In a review published in The Cochrane Library, researchers determined that atovaquone-proguanil and doxycycline were well tolerated by most travelers and are less likely than mefloquine to cause adverse neuropsychiatric outcomes.
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Cholesterol-lowering statin drugs do not reduce the risk of diabetes and might modestly elevate the chances of developing the condition, researchers found in a pooled analysis of trial data.
Atypical antipsychotic agents lead to a marked and rapid weight gain in children and adolescents, according to researchers at Zucker Hillside Hospital in Glen Oaks, NY and the Albert Einstein College of Medicine, NY.
Adding insulin to standard diabetes drugs results in better blood sugar control for many with type-2 diabetes, and the dose and timing of insulin received can make a big difference, British researchers report.
Horizon Therapeutics Inc., a privately held biopharmaceutical company, recently presented an analysis from 2 pivotal phase 3 trials (REDUCE-1 and REDUCE-2) evaluating its lead investigational compound HZT-501, a combination of ibuprofen with high-dose famotidine, PRNewswire reports.
Three prescription diet drugs are in the final stages of development. According to USA Today, the drugs' manufacturers still have to submit their new drug applications to FDA and go through a rigorous review and approval process.
The federal government?s push to control health costs through comparative effectiveness research could threaten strides in personalized medicine, in which medicines are tailored to an individual?s genetic makeup, said the National Institutes of Health chief at a recent forum sponsored by the American Association for the Advancement of Science.
Specialty pharmacy's role in REMS, FDA's new drug safety program; Focus on Fampridine-SR; FDA leadership promotes scientific integrity, quality standards
Agents in late-stage development for the treatment of mixed dyslipidemia, coronary heart disease, atherosclerosis, and hypertension
Recent FDA approvals (through October 2009) related to Sabril, Helixate FS, Valcyte, Metozolv ODT, Xyzal, Zevalin, Extavia, Astepro, Zenpep, and Bepreve
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FDA officials are taking steps to erase the charges of incompetency and ineffectiveness that have plagued the agency for several years.
New combination: Morphine/naltrexone extended-release capsules (Embeda) were approved on August 13, 2009, for the management of moderate-to-severe pain when continuous analgesia is needed for an extended time period
Recent FDA action (through October 2009) related to doxorubicin, trabectedin, carisbamate, alogliptin/pioglitazone, HPV vaccine, pralatrexate, romidepsin, hyaluronic acid, laromustine, clofarabine, prGCD, KNS-760704, rifaximin, hexvix, and quinazoline495
Generic drugs approved by FDA (through October 2009): 1% clindamycin/5% benzoyl peroxide gel, triamcinolone acetonide nasal spray, clonidine transdermal system, betamethasone acetate and betamathasone sodium phosphate injectable suspension
New formulation: Guanfacine extended-release tablets (Intuniv) were approved on September 2, 2009, for the treatment of attention-deficit/hyperactivity disorder (ADHD)
New molecular entity: Telavancin for injection (Vibativ) was approved on September 11, 2009, for the treatment of complicated skin and skin-structure infections (cSSSIs)
Fampridine-SR is a sustained-release oral medication that is pending FDA approval for the symptomatic treatment of multiple sclerosis (MS).
Specialty pharmacies are uniquely positioned to play a key role in the implementation of Risk Evaluation and Mitigation Strategies (REMS).
In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.
Novartis has issued a Dear Healthcare Professional letter regarding a risk of pure red cell aplasia (PRCA) in patients treated with mycophenolic acid (Myfortic).
FDA is reviewing reports of liver injury in patients treated with orlistat (prescription drug, Xenical; OTC drug, Alli) for obesity management or weight loss.
Tibotec has issued a Dear Healthcare Professionals letter regarding an increased risk of fatality caused by toxic epidermal necrolysis and hypersensitivity reactions, sometimes accompanied by hepatic failure, in patients treated with etravirine (Intelence).
Pharmacists can improve patient outcomes by following 3 major functions: identification of potential and actual medication-related problems (MRPs), resolution of actual MRPs, and prevention of potential MRPs. The best way to achieve these goals is through accurate documentation, and one of the chief obstacles to this is time?or rather the lack of it. Various software programs have been developed to help pharmacists reduce time spent identifying opportunities for interventions.
In the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography III (DECREASE III) trial published in the New England Journal of Medicine, patients undergoing noncardiac vascular surgery who were treated with perioperative fluvastatin demonstrated a lower incidence of myocardial ischemia than patients treated with placebo.
In the Study of Platelet Inhibition and Patient Outcomes (PLATO) published in the New England Journal of Medicine, patients with acute coronary syndrome (ACS) who were treated with ticagrelor had significant reductions in the rate of death from vascular causes, myocardial infarction (MI), or stroke and no significant increase in the rate of overall major bleeding versus patients treated with clopidogrel.
P&T considerations in fashioning a knowledge base, action plan for cardiometabolic disorders and weight; Focus on golimumab; Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders
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