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FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs
… da-drug-safety-communication-important-safety-label-changes-cholesterol-lowering-statin-drugs … Facts about statins A … to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”) Marketed as single-ingredient products, …
FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
… bility/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy … en Español … 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 …
Statins: Drug Safety Communication - FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During Pregnancy
… cation-fda-requests-removal-strongest-warning-against-using-cholesterol … [Posted 07/20/2021] AUDIENCE: Patient, Health … 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; still advises most pregnant patients should stop taking statins
… dcasts/fda-requests-removal-strongest-warning-against-using-cholesterol-lowering-statins-during-pregnancy … Listen … 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 Drug Safety Communication: Interactions between certain HIV or hepatitis C drugs and cholesterol-lowering statin drugs can increase the risk of muscle injury
… n-interactions-between-certain-hiv-or-hepatitis-c-drugs-and-cholesterol … Facts about statins and protease inhibitors … to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). HIV protease inhibitors are a class of …
Cholesterol-lowering drugs get labeling changes
… /drugs/special-features/cholesterol-lowering-drugs-get-labeling-changes … By Patrick … 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 …
Cholesterol Medicines Guide
… /consumers/womens-health-topics/cholesterol-medicines-guide … Cholesterol Medicines Print and Share (PDF 2496KB) Cholesterol is a kind of fat in your blood. Your body makes …
Cholesterol
… /medical-devices/home-use-tests/cholesterol … What this test does: This is a home-use test kit to measure total cholesterol. What cholesterol is: Cholesterol is a fat (lipid) in your blood. …
Cholesterol and Statins Infographic
… /drugs/drug-safety-and-availability/cholesterol-and-statins-infographic … Click here for a … 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 …
FDA approves add-on therapy for patients with genetic form of severely high cholesterol
… da-approves-add-therapy-patients-genetic-form-severely-high-cholesterol … [4/1/2021] FDA has approved Praluent … (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 …
FDA approves add-on therapy for patients with genetic form of severely high cholesterol
… da-approves-add-therapy-patients-genetic-form-severely-high-cholesterol-0 … FDA has approved Evkeeza (evinacumab-dgnb) … (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 …
Health Claim Notification for Saturated Fat, Cholesterol, and Trans Fat, and Reduced Risk of Heart Disease
… -labeling-nutrition/health-claim-notification-saturated-fat-cholesterol-and-trans-fat-and-reduced-risk-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 …
Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease - Interim Final Rule
… tions/food-labeling-health-claims-dietary-saturated-fat-and-cholesterol-and-risk-coronary-heart-disease … The Food and … 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 …
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
… rugs/news-events-human-drugs/fda-approves-add-therapy-lower-cholesterol-among-certain-high-risk-adults … Action FDA has … 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 …
FDA approves add-on drug for ages 10 & up with rare forms of high cholesterol
… s-human-drugs/fda-approves-add-drug-ages-10-rare-forms-high-cholesterol … Action FDA has approved Repatha (evolocumab) … (HoFH). Repatha works to reduce low-density lipoprotein cholesterol (LDL-C), known colloquially as “bad cholesterol.” FDA previously approved Repatha to reduce the …
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 …
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: 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, …