Here are what the editors at HealthDay consider to be the most important developments in Pharmacy for October 2010. 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: Methotrexate Injection Vials Recalled
FRIDAY, Oct. 29 (HealthDay News) -- The U.S. Food and Drug Administration and Sandoz have notified health care professionals of a voluntary recall of 24 lots of methotrexate injection (50 mg/2 mL and 250 mg/10 mL vials) due to the presence of small glass particulates in a limited number of vials in four lots.
Latuda Approved for Adult Schizophrenia
THURSDAY, Oct. 28 (HealthDay News) -- Lurasidone HCI (Latuda) tablets have been approved by the U.S. Food and Drug Administration to treat adult schizophrenia, which affects about 1 percent of the nation's adult population in a given year, the agency said Thursday in a news release.
CDC: Second Dose of Meningitis Vaccine Recommended
THURSDAY, Oct. 28 (HealthDay News) -- The U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices panel has recommended that 16-year-olds get a meningitis booster shot, as the vaccine does not appear to last as long as previously thought.
CDC: Whooping Cough Vaccine Recommended for Elderly
THURSDAY, Oct. 28 (HealthDay News) -- The U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended that adults aged 65 years and older who are in close contact with infants be vaccinated against whooping cough.
Sprycel Approval Expanded to Include Rare Leukemia
THURSDAY, Oct. 28 (HealthDay News) -- Sprycel (dasatinib) has received an additional approval from the U.S. Food and Drug Administration to treat a rare form of blood cancer called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP -CML), the agency said Thursday in a news release.
For Coronary Patients, H2RA Plus Clopidogrel Spikes Risk
THURSDAY, Oct. 28 (HealthDay News) -- The concomitant use of a histamine2-receptor antagonist (H2RA) and clopidogrel for patients with prior acute coronary syndrome (ACS) more than doubles the risk of rehospitalization or death compared to treatment with clopidogrel only, according to research published in the October issue of Gastroenterology.
Crizotinib Found to Inhibit Lung Tumor Growth
WEDNESDAY, Oct. 27 (HealthDay News) -- Crizotinib, a small-molecule inhibitor of anaplastic lymphoma kinase (ALK), appears to be effective in reducing or stabilizing lung tumors with ALK rearrangement, according to research published in the Oct. 28 issue of the New England Journal of Medicine.
Guideline for Erythropoiesis-Stimulating Agents Updated
WEDNESDAY, Oct. 27 (HealthDay News) -- A joint committee of the American Society of Hematology and the American Society of Clinical Oncology has published an updated guideline for the use of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia. The guideline was published online Oct. 25 in both Blood and the Journal of Clinical Oncology.
Red Yeast Rice Supplements Lacking Standardization
WEDNESDAY, Oct. 27 (HealthDay News) -- Red yeast rice, a popular dietary supplement for reducing cholesterol, contains widely differing concentrations of monacolins, the active ingredients, by brand, and some contain a potentially toxic substance, according to research published in the Oct. 25 issue of the Archives of Internal Medicine.
Opioid Substitution Rx Lowers Mortality Risk for Abusers
WEDNESDAY, Oct. 27 (HealthDay News) -- Despite increased risk during the first two weeks, the risk of death during opioid substitution therapy is lower, overall, than the risk of death out of treatment, according to research published online Oct. 26 in BMJ.
FDA: Fentanyl Transdermal System Patches Recalled
MONDAY, Oct. 25 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care professionals and patients that 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches (Duragesic) are being voluntarily recalled. The recall was issued due to the potential for the active ingredient, fentanyl, to release faster than indicated, which can lead to adverse events among at-risk patients, including excessive sedation, respiratory depression, hypoventilation, and apnea.
New Guidelines for Recurrent Stroke Prevention Published
FRIDAY, Oct. 22 (HealthDay News) -- A joint committee representing the American Heart Association and the American Stroke Association has published updated evidence-based recommendations on the prevention of ischemic stroke among survivors of ischemic stroke or transient ischemic attack; the statement has been published online Oct. 21 in Stroke.
HIV Drug Invirase Gets New Label Reflecting Risk
THURSDAY, Oct. 21 (HealthDay News) -- New risk information has been added to the label of the HIV antiviral drug Invirase (saquinavir), notifying patients and health care professionals that the drug can have potentially life-threatening adverse effects when used in combination with another antiviral drug, according to an announcement by the U.S. Food and Drug Administration.
CML Patients Stay in Remission Two Years After Imatinib
THURSDAY, Oct. 21 (HealthDay News) -- Some chronic myeloid leukemia (CML) patients achieve complete remission for up to two years after stopping imatinib treatment, suggesting some patients might actually be cured by treatment with the tyrosine kinase inhibitor, according to a study published online Oct. 20 in The Lancet Oncology.
FDA to Update Prescribing Labels of GnRH Agonists
THURSDAY, Oct. 21 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care professionals and consumers that the prescribing labels of gonadotropin-releasing hormone (GnRH) agonists will be updated with new safety information.
Weekly INR Self-Testing Not Superior to Monthly Clinic Tests
WEDNESDAY, Oct. 20 (HealthDay News) -- In patients using warfarin, self-testing of international normalized ratio (INR) doesn't appear superior to clinic testing for reducing the risk of adverse outcomes, including major bleeding and stroke, according to research published in the Oct. 21 issue of the New England Journal of Medicine.
Pradaxa Approved for Atrial Fibrillation
WEDNESDAY, Oct. 20 (HealthDay News) -- Pradaxa (dabigatran etexilate) has been approved by the U.S. Food and Drug Administration to help prevent stroke in people with a type of abnormal heart rhythm called atrial fibrillation.
Corticosteroids Decrease Recurrent A-Fib After Ablation
WEDNESDAY, Oct. 20 (HealthDay News) -- The short-term use of corticosteroids following atrial fibrillation (AF) ablation may safely prevent AF recurrences both immediately after pulmonary vein isolation and over longer follow-up, according to research published in the Oct. 26 issue of the Journal of the American College of Cardiology.
More Node+ Breast Cancer, Higher Mortality After HRT
TUESDAY, Oct. 19 (HealthDay News) -- Postmenopausal estrogen-plus-progestin therapy not only results in an increased incidence of invasive breast cancers but also in more node-positive cancers and an increased mortality rate, according to an analysis published in the Oct. 20 issue of the Journal of the American Medical Association.
DHA Supplements Don't Prevent Postpartum Depression
TUESDAY, Oct. 19 (HealthDay News) -- The results of the large, multicenter DOMInO (DHA to Optimize Mother Infant Outcome) trial do not support routine docosahexaenoic acid (DHA) supplementation for pregnant women to reduce depressive symptoms or to improve cognitive or language outcomes in early childhood, according to research published in the Oct. 20 issue of the Journal of the American Medical Association.
Very Few Clinical Trials Report Composition of Placebo Drug
TUESDAY, Oct. 19 (HealthDay News) -- The composition of placebos used in clinical trials -- including pills, injectables, and other substances -- are not regulated and rarely reported, which may ultimately compromise the integrity of clinical research, according to a study in the Oct. 19 issue of the Annals of Internal Medicine.
Baraclude Sanctioned for Severe Liver Disease
MONDAY, Oct. 18 (HealthDay News) -- Bristol-Myers Squibb said Monday its liver drug Baraclude (entecavir) has received expanded approval from the U.S. Food and Drug Administration to treat chronic hepatitis B in adults with decompensated liver disease, a form of severe liver damage.
FDA Approves Botox for Chronic Migraine Treatment
MONDAY, Oct. 18 (HealthDay News) -- On Friday, Oct. 15, 2010, the U.S. Food and Drug Administration announced the approval of onabotulinumtoxinA (Botox) injection for the prevention of headaches in adult patients with chronic migraines.
FDA Issues Warnings About Unapproved "Chelation" Drugs
FRIDAY, Oct. 15 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care professionals and consumers that no evidence has proved that nonprescription "chelation" products actually rid the body of toxic metals and can treat a variety of serious conditions and diseases.
Experimental HCV Drug Combination Shows Potential
FRIDAY, Oct. 15 (HealthDay News) -- An experimental oral drug combination appears to be well-tolerated and safe, showing promising antiviral activity for the treatment of patients with chronic hepatitis C virus (HCV) infection, according to a study published online Oct. 15 in The Lancet.
"Natural" Weight Loss Products Pose Danger
FRIDAY, Oct. 15 (HealthDay News) -- An examination of poisoning cases in Hong Kong linked to over-the-counter (OTC) weight loss products often advertised to contain only "natural" ingredients" revealed the products to be laced with multiple illicit ingredients with toxicities that can cause illness or even death, according to a report published online Oct. 13 in the British Journal of Clinical Pharmacology.
In Elderly, Algorithm Helps Reduce Number of Medications
THURSDAY, Oct. 14 (HealthDay News) -- A tool known as the Good Palliative-Geriatric Practice algorithm can help safely reduce the use of medications in community-dwelling elderly individuals, according to research published in the Oct. 11 issue of the Archives of Internal Medicine.
Studies Assess Regimens After Nevirapine
WEDNESDAY, Oct. 13 (HealthDay News) -- In women with HIV-1 who have taken peripartum single-dose nevirapine, the use of ritonavir-boosted lopinavir with tenofovir-emtricitabine is associated with better outcomes than therapy featuring nevirapine, and in children with prior nevirapine exposure, benefits are seen with zidovudine and lamivudine plus ritonavir-boosted lopinavir, according to two studies published in the Oct. 14 issue of The New England Journal of Medicine.
Bisphosphonate Users at Possible Risk of Thigh Fracture
WEDNESDAY, Oct. 13 (HealthDay News) -- Bisphosphonates may put users at risk for atypical thigh bone fractures, according to a warning to health care providers and patients issued Oct. 13 by the U.S. Food and Drug Administration; the risk will be reflected in a labeling change and Medication Guide.
Bisphosphonates Up Risk of A-Fib in Cancer Patients
WEDNESDAY, Oct. 13 (HealthDay News) -- Older cancer patients who receive intravenous bisphosphonate therapy may be at a modestly increased risk for atrial fibrillation, supraventricular tachycardia (SVT), and stroke, according to research published online Oct. 12 in the Journal of Clinical Oncology.
Prior Aspirin Use Is Marker for Recurrent MI Risk After ACS
WEDNESDAY, Oct. 13 (HealthDay News) -- Patients with a history of aspirin use who experience an incident of acute coronary syndrome (ACS) are at modestly higher risk of recurrent myocardial infarction (MI), but not mortality, compared with non-prior aspirin users, according to a study in the Oct. 19 issue of the Journal of the American College of Cardiology.
Meta-analysis Shows Reboxetine Likely Ineffective
WEDNESDAY, Oct. 13 (HealthDay News) -- Reboxetine is likely ineffective for the treatment of major depressive disorder and associated with harmful adverse events, according to a study published online Oct. 12 in BMJ.
Macular Degeneration Treatments Assessed
TUESDAY, Oct. 12 (HealthDay News) -- Among patients with age-related macular degeneration, the use of bevacizumab and ranibizumab is not associated with higher risk of adverse outcomes including death, myocardial infarction, bleeding, and stroke, according to research published in the October Archives of Ophthalmology.
Nightly Blood Pressure Dosing Improves Outcomes
TUESDAY, Oct. 12 (HealthDay News) -- Administration of at least one blood pressure (BP) medication at night instead of upon waking appears to significantly improve BP control, decrease the prevalence of non-dipping, and reduce cardiovascular disease (CVD) morbidity and mortality, according to a study published in the September issue of Chronobiology International.
M.D.-Pharmacist Collaboration Helps Hypertensive Patients
TUESDAY, Oct. 12 (HealthDay News) -- A collaborative effort of physicians and pharmacists appears to result in improved blood pressure (BP) control in hypertensive patients, and continued education in cessation counseling may help physicians, but perhaps not pharmacists, do a better job at helping patients quit smoking, according to two articles published Oct. 11 in the Archives of Internal Medicine.
B-Vitamin Therapy May Not Be Useful
MONDAY, Oct. 11 (HealthDay News) -- Routine supplementation with folic acid for five years has no effect on cardiovascular outcomes, cancer incidence, or mortality, according to a meta-analysis published Oct. 11 in the Archives of Internal Medicine.
Obesity Drug Pulled From U.S. Market
FRIDAY, Oct. 8 (HealthDay News) -- Abbott Laboratories, maker of Meridia (sibutramine), agreed to voluntarily withdraw the obesity drug from the market because it might place users at increased risk of heart attack and stroke, according to an Oct. 8 announcement from the U.S. Food and Drug Administration.
Artemether-Lumefantrine As Effective As Quinine
THURSDAY, Oct. 7 (HealthDay News) -- The combination of artemether and lumefantrine appears to be better tolerated than, and as effective as, oral quinine for the treatment of uncomplicated malaria in the second and third trimesters of pregnancy, according to a study published online Oct. 6 in The Lancet Infectious Diseases.
Abatacept Found Ineffective for Non-Life-Threatening Lupus
THURSDAY, Oct. 7 (HealthDay News) -- In patients with non-life-threatening systemic lupus erythematosus (SLE), abatacept fails to prevent new flares and has a nearly one-in-five rate of serious adverse events (SAEs), according to a study in the October issue of Arthritis & Rheumatism.
Rolofylline Not Found to Help Acute Heart Failure Patients
WEDNESDAY, Oct. 6 (HealthDay News) -- The adenosine A1-receptor antagonist rolofylline does not appear beneficial in treating acute heart failure patients with renal dysfunction, according to research published in the Oct. 7 issue of the New England Journal of Medicine.
Omeprazole Shows Benefit With Aspirin, Clopidogrel
WEDNESDAY, Oct. 6 (HealthDay News) -- Omeprazole may be associated with a lower risk of upper gastrointestinal bleeding in patients taking aspirin and clopidogrel, without a significant increase in risk of cardiovascular events, according to research published online Oct. 6 in the New England Journal of Medicine.
Epinephrine for Anaphylaxis by Trained Individuals Endorsed
WEDNESDAY, Oct. 6 (HealthDay News) -- The Wilderness Medical Society has endorsed the administration of epinephrine to treat anaphylaxis in the field under emergency conditions by trained non-medical professionals, according to a panel statement published in the September issue of Wilderness & Environmental Health.
Consensus Statement Pushes Lower BP Goals in Blacks
TUESDAY, Oct. 5 (HealthDay News) -- The updated International Society on Hypertension in Blacks (ISHIB) consensus statement on the management of hypertension in this population places a major emphasis on comprehensive assessment and appropriate risk stratification of individual patients with hypertension, according to a report published online Oct. 4 in Hypertension.
Immunosuppressive Regimen Treats Pediatric Brain Illness
MONDAY, Oct. 4 (HealthDay News) -- Immunosuppressive therapy may improve long-term neurological outcomes in children with childhood primary angiitis of the central nervous system (CNS), according to research published online Oct. 4 in The Lancet Neurology.
Adjunctive Drug Helpful in Controlling Epileptic Seizures
MONDAY, Oct. 4 (HealthDay News) -- Patients taking rufinamide in addition to their regular antiepileptic medication experience a significant reduction in total partial seizures, according to research published online Sept. 30 in Epilepsia.
Cabazitaxel Prolongs Life in Advanced Prostate Cancer
FRIDAY, Oct. 1 (HealthDay News) -- Men with advanced prostate cancer that has resisted prior chemotherapy with docetaxel survive a median 2.4 months longer if they take cabazitaxel instead of mitoxantrone, according to the results of a phase III trial published in the Oct. 2, cancer-themed issue of The Lancet.
DMARDs, Glucocorticoids, Biologics Similar for RA
FRIDAY, Oct. 1 (HealthDay News) -- Treatment of rheumatoid arthritis (RA) with disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, biologics, or a combination of these agents significantly reduces radiographic evidence of joint destruction, with no advantage seen for patients whose treatment includes biologics, according to research published in the October issue of Arthritis & Rheumatism.
FDA Calls for Halt on Marketing of Unapproved Colchicine
FRIDAY, Oct. 1 (HealthDay News) -- The U.S. Food and Drug Administration has ordered companies manufacturing, distributing, or marketing unapproved single-ingredient oral colchicine to cease doing so.
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