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PCSK9 Drugs Upgraded in Lipid Recs
(MedPage Today) -- PCSK9 inhibitors no longer behind ezetimibe (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - September 5, 2017 Category: Geriatrics Source Type: news

For Most Patients, Maximize Oral Lipid Therapy and Skip PCSK9s For Most Patients, Maximize Oral Lipid Therapy and Skip PCSK9s
A simulation study shows that for 86% of patients who require cholesterol lowering, statins and ezetimibe are sufficient, while the remaining 14% will need add-on PCSK9 inhibitors to reach target LDL levels.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 14, 2017 Category: Consumer Health News Tags: Cardiology News Source Type: news

Forget PCSK9 Drugs? Almost All Could Reach Target LDL With Oral Agents (CME/CE)
Debate is done (MedPage Today) -- focus on intense statin and ezetimibe use, groups argue (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - August 3, 2017 Category: Cardiology Source Type: news

High-fat diet leads to same intestinal inflammation as a virus
FINDINGSA new study by scientists at UCLA found that when mice eat a high-fat diet, the cells in their small intestines respond the same way they do to a viral infection, turning up production of certain immune molecules and causing inflammation throughout the body. The scientists also found that feeding the mice tomatoes containing a protein similar to that in HDL, or “good cholesterol,” along with the generic cholesterol drug Ezetimibe, reversed the inflammation.The results could lead to new types of drugs, targeting the intestinal cells, to reduce people ’s risk of heart attacks and strokes, or to trea...
Source: UCLA Newsroom: Health Sciences - June 21, 2017 Category: Universities & Medical Training Source Type: news

Sun Pharma receives USFDA nod for anti-cholesterol drug
"As per IMS, ezetimibe tablets had annual sales of approximately USD 2.7 billion in the US for the 12 months ended April 2017," it added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 13, 2017 Category: Pharmaceuticals Source Type: news

Zydus Cadila gets USFDA nod for ezetimibe tablets
The group now has around 115 approvals from USFDA and has so far filed 300 abbreviated new drug applications (ANDAs), the company said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 13, 2017 Category: Pharmaceuticals Source Type: news

Teva launches generic version of Merck cholesterol-lowering medicine
Teva Pharmaceutical Industries Ltd. said Monday it has launched a generic version of the cholesterol lowering medication Zetia. Zetia, which contains the active ingredient ezetimibe, is a prescription medicine made by Merck (NYSE: MRK) used to lower levels of total cholesterol and low-density lipoprotein (LDL) cholesterol in the blood. Ezetimibe tablets are for patients who cannot control their cholesterol levels by diet a nd exercise alone. Teva said the product can be used by itself or with other… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 12, 2017 Category: Biotechnology Authors: John George Source Type: news

Teva launches generic version of Merck cholesterol-lowering medicine
Teva Pharmaceutical Industries Ltd. said Monday it has launched a generic version of the cholesterol lowering medication Zetia. Zetia, which contains the active ingredient ezetimibe, is a prescription medicine made by Merck (NYSE: MRK) used to lower levels of total cholesterol and low-density lipoprotein (LDL) cholesterol in the blood. Ezetimibe tablets are for patients who cannot control their cholesterol levels by diet a nd exercise alone. Teva said the product can be used by itself or with other… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - June 12, 2017 Category: American Health Authors: John George Source Type: news

Generic Vytorin to Hit U.S. Market (FREE)
By the Editors Clinicians may soon be able to prescribe generic Vytorin (ezetimibe/simvastatin) … (Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - April 28, 2017 Category: Primary Care Source Type: news

Dr Reddy's launches cholesterol lowering drug in US
The company has launched Ezetimibe and Simvastatin tablets in the strengths of 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg in the US market. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - April 27, 2017 Category: Pharmaceuticals Source Type: news

Impax Announces FDA Approval and Launch of a Generic Version of Vytorin(R) (Ezetimibe/Simvastatin Tablets)
HAYWARD, Calif., April 26, 2017 -- (Healthcare Sales & Marketing Network) -- Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug Administration (FDA) approval for a generic ... Biopharmaceuticals, Generics, FDA, Product Launch Impax Laboratories, Vytorin, ezetimibe, simvastatin (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 26, 2017 Category: Pharmaceuticals Source Type: news

Vytorin (Ezetimibe and Simvastatin) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 3, 2017 Category: Drugs & Pharmacology Source Type: news

CardioBreak: Heart'Hugger'; Watchman Without Warfarin; U.K. Rationing for Zetia?
(MedPage Today) -- Recent developments of interest in cardiovascular medicine (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - January 23, 2017 Category: Psychiatry Source Type: news

Endo unit launches generic version of Merck blockbuster
An Endo International operating company this week launched the first generic version Merck ’s multibillion-dollar, cholesterol-lowering medicine Zetia. North Jersey-based Par Pharmaceuticals, which Endo (NASDAQ: ENDP) acquired last year for $8 billion, is the marketer and distributor of the product in the United States. Endo, based in Dublin, Ireland, has its U.S. headquarters in Malve rn. Endo eliminates 375 sales jobs According to data from IMS Health, U.S. sales of Zetia were about $2.6 billion… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - December 14, 2016 Category: American Health Authors: John George Source Type: news

India Launches First Generic of Merck's Zetia in U.S.
India's Glenmark Pharmaceuticals has launched the first and only generic version of Zetia -- Merck's cholesterol drug -- in the U.S. market. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - December 13, 2016 Category: Pharmaceuticals Source Type: news

Glenmark launches generic version of Zetia in US market
"We have launched ezetimibe, the first and only generic version of Zetia (Merck) in the United States for the treatment of high cholesterol," (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 12, 2016 Category: Pharmaceuticals Source Type: news

Liptruzet (Ezetimibe and Atorvastatin Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 9, 2016 Category: Drugs & Pharmacology Source Type: news

Zetia (Ezetimibe Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 12, 2016 Category: Drugs & Pharmacology Source Type: news

Farewell to the fasting cholesterol test?
At a recent meeting I offered a visitor lunch which she declined with obvious regret. She was hungry, and it was noon. But she was headed to her annual physical, and eating beforehand would mean returning another morning for a fasting cholesterol level. Most of us can relate to her annoyance, but thankfully this may soon be a thing of the past. Doctors have traditionally ordered cholesterol tests to be drawn after an overnight fast. But this requirement causes a significant burden on both sides of the health care equation. Most people hate to fast. Skipping meals is particularly difficult for active people, people with dia...
Source: New Harvard Health Information - June 16, 2016 Category: Consumer Health News Authors: Naomi D. L. Fisher, MD Tags: Health Heart Health Prevention Screening Tests and procedures Source Type: news

Merck posts better-than-expected profit, raises forecast
(Reuters) - Merck & Co Inc reported better-than-expected profit in the first quarter, driven by higher sales of its diabetes drug Januvia and heart drug Zetia. (Source: Reuters: Health)
Source: Reuters: Health - May 5, 2016 Category: Consumer Health News Tags: healthNews Source Type: news

New drug 'effective' for those with intolerable statin side effects
Conclusion The main results of this study relate to the lipid-lowering effects of two alternative non-statin medications. However, it highlights the muscle-related adverse effects that can occur with statins. The study is carefully designed and has many strengths, including: a washout period between drugs to remove any residual effects double-blind design throughout so people didn't know what they were taking sufficient duration for each phase of the study (10 and 24 weeks) to allow effects to develop a good sample size – the researchers calculated beforehand how many people would need to be recruited to...
Source: NHS News Feed - April 4, 2016 Category: Consumer Health News Tags: Heart/lungs Medication Older people Source Type: news

Trial offers objective evidence of muscle-related side effects with statins
The first major clinical trial to include a blinded, placebo-controlled “statin re-challenge” in patients with a history of muscle-related side effects sheds new light on statin-associated muscle symptoms, according to new research. The trial also demonstrates that monthly self-injection of the relatively new non-statin cholesterol-lowering drug evolocumab reduces levels of low-density lipoprotein, or LDL, cholesterol to a greater extent than ezetimibe, a traditional drug used in statin-intolerant patients. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - April 4, 2016 Category: Science Source Type: news

Some People Really Can't Take Statins For High Cholesterol, Scientists Prove
You can't write a story about the lifesaving benefits of the cholesterol-lowering drugs called statins without getting comments like this one, from reader Bill Hayman, on my story yesterday: I cannot take Crestor or Zetia or any form of statin drug! I can barely walk with any statin drug. My legs become painful and so weak, they feel like rubber. Several years ago, I used Lipitor and had four pancreatic attacks until I stopped the Lipitor. Or this, from reader James Leedy: People should be warned of side effects. Doctors should listen to patients . I have taken statins for several years. I had extreme muscle pains all t...
Source: Forbes.com Healthcare News - April 3, 2016 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news

Positive Efficacy And Tolerability Study Of Repatha® (evolocumab) In Statin-Intolerant Patients Published In "Journal of the American Medical Association"
Data Simultaneously Presented in Late-Breaking Session at ACC.16 Repatha Compared to Ezetimibe Resulted in Significantly Greater Reduction in LDL-C THOUSAND OAKS, Calif., April 3, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new detailed data from the Phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) trial evaluating Repatha® (evolocumab) in patients with high cholesterol who cannot tolerate statins. The study showed that in patients with reproducible statin intolerance due to muscle-related side effects (MRSE), the use of Repatha compared to ez...
Source: Amgen News Release - April 3, 2016 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Positive Efficacy And Tolerability Study Of Repatha® (evolocumab) In Statin-Intolerant Patients Published In Journal of the American Medical Association
Data Simultaneously Presented in Late-Breaking Session at ACC.16 Repatha Compared to Ezetimibe Resulted in Significantly Greater Reduction in LDL-C THOUSAND OAKS, Calif., April 3, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new detailed data from the Phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) trial evaluating Repatha® (evolocumab) in patients with high cholesterol who cannot tolerate statins. The study showed that in patients with reproducible statin intolerance due to muscle-related side effects (MRSE), the use of Repatha compared to ez...
Source: Amgen News Release - April 3, 2016 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Statin intolerance objectively identified in patients
(Cleveland Clinic) In the first major trial of its kind, Cleveland Clinic researchers used a blinded rechallenge with atorvastatin or placebo to objectively confirm the presence of muscle-related symptoms in patients with a history of intolerance to multiple statins and found that evolocumab (a PCSK9 inhibitor) was a more effective option to lower cholesterol than ezetimibe in these patients. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 3, 2016 Category: Global & Universal Source Type: news

Cholesterol lowering therapies for patients with muscle-related statin intolerance
(The JAMA Network Journals) Steven E. Nissen, M.D., of the Cleveland Clinic, and colleagues identified patients with muscle-related adverse effects from statins and compared lipid-lowering efficacy for two nonstatin therapies, ezetimibe and evolocumab. The study was published online by JAMA, and is being released to coincide with its presentation at the American College of Cardiology's 65th Annual Scientific Session & Expo. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 3, 2016 Category: Global & Universal Source Type: news

Lupus Lipids Improve With Combo Tx (CME/CE)
(MedPage Today) -- Treatment with pravastatin and ezetimibe also benefited endothelial function (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - March 12, 2016 Category: Primary Care Source Type: news

Ezetimibe/Simvastatin Post-Acute Coronary SyndromeEzetimibe/Simvastatin Post-Acute Coronary Syndrome
Can lipid-lowering therapy with ezetimibe plus simvastatin improve clinical outcomes among survivors of acute coronary syndromes? Journal of the American College of Cardiology (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - March 7, 2016 Category: Intensive Care Tags: Cardiology Journal Article Source Type: news

Muscle problems caused by statins: Can a genetic test reveal your risk?
In the United States, more than 40% of people ages 60 and older take a cholesterol-lowering statin to reduce their risk of a heart attack. But up to half of people who are prescribed these drugs quit taking them because they experience what they believe to be statin-related side effects — most often muscle pain. Others avoid statins altogether because of that worry. That’s why many people might be curious about a mail-order genetic test called StatinSmart, which bills itself as the first test to identify a person’s risk of experiencing muscle pain from a statin. But here’s the rub: muscle problems c...
Source: New Harvard Health Information - March 3, 2016 Category: Consumer Health News Authors: Julie Corliss Tags: Drugs and Supplements Genes Health Heart Health muscles statins Source Type: news

D.C. Week: FDA Turns Down New Indication for Ezetimibe
(MedPage Today) -- And, CMS releases core clinical quality measures (Source: MedPage Today Allergy)
Source: MedPage Today Allergy - February 20, 2016 Category: Allergy & Immunology Source Type: news

CardioBrief: FDA Turns Down Expanded Indication for Ezetimibe
(MedPage Today) -- Follows advisory committee vote in December (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - February 16, 2016 Category: Cardiology Source Type: news

US FDA refuses to approve Merck's Zetia and Vytorin medicines
The US Food and Drug Administration (FDA) has refused to approve Zetia and Vytorin, Merck's medicines that are used to reduce the risk of cardiovascular events in patients with coronary heart disease. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - February 16, 2016 Category: Pharmaceuticals Source Type: news

Merck Receives Complete Response Letter from the U.S. FDA for ZETIA® (ezetimibe) and VYTORIN® (ezetimibe and simvastatin)
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck's Supplemental New Drug Applications for ZETIA® and VYTORIN® for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease. Language: ...
Source: Merck.com - Product News - February 15, 2016 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news

Merck Receives Complete Response Letter from the U.S. FDA for ZETIA ® (ezetimibe) and VYTORIN® (ezetimibe and simvastatin)
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck's Supplemental New Drug Applications for ZETIA ® and VYTORIN® for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease. Language: Englis...
Source: Merck.com - Product News - February 15, 2016 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news

Amgen on GAUSS-3: Evolocumab Meets LDL-Based Primary End PointsAmgen on GAUSS-3: Evolocumab Meets LDL-Based Primary End Points
Teasing with top-line results, the company says the PCSK9 inhibitor dropped LDL-C vs ezetimibe at 24 weeks in patients intolerant of statins, similar to what was shown in the 12-week GAUSS-2 trial. Heartwire from Medscape (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 5, 2016 Category: Consumer Health News Tags: Cardiology News Source Type: news

Amgen Announces Positive Top-Line Results From Phase 3 GAUSS-3 Trial Of Repatha® (Evolocumab) In Statin-Intolerant Patients With High Cholesterol
Study Meets Co-Primary Endpoints of LDL Cholesterol Reduction THOUSAND OAKS, Calif., Feb. 4, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) trial evaluating Repatha® (evolocumab) in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints: mean percent reductions from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 22 and 24, and the percent reduction from baseline in LDL-C at week 24. The mean percent reductions in LDL-C, or "bad&quo...
Source: Amgen News Release - February 4, 2016 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Impax Receives Tentative FDA Approval for Generic Version of Vytorin(R) (ezetimibe and simvastatin) Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg
HAYWARD, Calif., Feb. 2, 2016 -- (Healthcare Sales & Marketing Network) -- Impax Laboratories, Inc. (IPXL) today announced that Impax has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application... Biopharmaceuticals, Generic, FDAImpax Laboratories, ezetimibe, simvastatin, Vytorin (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 2, 2016 Category: Pharmaceuticals Source Type: news

Patent Expirations Of Crestor And Zetia And The Impact On Other Cholesterol Drugs
But the availability of the generic forms of these drugs will also have an impact on physician prescribing habits and even drugs not yet on the market. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 18, 2016 Category: Pharmaceuticals Authors: John LaMattina Source Type: news

ezetimibe, Zetia
Title: ezetimibe, ZetiaCategory: MedicationsCreated: 2/5/2003 12:00:00 AMLast Editorial Review: 12/22/2015 12:00:00 AM (Source: MedicineNet Cholesterol General)
Source: MedicineNet Cholesterol General - December 22, 2015 Category: Cardiology Source Type: news

Dec 18 Cardiology NewsDec 18 Cardiology News
Ezetimibe, bioresorbable stents, guideline adherence, cardiac rehab, ABIM concessions, and end-of-year reviews are covered in this week's podcast. theheart.org on Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - December 18, 2015 Category: Cardiology Tags: Cardiology News Source Type: news

CardioBrief: FDA Panel Rejects Broader Ezetimibe Indication
(MedPage Today) -- Majority finds event reduction in IMPROVE-IT too small to justify label change (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - December 15, 2015 Category: Primary Care Source Type: news

FDA Advisors: Reject Secondary-Prevention Ezetimibe IndicationFDA Advisors: Reject Secondary-Prevention Ezetimibe Indication
UPDATED // Noting that the secondary-prevention IMPROVE-IT trial's results weren't "clinically substantial," the panel also voiced concerns with hemorrhagic stroke risk and missing study data. Heartwire from Medscape (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - December 15, 2015 Category: Cardiology Tags: Cardiology News Source Type: news

Merck Statement on FDA Advisory Committee Meeting on IMPROVE-IT Study with VYTORIN® (ezetimibe and simvastatin)
Dateline City: KENILWORTH, N.J. Merck (NYSE: MRK), known as MSD outside the United States and Canada, issued today the following statement after the conclusion of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss the results of IMPROVE-IT, an investigational study comparing treatment with VYTORIN® (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes. Language: English read more (Source: Merck.com - Corporate News)
Source: Merck.com - Corporate News - December 14, 2015 Category: Pharmaceuticals Tags: Corporate News Latest News Source Type: news

FDA panel rejects Merck claim Zetia/Vytorin cut heart risk
(Reuters) - Merck & Co should not be allowed to claim that its cholesterol-lowering drugs Zetia and Vytorin reduce the risk of heart attacks and strokes in patients with coronary heart disease, an advisory committee to the U.S. Food and Drug Administration concluded on Monday. (Source: Reuters: Health)
Source: Reuters: Health - December 14, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

CardioBreak: FDA Looks at Ezetimibe, VTE Tx in Cancer
(MedPage Today) -- Recent developments of interest in cardiovascular medicine (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - December 14, 2015 Category: Geriatrics Source Type: news

FDA Takes Another Look at Ezetimibe
(MedPage Today) -- Live blog from Larry Husten (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - December 14, 2015 Category: American Health Source Type: news

CardioBrief: FDA Panel Poised to Upgrade Ezetimibe Labels?
(MedPage Today) -- Intellectual fireworks, but no real obstacles, expected at advisory meeting (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - December 11, 2015 Category: Cardiology Source Type: news

Do statins interfere with the flu vaccine?
Statins are powerful, unusual, and, like El Niño and Tom Cruise, not well understood. Statins have a huge upside. They improve survival after heart attacks and lower the risk of recurrent strokes. They are also the only cholesterol-lowering medications that have been clearly shown to reduce heart attacks and deaths in high-risk patients without heart disease. In addition to reducing cholesterol, statins also lower levels of inflammation in the body. Reducing inflammation probably helps statins to prevent heart attack and stroke. However, evidence is emerging that these statin effects may also have a downside, hinder...
Source: New Harvard Health Information - November 30, 2015 Category: Consumer Health News Authors: John Ross, MD, FIDSA Tags: Cold and Flu Drugs and Supplements Health Heart Health Vaccines flu vaccine statins Source Type: news