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Category: Pharmacy | Monthly Briefing

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December 2012 Briefing - Pharmacy

Last Updated: January 01, 2013.

 

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Here are what the editors at HealthDay consider to be the most important developments in Pharmacy for December 2012. 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.

rhBMP-2 Linked to Increased Rate of Retrograde Ejaculation

FRIDAY, Dec. 28 (HealthDay News) -- For patients with lumbar spondylosis or spondylolisthesis of the lowest lumbar levels who undergo open anterior lumbar interbody fusion (ALIF), use of recombinant human bone morphogenetic protein-2 (rhBMP-2) is associated with an increased rate of retrograde ejaculation (RE), according to research published in the October issue of The Spine Journal.

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Indicators Show Little Change in Overuse of Ambulatory Care

THURSDAY, Dec. 27 (HealthDay News) -- In the United States from 1999 to 2009, the delivery of underused care in the ambulatory setting improved, but fewer changes were seen in inappropriate care, according to a study published online Dec. 24 in the Archives of Internal Medicine.

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Teen Vitamin D Intake Not Related to Adult RA or SLE Risk

THURSDAY, Dec. 27 (HealthDay News) -- Dietary vitamin D intake during adolescence does not appear to be associated with the risk of adult-onset rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE), according to research published in the December issue of Arthritis Care & Research.

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Understanding of Infantile Hemangiomas Is Improving

THURSDAY, Dec. 27 (HealthDay News) -- Improved understanding of the pathogenesis of infantile hemangiomas (IHs) is leading to better treatment options, according to a review published online Dec. 24 in Pediatrics.

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FDA Approves Juxtapid for Rare Cholesterol Disorder

THURSDAY, Dec. 27 (HealthDay News) -- The U.S. Food and Drug Administration has approved the orphan drug Juxtapid (lomitapide) for patients with homozygous familial hypercholesterolemia (HoFH), for use in combination with a low-fat diet and other lipid lowering treatments, according to a Dec. 26 press release.

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Impact of Drug Shortages, Including Chemo Drugs, Explored

WEDNESDAY, Dec. 26 (HealthDay News) -- A number of drugs, including chemotherapeutic agents that have been available for many years, have recently been in short supply, which may have serious consequences for patients, according to a perspective piece published in the Dec. 27 issue of the New England Journal of Medicine.

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Positive Preclinical Results for Smo Inhibitor in Esophageal CA

WEDNESDAY, Dec. 26 (HealthDay News) -- In rats with induced gastroduodenoesophageal reflux, a small molecular inhibitor of smoothened (Smo) can reduce the risk of developing Barrett's esophagus and esophageal adenocarcinoma, according to a study published online Oct. 26 in the Annals of Surgery.

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Androgen Deprivation May Be Harmful for Some Prostate CA

WEDNESDAY, Dec. 26 (HealthDay News) -- In a mouse model, androgen deprivation treatment of some high-grade but stable prostate cancers accelerates their progression to invasive disease, according to an experimental study published online Dec. 20 in Cancer Discovery.

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Fertility Drugs Not Linked to Uterine Cancer Recurrence

WEDNESDAY, Dec. 26 (HealthDay News) -- For women who undergo fertility-sparing treatment for uterine cancer, subsequent use of fertility drugs is not associated with a higher incidence of cancer recurrence, according to research published in the January issue of Obstetrics & Gynecology.

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FDA Recommends Against Drug to Treat Chronic Fatigue Syndrome

FRIDAY, Dec. 21 (HealthDay News) -- A U.S. Food and Drug Administration advisory committee on Thursday recommended against approval of the first proposed drug to treat chronic fatigue syndrome (CFS), intravenous Ampligen (rintatolimod).

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Gattex Approved for Short Bowel Syndrome

FRIDAY, Dec. 21 (HealthDay News) -- Gattex (teduglutide) has been approved by the U.S. Food and Drug Administration to treat nutritional problems caused by short bowel syndrome.

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Varizig Approved to Reduce Chickenpox Symptoms

FRIDAY, Dec. 21 (HealthDay News) -- Varizig (varicella zoster immune globulin) has been approved by the U.S. Food and Drug Administration to minimize chickenpox symptoms when administered within four days of exposure to the virus that causes the disease.

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FDA Expands Tamiflu Use to Treat Babies Under 1 Year Old

FRIDAY, Dec. 21 (HealthDay News) -- Tamiflu (oseltamivir) can now be given to children as young as 2 weeks old under an expanded approval announced Friday by the U.S. Food and Drug Administration.

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FDA Calls for New Rules for Compounding Pharmacies

THURSDAY, Dec. 20 (HealthDay News) -- The U.S. Food and Drug Administration is pushing for new rules to regulate compounding pharmacies, according to reports from the FDA's Dec. 19 meeting with state pharmacy regulators.

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FDA: Pradaxa Not for Patients With Mechanical Heart Valves

THURSDAY, Dec. 20 (HealthDay News) -- Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, according to a Dec. 19 safety announcement issued by the U.S. Food and Drug Administration.

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Fatty Acids Don't Reduce Atrial Fibrillation Recurrence

THURSDAY, Dec. 20 (HealthDay News) -- Polyunsaturated fatty acids (n-3 PUFA) do not reduce the recurrence of atrial fibrillation (AF), according to a study published online Dec. 19 in the Journal of the American College of Cardiology.

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Data Suggest Smoking Doesn't Impact RA Treatment Response

THURSDAY, Dec. 20 (HealthDay News) -- For patients with early rheumatoid arthritis (RA), smoking status does not impact treatment response to early combination therapy or initial methotrexate treatment with step-up therapy, according to a study published in the December issue of Arthritis Care & Research.

Abstract
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Metformin Treatment Beneficial for Obese Children, Teens

THURSDAY, Dec. 20 (HealthDay News) -- Obese children and adolescents treated with twice-daily metformin have significantly improved body mass index standard deviation scores (BMI-SDS), fasting glucose, and other metabolic risk factors, according to research published online Nov. 21 in the Journal of Clinical Endocrinology & Metabolism.

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Overall, Teen Drug Use Remains Steady in 2012

THURSDAY, Dec. 20 (HealthDay News) -- Overall, illicit drug use among U.S. teenagers was unchanged over the past year; however, from 2007 to 2012, there has been an increase in illicit drug use among 12th graders and an increase in the use of marijuana among 10th graders, according to a report issued Dec. 19 by the White House Office of National Drug Control Policy.

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Vertex Announces Boxed Warning on Hepatitis C Drug

WEDNESDAY, Dec. 19 (HealthDay News) -- In the wake of multiple deaths, the oral hepatitis C drug telaprevir (Incivek) will now carry a boxed warning, according to a statement released Dec. 19 by Vertex Pharmaceuticals.

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Substantial Morbidity, Mortality From Fungus-Tainted Steroid

WEDNESDAY, Dec. 19 (HealthDay News) -- Considerable morbidity and mortality resulted from the use of three lots of fungus-contaminated methylprednisolone acetate, recalled by the pharmacy, according to a preliminary report published online Dec. 19 in the New England Journal of Medicine.

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Two Drugs Promising for Juvenile Idiopathic Arthritis Treatment

WEDNESDAY, Dec. 19 (HealthDay News) -- Two drugs show promise in the treatment of active systemic juvenile idiopathic arthritis (JIA), according to two studies published in the Dec. 20 issue of the New England Journal of Medicine.

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Amoxicillin of Little Benefit in Lower-Respiratory Infection

WEDNESDAY, Dec. 19 (HealthDay News) -- In cases of lower-respiratory-tract infection when pneumonia is not suspected, amoxicillin provides little symptomatic benefit, according to a study published online Dec. 19 in The Lancet Infectious Diseases.

Abstract
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Denosumab Does Not Delay Nonvertebral Fracture Healing

WEDNESDAY, Dec. 19 (HealthDay News) -- Denosumab does not appear to delay fracture healing or contribute to other complications when used to treat postmenopausal women with osteoporosis, according to research published in the Dec. 5 issue of The Journal of Bone & Joint Surgery.

Abstract
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Editorial

Paroxetine Protects Endothelial Cells From Hyperglycemia

WEDNESDAY, Dec. 19 (HealthDay News) -- The antidepressant paroxetine protects endothelial cells against hyperglycemia-induced injury, including reactive oxygen species (ROS) formation, according to a study published online Dec. 7 in Diabetes.

Abstract
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Aspirin Use 10 Years Prior Tied to Incidence of Late AMD

TUESDAY, Dec. 18 (HealthDay News) -- For adults, regular use of aspirin 10 years prior to retinal examination is associated with increased incidence of late and neovascular age-related macular degeneration (AMD), according to a study published in the Dec. 19 issue of the Journal of the American Medical Association.

Abstract
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Workplace Bullying Linked to Psychotropic Medication Use

TUESDAY, Dec. 18 (HealthDay News) -- Experiencing or observing workplace bullying increases the risk of subsequent psychotropic medication use, according to a study published online Dec. 12 in BMJ Open.

Abstract
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Adalimumab Relieves Hidradenitis Suppurativa

TUESDAY, Dec. 18 (HealthDay News) -- For patients with moderate-to-severe hidradenitis suppurativa (HS), a chronic skin disease characterized by painful abscesses, nodules, and draining fistulas in the axilla and groin, treatment with once-weekly adalimumab is associated with improvements in pain and inflammation, according to a study published online Dec. 17 in the Annals of Internal Medicine.

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Signifor Approved for Cushing's Disease

MONDAY, Dec. 17 (HealthDay News) -- Signifor (pasireotide diaspartate) has been approved by the U.S. Food and Drug Administration to treat Cushing's disease in cases that cannot be treated by surgery.

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AAP Urges United Nations Not to Ban Thimerosal in Vaccines

MONDAY, Dec. 17 (HealthDay News) -- In response to the United Nations (UN) Environmental Program international treaty, which seeks to reduce mercury exposure from different sources, the American Academy of Pediatrics (AAP) has joined the World Health Organization (WHO) in urging the UN to reconsider their stance on thimerosal (ethyl mercury), a component used in multi-dose vaccine vials to prevent contamination. The AAP's statement of endorsement of the WHO's recommendation along with three related commentaries have been published online Dec. 17 in Pediatrics.

Statement of Endorsement
Commentary 1
Commentary 2
Commentary 3

Raxibacumab Approved for Inhalational Anthrax

MONDAY, Dec. 17 (HealthDay News) -- Raxibacumab injection has been approved by the U.S. Food and Drug Administration to treat inhalational anthrax, an infectious disease caused by breathing in deadly anthrax spores, the agency said Friday.

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Health Care Satisfaction Rated As High by Unacculturated Hispanics

MONDAY, Dec. 17 (HealthDay News) -- Hispanic patients, particularly unacculturated Hispanics, rate their health care experience more highly than do other patient groups, according to a study published in the October issue of the Journal of Immigrant and Minority Health.

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Tenofovir Effectively Treats Adolescents With Chronic HBV

FRIDAY, Dec. 14 (HealthDay News) -- In adolescents infected with hepatitis B virus (HBV), once-daily tenofovir treatment for 72 weeks effectively suppresses HBV DNA and normalizes alanine aminotransferase (ALT) values, regardless of prior HBV treatment exposure, according to research published in the December issue of Hepatology.

Abstract
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Drug Combinations Target Mutant BRAF Melanomas

FRIDAY, Dec. 14 (HealthDay News) -- Melanomas carrying mutations that make them resistant to many drugs can be effectively targeted by drug combinations, some of which include statins, according to a study published online Dec. 13 in Cancer Discovery.

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Iclusig Approved for Rare Leukemias

FRIDAY, Dec. 14 (HealthDay News) -- Iclusig (ponatinib) has been approved by the U.S. Food and Drug Administration to treat two rare forms of leukemia..

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Imeglimin Beneficial As Add-On to Metformin in T2DM

THURSDAY, Dec. 13 (HealthDay News) -- For patients with type 2 diabetes inadequately controlled by metformin alone, addition of the new oral anti-diabetes agent imeglimin improves glycemic control with good tolerability and safety, according to a study published online Nov. 16 in Diabetes Care.

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~40 Percent of Cancer Patients Receive Opioids at End of Life

THURSDAY, Dec. 13 (HealthDay News) -- For patients with one of five common cancers, 43.6 percent receive at least one prescription of opioids in the last three months of life, according to a study published in the Dec. 10 issue of the Journal of Clinical Oncology.

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FDA: Chantix May Raise Risk for Cardiovascular Events

THURSDAY, Dec. 13 (HealthDay News) -- People who take the smoking cessation drug Chantix may be at increased risk for major adverse cardiovascular events (MACE), according to a Dec. 12 Drug Safety Coummnication bulletin posted by the U.S. Food and Drug Administration.

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Racial/Ethnic Differences ID'd in HTN Medication Behaviors

THURSDAY, Dec. 13 (HealthDay News) -- For adults with hypertension who are new users of antihypertensive medication, racial/ethnic differences in medication-taking behavior occur early in the course of treatment and may be mediated by health system factors, according to a study published online Dec. 10 in the Archives of Internal Medicine.

Abstract
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Immunogenicity Strongly Impacts Response to Adalimumab in RA

THURSDAY, Dec. 13 (HealthDay News) -- For patients with rheumatoid arthritis (RA), long-term clinical outcomes are good with etanercept and adalimumab; but for adalimumab, treatment response is strongly dependent on the presence or absence of anti-adalimumab antibodies, according to research published in the December issue of Arthritis & Rheumatism.

Abstract
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ACOG to HHS: Reconsider Age Limit on Plan B Access

WEDNESDAY, Dec. 12 (HealthDay News) -- Physicians from the American Congress of Obstetricians and Gynecologists (ACOG), together with other health organizations, are urging the U.S. Department of Health and Human Services (HHS) to reconsider the age limit for access to Plan B One-Step emergency contraception.

Letter

Any Amount of Smoking Ups Sudden Cardiac Death in Women

WEDNESDAY, Dec. 12 (HealthDay News) -- For women without coronary heart disease (CHD) at baseline, smoking, even in small quantities, is associated with a significantly increased risk of sudden cardiac death (SCD), according to research published online Dec. 11 in Circulation: Arrhythmia and Electrophysiology.

Abstract
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NSAIDs Exacerbate Exercise-Induced Small Intestinal Injury

WEDNESDAY, Dec. 12 (HealthDay News) -- Nonsteroidal anti-inflammatory drugs (NSAIDs) aggravate exercise-induced small intestinal injury in athletes, according to a study published in the December issue of Medicine & Science in Sports & Exercise.

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Teduglutide Seems Effective, Safe for Short Bowel Syndrome

WEDNESDAY, Dec. 12 (HealthDay News) -- For patients with short bowel syndrome with intestinal failure (SBS-IF), the glucagon-like peptide 2 analogue teduglutide appears to be safe and reduces the number of days off parenteral support, according to a phase 3 study published in the December issue of Gastroenterology.

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Benzodiazepines Linked to Higher Risk of Pneumonia

TUESDAY, Dec. 11 (HealthDay News) -- Benzodiazepine use is associated with an increased risk of developing pneumonia as well as increased mortality following pneumonia, according to a study published online Dec. 5 in Thorax.

Abstract
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Menopause Weight Gain May Up Breast Tumor Growth in Obese

TUESDAY, Dec. 11 (HealthDay News) -- Excess nutrients associated with menopausal weight gain are deposited into the breast tumors of rats who were already obese before menopause, but the tumors can regress after treatment with an insulin sensitizer, according to a study published online Dec. 7 in Cancer Research.

Abstract
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Abiraterone Benefits Chemo-Naive With Advanced Prostate CA

TUESDAY, Dec. 11 (HealthDay News) -- For chemotherapy-naive patients with metastatic castration-resistant prostate cancer, abiraterone acetate correlates with improved radiographic progression-free survival, according to a study published online Dec. 10 in the New England Journal of Medicine to coincide with the U.S. Food and Drug Administration's recent approval for expanded use of the drug.

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Zytiga's Use Expanded for Advanced Prostate Cancer

MONDAY, Dec. 10 (HealthDay News) -- U.S. Food and Drug Administration approval of Zytiga (abiraterone acetate) has been expanded to include treating late-stage castration-resistant prostate cancer before the administration of chemotherapy, the agency said today.

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Raised Risk of Ischemic Stroke in Women With A-Fib Explored

MONDAY, Dec. 10 (HealthDay News) -- Women with atrial fibrillation (AF) have a higher risk of ischemic stroke than men with AF, related in part to differences in the percent time in the therapeutic range (TTR) associated with warfarin anticoagulation control, according to research published in the Dec. 15 issue of The American Journal of Cardiology.

Abstract
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No Evidence That Doping Enhances Athletic Performance

FRIDAY, Dec. 7 (HealthDay News) -- Although use of recombinant human erythropoietin (rHuEPO) is prohibited among athletes because it reportedly enhances performance, there is no scientific evidence that it does so, according to a study published online Dec. 6 in the British Journal of Clinical Pharmacology.

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Concerns for Long-Term Safety of Antipsychotics in Over 40s

FRIDAY, Dec. 7 (HealthDay News) -- For patients over the age of 40 with psychosis, treatment with one of the four most commonly used atypical antipsychotic (AAP) drugs (aripiprazole, olanzapine, quetiapine, and risperidone) may lack effectiveness and is associated with a high incidence of side effects, according to a study published online Nov. 27 in the Journal of Clinical Psychiatry.

Abstract
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Rituximab Benefits Some APS Non-Criteria Manifestations

FRIDAY, Dec. 7 (HealthDay News) -- Some patients with antiphospholipid syndrome with non-criteria manifestations may improve after treatment with rituximab, according to a study published online Nov. 2 in Arthritis & Rheumatism.

Abstract
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Synergistic Risk of VTE for Women With PCOS Using the Pill

FRIDAY, Dec. 7 (HealthDay News) -- For women with polycystic ovary syndrome (PCOS), the risk of venous thromboembolism is increased for non-users of oral contraceptives, and further increased for users of combined oral contraceptives, according to a study published online Dec. 3 in CMAJ, the journal of the Canadian Medical Association.

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Anticompetitive Market Power Common in Managed Care Plans

FRIDAY, Dec. 7 (HealthDay News) -- For each of the three most popular types of managed care plans in the United States (point-of-service plan [POS], health maintenance organization [HMO], and preferred provider organization [PPO]), anticompetitive market power is widespread, according to a Nov. 28 news release from the American Medical Association (AMA).

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Health Care Law Boosts Savings on Meds for Medicare Recipients

FRIDAY, Dec. 7 (HealthDay News) -- Savings on prescription drugs related to the Affordable Care Act have reached $5.1 billion, according to a Dec. 3 news release from the U.S. Department of Health and Human Services.

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Socioeconomic Status Affects Cancer Trial Referrals

THURSDAY, Dec. 6 (HealthDay News) -- Patients of lower socioeconomic status are less likely to be referred to participate in early-phase cancer trials compared with patients of higher socioeconomic status, according to research published online Dec. 3 in the Journal of Clinical Oncology.

Abstract
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Impact of HTN Meds on Cardio Risk Affected by Body Size

THURSDAY, Dec. 6 (HealthDay News) -- For patients with hypertension, the impact of the type of treatment on cardiovascular risk is affected by body size, according to a study published online Dec. 6 in The Lancet.

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FDA: Zofran 32-mg Dose Pulled From Market

WEDNESDAY, Dec. 5 (HealthDay News) -- The 32-mg, single intravenous dose of Zofran (ondansetron), an anti-nausea drug, is being removed from the market due to its potential to cause serious, even fatal, cardiac damage, according to a Drug Safety Communication (DSC) issued Dec. 4 by the U.S. Food and Drug Administration.

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FDA Requests Removal of Generic Budeprion XL 300 mg

WEDNESDAY, Dec. 5 (HealthDay News) -- The U.S. Food and Drug Administration has concluded that generic Budeprion XL 300 mg (extended-release bupropion hydrochloride, manufactured by Impax Laboratories and distributed by Teva Pharmaceuticals) cannot be considered therapeutically equivalent to the brand-name product, according to a perspective piece published online Dec. 5 in the New England Journal of Medicine.

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Stimulant Still Available for Sale Despite FDA Action

WEDNESDAY, Dec. 5 (HealthDay News) -- Products containing 1,3-dimethylamylamine (DMAA), a stimulant marketed as a dietary supplement in the United States, are still available for sale despite a warning from the U.S. Food and Drug Administration, according to a research letter published online Dec. 3 in the Archives of Internal Medicine.

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Tetanus-Diphtheria-Pertussis Shot Deemed Safe for Seniors

WEDNESDAY, Dec. 5 (HealthDay News) -- Immunizing older adults with the tetanus-diphtheria-acellular pertussis (Tdap) vaccine appears to be safe, according to a study published online Nov. 28 in Clinical Infectious Diseases.

Abstract
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Psychotropics Seem to Be Appropriately Prescribed to Teens

TUESDAY, Dec. 4 (HealthDay News) -- There is no evidence that psychotropic medications are being overly prescribed or misused by U.S. adolescents, according to a study published online Dec. 3 in the Archives of Pediatrics & Adolescent Medicine.

Abstract
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CDC: Flu Season Has Started and Hitting Hard

TUESDAY, Dec. 4 (HealthDay News) -- Flu season descended on the United States early and hard this year, with significant increases in flu activity observed in just the past two weeks, according to a Nov. 30 weekly surveillance report published by the U.S. Centers for Disease Control and Prevention.

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Intravitreal Pegaptanib Useful in Diabetic Macular Edema

MONDAY, Dec. 3 (HealthDay News) -- For patients with diabetes with clinically significant macular edema (CME), treatment with intravitreal pegaptanib sodium (Macugen), which selectively inhibits vascular endothelial growth factor-165 isoforms, is associated with significant morphological and functional changes, according to a study published in the December issue of the British Journal of Clinical Pharmacology.

Abstract
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Fetal NSAID Exposure Not Tied to Persistent Pulmonary HTN

MONDAY, Dec. 3 (HealthDay News) -- There appears to be no association between persistent pulmonary hypertension of the newborn (PPHN) and gestational exposure to nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, according to a study published online Dec. 3 in Pediatrics.

Abstract
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Improved Survival Seen in Ovarian CA With Metformin Use

MONDAY, Dec. 3 (HealthDay News) -- For women with ovarian cancer, metformin use is associated with significantly improved survival, according to a study published online Dec. 3 in Cancer.

Abstract
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Topical Simvastatin Accelerates Wound Healing in Diabetes

MONDAY, Dec. 3 (HealthDay News) -- Topically applied simvastatin accelerates wound healing by directly influencing lymphatics and indirectly via recruitment of macrophages, according to a study published in the December issue of The American Journal of Pathology.

Abstract
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ART Cuts HIV Infection in Serodiscordant Couples in China

MONDAY, Dec. 3 (HealthDay News) -- For uninfected partners of HIV-positive individuals in China, transmission is reduced with antiretroviral therapy for the HIV-positive individual, according to a study published online Dec. 1 in The Lancet.

Abstract
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Increasing Number of Workers in Self-Insured Health Plans

MONDAY, Dec. 3 (HealthDay News) -- There has been a recent increase in the percentage of workers in the private sector who are enrolled in self-insured health plans, in which the employer assumes the financial risk related to health insurance (unlike a fully-insured plan, where the insurance company assumes the risk), according to research published in the November issue of the Employee Benefit Research Institute's Notes.

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Epidural Steroid Shot Has Adverse Effect on Bone Density

MONDAY, Dec. 3 (HealthDay News) -- For postmenopausal women, treatment of the pain associated with radiculopathy with epidural steroid injection (ESI) has an adverse effect on bone mineral density (BMD), according to a study published in the Dec. 1 issue of Spine.

Abstract
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Recent Increase in Adverse TMP-SMX Reactions in Children

MONDAY, Dec. 3 (HealthDay News) -- There has been a significant increase in adverse drug reactions (ADRs) associated with use of trimethoprim-sulfamethoxazole (TMP-SMX) for treatment of skin and soft tissue infection (SSTI) in children, according to research published online Dec. 3 in Pediatrics.

Abstract
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