Formulary Watch |

Prasugrel versus clopidogrel in patients with ACS

Prasugrel may not improve outcomes for patients under the age of 75 years with unstable angina or non-ST-segment elevation myocardial infarction who have not undergone revascularization, according to a study published in the New England Journal of Medicine.

ACIP: 2012-13 influenza vaccination recommendations

Recommendations for the 2012-2013 influenza season were recently published by the Advisory Committee on Immunization Practices. The recommendations include an updated vaccination schedule for children and information on virus strains, seizures, and egg allergy.

Aspirin may benefit prostate cancer patients

Anticoagulant therapy, particularly the use of aspirin, may reduce the risk of prostate cancer-specific mortality in men treated with radical prostatectomy or radiotherapy for prostate cancer, according to a study published online in the Journal of Clinical Oncology.

Acetaminophen dosing guidelines needed for overweight children, study shows

There is considerable discrepancy among caregivers and pharmacists regarding the appropriate dosage of acetaminophen for overweight and obese children, according to a recent study published online in the European Journal of Hospital Pharmacy Science and Practice.

FDA's CRDAC recommends against approving lixivaptan

FDA's Cardiovascular and Renal Drugs Advisory Committee recommended against approving lixivaptan (CRTX 080, Cornerstone Therapeutics), for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone, respectively.

FDA approves teriflunomide for patients with relapsing forms of MS

FDA has approved teriflunomide (Aubagio, Genzyme, a Sanofi company), a once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis.

Qualitest issues voluntary, nationwide recall for lot of hydrocodone bitartrate and acetaminophen tablets

Qualitest, a subsidiary of Endo Health Solutions, has issued a voluntary, nationwide retail-level recall for 1 lot of hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg.

FDA approves production of imaging agent to help detect prostate cancer

FDA has approved the production and use of Choline C-11 Injection (Mayo Clinic PET Radiochemistry Facility), a PET imaging agent used to help detect recurrent prostate cancer.

Gabapentin effective for chronic cough

Gabapentin may be an effective and well-tolerated treatment for patients with refractory chronic cough, according to a study published August 28 in The Lancet.

Azilsartan medoxomil-chlorthalidone fixed combination superior at reducing SBP

A fixed-dose combination of azilsartan medoxomil plus chlorthalidone (Edarbyclor, Takeda) was statistically superior to azilsartan medoxomil coadministered with hydrochlorothiazide at reducing and maintaining systolic blood pressure, according to the results of a phase 3 study published online August 31 in The American Journal of Medicine.

Clinical trials moving to emerging countries

International pharmaceutical companies are increasingly out-sourcing clinical trials to countries in Asia, Latin America, and Eastern Europe, in an attempt to save time, money, and resources, according to a new report from GBI Research.

Smoking quit rate and community-based programs

Retail pharmacies’ smoking cessation programs are effective in helping smokers quit, according to a study published in the September issue of The Annals of Pharmacotherapy.

Early administration of aspirin plus alteplase does not improve outcome in stroke patients

Early administration of intravenous aspirin, in addition to alteplase, does not improve functional outcome at 3 months for patients with acute ischemic stroke, but increases the risk of symptomatic intracranial hemorrhage, according to a study published online August 25 in The Lancet.

Mepolizumab effective in treating eosinophilic asthma

Mepolizumab significantly reduces asthma exacerbations in patients with severe eosinophilic asthma, according to a study published in the August 18 issue of The Lancet.

FDA panel backs tobramycin inhalation powder for patients with cystic fibrosis

An FDA advisory panel voted 13 to 1 that there was adequate evidence of efficacy and safety to support the use of tobramycin inhalation powder (Novartis) for the management of cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa.

FDA grants priority review to TB drug

FDA has granted priority review to bedaquiline, or TMC207 (Johnson & Johnson's Janssen Research & Development), for treatment of multidrug-resistant tuberculosis.

FDA approves new orphan drug for chronic myelogenous leukemia

FDA approved bosutinib (Bosulif, Pfizer) to treat chronic myelogenous leukemia, a blood and bone marrow disease that usually affects older adults.

Medicare Part D plans control drug spending

Drug Watch: Pain

Drug Watch: Pain

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Recent FDA action (through August 2012) related to, ferric carboxymaltose injection, Injectafer, abiraterone acetate, Zytiga, cabozantinib, Exelixis, eltrombopag, Promacta, AEZS-130 oral ghrelin agonist, inhaled nitric oxide, GeNO LLC, gevokizumab, XOMA, calcipotriene cream, Dovonex, montelukast sodium, Singulair, lidocaine topical patch 5%, Lidoderm, filgrastim, Neupogen

Myrbetriq (Mirabegron): A beta-3 adrenergic agonist indicated for the treatment of overactive bladder

New molecular entity: FDA approved Mirabegron (Myrbetriq, Astellas Pharma US) for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.

An evidence-based review of treatment options for irritable bowel syndrome

Irritable bowel syndrome is functional gastrointestinal disorder that is expensive to treat and can impair quality of life. Current therapies are reviewed.

From the American College of Cardiology Annual Scientific Session & Expo 2012: Formulary decision process at Mayo Clinic leads to abandoning 80-mg of simvastatin

A look at the decision process that lead the Mayo Clinic to abandon the 80-mg dose of simvastatin

Statin use may be linked to increased cataract risk

FDA Actions in Brief August 2012

Recent FDA Approvals (through August 2012) related to (CSL Limited, GlaxoSmithKline Biologicals, ID Biomedical Corp, MedImmune Vaccines, Novartis Vaccines and Diagnostics Limited, Sanofi Pasteur, Genentech, Talon Therapeutics, Amarin, Regeneron Pharmaceuticals, Horizon Pharma, Forest Pharmaceuticals, Onyx Pharmaceuticals, Novartis, Pfizer, Sagent Pharmaceuticals)

Belviq (Lorcaserin): A 5-HT2C receptor agonist indicated to treat certain overweight or obese adults

New molecular entity: FDA approved Lorcaserin (Belviq, Arena Pharmaceuticals GMBH), as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index deemed obese and the presence of at least 1 weight-related comorbid condition.

Former finasteride users with sexual side effects at increased risk for depressive symptoms, suicidal thoughts

Targeting the incretin system: Novel advances in the treatment of diabetes

Incretin-based therapies are now the most promising therapies for type 2 diabetes.

Teduglutide: A novel recombinant analog of human glucagon-like peptide-2 for short bowel syndrome

Teduglutide is a recombinant analog of human glucagon-like peptide-2 that is awaiting FDA approval for the treatment of short bowel syndrome (SBS) as a once-daily subcutaneous injection.

FDA approves new treatment for a type of late-stage prostate cancer

FDA approved enzalutamide (Xtandi, Astellas Pharma U.S. Inc. and Medivation) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.