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May 2011 Briefing - Pharmacy

Here are what the editors at HealthDay consider to be the most important developments in Pharmacy for May 2011. 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.

Effect Estimates May Be Inflated in Biomarker Studies

TUESDAY, May 31 (HealthDay News) -- Biomarker effects are often overestimated in highly cited studies compared to the effects reported in subsequent meta-analyses of the same associations, according to a review published in the June 1 issue of the Journal of the American Medical Association.

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Solesta Gel Approved for Fecal Incontinence

TUESDAY, May 31 (HealthDay News) -- Solesta gel has been approved by the U.S. Food and Drug Administration to treat fecal incontinence in adults after other therapies have failed.

fecal incontinence

Dificid Approved to Treat C. diff Diarrhea

TUESDAY, May 31 (HealthDay News) -- Dificid (fidaxomicin) has been approved by the U.S. Food and Drug Administration to treat diarrhea associated with Clostridium difficile infection.

Centers for Disease Control and Prevention

PDE4 Inhibitors Improve Some COPD-Related Symptoms

TUESDAY, May 31 (HealthDay News) -- In chronic obstructive pulmonary disease (COPD), oral phosphodiesterase 4 (PDE4) inhibitors improve lung function and reduce the likelihood of exacerbations with little impact on quality of life or symptoms, according to a study published online May 11 in the Cochrane Database of Systematic Reviews.

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Acetaminophen Prescriptions for Children Often Incorrect

FRIDAY, May 27 (HealthDay News) -- Off-label prescribing of acetaminophen (paracetamol) occurs frequently, with potential overdosing risks in infants, and potential underdosing for children aged 6 to 12, according to a study published online May 18 in the British Journal of Clinical Pharmacology.

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BoNT-A Alleviates Neurogenic Detrusor Overactivity

FRIDAY, May 27 (HealthDay News) -- OnabotulinumtoxinA (BoNT-A) intradetrusor injection may be clinically beneficial and is well tolerated by adults with neurogenic detrusor overactivity (NDO) and antimuscarinic-refractory incontinence, according to a study published in the June issue of The Journal of Urology.

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Sickle Cell Disease Linked to Faster Morphine Clearance

FRIDAY, May 27 (HealthDay News) -- Patients with sickle cell disease (SCD) may require higher and more frequent opioid doses to achieve the required plasma levels due to increased morphine clearance, according to a study published in the May issue of the Journal of Pain.

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Omega-3 Fatty Acids Have Novel Antithrombotic Effects

FRIDAY, May 27 (HealthDay News) -- Omega-3 polyunsaturated fatty acid (n-3 PUFA) treatment for patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) may decrease thrombin formation and oxidative stress, and improve fibrin clot properties, according to a study published online May 26 in Arteriosclerosis, Thrombosis, and Vascular Biology.

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Polypills May Reduce Blood Pressure and LDL Cholesterol

THURSDAY, May 26 (HealthDay News) -- Use of combination cardiovascular medications, or polypills, is associated with significant reductions in systolic blood pressure (SBP) and low-density lipoprotein (LDL) cholesterol, according to a study published online May 25 in PLoS One.

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Low Statin Adherence After Coronary Revascularization

THURSDAY, May 26 (HealthDay News) -- Patients hospitalized for coronary artery disease (CAD) have significantly lower statin adherence following coronary revascularization (percutaneous coronary intervention [PCI] and coronary artery bypass graft surgery [CABG]) than after medical therapy, according to a study published in the May 15 issue of The American Journal of Cardiology.

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Drug May Retain Eosinophilic Esophagitis Remission

THURSDAY, May 26 (HealthDay News) -- Use of low-dose budesonide may be more effective than placebo for maintaining eosinophilic esophagitis (EoE) in clinical and histological remission, according to a study published in the May issue of Clinical Gastroenterology and Hepatology.

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Lupus Factors Tied to Weak Response to Influenza Vaccine

THURSDAY, May 26 (HealthDay News) -- Patients with systemic lupus erythematosus (SLE), particularly those with a history of hematological disorder or taking prednisone, may have a low antibody response to influenza vaccination, according to a study published online May 19 in Arthritis & Rheumatism.

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Co-Pay Tied to Noncompliance for Breast Cancer Therapy

THURSDAY, May 26 (HealthDay News) -- Higher prescription co-payments are associated with noncompliance with hormonal therapy for breast cancer, according to a study published online May 23 in the Journal of Clinical Oncology.

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Abiraterone Tied to Metastatic Prostate Cancer Survival

WEDNESDAY, May 25 (HealthDay News) -- Abiraterone acetate prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy, according to a study published in the May 26 issue of the New England Journal of Medicine.

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More Psychiatrists Believe in Clinical Value of Placebos

WEDNESDAY, May 25 (HealthDay News) -- Psychiatrists are more likely than nonpsychiatrists to prescribe subtherapeutic doses of medication and believe in the clinical value of placebos, according to a study published in the April issue of the Canadian Journal of Psychiatry.

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Contact With Drug Industry Linked to Positive Attitudes

WEDNESDAY, May 25 (HealthDay News) -- The extent of contact that medical students have with the pharmaceutical industry is associated with positive attitudes about marketing, according to a review published online May 24 in PLoS Medicine.

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Intratympanic Steroids Effectively Treat Hearing Loss

TUESDAY, May 24 (HealthDay News) -- Intratympanic corticosteroids are as effective as oral steroids for the treatment of sudden sensorineural hearing loss, according to a study published in the May 25 issue of the Journal of the American Medical Association.

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Heart-Friendly Fatty Acids Linked to Prostate Cancer

TUESDAY, May 24 (HealthDay News) -- High levels of the ω-3 fatty acid docosahexaenoic acid may increase the risk of high-grade prostate cancer; whereas, high levels of trans-fatty acids (TFAs) may reduce the risk, according to a study published online April 24 in the American Journal of Epidemiology.

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Inhaled Anticholinergics Tied to Acute Urinary Retention

TUESDAY, May 24 (HealthDay News) -- Men with chronic obstructive pulmonary disease (COPD) using both short- and long-acting inhaled anticholinergic (IAC) drugs have an increased risk of developing acute urinary retention (AUR), according to a study published in the May 23 issue of the Archives of Internal Medicine.

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Depression Drug Combos Not Superior to Monotherapy

TUESDAY, May 24 (HealthDay News) -- Response and remission rates do not seem to differ between two antidepressant drug combinations and monotherapy with a selective serotonin reuptake inhibitor; however, there may be more serious adverse events with a drug combination, according to a study published online May 2 in The American Journal of Psychiatry.

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Use of CCTA Screening Tied to Increased Invasive Testing

TUESDAY, May 24 (HealthDay News) -- Low-risk adults who undergo coronary computed tomographic angiography (CCTA) screening use more medications and undergo invasive coronary procedures, according to a study published online May 23 in Archives of Internal Medicine.

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Excess Medical Costs Tied to Diabetes in Youth Substantial

MONDAY, May 23 (HealthDay News) -- The excess medical expenditures related to diabetes among youth are substantial, and this is particularly true for insulin-treated diabetes mellitus (ITDM), according to a study published in the May issue of Diabetes Care.

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End-of-Life Cancer Care Differs in the U.S. and Canada

MONDAY, May 23 (HealthDay News) -- End-of-life care for patients with non-small-cell lung cancer (NSCLC) differs in the United States and Ontario, Canada, according to a study published online May 18 in the Journal of the National Cancer Institute.

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Sutent Approved for Rare Pancreatic Cancer

MONDAY, May 23 (HealthDay News) -- U.S. Food and Drug Administration approval of Sutent (sunitinib) has been expanded to include people with neuroendocrine pancreatic cancer that is inoperable or has metastasized to other parts of the body.

this type of cancer

Inappropriate Antibiotic Prescribing Common in Asthma

MONDAY, May 23 (HealthDay News) -- Inappropriate antibiotic prescribing appears to be relatively common among children with asthma, according to two studies published online May 23 in Pediatrics.

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FDA: SimplyThick Should Not Be Used in Premature Infants

MONDAY, May 23 (HealthDay News) -- The U.S. Food and Drug Administration has notified parents, caregivers, and health care providers not to administer SimplyThick to infants born prior to 37 weeks, as the product may cause necrotizing enterocolitis (NEC), a life-threatening gastrointestinal condition.

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L-Arginine Linked to Decreased Pre-Eclampsia Risk

FRIDAY, May 20 (HealthDay News) -- The risk of pre-eclampsia may be reduced by dietary supplementation with both L-arginine and antioxidant vitamins in high-risk women, according to a study published online May 19 in BMJ.

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Edurant Approved to Treat HIV-1

FRIDAY, May 20 (HealthDay News) -- Edurant (rilpivirine), in combination with other antiretroviral drugs, has been approved by the U.S. Food and Drug Administration to treat HIV-1 infection in adults who haven't taken any prior HIV therapy

aids.gov

No Skin Atrophy With Long-Term Topical Corticosteroids

FRIDAY, May 20 (HealthDay News) -- Long-term use of topical corticosteroids (TCS) in children with dermatitis does not cause skin atrophy, according to a study published online April 20 in Pediatric Dermatology.

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Limiting Gadolinium Use May Avert Renal Systemic Fibrosis

FRIDAY, May 20 (HealthDay News) -- Following the adoption of restrictive guidelines for gadolinium-based contrast agent (GBCA) administration, no new nephrogenic systemic fibrosis (NSF) cases have been identified in contrast-enhanced magnetic resonance (MR) examinations, even in patients with a low estimated glomerular filtration rate (eGFR), according to a study published online May 17 in Radiology.

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Internet Gambling Ups Access for Those With Gambling Disorders

THURSDAY, May 19 (HealthDay News) -- The increased availability of gambling opportunities has drawn attention to gambling disorders, which affect 0.2 to 5.3 percent of adults worldwide, according to a review published online May 19 in The Lancet.

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Lower HIV-Related Mortality, Increased Treatment in China

THURSDAY, May 19 (HealthDay News) -- HIV-related mortality has decreased and concomitant treatment coverage has increased in China, but mortality is higher and treatment cover lower in injecting drug users and those infected sexually, according to a study published online May 19 in The Lancet Infectious Diseases.

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Nerve Blockade May Reduce Acute Pain After Hip Surgery

THURSDAY, May 19 (HealthDay News) -- Nerve blockade may be effective for reducing acute pain after hip fracture, but evidence is lacking for most other pain management interventions, according to a review published online May 16 in the Annals of Internal Medicine.

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Alemtuzumab May Reduce Renal-Transplant Rejection

WEDNESDAY, May 18 (HealthDay News) -- In renal-transplant patients at low risk of rejection, biopsy-confirmed acute rejection is less frequent with alemtuzumab than conventional induction therapy, according to a study published in the May 19 issue of the New England Journal of Medicine.

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Melatonin Analogues May Help Treat Depression

WEDNESDAY, May 18 (HealthDay News) -- Melatonin analogues, including agomelatine, may help in the treatment of depression and may help restore circadian function, according to a review published online May 18 in The Lancet.

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Third Antihyperglycemic Agents Produce Similar Results

WEDNESDAY, May 18 (HealthDay News) -- There are no significant differences between the class of antihyperglycemic agents given to patients with uncontrolled type 2 diabetes who are already treated with metformin and a sulfonylurea, according to a meta-analysis published in the May 17 issue of the Annals of Internal Medicine.

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Most Patients Treated for GERD Attain Remission

WEDNESDAY, May 18 (HealthDay News) -- Most patients with gastroesophageal reflux disease (GERD) who are treated with esomeprazole therapy or laparoscopic antireflux surgery (LARS) attain remission at five years, according to a study published in the May 18 issue of the Journal of the American Medical Association.

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Propranolol Effectively Treats Infantile Hemangiomas

WEDNESDAY, May 18 (HealthDay News) -- Propranolol appears to be an effective first-line therapy in the treatment of infantile head and neck hemangiomas, according to research published in the May issue of the Archives of Otolaryngology -- Head & Neck Surgery.

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Triamcinolone Ineffective in Eustachian Tube Dysfunction

WEDNESDAY, May 18 (HealthDay News) -- Tympanometric manifestation of eustachian tube dysfunction (ETD) may not be normalized by treatment with intranasal aqueous triamcinolone acetonide (TAA-AQ), according to a study published in the May issue of the Archives of Otolaryngology -- Head & Neck Surgery.

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Major Birth Defects Not Linked to Newer Antiepileptic Drugs

TUESDAY, May 17 (HealthDay News) -- Exposure to newer-generation antiepileptic drugs in the first trimester of pregnancy is not correlated with an increase in major birth defects in a Danish cohort of live-born infants, according to a study published in the May 18 issue of the Journal of the American Medical Association.

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Patients With Type 2 Diabetes Do Not Benefit From Leptin

TUESDAY, May 17 (HealthDay News) -- Recombinant methionyl human (r-Met hu) leptin does not have clinically important effects on insulin sensitivity independent of weight loss in obese people with newly diagnosed type 2 diabetes, according to a study published in the May issue of Diabetes.

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Heart Disease Risk Similar in Children Treated for ADHD

TUESDAY, May 17 (HealthDay News) -- Use of attention-deficit/hyperactivity disorder (ADHD) agents by children is not significantly associated with cardiovascular events or death, according to a study published online May 16 in Pediatrics.

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Victrelis Approved for Chronic Hepatitis C

MONDAY, May 16 (HealthDay News) -- Victrelis (boceprevir) has been approved by the U.S. Food and Drug Administration to treat chronic hepatitis C in tandem with two additional drugs, pegylated interferon alfa and ribavirin.

CDC

MRKAd5 Vaccine Found Ineffective Against HIV-1

MONDAY, May 16 (HealthDay News) -- A vaccine tested in a cohort of men and women in South Africa failed to prevent acquisition of HIV-1 or a decrease in viral load in those who acquired the virus, according to research published online May 12 in The Lancet Infectious Diseases.

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Pirfenidone May Slow Lung Decline in Patients With IPF

MONDAY, May 16 (HealthDay News) -- Use of pirfenidone may reduce the deterioration in lung function seen in patients with idiopathic pulmonary fibrosis (IPF), according to a study published online May 14 in The Lancet.

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Early HIV Therapy Reduces Partner's Infection Risk

FRIDAY, May 13 (HealthDay News) -- People with HIV may be able to reduce the risk of transmitting the infection to sexual partners by starting an antiretroviral regimen early, while their immune systems are healthy, according the results of the HPTN 052 trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The trial was slated to end in 2015, but the findings are being released early after a scheduled interim data review by an independent data and safety monitoring board.

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Hydroxycarbamide Effective for Infant Sickle-Cell Anemia

FRIDAY, May 13 (HealthDay News) -- Hydroxycarbamide therapy may be safe and effective for treating infants with sickle-cell anemia, according to a study published in the May 14 issue of The Lancet.

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Peginterferon in Hepatitis C Linked to Higher Mortality

FRIDAY, May 13 (HealthDay News) -- Long-term peginterferon treatment in patients with advanced chronic hepatitis C is associated with higher overall mortality mainly due to non-liver-related causes, according to a study published in the April issue of Hepatology.

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GnRH Antagonists Effective Option in IVF

FRIDAY, May 13 (HealthDay News) -- The treatment of women with in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with gonadotrophin-releasing hormone (GnRH) antagonists results in a similar live-birth rate, and is associated with a lower incidence of ovarian hyperstimulation syndrome (OHSS) compared to standard treatment with GnRH agonists, according to a meta-analysis published online May 11 in the Cochrane Database of Systematic Reviews.

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Aromatase Inhibitors Improve Breast Conservation Rates

THURSDAY, May 12 (HealthDay News) -- Patients with clinical stage II to III estrogen receptor (ER)-positive breast cancer who undergo preoperative treatment with the aromatase inhibitors (AIs) exemestane, letrozole, or anastrozole have improved surgical outcomes, according to a study published online May 9 in the Journal of Clinical Oncology.

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Blacks Screened More Often Than Whites for Opioid Misuse

THURSDAY, May 12 (HealthDay News) -- Black patients on opioid analgesics for chronic noncancer pain are significantly more likely to receive recommended opioid risk reduction strategies than white patients, according to a study published in the May/June issue of the Annals of Family Medicine.

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Combination Therapy Improves Pancreatic Cancer Survival

WEDNESDAY, May 11 (HealthDay News) -- Pancreatic cancer patients in a trial assessing the combination chemotherapy FOLFIRINOX experienced longer overall and progression-free survival than those on gemcitabine, though the combination treatment is associated with greater toxicity, according to research published in the May 12 issue of the New England Journal of Medicine.

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Case-Based Training for GPs Lowers Heart Disease Risks

WEDNESDAY, May 11 (HealthDay News) -- Use of case-based training for general practitioners to implement evidence-based guidelines with intensified lipid-lowering recommendations is associated with a decrease in the 10-year mortality rates in patients with coronary heart disease (CHD), according to a study published in the May/June issue of the Annals of Family Medicine.

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Proton Pump Inhibitors May Increase Fracture Risk

WEDNESDAY, May 11 (HealthDay News) -- Use of proton pump inhibitors (PPIs), but not histamine 2 receptor antagonists (H2RAs), is associated with an increased risk of fracture, according to a meta-analysis published in the May/June issue of the Annals of Family Medicine.

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Exogenous Estrogen Use Linked to Cerebral Aneurysms

WEDNESDAY, May 11 (HealthDay News) -- Women who use oral contraceptive pills or hormone replacement therapy may be less likely to have a cerebral aneurysm, according to a study published in the June issue of the Journal of NeuroInterventional Surgery.

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Medical Education Participants Recognize Funding Bias

WEDNESDAY, May 11 (HealthDay News) -- Although most medical professionals believe that commercial funding of continuing medical education (CME) introduces bias, most are not willing to pay higher fees to offset or eliminate such funding sources, according to a study published in the May 9 issue of the Archives of Internal Medicine.

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No Benefit to Epoetin Alfa Bolus After PCI for STEMI

TUESDAY, May 10 (HealthDay News) -- Patients with ST-segment elevation myocardial infarction (STEMI) who undergo successful reperfusion may not benefit from a single intravenous bolus of epoetin alfa within four hours of percutaneous coronary intervention (PCI), according to a study published in the May 11 issue of the Journal of the American Medical Association.

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Optimal Medical Therapy Often Not Applied Before PCI

TUESDAY, May 10 (HealthDay News) -- Less than half the patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) receive optimal medical therapy (OMT) before PCI; whereas, approximately two-thirds receive it following PCI, with similar practice patterns seen before and after publication of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, according to a study published in the May 11 issue of the Journal of the American Medical Association.

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NSAIDs May Increase Cardio Risk in MI Patients

TUESDAY, May 10 (HealthDay News) -- In patients with prior myocardial infarction (MI), even short-term treatment with most nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with an increased risk of recurrent MI and death, according to a study published online May 9 in Circulation.

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Fourteen Percent of Ischemic Strokes Are Wake-Up Strokes

TUESDAY, May 10 (HealthDay News) -- Wake-up strokes constitute a substantial percentage of all strokes and cannot be easily distinguished from non-wake-up strokes, according to a study published in the May 10 issue of Neurology.

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High Acetaminophen Use Linked to Cancer Risk

TUESDAY, May 10 (HealthDay News) -- High use of acetaminophen for four or more days per week for four or more years is associated with an almost two-fold increased risk of incident hematologic malignancies other than chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), according to a study published online May 9 in the Journal of Clinical Oncology.

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Residual Depressive Symptoms in Responders to Citalopram

MONDAY, May 9 (HealthDay News) -- Patients with major depressive disorder (MDD) who respond to citalopram but do not remit report a range of residual domains and depressive symptoms, according to a study published in the April issue of the Journal of Clinical Psychopharmacology.

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NSAIDs, Aspirin May Increase Risk of Diverticulitis

MONDAY, May 9 (HealthDay News) -- Men who regularly use aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) may have an increased risk of diverticulitis and diverticular bleeding, according to a study published in the May issue of Gastroenterology.

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Golimumab Plus Methotrexate May Inhibit RA Progression

MONDAY, May 9 (HealthDay News) -- Golimumab plus methotrexate (MTX) inhibits radiographic progression of rheumatoid arthritis (RA) in MTX-naive patients significantly better than MTX alone, according to a study published in the May issue of Arthritis & Rheumatism.

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Antibiotic Treatment Less Effective in Acute Appendicitis

FRIDAY, May 6 (HealthDay News) -- Treatment of acute uncomplicated appendicitis with amoxicillin and clavulanic acid is not as effective as emergency appendectomy, according to a study published online May 7 in The Lancet.

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Icons May Help Adults Identify Acetaminophen Medicines

FRIDAY, May 6 (HealthDay News) -- Use of simple, explicit messages and icons identifiable by consumers may promote safe use of over-the-counter (OTC) medications such as acetaminophen, according to a study published online May 3 in the American Journal of Preventive Medicine.

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Infant Acetaminophen Drugs to Be Discontinued

THURSDAY, May 5 (HealthDay News) -- The manufacturers of cold and fever medications that contain acetaminophen have announced that they will discontinue production of infant-drop formulations of the products to avoid confusion that could result in overdoses, according to a report from the Associated Press.

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High Cost of Care for Patients With Atrial Fibrillation

THURSDAY, May 5 (HealthDay News) -- Medical costs are higher for patients with atrial fibrillation (AF) compared with controls, due to increased inpatient and outpatient costs, according to a study published online May 3 in Circulation: Cardiovascular Quality and Outcomes.

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Bisphosphonates Tied to Small Risk of Atypical Fractures

WEDNESDAY, May 4 (HealthDay News) -- Among patients with atypical fractures, there is a high prevalence of current bisphosphonate use, but the absolute risk of these fractures is small, according to a study published in the May 5 issue of the New England Journal of Medicine.

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Leukotriene-Receptor Antagonists Effective in Asthma

WEDNESDAY, May 4 (HealthDay News) -- Use of a leukotriene-receptor antagonist (LTRA) may be as effective as an inhaled glucocorticoid as first-line controller therapy, and as effective as a long-acting beta2-agonist (LABA) as an add-on therapy, for the treatment of asthma patients, according to the findings of two pragmatic trials published in the May 5 issue of the New England Journal of Medicine.

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Individualized Guidelines May Improve Quality of Care

WEDNESDAY, May 4 (HealthDay News) -- Individualized guidelines that calculate the risk reduction expected from treatment, and which rank individuals in order of decreasing expected benefit, may be useful for increasing the quality and reducing the cost of care, according to a study published in the May 3 issue of the Annals of Internal Medicine.

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Half of New Drugs in the U.S. Have Comparative Efficacy Data

WEDNESDAY, May 4 (HealthDay News) -- Approximately half of all new molecular entities (NMEs) recently approved in the United States contain comparative efficacy data in the U.S. Food and Drug Administration approval packages, according to a study published May 4 in the Journal of the American Medical Association.

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Lot of Warfarin Tablets Recalled

WEDNESDAY, May 4 (HealthDay News) -- Bristol-Myers Squibb is voluntarily recalling a lot of warfarin sodium (Coumadin) 5 mg tablets after a tablet from one bottle was discovered to have a higher potency than it should, according to a safety alert posted by the U.S. Food and Drug Administration.

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CDC: Asthma Prevalence on the Rise in United States

TUESDAY, May 3 (HealthDay News) -- The prevalence of asthma among both adults and children has increased in the last decade, and asthma costs have increased in recent years as well, according to a report in the May 3 early-release issue of the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.

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Nearly One in 10 Infants Given Supplements and Teas

TUESDAY, May 3 (HealthDay News) -- Approximately 9 percent of infants, including some as young as 1 month, are given dietary botanical supplements (DBS) and teas by their mothers, according to a study published online May 2 in Pediatrics.

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Tradjenta Approved for Type 2 Diabetes

MONDAY, May 2 (HealthDay News) -- Tradjenta (linagliptin) tablets, combined with diet and exercise, have been approved by the U.S. Food and Drug Administration to control blood sugar in people with type 2 diabetes, the agency said Monday.

National Diabetes Information Clearinghouse

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