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All News - Page 160
Treatment of bipolar disorder: A focus on medication therapy for mania
March 1, 2011
In recent years there has been an explosion of new investigations into the pathophysiology of bipolar disorder and its medication therapies. This article will review current, emerging, and controversial therapies for the treatment of bipolar disorder, specifically the mania aspect.
Ceftaroline: A novel cephalosporin with methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae activity
March 1, 2011
Ceftaroline has demonstrated activity against methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae as well as common respiratory Gram-negatives including Haemophilus, Moraxella, and Klebsiella species.
FDA approves azilsartan medoxomil to treat hypertension
February 28, 2011
FDA approved azilsartan medoxomil tablets (Edarbi, Takeda Pharmaceutical North America) to treat hypertension in adults.
Drugs in short supply: Change and challenge among all stakeholders
February 25, 2011
Unprecedented levels of drug shortages, especially those drugs for which there are no substitutes, has prompted legislators to take action. Since the inception of the FDA Drug Shortage Program in 2000, the agency has been tracking the nation?s prescription pharmaceuticals and publishing a list of drugs in short supply.
Two drugs show promise in advanced pancreatic neuroendocrine tumors
February 24, 2011
Sunitinib and everolimus improved progression-free survival in patients with advanced pancreatic neuroendocrine tumors, according to 2 recent studies.
Black box warnings accelerate reduced antipsychotic use in dementia
February 24, 2011
The rate of decline in the use of atypical antipsychotics in outpatients with dementia accelerated following a black box warning by FDA, according to a multicenter study of national Veterans Affairs data.
TXA reduces death from bleeding in trauma patients
February 24, 2011
Tranexamic acid reduces the risk of death from bleeding without increasing the risk of vascular occlusive events or the need for surgical intervention in patients with acute traumatic injury, according to a review published in the 2011 Cochrane Database of Systematic Reviews.
FDA warns against terbutaline for preterm labor
February 24, 2011
FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor because of the risk for serious maternal heart problems and death.
Merck Serono pulls European application for oral MS drug Movectro
February 23, 2011
Merck Serono Europe informed the European Medicines Agency that it was withdrawing its marketing authorization application for oral cladribine (Movectro), 10-mg tablets, intended for the treatment of relapsing-remitting multiple sclerosis.
Forest to acquire Clinical Data
February 23, 2011
Forest Laboratories $1.2 billion acquisition of Clinical Data, the developer of Viibryd (vilazodone HCl) for the treatment of adults with major depressive disorder, is expected to allow Forest to leverage its existing presence in the antidepressant category.
FDA approves Corifact to prevent bleeding in people with rare genetic defect
February 18, 2011
FDA has approved Corifact (CSL Behring), the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.
FDA fast tracks Vascugel
February 18, 2011
FDA has granted fast-track designation to a novel endothelial cell-based therapy (Vascugel, Pervasis) for the prevention of hemodialysis access failure in patients with end-stage renal disease.
Herpes zoster vaccine on back order
February 18, 2011
Less than 1 month after the Centers for Disease Control and Prevention?s Advisory Committee on Immunization Practices recommended that most Americans aged 60 years and older get vaccinated to prevent herpes zoster, the vaccine (Zostavax, Merck) is on back order.
Rosiglitazone label and medication guide updated with cardiovascular risks
February 18, 2011
FDA has announced that the physician labeling and patient medication guide for rosiglitazone (Avandia, GlaxoSmithKline) have been changed to include information on cardiovascular risks (including death) of this agent.
ACIP revises adult immunization schedule for 2011
February 18, 2011
The Advisory Committee on Immunization Practices announces several changes to the recommended adult immunization schedule for 2011.
Variations in DMARD receipt exist in Medicare managed care patients with RA
February 18, 2011
An analysis of data from more than 90,000 Medicare managed care enrollees who received care for rheumatoid arthritis found that more than one-third did not receive the recommended treatment with a disease-modifying antirheumatic drug, and that receipt varied by demographic factors, socioeconomic status, geographic location, and health plan, according to a study in JAMA.
Oseltamivir oral suspension on back order due to increased demand
February 18, 2011
Oseltamivir phosphate oral suspension (Tamiflu) is on back order due to increased demand, manufacturer Genentech announced.
Sanofi-aventis to acquire Genzyme
February 17, 2011
The $20.1 billion acquisition of Genzyme by Sanofi-aventis will allow Sanotif-aventis to expand its footprint in biotechnology and give it an edge in the market for drugs for rare diseases, according to experts.
Zinc may shorten common cold
February 16, 2011
Zinc, in lozenge or syrup form, is beneficial in reducing the duration and severity of the common cold in healthy people, when taken within at least 24 hours of onset of symptoms, according to a new report published in the Cochran Library.
FDA issues CRL for Contrave
February 11, 2011
FDA has issued a complete response letter for Orexigen's and Takeda's Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.
FDA approves drug to prevent premature births
February 11, 2011
FDA has approved hydroxyprogesterone caproate injection (Makena [formerly known as Gestiva], Hologic and KV Pharmaceutical Co.), the first drug to help prevent premature delivery before 37 weeks in women who have had at least 1 previous preterm birth.
FDA approves vaccine for meningococcal disease in children
February 11, 2011
FDA has approved a vaccine for preventing meningococcal disease in children.
Vaccine may help patients avoid herpes zoster recurrence
February 11, 2011
Recurrences of herpes zoster may be more common in immunocompetent adults than once thought, according to a study published in the February issue of Mayo Clinic Proceedings, as reported in Newswise.
Escitalopram reduces number and severity of menopausal hot flashes
February 4, 2011
Escitalopram, a selective serotonin reuptake inhibitor, at doses of 10 or 20 mg/d significantly reduced hot flash frequency and severity compared with placebo, according to a recent multi-center, double-blind study.
FDA approves gabapentin once-daily for post-herpetic neuralgia
February 4, 2011
FDA has approved gabapentin (Gralise, Depomed and Abbott Products) tablets for once-daily treatment of post-herpetic neuralgia.
Analgesic medication errors, including prescribing errors, common but preventable
February 4, 2011
Medication errors involving analgesics, including mistakes in prescribing, are a major contributor to suboptimal therapeutic outcomes and preventable adverse patient events, according to a study published in the Journal of Pain, reported Newswise.com.
ACIP revises guidelines for influenza vaccination
February 4, 2011
The Centers for Disease Control and Prevention?s Advisory Committee on Immunization Practices has issued revised guidelines for vaccinating patients against influenza, reported Medscape Medical News.
Eisai receives CRL for GERD drug
February 2, 2011
FDA has issued a complete response letter to Eisai for its rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive GERD, and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.
FDA issues CRL for obesity treatment due to concerns about cardiovascular safety
February 2, 2011
FDA has issued a complete response letter for Orexigen?s and Takeda?s Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.
