered a serious injury after taking Lipitor, Zocor, Crestor or any other statin drug, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the statin drug and we can help. What’s the Problem with Statin Drugs? The new diabetes warning for statin drugs was prompted by findings from the so-called JUPITER trial involving Crestor, which found an unanticipated 27% increase in new onset diabetes among test subjects taking the drug. The findings are particularly troubling due to the fact that JUPITER was an analysis of statins in users who had no previous history of cardiovascular disease. Moreover, the FDA based its decision to approve Crestor for primary prevention from JUPITER results. In addition to finding unexpected cases of diabetes, the FDA said that it also found hyperglycemia in patients who took 40-mg doses of Lipitor in a substudy of PROVE-IT TIMI 22. As well, a meta-analysis of data from 13 statin trials “reported that statin therapy Continue reading >>

Statins And Type 2 Diabetes: What You Need To Know

Statins And Type 2 Diabetes: What You Need To Know

Statins are a type of drug prescribed to patients with high levels of low-density lipoprotein (LDL) cholesterol. They work by blocking a substance needed to make LDL cholesterol, or “bad” cholesterol, in your liver. As it travels through the blood, LDL cholesterol deposits fatty particles on the arterial walls in the heart and brain. Over time, buildup can cause a blockage that can lead to heart attack or stroke. Statins help lower LDL cholesterol. This can lower your risk of stroke and heart attack. Statins also help to: reduce inflammation improve the health of the lining of blood vessels reduce the risk of blood clots Statins have been used for more than 25 years. In February 2012, though, the U.S. Food and Drug Administration (FDA) advised health providers and consumers that the use of statins may increase the risk of developing type 2 diabetes. Statins are usually safe and provide many benefits. As with many drugs, you and your doctor must weigh the pros and cons of taking a statin drug. The FDA still believes in the benefits of statins. The 2012 announcement isn’t meant to urge all people to stop taking statins. Rather, it advises doctors to monitor the blood sugar levels of their patients who take these drugs. The American Diabetes Association states that the benefits of taking a statin outweigh the risk of acquiring diabetes. The American Heart Association suggests that there isn’t enough data to support stopping your statin use if you have type 2 diabetes. Diabetes is a disorder that affects how much insulin your body releases, how your body uses it, or both. Insulin is a hormone your pancreas makes and releases after your body breaks food down into glucose. The hormone helps transport the glucose from your blood into your body’s cells, where it is us Continue reading >>

Statins Can Raise Risk Of Type 2 Diabetes

Statins Can Raise Risk Of Type 2 Diabetes

Taking cholesterol-lowering statin drugs can raise the risk of developing Type 2 diabetes by 30 percent in some vulnerable people, say scientists from Albert Einstein School of Medicine. The study was a follow-up to an earlier study which investigated whether or not modest weight loss or treatment with metformin — a diabetes medication that helps control blood sugar levels — could reduce the risk of Type 2 diabetes in people at high risk. For the study, obese people were given standard advice on healthy eating and exercise, and were randomly assigned to either an intensive lifestyle program, treatment with metformin, or a dummy drug (placebo). Their blood fats and blood pressure were measured annually. Blood glucose was measured twice a year, at which point new statin treatment was recorded. The most commonly prescribed statins were simvastatin (40 percent) and atorvastatin (37 percent). The likelihood of being prescribed a statin drug rose substantially after a diagnosis of diabetes. At the beginning of the trial fewer than 4 percent of volunteers were taking statin drugs, but usage gradually increased so that by the end of the 10-year study period, about a third of patients were taking them. When treatment groups were combined, taking a statin was associated with a 36 per cent heightened risk of being diagnosed with Type 2 diabetes, compared to those who had not been prescribed these drugs. This risk fell slightly to 30 percent after taking account of the clinical criteria used to determine the need for statins. After analyzing all risk factors for developing diabetes, statin use was itself associated with an increased risk of being diagnosed with diabetes, regardless of which treatment group the participants had been in during the trial. To find out if the streng Continue reading >>

Do Statins Raise Odds For Type 2 Diabetes?

Do Statins Raise Odds For Type 2 Diabetes?

HealthDay Reporter TUESDAY, Oct. 24, 2017 (HealthDay News) -- Cholesterol-lowering medications known as statins may lower your risk of heart disease, but also might boost the odds you'll develop type 2 diabetes, new research suggests. "In a group of people at high risk of type 2 diabetes, statins do seem to increase the risk of developing diabetes by about 30 percent," said the study's lead author, Dr. Jill Crandall. She's a professor of medicine and director of the diabetes clinical trials unit at Albert Einstein College of Medicine in New York City. But, she added, that doesn't mean anyone should give up on statins. "The benefits of statins in terms of cardiovascular risk are so strong and so well established that our recommendation isn't that people should stop taking statins, but people should be monitored for the development of diabetes while on a statin," she explained. At least one other diabetes expert agreed that statins are still beneficial for those at risk of heart trouble. Dr. Daniel Donovan Jr. is professor of medicine and director of clinical research at the Icahn School of Medicine at Mount Sinai Diabetes, Obesity and Metabolism Institute in New York City. "We still need to give statins when LDL (bad) cholesterol isn't under control. A statin intervention can lower the risk of a cardiovascular event by 40 percent, and it's possible the diabetes may have been destined to happen," he said. The new study is an analysis of data collected from another ongoing study. More than 3,200 adults were recruited from 27 diabetes centers across the United States for the study. The research goal was to prevent the progression of type 2 diabetes in people with a high risk of the disease, Crandall said. All of the study participants were overweight or obese. They also all Continue reading >>

Statin Drugs Create Over 60,000 New Diabetics Each Year

Statin Drugs Create Over 60,000 New Diabetics Each Year

The U.S. Food and Drug Administration (FDA) is requiring additional warning labels for the cholesterol-lowering drug class known as statins, warning that the drugs may increase your risk of liver damage, memory loss and confusion, type 2 diabetes and muscle weakness The FDA has removed a long-standing warning advising routine monitoring of liver enzymes in people taking statins, even though the drugs are linked to serious liver damage One in four Americans aged 45 and older take statin drugs to lower cholesterol, and many are unaware of the serious risks associated with the drugs The majority of people taking statin drugs do not need them, and in fact are risking their health unnecessarily by doing so Over 60,000 people EVERY year in the US will develop diabetes solely as a result of taking statin drugs By Dr. Mercola One in four Americans aged 45 and older take statin drugs to lower cholesterol and supposedly "prevent heart disease." That amounts to 32 million Americans or, as Peter Wehrwein pointed out in the Harvard Health Letter, the equivalent of the entire populations of Florida and Illinois combined.1 If you're one of these millions, or if you're considering starting a statin prescription anytime soon, you should know that there are serious risks involved with taking these drugs, a fact that even the U.S. Food and Drug Administration (FDA) is now acknowledging. Evidence includes diaries, court records, medical books and literature, in which these two sleep cycles are referred to in such a way as to make it clear that it was common knowledge at the time. FDA Adds New Warning Labels to Statin Drugs Following an internal meeting between the FDA's Office of Surveillance and Epidemiology and Office of New Drugs, the Agency announced it would be requiring additional wa Continue reading >>

Some Statins 'raise Diabetes Risk'

Some Statins 'raise Diabetes Risk'

Some drugs taken to protect the heart may increase the risk of developing type-2 diabetes, according to researchers in Canada. Their study of 1.5 million people, in the British Medical Journal, suggested powerful statins could increase the risk by 22% compared with weaker drugs. Atorvastatin was linked to one extra case of diabetes for every 160 patients treated. Experts said the benefits of statins still outweighed any risks. Statins are a group of commonly prescribed drugs that lower the levels of bad cholesterol in the blood. This reduces the chances of a heart attack or stroke. All drugs come with side-effects, but a team of researchers from hospitals in Toronto said there had been controversy around the risk of diabetes with different statins. They looked at medical records of 1.5 million people over the age of 66 and compared the incidence of diabetes between people taking different statins. Their report said: "We found that patients treated with atorvastatin, rosuvastatin, or simvastatin were at increased risk of new onset diabetes compared with those treated with pravastatin. "Clinicians should considers this risk when they are contemplating statin treatment for individual patients. "Preferential use of pravastatin... might be warranted." Benefit Commenting on the study, Prof Risto Huupponen and Prof Jorma Viikari, from the University of Turku, in Finland, said: "The overall benefit of statins still clearly outweighs the potential risk of diabetes." However, they said, the different statins should be targeted at the right patients. They said: "The most potent statins, at least in higher doses, should preferably be reserved for patients who do not respond to low-potency treatment, but have a high total risk of cardiovascular disease." Maureen Talbot, from the Bri Continue reading >>

New Statin Study Confirms Scary Link To Diabetes

New Statin Study Confirms Scary Link To Diabetes

Statin-type cholesterol-lowering drugs like atorvastatin, lovastatin and simvastatin are supposed to prevent heart attacks and strokes. New research from Finland suggests that such drugs may increase the risk of developing type 2 diabetes by 46 percent, a condition that is strongly linked to heart attacks and strokes. What gives? In 2003 People’s Pharmacy Readers Were Alerted We received a signal from readers more than a decade ago that statins could Trigger diabetes in people with normal blood sugar and Make control of diabetes more challenging in people who already had the disease. As long ago as 2003 we began getting messages like this one: “Since we started on Lipitor, our blood sugar has been rising rapidly. My husband asked the doctor about changing to Tricor, but he was told it would not help him much and he should stay with Lipitor. It seems that Lipitor is affecting our blood sugar. Is this possible?” At that time most physicians did not believe statins could affect blood sugar. We scoured the official prescribing information for atorvastatin (Lipitor) and found hidden away in a long list of other possible adverse reactions the word “hyperglycemia.” In other words, elevated blood sugar. But this side effect was buried along with lots of other seemingly rare complications. Most patients were never warned that there was a connection between Lipitor and blood sugar elevations. JUPITER and Diabetes: Dodging and Weaving In 2008 a study called JUPITER (New England Journal of Medicine, Nov. 8, 2008) revealed a link between rosuvastatin (Crestor) and type 2 diabetes. Nowhere in the abstract or the conclusions was there mention of this connection. That is what busy doctors often look at rather than read the entire article. If, however, you took the time to act Continue reading >>

Fda Warns Statin Users Of Memory Loss And Diabetes Risks

Fda Warns Statin Users Of Memory Loss And Diabetes Risks

The Food and Drug Administration (FDA) added new safety warnings to cholesterol-reducing statin drugs on Wednesday, noting increased risks of Type 2 diabetes and memory loss for patients who take the medications. The changes to the prescribing information apply to the class of statins, including many popularly prescribed drugs such as Lipitor (atorvastatin), Crestor (rosuvastatin), Zocor (simvastatin) and Vytorin (simvastatin/ezetimibe). The new warnings are based on results from the latest clinical trials and reports of adverse events from patients, physicians and drugmakers. The FDA said that statins may increase users’ risk of brain-related effects like memory loss and confusion. The reports have generally not been serious, however, and the symptoms go away once the drug is stopped, the agency said. Statins’ labels will now also warn patients and doctors that the drugs may cause a small increase in blood sugar levels and Type 2 diabetes — an effect that has been shown previously in studies. Type 2 diabetes can further increase the risk of heart disease. In addition, the FDA made a label change specific to Mevacor (lovastatin). Mevacor can interact with other drugs, increasing the risk for muscle pain and weakness, another side effect that has previously been associated with high-dose statin use. Other drugs may raise such risks by increasing the amount of statins in the blood, and the FDA warned that Mevacor should not be taken with protease inhibitors, which are used to treat HIV, certain antibiotics and some anti-fungal medications. At the same time, the statins’ labeling will no longer require the routine monitoring of patients’ liver enzymes, which was originally intended to alert doctors if the medications were becoming toxic and starting to damage the Continue reading >>

Statin Use Raises Diabetes Risk

Statin Use Raises Diabetes Risk

A A A Liam Davenport Long-term statin use is associated with an increased risk of type 2 diabetes of approximately 30% in individuals at high-risk of the disease, even after taking into account known risk factors and potential confounders, say US researchers. They looked at the development of diabetes among statin users in the Diabetes Prevention Program (DPP), which included more than 3200 participants. Over 10 years, statin use was linked to a 36% increased risk of being diagnosed with type 2 diabetes, falling to 27% after taking into account baseline risk factors and clinical criteria used to determine the need for statins. The findings are consistent with previous studies suggesting that statin use substantially increases the risk of type 2 diabetes. The new study was published online October 23 in BMJ Open Diabetes Research & Care by lead author Jill P Crandall, MD, department of medicine and diabetes research center, Albert Einstein College of Medicine, New York, New York, and colleagues. As previously reported by Medscape Medical News, a study of more than 8700 Finnish men aged 45 to 73 years showed that over 6 years statins were linked to a 46% increased risk of type 2 diabetes — more than double prior estimates. This was followed by recent data from the Australian Longitudinal Study on Women's Health, which indicated that, among almost 8400 women aged 76 to 82 years, the risk of new-onset diabetes ranged from 17% with the lowest statin doses to 51% with the highest doses. Despite accumulating evidence, the current researchers still maintain that the overall healthcare advice remains unchanged — the benefits of statins outweigh the risks. "For individual patients, a potential modest increase in diabetes risk clearly needs to be balanced against the consisten Continue reading >>

Controlling Cholesterol With Statins

Controlling Cholesterol With Statins

Whether you’re taking a statin or not, the following tips can help keep your cholesterol in check: Talk with your healthcare provider about how often you should have your cholesterol checked. Maintain a healthy weight. Exercise regularly. When buying groceries, use the Nutrition Facts Label to choose foods lower in saturated fat, trans fats, and calories. Eat more fruits and vegetables. And remember, you should not stop taking any cholesterol-lowering medication you may be on without first talking to your healthcare provider. Subscribe: FDA Consumer Health Information You go to the gym faithfully, and try to watch your diet. But after your annual physical, you find out that your blood cholesterol is surprisingly high. Your doctor calls you back to discuss taking a medication known as a statin. Here are some commonly asked questions about cholesterol and statins. 1. What are statins? How do they work? Statins are a class of medicines used to lower cholesterol in the blood. Most of the cholesterol in your blood is made by the liver. Statins work by reducing the amount of cholesterol made by the liver and by helping the liver remove cholesterol that is already in the blood. According to James P. Smith, M.D., M.S., deputy director of the Division of Metabolism and Endocrinology at the U.S. Food and Drug Administration (FDA), “An important first step is to have a discussion with your healthcare provider about your risk of having heart disease or a stroke, how a statin would reduce that risk, and any side effects that you should consider.” 2. Why is it important to keep cholesterol levels in the blood low? Your body needs cholesterol, but too much of it in your blood can lead to buildup on the walls of your arteries (this buildup is called “plaque”), putting you at Continue reading >>

Statin Use Linked To Heightened Type 2 Diabetes Risk In Susceptible Individuals

Statin Use Linked To Heightened Type 2 Diabetes Risk In Susceptible Individuals

Long term use of statins to lower blood fats and stave off cardiovascular disease is associated with a 30 per cent heightened risk of developing type 2 diabetes in susceptible individuals, suggests a large study published in the online journal BMJ Open Diabetes Research & Care. The findings held true irrespective of the criteria used to determine the need for treatment, suggesting that these factors weren't major contributors to diabetes risk, say the researchers. They base their findings on 3234 participants in the US Diabetes Prevention Program Outcomes Study (DPPOS). This is a long-term follow up study to a randomised clinical trial which looked at whether modest weight loss through lifestyle changes or treatment with metformin could reduce or delay development of type 2 diabetes in people at high risk. The trial participants were given standard advice on healthy eating and exercise and were randomly assigned to either an intensive lifestyle programme, treatment with metformin, or a dummy drug (placebo). At the end of the trial they were invited to take part in DPPOS, during which their blood fats and blood pressure were measured annually. Blood glucose was measured twice a year, at which point new statin treatment was recorded. At the start of DPPOS fewer than 4 per cent of participants were taking statins, but use of these drugs gradually increased until after 10 years around a third of the participants were taking them. The most commonly prescribed statins were simvastatin (40%) and atorvastatin (37%). The likelihood of a prescription rose substantially after a diagnosis of diabetes. However, statin use was itself associated with a heightened risk of being diagnosed with diabetes, irrespective of which treatment group the participants had been in during the trial. Continue reading >>

Fda Adds Diabetes, Memory Loss Warnings To Statins

Fda Adds Diabetes, Memory Loss Warnings To Statins

(Reuters) - Health regulators are adding warnings to the labels of widely used cholesterol lowering drugs, such as Lipitor, to say they may raise levels of blood sugar and could cause memory loss. The Food and Drug Administration announced on Tuesday the changes to the safety information on the labels of statins such as Pfizer Inc’s Lipitor, AstraZeneca’s Crestor and Merck & Co’s Zocor that are taken by tens of millions of people. Statins have been shown to significantly reduce the risk of heart attack and heart disease, and the FDA said the new information should not scare people into stopping taking the drugs. “The value of statins in preventing heart disease has been clearly established,” Amy Egan, deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products, said in a statement. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.” Lipitor, which became available late last year in generic form as atorvastatin, is the world’s all-time biggest selling prescription medicine with cumulative sales in excess of $130 billion. As a class, statins have helped enrich the world’s largest drugmakers, but most of the major brands are now prescribed as far cheaper generic medicines. Last year, more than 20 million Americans were taking some form of statin, according to IMS Health. ”These are nuances, tiny little tweaks to the label, and the bigger picture doesn’t change,“ said Steven Nissen, chief of cardiology at Cleveland Clinic. ”There are few drugs that have saved as many lives as statins and we don’t want to throw the baby out with the bathwater here. “If you have heart disease, you probably should be on a statin. If you’re at high risk, a statin may be warranted. B Continue reading >>

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