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April 2013 Briefing - Pharmacy

Here are what the editors at HealthDay consider to be the most important developments in Pharmacy for April 2013. This roundup includes the latest research news from journal articles, as well as the FDA approvals and regulatory changes that are the most likely to affect clinical practice.

FDA Approves Kcentra to Reverse Anticoagulation

TUESDAY, April 30 (HealthDay News) -- Kcentra (prothrombin complex concentrate, human) has been approved by the U.S. Food and Drug Administration to treat severe acute bleeding in adults after administration of warfarin and similar products.

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FDA Concerned Caffeinated Foods Could Harm Children

TUESDAY, April 30 (HealthDay News) -- On the heels of the introduction of a new chewing gum containing as much caffeine as half a cup of coffee, the U.S. Food and Drug Administration is taking a closer look at the impact of caffeinated products on children's health.

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Non-Inferior Response With Two-Dose HPV Vaccine

TUESDAY, April 30 (HealthDay News) -- For girls receiving two versus three doses of human papillomavirus (HPV) vaccine, antibody responses to HPV-16 and HPV-18 are non-inferior one month after the last dose, according to a study published in the May 1 issue of the Journal of the American Medical Association, a theme issue on child health.

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Virological Failure Up With Nevirapine in HIV-Infected Youth

TUESDAY, April 30 (HealthDay News) -- For children with HIV infection in Botswana, treatment with nevirapine is associated with increased rates of virological failure compared with efavirenz, according to a study published in the May 1 issue of the Journal of the American Medical Association, a theme issue on child health.

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Multicenter Study Links Peri-Op SSRI Use to Adverse Outcomes

TUESDAY, April 30 (HealthDay News) -- Perioperative use of selective serotonin reuptake inhibitors (SSRIs) is associated with adverse outcomes, including in-hospital mortality, bleeding, and 30-day readmission, according to a multicenter study published online April 29 in JAMA Internal Medicine.

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Novel System Proposed for Accountable Cancer Care

TUESDAY, April 30 (HealthDay News) -- A novel structural and payment-reform system is proposed to foster accountable cancer care, according to a viewpoint piece published online April 29 in JAMA Internal Medicine.

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Renewed Efforts From AAFP to Repeal OTC Provision in ACA

TUESDAY, April 30 (HealthDay News) -- Members of the American Academy of Family Physicians (AAFP) and other medical associations are urging further consideration of Section 9003 of the Patient Protection and Affordable Care Act (ACA) that requires holders of tax-preferred health care accounts to obtain a physician's prescription to use funds from those accounts to pay for over-the-counter (OTC) medications. The concerns have been laid out in a letter to the chair and the ranking member of the House Committee on Ways and Means.

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Comprehensive Analysis Supports SERMs for Cutting Breast Cancer

TUESDAY, April 30 (HealthDay News) -- Treatment with selective estrogen receptor modulators (SERMs) is associated with a significant reduction in the incidence of breast cancer, especially for the first five years after treatment, according to research described as the first comprehensive analysis, published online April 30 in The Lancet.

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High Doses of Saw Palmetto Appear Safe Over 18 Months

MONDAY, April 29 (HealthDay News) -- Extracts of saw palmetto berry used at doses of up to 960 mg daily appear to be safe over an 18-month period, according to a study published in the April issue of The Journal of Urology.

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Rx for High-Risk Meds Varies Widely in Medicare Advantage

MONDAY, April 29 (HealthDay News) -- There is wide variation in the prescription rates of high-risk medications (HRM) among Medicare Advantage (MA) enrollees, according to a study published in the April issue of the Journal of General Internal Medicine.

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FDA Announces New Network to Focus Exclusively on Patients

MONDAY, April 29 (HealthDay News) -- The U.S. Food and Drug Administration has announced the launch of a new interactive tool for educating patients, their advocates, and consumers about the processes involved in medication development.

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FDA: Purveyors of Phony Botox Targeting U.S. Practices

MONDAY, April 29 (HealthDay News) -- Medical practices that purchase Botox may unwittingly be purchasing a fraudulent product not approved by the U.S. Food and Drug Administration for sale in the United States, according to an April 26 drug safety alert issued by the agency.

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Med Errors Common Among Pediatric Cancer Outpatients

MONDAY, April 29 (HealthDay News) -- Among pediatric cancer patients who receive medications at home, errors are common, with a rate of 3.6 errors with injury per 100 patients, according to a study published online April 29 in Pediatrics.

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Zoledronic Acid Linked to Early Increase in Sclerostin Levels

MONDAY, April 29 (HealthDay News) -- Women with postmenopausal osteoporosis treated with zoledronic acid show an early increase in serum levels of the negative regulator of bone formation, sclerostin, that return close to baseline after 360 days, according to a study published online April 17 in the Journal of Clinical Endocrinology & Metabolism.

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Medical Interns Spending Less Time With Patients

FRIDAY, April 26 (HealthDay News) -- Medical interns are spending less time with patients and more time at a computer since new rules limiting total work hours were instituted in 2011, according to a study published online April 18 in the Journal of General Internal Medicine.

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L-Carnitine Found to Improve Heart Attack Outcomes

FRIDAY, April 26 (HealthDay News) -- L-carnitine significantly improves patient outcomes following heart attack, according to a review published online April 17 in the Mayo Clinic Proceedings.

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Saturday Marks Sixth Annual Rx Drug Take-Back Day

FRIDAY, April 26 (HealthDay News) -- United States residents across the nation will have an opportunity to safely and anonymously unload expired, unwanted prescription medications on Saturday, April 27, during the sixth annual National Prescription Drug Take-Back Day.

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Report Updates Impact of Hypoglycemia in Diabetes

FRIDAY, April 26 (HealthDay News) -- An update of the current state of knowledge about the impact of hypoglycemia on patients with diabetes reviews outcomes, strategies to prevent hypoglycemia, and current knowledge gaps, and has been published in the May issue of Diabetes Care.

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Review: All Approved Drugs Similarly Prevent Migraines

THURSDAY, April 25 (HealthDay News) -- There is no significant difference in effectiveness in approved drugs for preventing episodic migraine frequency by 50 percent or more, according to a review published in the April issue of the Journal of General Internal Medicine.

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Analgesics in Endurance Events Can Have Serious Adverse Effects

THURSDAY, April 25 (HealthDay News) -- Analgesic use before endurance sports can cause serious medical events, according to a study published online April 19 in BMJ Open.

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Physicians Less Empathetic in Talking to Heavy Patients

THURSDAY, April 25 (HealthDay News) -- Primary care physicians (PCPs) are less likely to bond with overweight and obese patients, according to research published online March 20 in Obesity.

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One 12-Ounce Sweet Drink a Day Ups Risk of T2DM 22 Percent

THURSDAY, April 25 (HealthDay News) -- Consumption of sweetened soft drinks correlates with the incidence of type 2 diabetes in European adults, with one 12-ounce daily increase in sweetened soft drinks correlating with a 22 percent increase in risk of the disease, according to a study published online April 25 in Diabetologia.

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Prevalence, Costs of Heart Failure Estimated for 2030

THURSDAY, April 25 (HealthDay News) -- The impact of heart failure is likely to increase, with more than eight million U.S. adults anticipated to have heart failure by 2030, at an estimated total cost of $70 billion, according to a study published online April 24 in Circulation: Heart Failure.

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Fumarate Linked to Progressive Multifocal Encephalopathy

WEDNESDAY, April 24 (HealthDay News) -- Fumaric acid or fumarate-induced lymphopenia may contribute to the development of progressive multifocal encephalopathy (PML), according to two letters published in the April 25 issue of the New England Journal of Medicine.

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Diabetes Target Achievement Up From 1999 to 2010, More Needed

WEDNESDAY, April 24 (HealthDay News) -- For U.S. adults with diabetes there has been an improvement in achievement of targets from 1999 to 2010, but many still do not meet the recommended goals, according to research published in the April 25 issue of the New England Journal of Medicine.

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Diagnostic Errors Are the Leading Type of Malpractice Claim

WEDNESDAY, April 24 (HealthDay News) -- In the past 25 years, diagnostic errors have been the leading type of malpractice claim and account for the highest proportion of total payments, according to a study published online April 22 in BMJ Quality & Safety.

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Peri-Noncardiac Op Exposure to β-Blockers Improves Outcome

TUESDAY, April 23 (HealthDay News) -- For patients undergoing major noncardiac surgery with two or more Revised Cardiac Risk Index factors, early exposure to β-blockers is associated with improved 30-day postoperative outcome, according to research published in the April 24 issue of the Journal of the American Medical Association.

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>40 Percent of Parents Give Cough Meds to Young Children

TUESDAY, April 23 (HealthDay News) -- More than 40 percent of parents with children younger than 4 years of age give them cough medicine or multi-symptom cough and cold medicine, despite warning labels that products should not be used for young children, according to a report published by the C.S. Mott Children's Hospital.

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Maternal Use of Valproate Ups Risk of Autism in Offspring

TUESDAY, April 23 (HealthDay News) -- Prenatal exposure to valproate correlates with an increased risk of autism spectrum disorder and childhood autism in offspring, according to a study published in the April 24 issue of the Journal of the American Medical Association.

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Drop in Genital Warts in Young Women Since HPV Vaccination

TUESDAY, April 23 (HealthDay News) -- For Australian women aged 30 years or younger there has been a decrease in the proportion found to have genital warts following the introduction of the human papillomavirus (HPV) vaccine program, according to research published online April 18 in BMJ.

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Severe Cutaneous Adverse Rxns Up in Allopurinol Initiators

TUESDAY, April 23 (HealthDay News) -- Allopurinol initiators have an almost 10-fold increased risk of severe cutaneous adverse reactions (SCARs) compared with nonusers, according to a study published in the April issue of Arthritis Care & Research.

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Sofosbuvir Shows Promise for Chronic Hepatitis C Infection

TUESDAY, April 23 (HealthDay News) -- Sofosbuvir seems to be a promising treatment option for patients with chronic hepatitis C virus (HCV) infection, according to two studies published online April 23 in the New England Journal of Medicine to coincide with presentation at The International Liver Congress, the annual meeting of the European Association for the Study of the Liver, held from April 24 to 28 in Amsterdam.

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Breast Density Linked to Breast Cancer-Specific Survival

TUESDAY, April 23 (HealthDay News) -- For women with breast cancer receiving adjuvant tamoxifen treatment, a decrease in mammographic density appears to be associated with improved breast cancer-specific survival, according to a study published online April 22 in the Journal of Clinical Oncology.

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Parental Permissiveness Linked to Rx Drug Abuse, Misuse

TUESDAY, April 23 (HealthDay News) -- Nearly one-quarter of teenagers misuse or abuse a prescription drug at least once in their lifetime, with perceived parental permissiveness linked to misuse and abuse of prescription drugs as well as use of alcohol and marijuana, according to a report published online April 23 by The Partnership at Drugfree.org.

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FDA Approves Updated Label for Reformulated OxyContin

FRIDAY, April 19 (HealthDay News) -- The U.S. Food and Drug Administration has approved updated labeling for Purdue Pharma L.P.'s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets, which will indicate that the reformulated product has physical and chemical properties that should make abuse by injection very difficult and reduce intranasal abuse.

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Patient-Centered Decision Making Ups Health Outcomes

FRIDAY, April 19 (HealthDay News) -- Patient-centered decision making (PCDM) is associated with improved health care outcomes, according to a study published in the April 16 issue of the Annals of Internal Medicine.

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Pot Smoking Linked to Some Metabolic Changes

FRIDAY, April 19 (HealthDay News) -- Regularly smoking pot is associated with visceral adiposity and adipose tissue insulin resistance, but not other metabolic changes such as impaired β-cell function or hepatic steatosis, according to a study published online March 25 in Diabetes Care.

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Family-Centered Teaching Rounds Good for Patients, Students

THURSDAY, April 18 (HealthDay News) -- Teaching and conducting rounds in the presence of patients and their families can be beneficial for patients and learners, according to research published online April 15 in Pediatrics.

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Patient Expresses Concern About Lack of Data on Biological Drugs

THURSDAY, April 18 (HealthDay News) -- A patient with Crohn's disease is concerned about the attempt by the makers of adalimumab to prevent disclosure of trial data submitted during the drug's approval process, according to a personal view piece published online April 16 in BMJ.

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Relative Proportion of MRSA Increasing in S. aureus Isolates

THURSDAY, April 18 (HealthDay News) -- The relative proportion of methicillin-resistant Staphylococcus aureus (MRSA) is increasing in S. aureus isolates, and methicillin-sensitive S. aureus (MSSA) is becoming increasingly resistant to antibiotics, according to a study published in the April issue of JAMA Dermatology.

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Glutamine, Antioxidants No Benefit to Critically Ill Patients

WEDNESDAY, April 17 (HealthDay News) -- For critically ill patients with multiorgan failure, early supplementation with glutamine or antioxidants does not improve clinical outcomes, according to a study published in the April 18 issue of the New England Journal of Medicine.

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Community Benefit Spending Varies for Tax-Exempt Hospitals

WEDNESDAY, April 17 (HealthDay News) -- There is considerable variation in the level of community benefit expenditure by tax-exempt hospitals, according to a study published in the April 18 issue of the New England Journal of Medicine.

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Induced Abortion Rate Lower With Methotrexate Tx in RA

WEDNESDAY, April 17 (HealthDay News) -- For women with rheumatoid arthritis (RA), exposure to methotrexate is associated with a reduced risk of induced abortions, according to a study published online April 16 in Arthritis Care & Research.

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Endocrine Therapy Often Incomplete after Breast Cancer

TUESDAY, April 16 (HealthDay News) -- About 25 percent of women with breast cancer either never initiate adjuvant endocrine treatment or stop treatment prematurely, according to a study published in the March issue of Breast Cancer Research and Treatment.

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USPSTF: Offer Preventive Meds to Women at Risk of Breast Cancer

TUESDAY, April 16 (HealthDay News) -- The U.S. Preventive Services Task Force recommends that women who are at increased risk of primary breast cancer consider taking preventive medications such as tamoxifen. This Recommendation Statement is based on an evidence review published in the April 16 issue of the Annals of Internal Medicine.

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Risk of New-Onset Diabetes Varies With Different Statins

THURSDAY, April 11 (HealthDay News) -- Different types and doses of statins seem to correlate with distinct risks of developing new-onset diabetes mellitus (DM), according to a meta-analysis published in the April 15 issue of The American Journal of Cardiology.

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FDA Warns Consumers of Dangers of the Stimulant DMAA

MONDAY, April 15 (HealthDay News) -- The U.S. Food and Drug Administration is attempting to halt distribution of dietary supplements that contain the stimulant dimethylamylamine (DMAA), following reports of illness and death associated with these supplements.

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Quality Improvement Methods Up Appropriate Antibiotic Rx

MONDAY, April 15 (HealthDay News) -- Quality improvement (QI) methods can be used to rapidly implement national guidelines relating to appropriate first-line antibiotic therapy for children aged 3 months or older with community-acquired pneumonia (CAP), according to a study published online April 15 in Pediatrics.

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Topical Anesthetics Effective for Premature Ejaculation

FRIDAY, April 12 (HealthDay News) -- Topical anesthetic agents seem to be effective and are generally well tolerated for patients with premature ejaculation (PE), according to a review published in the April issue of Urology.

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Drug-Facilitated Weight Loss Benefits Cardiometabolic Status

FRIDAY, April 12 (HealthDay News) -- Obese and overweight patients with dyslipidemia or hypertension treated with phentermine and topiramate extended-release (PHEN/TPM ER) for weight loss had significant improvements in cardiovascular disease risk factors, according to research published in the April 15 issue of The American Journal of Cardiology.

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Topical Treatment Effective for Toenail Fungal Infection

FRIDAY, April 12 (HealthDay News) -- Once daily topical efinaconazole is effective in treating fungal infections of the toenail, according to a study published in the April issue of the Journal of the American Academy of Dermatology.

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Cardiac Function Unaffected by Prior Intensive Insulin Therapy

FRIDAY, April 12 (HealthDay News) -- There was no effect of intensive versus conventional insulin therapy during the Diabetes Control and Complications Trial (DCCT) on cardiac parameters as assessed by cardiac magnetic resonance (CMR) in the Epidemiology of Diabetes Interventions and Complications (EDIC) cohort (follow-up to the DCCT), but prior glycemic exposure had an impact on cardiac parameters, according to research published online March 21 in Diabetes.

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Speech Details Practices to Improve U.S. Health Systems

THURSDAY, April 11 (HealthDay News) -- There are specific steps health care providers and policymakers should take to create high-quality, patient-centered care at lower costs, according to remarks made in an April 9 speech to the National Press Club.

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Fish Oil Has No Effect on Depression in Pregnancy

THURSDAY, April 11 (HealthDay News) -- Fish oil supplements do not prevent depression in late pregnancy and postpartum in women at risk of depression, according to a study in the April issue of the American Journal of Obstetrics & Gynecology.

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Sales Representatives Provide Inadequate Safety Information

THURSDAY, April 11 (HealthDay News) -- Pharmaceutical sales representatives (PSRs) rarely inform primary care physicians about drug safety information during sales visits, according to research published online April 10 in the Journal of General Internal Medicine.

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Adherence Is Generally High to Tobacco Control Act Provisions

THURSDAY, April 11 (HealthDay News) -- Tobacco retailers are generally adherent to all provisions of the Tobacco Control Act, according to a study published in April issue of the U.S. Centers for Disease Control and Prevention's Preventing Chronic Disease.

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Variation Seen in U.S. Antibiotic Prescription Rates

WEDNESDAY, April 10 (HealthDay News) -- U.S. outpatient antibiotic prescribing in 2010 varied with patient age, geographically, and according to provider specialty, according to a letter published in the April 11 issue of the New England Journal of Medicine.

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Diclegis Approved for Nausea/Vomiting in Pregnancy

TUESDAY, April 9 (HealthDay News) -- Diclegis (doxylamine succinate and pyridoxine hydrochloride) has been approved by the U.S. Food and Drug Administration to treat nausea and vomiting during pregnancy.

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Patients Using Different Rx Strategies to Save Money

TUESDAY, April 9 (HealthDay News) -- Adults in the U.S. who are poor or uninsured are more likely to ask for lower-cost alternatives or not to take their prescribed medications, according to research published in the April NCHS Data Brief.

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NYC Health Department, ER Docs Clash Over Opioid Guidelines

TUESDAY, April 9 (HealthDay News) -- There is uncertainty as to whether the New York City Emergency Department Discharge Opioid Prescribing Guidelines will aid emergency physicians as they weigh the complex decisions of relieving patient pain while working to ensure patient safety, according to opposing viewpoints published online April 8 in the Annals of Internal Medicine.

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AAN Issues Guidelines for Tapeworm Ix on Rise in U.S.

TUESDAY, April 9 (HealthDay News) -- Adults and children with intraparenchymal neurocysticercosis, a tapeworm infection causing seizures most commonly in developing countries of Africa, Asia, and Latin America, should be treated with albendazole plus either dexamethasone or prednisolone, according to guidelines published online April 8 in Neurology.

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Amiodarone Treatment Is Linked to Higher Cancer Risk

MONDAY, April 8 (HealthDay News) -- Amiodarone treatment for arrhythmias is associated with a higher risk of developing cancer, particularly in males and with increasing dose, according to a study published online April 8 in Cancer.

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Majority of Americans Now Favor Legalizing Marijuana

MONDAY, April 8 (HealthDay News) -- A majority of Americans (52 percent) now favor legalizing marijuana, and 72 percent feel that the government efforts to enforce marijuana laws are not worth their cost, according to research published by the Pew Research Center.

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Resveratrol Has No Effect in Healthy Obese Men, Study Finds

MONDAY, April 8 (HealthDay News) -- Resveratrol appears not to have a metabolic effect in obese men, according to a study published in the April issue of Diabetes.

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Growth Hormone Ups Height in Pediatric Dialysis Patients

FRIDAY, April 5 (HealthDay News) -- For pediatric dialysis patients, growth hormone (GH) therapy is associated with an increased rate of bone formation and results in greater increases in height, according to research published online April 4 in the Clinical Journal of the American Society of Nephrology.

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Federal Judge Rules FDA Must Lift Restrictions on Plan B

FRIDAY, April 5 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) must lift any age and sale restrictions on Plan B One-Step and its generic versions within 30 days, a federal judge ruled today.

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Statins Show Protective Effect Against Acute Kidney Injury

FRIDAY, April 5 (HealthDay News) --Initiating a statin prior to coronary artery bypass grafting (CABG) surgery may modestly reduce the risk of acute kidney injury (AKI) post-CABG, especially in patients less than 65 years old, according to research published March 15 in The American Journal of Cardiology.

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Prevalence of Self-Reported Hypertension Rises in U.S.

THURSDAY, April 4 (HealthDay News) -- The prevalence of self-reported hypertension among U.S. adults increased slightly, but significantly from 2005 to 2009, and the proportion of adults using anti-hypertensive medications also increased, according to research published April 4 in Morbidity and Mortality Weekly.

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Glucocorticoids Are Tied to Increased Risk of Clots

THURSDAY, April 4 (HealthDay News) -- Glucocorticoid users face an increased risk of venous thromboembolism (VTE), according to a study published online April 1 in JAMA Internal Medicine.

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CMS Announces Final Rates for Medicare Drug, Health Plans

THURSDAY, April 4 (HealthDay News) -- The Centers for Medicare & Medicaid Services (CMS) has issued the 2014 rate announcement and final call letter for Medicare Advantage and prescription drug benefit Part D programs.

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Patients Taken Off Statins Can Be Re-Challenged With Success

TUESDAY, April 2 (HealthDay News) -- Most patients who reported statin-related clinical events that resulted in statins being discontinued can often be re-challenged, and they can often tolerate the same or different statins long-term, according to research published in the April 2 issue of the Annals of Internal Medicine.

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FDA Allows Change to Nicotine Replacement Therapy Labels

TUESDAY, April 2 (HealthDay News) -- The U.S. Food and Drug Administration will allow companies which manufacture over the counter nicotine replacement therapies to update labels allowing longer use and more flexible conditions of use.

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New Drug Approved for Type 2 Diabetes

MONDAY, April 1 (HealthDay News) -- Invokana (canaglifozin) has been approved by the U.S. Food and Drug Administration to treat type 2 diabetes, which affects about 24 million Americans.

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Physician's Briefing