Statin Side Effects – New Fda Warnings
Possible Statin Side Effects: Memory Loss, High Blood Sugar, Diabetes The Food and Drug Administration recently announced that statin drugs, used by millions of Americans to lower cholesterol, must carry warnings on their labels about the following potential side effects: Memory loss and mental confusion Risk of high blood sugar Risk of being diagnosed with Type 2 diabetes “The value of statins in preventing heart disease has been clearly established,” said Amy G. Egan, M.D., M.PH., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.” By contrast, the effects of very healthy lifestyle like the Pritikin Program to prevent heart disease are all positive. With lifestyle changes, you don’t have to worry about negative side effects. States cardiologist Ronald Scheib, MD, Medical Director of the Pritikin Longevity Center: “Statins have important benefits like lowering cholesterol and perhaps reducing the inflammation in blood vessel walls that are associated with the development of cholesterol-related plaque. But statins are drugs, and drugs, by their very nature, have both risks and benefits. It is wrong to assume that any drug is 100 percent ‘safe.’” “Individualization of statin therapy is necessary,” continues Dr. Scheib. “For each patient, the decision-making process regarding the risk/benefit ratio must take into consideration several factors, including the occurrence of a previous coronary event and multiple risk factors. For many, the benefits of statins outweigh the potential negative side effects.” Lifestyle Change – No Risks One form of cholesterol-lowering therapy that is side-effect-free is lifest Continue reading >>
Fda Adds Diabetes, Memory Loss Warnings To Statins
February 29, 2012 / 6:15 AM / in 6 years FDA adds diabetes, memory loss warnings to statins (Reuters) - U.S. health regulators will add warnings to the labels of widely used cholesterol lowering drugs, such as Lipitor, to indicate that they may raise levels of blood sugar and could cause memory loss. People walk past the Pfizer World headquarters in New York, February 3, 2010. REUTERS/Brendan McDermid The Food and Drug administration announced the changes to the safety information on the labels of statins such as Pfizer Incs Lipitor, AstraZenecas Crestor and Merck & Cos Zocor. 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 FDAs 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 worlds all-time biggest selling prescription medicine with cumulative sales of over $130 billion. The generic version of Zocor, simvastatin, in 2010 was the second most widely prescribed drug in the United States, according to IMS Health. The FDA said it was aware of studies in which some patients taking statins may have a small increased risk of higher blood sugar levels and of being diagnosed with type 2 diabetes. The statin labels will also now reflect reports of certain cognitive effects such as memory loss and confusion experienced by some patients taking the drugs, the agency said. It said those reports generally have not been se Continue reading >>
Statin Side Effects: Weigh The Benefits And Risks
Statin side effects can be uncomfortable, making it seem like the risks outweigh the benefits of these powerful cholesterol-lowering medications. Doctors often prescribe statins for people with high cholesterol to lower their total cholesterol and reduce their risk of a heart attack or stroke. While statins are highly effective, they have been linked to muscle pain, digestive problems and mental fuzziness in some people and may rarely cause liver damage. Statins include atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor) and simvastatin (Zocor). Having too much cholesterol in your blood increases your risk of heart attacks and strokes. Statins block a substance your liver needs to make cholesterol. This causes your liver to remove cholesterol from your blood. If you think you're experiencing side effects from statins, don't just stop taking the pills. Talk to your doctor to see if a change of dosage or even a different type of medication might be helpful. What are statin side effects? Muscle pain and damage One of the most common complaints of people taking statins is muscle pain. You may feel this pain as a soreness, tiredness or weakness in your muscles. The pain can be a mild discomfort, or it can be severe enough to make your daily activities difficult. Oddly enough, most randomized controlled studies of statins indicate that people taking statins develop muscle pain at the same rate as people taking placebo. But up to 29 percent of the people who start taking statins report muscle pain and many discontinue statins because of it. Many of these people do well when they are switched to a different variety of statin. Very rarely, statins can cause life-threatening muscle damage call Continue reading >>
Fda Issues New Warnings On Statin Drugs
FDA Issues New Warnings On Statin Drugs Federal health officials have added new safety alerts to statins, a class of drugs used to lower cholesterol levels. The Food and Drug Administration cited rare side effects, including memory loss, diabetes and muscle pain. Robert Siegel talks to Rob Stein about the news. Federal health officials have added new safety alerts to statins, a class of drugs used to lower cholesterol levels. The Food and Drug Administration cited rare side effects, including memory loss, diabetes and muscle pain. Robert Siegel talks to Rob Stein about the news. The Food and Drug Administration has issued new safety warnings about a popular class of drugs used to control cholesterol levels. The FDA says the drugs, known as statins, can cause several side effects, including cognitive problems such as memory lapses and confusion. But the agency is stressing that the side effects appear to be rare and not serious. NPR's Rob Stein joins us now to discuss the new warnings. And, Rob, the drugs we're talking about here - statins - are used by millions of Americans. I want you to remind us what statins are exactly and what they do. ROB STEIN, BYLINE: Right, Robert. Statins, as you mentioned, are one of the most commonly used drugs in the United States. In fact, more than 20 million Americans take them. And the one people probably have heard about the most is called Lipitor. It's been on the market for a long time and it's been one of the top selling - if not the top selling - prescription drug on the market for years. And what they do is they lower a form of cholesterol that's called bad cholesterol. It's LDL cholesterol and high levels of this type of cholesterol can increase the risk for heart attacks and strokes. SIEGEL: And tell us more about the problems Continue reading >>
Fda Cautions On Memory, Diabetes Side Effects In Cholesterol-lowering Drugs
The Food and Drug Administration just added new language telling consumers about potential memory problems and an increased risk of high blood sugar for patients on statin cholesterol-lowering medicines. These medicines, including Lipitor, Zocor, and Crestor, are the most-prescribed class of drug in the country. According to drug data firm IMS Health, 255 million prescriptions for cholesterol-lowering drugs were written in 2010. According to the FDA, the changes to the statin labels are: * The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes. * Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur. * Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treate Continue reading >>
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 >>
Statins And Memory Loss: Is There A Link?
Statins are one of the most commonly prescribed drugs for high cholesterol in the United States. However, recently there have been concerns over their side effects. Some statin users have reported that they experienced memory loss while taking the medication. The Food and Drug Administration (FDA) updated its safety information for statins to include memory loss, forgetfulness, and confusion as possible risks. But is there really a link between taking statins and memory loss? Statins are a prescription drug that blocks the substance in your liver that the body uses to make low-density lipoprotein (LDL) cholesterol, often called “bad cholesterol.” Your body needs some cholesterol, but having high levels of LDL cholesterol puts your health at risk. If you have high levels of LDL cholesterol, it can cause blockages in your blood vessels that may lead to a heart attack or stroke. Some types of statins help your body reduce the amount of bad cholesterol that has already built up in your artery walls. Statins come in pill form. If your LDL cholesterol levels are above 100 mg/dL, and you aren’t able to lower those levels with lifestyle changes, your doctor may prescribe a statin. It’s also common for your doctor to prescribe a statin if you have a higher risk of heart disease, or if you’ve already had a heart attack or stroke. The American Heart Association and the American College of Cardiology recently released new guidelines on statin use. The new guidelines suggest that more people can benefit from statins than previously believed. They recommend statin treatment for people ages 40 to 75 without heart disease who have a 7.5 percent (or higher) risk of having a heart attack or stroke in the next 10 years. Your doctor is most likely to prescribe statins if you: hav Continue reading >>
Fda Adds Diabetes, Memory Loss Warnings To Statin Labels: Cause For Concern?
FDA adds diabetes, memory loss warnings to statin labels: Cause for concern? Pfizer's Lipitor is one of the most commonly prescribed drugs in the U.S, taken by almost 4.3 million Americans. It's a once daily statin that's taken to reduce the risk of heart attack and stroke. Lipitor currently costs about $150 a month, but could plummet as low as $5 on some drug plans when its patent expires in November 2011. (CBS/AP) The Food and Drug Administration announced Tuesday that it's making "important safety" changes" to warning labels on statin medications. The cholesterol-lowering drugs that are taken by tens of millions of Americans will carry new safety warnings about an increased risk for memory loss and diabetes among users. PICTURES: Cheaper pills? 7 top-selling drugs set to go generic "We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol," Dr. Mary Parks of the FDA's Center for Drug Evaluation and Research, said in a written statement . The FDA said it is making labeling changes to the medicines that are used to prevent heart related problems associated with cholesterol. According to the FDA, the full list of statins include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). In addition to statins, the new labeling changes apply to several combination drugs that mix older statins with newer cholesterol medicines, including Advicor, Vytorin, and Simcor. New labels will warn of memory loss and confusion reported among certain patients taking stati Continue reading >>
10 Drugs That May Cause Memory Loss
En español l For a long time doctors dismissed forgetfulness and mental confusion as a normal part of aging. But scientists now know that memory loss as you get older is by no means inevitable. Indeed, the brain can grow new brain cells and reshape their connections throughout life. Most people are familiar with at least some of the things that can impair memory, including alcohol and drug abuse, heavy cigarette smoking, head injuries, stroke, sleep deprivation, severe stress, vitamin B12 deficiency, and illnesses such as Alzheimer's disease and depression. But what many people don't realize is that many commonly prescribed drugs also can interfere with memory. Here are 10 of the top types of offenders. 1. Antianxiety drugs (Benzodiazepines) Why they are prescribed: Benzodiazepines are used to treat a variety of anxiety disorders, agitation, delirium and muscle spasms, and to prevent seizures. Because benzodiazepines have a sedative effect, they are sometimes used to treat insomnia and the anxiety that can accompany depression. Examples: Alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Valium), flurazepam (Dalmane), lorazepam (Ativan), midazolam (Versed), quazepam (Doral), temazepam (Restoril) and triazolam (Halcion). How they can cause memory loss: Benzodiazepines dampen activity in key parts of the brain, including those involved in the transfer of events from short-term to long-term memory. Indeed, benzodiazepines are used in anesthesia for this very reason. When they're added to the anesthesiologist's cocktail of meds, patients rarely remember any unpleasantness from a procedure. Midazolam (Versed) has particularly marked amnesic properties. Alternatives: Benzodiazepines should be prescribed only rarely in older adults, in my judgmen Continue reading >>
Fda Adds Risk Of Diabetes, Memory Problems To Lipitor And Similar Drugs
FDA adds risk of diabetes, memory problems to Lipitor and similar drugs Consumer Reports News: March 01, 2012 01:53 PM Cholesterol-lowering medications called statins, including atorvastatin (Lipitor and generic), lovastatin (Mevacor and generic) and simvastatin (Zocor and generic), can increase the risk of type 2 diabetes and might cause rare cases of memory loss, according to the Food and Drug Administration. Earlier this week, the agency said these new side effects would be added to the labeling of these drugs. Such risks underscore our advice to first try to reduce high cholesterol through lifestyle changes, such as a healthy diet and exercise before turning to a statin. The FDA said it added the diabetes risk because several studies in recent years found an increased risk of elevated blood sugar levels and diabetes in people who took statins. The memory risk is based on the FDA's review of studies and reports it has received of rare cases of people who developed memory loss or impairment after taking statins. The memory problems, which occurred in people over the age of 50, went away when the statin was stopped. Bottom line: In addition to diabetes and memory problems, statins can cause other serious side effects, including muscle soreness and a rare condition that can cause kidney damage, kidney failure, and death, so you don't want to take one if you can avoid it. Many people with high cholesterol might be able to reduce it to healthy levels with exercise, modifying their diet, losing weight and other lifestyle changes, without the need for medication. If you already take a statin, these changes might allow you to discontinue your medication or lower your dose, which can in turn reduce your risk of side effects. Continue reading >>
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 >>
Fda Mandates New Safety Warnings For Statin Drugs Due To Risks Of Memory Loss, Diabetes And Muscle Pain
FDA mandates new safety warnings for statin drugs due to risks of memory loss, diabetes and muscle pain On February 28, federal health officials added new safety alerts to the prescribing information for statin drugs, citing increased risks of memory loss, diabetes and muscle pain. It is the first time the United States Food and Drug Administration (FDA) has officially linked statins to cognitive problems like forgetfulness and confusion, though such problems have been reported for several years. Statin drugs, which are widely known as cholesterol-lowering medications, are among the most widely prescribed drugs in the world with annual sales of tens of billions of dollars. In the United States alone, almost 32 million people regularly take statins. Despite the new warnings and several studies linking statins to increased incidences of a wide variety of health problems, FDA officials and some mainstream medical professionals said the new warnings should not scare people away from statins. Dr. Amy G. Egan, deputy director for safety in the FDAs division of metabolism and endocrinology products, was quoted in a New York Times article as saying, The value of statins in preventing heart disease has been clearly established. Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects. In the same article, Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, said that diabetic patients and even those who develop diabetes while taking statins should continue taking the medicines. According to Nissen, the new warnings are not major issues and should not alter the decision-making process with regard to statins. The questionable benefits and indisputable dangers of statin drugs Although studies have indicated t Continue reading >>
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 >>
Statin Medications Can Cause Diabetes, Memory Loss
A few years ago, the Food and Drug Administration (FDA) announced that it’s now going to require makers of cholesterol-lowering statin medications to put new warnings on the label—namely that these drugs can up your risk of developing type 2 diabetes and memory loss. First off, I praise the FDA for finally stepping up and doing the job they should be doing. As I'll mention in a minute, I do recommend statin medications in certain cases, so having the warnings out there is important. But, unfortunately, for many people these warnings are coming way too late. Statin Medications and Diabetes Let’s start with diabetes, an issue that’s been swept under the carpet for far too long! What should have alerted the FDA to take stronger measures earlier was the well-publicized JUPITER study, the one that came out flags waving suggesting that that statin drug Crestor is the heart disease cure-all. At that point, more people were put on statin medications even if they had healthy LDL cholesterol because statins were touted as “primary prevention.” What was lost in the hoopla was that those taking Crestor were developing diabetes at a higher rate than the placebo group. This was followed by several more studies showing the statin-diabetes link. What’s concerning to me is that it took so many years for the FDA to acknowledge the connection and warn the public. Statins Medications and Memory Loss Now, let’s talk about statins and memory loss. This issue has been less publicized, and quite frankly less clear cut. But it’s been bubbling up for quite some time. The reason statin medications can affect the brain is that cholesterol is vital for the formation and function of synapses (the connections between neurons) in the brain that allow you to think and process informat Continue reading >>
Remembering Statins: Do Statins Have Adverse Cognitive Effects?
The issue of statin-associated cognitive impairment has been a hot topic among both patients and health care providers, especially since the U.S. Food and Drug Administration (FDA) issued a statement regarding rare postmarketing reports of ill-defined cognitive impairment associated with statin use. This statement was based on case reports, and no objective measures of cognitive function were used. Nevertheless, many patients at high risk of cardiovascular disease have expressed concerns about possible cognitive decline and may have opted to forgo statin therapy. In this overview, the evidence leading to the statement by the FDA is reviewed. Potential mechanisms of the effect of LDL cholesterol reduction and statin therapy on cognition are discussed. Evidence from observational and prospective randomized trials is summarized, leading to the conclusion that as for now, there is no good evidence that statins cause cognitive impairment to a significant degree. Reported cases seem to be rare, and a causal relationship has not been established. Hydroxymethylglutaryl CoA reductase inhibitors (statins) are a major contributor to cardiovascular disease prevention in patients with diabetes. In a prospective meta-analysis of more than 18,000 people with diabetes (mean age 63 years, with 43% over the age of 65 years) in 14 randomized trials, statins were shown to reduce both cardiovascular morbidity and mortality (1). As a result, both European (2) and U.S. (3) guidelines recommend statin treatment for almost all patients with diabetes. It is estimated that for people over the age of 55 years, statins would be recommended for 96.4% of men and 65.8% of women by the American College of Cardiology/American Heart Association guidelines and 66.1% of men and 39.1% of women by European S Continue reading >>
