FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs

… to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”) Marketed as single-ingredient products, … approved important safety label changes for the class of cholesterol-lowering drugs known as statins. These changes …

FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins

… requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. … decades to lower low-density lipoprotein (LDL-C or “bad”) cholesterol in the blood. Statins work by reducing the amount of cholesterol made by the liver and helping the liver remove …

Statins: Drug Safety Communication - FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During Pregnancy

… decades to lower low-density lipoprotein (LDL-C or “bad”) cholesterol in the blood. Medicines in the statin class … requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. … … - FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During Pregnancy …

FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins

… requested removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. … FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises … FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises …

FDA Drug Safety Communication: Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury

… to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). HIV protease inhibitors are a class of … side effect of taking HIV protease inhibitors is increased cholesterol and triglyceride (fat) levels. Therefore, some …

Cholesterol-lowering drugs get labeling changes

… and Vytorin (simvastatin/ezetimibe) Infographic About Cholesterol and Statins The U.S. Food and Drug Administration … and exercise -- to reduce the amount of low-density (LDL) cholesterol. All of the new labeling changes provide the … risk of muscle injury when statins are used with: Cholesterol-lowering drugs known as fibrates Large doses of …

Cholesterol Medicines Guide

… Cholesterol Medicines Print and Share (PDF 2496KB) Cholesterol is a kind of fat in your blood. Your body makes its own cholesterol, but you also get it from the foods you eat, such …

Cholesterol

… test does: This is a home-use test kit to measure total cholesterol. What cholesterol is: Cholesterol is a fat (lipid) in your blood. High-density …

Cholesterol and Statins Infographic

… printable PDF of this infographic. Related Information Cholesterol-lowering drugs get labeling changes Su Colesterol … Center for Drug Evaluation and Research … Cholesterol and Statins Infographic … Cholesterol and Statins Infographic … Consumer Health … …

FDA approves add-on therapy for patients with genetic form of severely high cholesterol

… (HoFH), a genetic condition that causes severely high cholesterol. Praluent is not intended to be used alone but … small group of genes that controls the way the body clears cholesterol. As a result, patients have extremely high circulating levels of low-density lipoprotein cholesterol (LDL-C), commonly known as “bad cholesterol.” …

FDA approves add-on therapy for patients with genetic form of severely high cholesterol

… (HoFH), a genetic condition that causes severely high cholesterol. HoFH is a rare, life-threatening condition that … small group of genes that controls the way the body clears cholesterol. As a result, patients have extremely high circulating levels of low-density lipoprotein cholesterol (LDL-C), known as “bad cholesterol.” These …

Health Claim Notification for Saturated Fat, Cholesterol, and Trans Fat, and Reduced Risk of Heart Disease

… relationship between dietary consumption of saturated fat, cholesterol, and trans fat, and the risk of heart disease. … from saturated fatty acids and less than 300 mg/day of cholesterol, and keep trans fatty acid consumption as low as … (page 29): "High intake of saturated fats, trans fats, and cholesterol increases the risk of unhealthy blood lipids …

Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease - Interim Final Rule

… on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) (21 CFR … Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease interim final … Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease (Interim Final …

FDA Issues Interim Final Rule Allowing More Raw Fruits and Vegetables to Bear Health Claims about Relationship between Dietary Saturated Fat and Cholesterol and the Risk of Coronary Heart Disease

… on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) to … the relationship between dietary saturated fat and cholesterol and the risk of coronary heart disease a food … definitions of a “low saturated fat,” “low fat” and “low cholesterol” food. Some fruits and vegetables had been …

FDA approves add-on therapy to lower cholesterol among certain high-risk adults

… who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Leqvio works to reduce circulating levels of LDL-C, commonly known as “bad cholesterol.” Leqvio is approved at a 284 mg dose … small group of genes that controls the way the body clears cholesterol. As a result, patients have extremely high levels …

FDA approves add-on drug for ages 10 & up with rare forms of high cholesterol

… (HoFH). Repatha works to reduce low-density lipoprotein cholesterol (LDL-C), known colloquially as “bad cholesterol.”   FDA previously approved Repatha to reduce the … previously approved as an add-on therapy to reduce LDL-C cholesterol levels in adults with HeFH and patients with HoFH …

Drug Trials Snapshot: PRALUENT

… drug for? PRALUENT is a drug for the treatment of high LDL cholesterol, which is sometimes referred to as “bad cholesterol”. PRALUENT is to be used in the following two … 2) patients who have had complications of having too much cholesterol, such as heart attacks and strokes. It is …

FDA Drug Safety Communication: Revised dose limitation for Zocor (simvastatin) when taken with amiodarone

… the public that it has revised the dose limitation for the cholesterol-lowering drug simvastatin from 10 mg to 20 mg … the public that it has revised the dose limitation for the cholesterol-lowering drug simvastatin from 10 mg to 20 mg …

FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury

… injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor* (simvastatin) 80 mg, … Chinese descent should not receive simvastatin 80 mg with cholesterol-modifying doses of niacin-containing products. … treated with simvastatin 40 mg or less in combination with cholesterol-modifying doses of niacin-containing products. …

Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk

… oleic acid (at least 70 percent per serving) and improved cholesterol levels, which indicates a reduced risk for … saturated fat experienced a modest lowering in their total cholesterol and heart-damaging low-density lipoprotein (LDL) cholesterol levels compared to those who ate a more …

Drug Trial Snapshot: EVKEEZA

… in people older than 12 years of age with a type of high cholesterol called homozygous familial hypercholesterolemia … who received EVKEEZA had a 49% reduction in LDL cholesterol compared to participants who received placebo … efficacy)? The table below summarizes changes in LDL cholesterol at week 24 for EVKEEZA compared with placebo. …

Health Claim Notification for Whole Grain Foods with Moderate Fat Content

… foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease." The … explained by the usually low saturated fatty acid and cholesterol content of such diets. Such diets are also low in … types of fatty acids, is not associated with high blood cholesterol levels and coronary heart disease. A reduction in …

Public Notification: Cholestene contains hidden drug ingredient

… or use Cholestene, a product promoted and sold for cholesterol management on various websites and possibly in … drug Mevacor, used to treat patients with high blood cholesterol levels. FDA approval of Mevacor is restricted to … or use Cholestene, a product promoted and sold for cholesterol management on various websites and possibly in …

Public Notification: Tawon Liar contains hidden drug ingredient

… the immune system, increasing energy, and lowering cholesterol on various websites, including … the immune system, increasing energy, and lowering cholesterol on various websites, including www.etsy.com , and … the immune system, increasing energy, and lowering cholesterol on various websites, including www.etsy.com, and …

Public Notification: CholesLo contains hidden drug ingredient

… or use CholesLo, a product promoted and sold for lowering cholesterol on various websites, including www.choleslo.com , … or use CholesLo, a product promoted and sold for lowering cholesterol on various websites, including www.choleslo.com, …