Formulary Watch |
All News - Page 150
Intensive-dose statin therapy may increase diabetes risk
July 1, 2011
Intensive-dose statin therapy appears to be associated with an increased risk of new-onset diabetes compared with moderate-dose therapy, according to a meta-analysis of data from 5 statin trials published in the June 22/29 issue of JAMA.
American Urological Association: 5-ARI, alpha-blocker differ in number of BPH-related complications
July 1, 2011
The 5-alpha-reductase inhibitor dutasteride is associated with markedly lower BPH-related complication rates than the alpha-blocker tamsulosin, according to analysis of 2 large trials.
Guidelines tailored to each individual's needs can improve outcomes, reduce costs
July 1, 2011
Individualized guidelines present a much more efficient way of using drugs and other treatments compared with current guidelines.
Alzheimer's disease: Current treatment options and future developments
July 1, 2011
The incidence of Alzheimer's disease is expected to increase through the year 2050 with an estimated prevalence of 11 to 16 million cases. Two classes of medications are FDA approved for managing symptoms of AD, cholinesterase inhibitors and an N-methyl-D-aspartase receptor antagonist..
First-time generic approval July 2011
July 1, 2011
Generic drug approved by FDA (through June 2011): levofloxacin
FDA Actions in Brief July 2011 (Oxecta, Creon, Lupron Depot, Nulojix, Zutripro Oral Solution, Potiga, Solesta, Dificid, Istodax, Rectiv, IaViv)
July 1, 2011
Recent FDA Approvals (through June 2011) related to Oxecta, Creon, Lupron Depot, Nulojix, Zutripro Oral Solution, Potiga, Solesta, Dificid, Istodax, Rectiv, IaViv
Development of biosimilars creates challenges for FDA, manufacturers
July 1, 2011
FDA is developing guidelines for documenting similarity and interchangeability of copycat versions of biotech therapies, a process that is drawing considerable scrutiny from a broad spectrum of stakeholders.
Short-cycle prescribing puts a lid on medication waste
July 1, 2011
With more and more costly drugs breaking the bank for patients and payers, managed care organizations are developing programs to reduce a small niche of waste associated with early discontinuation of medication therapy.
Academy of Managed Care Pharmacy: CER reviews valuable, but not used to full potential
July 1, 2011
Comparative effectiveness research reviews are valuable resources for guiding medication use decisions, but they are underutilized, according to a recent presentation.
Drospirenone-containing contraceptives associated more commonly with venous thromboembolism than those utilizing levonorgestrel
July 1, 2011
In a recently published study, researchers have presented new evidence suggesting that oral contraceptives containing drospirenone result in a greater than 2-fold increased odds of developing non-fatal, idiopathic venous thromboembolism compared to current users of products containing levonorgestrel.
American Urological Association: Overactive bladder agent demonstrates efficacy, tolerability in phase 3 trial
July 1, 2011
The selective beta3-adrenoceptor agonist mirabegron effectively improves symptoms of overactive bladder and is very safe and well tolderated, according to results of a phase 3 study.
Low vitamin D levels may be associated with diabetes; supplementation trials needed
July 1, 2011
New studies confirm the lower levels of vitamin D are associated with a higher risk of developing diabetes and diabetic retinopathy.
Quadrivalent meningococcal polysacchardie diptheria toxoid conjugate vaccine (Menactra): Treatment to prevent invasive meningococcal disease caused by Neisseria meningitis serogroups A, C, Y, and W-135
July 1, 2011
New indication: Menactra Quadrivalent meningococcal polysacchardie diptheria toxoid conjugate vaccine was approved by FDA as treatment to prevent meningococcal disease in infants and toddlers as young as 9 months of age.
Reports of hepatosplenic T-cell lymphoma in patients taking tumor necrosis factor blockers, azathioprine, mercaptopurine continue
July 1, 2011
According to a new safety communication recently released by FDA, the agency is continuing to receive reports of a rare but aggressive white blood cell cancer often referred to as hepatosplenic T-cell lymphoma in patients receiving tumor necrosis factor blockers, azathioprine, and mercaptopurine.
Vandetanib oral kinase inhibitor (Vandetanib): Oral kinase inhibitor for the treatment of progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
July 1, 2011
New molecular entity: Vandetanib is a oral kinase inhibitor approved by FDA to treat progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
Academy of Managed Care Pharmacy: Generic drug trend forecasting can help MCOs rein in costs
July 1, 2011
Some of the most prescribed blockbuster medications will lose market exclusivity in the next couple of years, according to a recent presentation.
Rivaroxaban: a novel oral factor Xa inhibitor to prevent stroke in nonvalvular atrial fibrillation
July 1, 2011
Rivaroxaban is an oral, direct factor Xa inhibitor under review by FDA for stroke prevention in patients with atrial fibrillation. Atrial fibrillation conveys a 5-fold increased risk for stroke.
FDA Pipeline Preview, July 2011 (Pfizer, Pain Therapeutics, Regeneron Pharmaceuticals, Alexion, Tioga Pharmaceuticals, Emergent BioSolutions, Synageva BioPharma, Aradigm, Mobius Therapeutics, Morphotek)
July 1, 2011
Recent FDA action (through June 2011) related to oxycodone, aflibercept opthalmic solution, icatibant, eculizumab, asimadoline, anthrax vaccine, SBC-102 enzyme replacement therapy, ciprofloxacin, mitosol, MORAb-004 and MORAb-066, levofloxacin.
Adoption of evidence-based therapies associated with increased survival of STEMI patients
July 1, 2011
In a recently published observational registry study, researchers have demonstrated that the utilizatio of evidence-based therapies in patients experiencing ST-elevation myocardial infarction is on the rise.
Low-cost generics are mixed blessing for diabetes treatment
July 1, 2011
Low-cost generic drug programs pioneered by Wal-Mart and other big-box retailers are a mixed blessing for patients with diabetes.
Breaking news: FDA issues CRL for Remoxy, cites inconsistencies in its drug release performance
June 28, 2011
Pfizer?s second attempt at an abuse-resistant formulation of oxycodone (Remoxy) recently received a complete response letter (CRL) from FDA. Just a week earlier, FDA approved another of the drug maker?s abuse-resistant products ? immediate-release Oxecta (oxycodone HCl) ? for the management of acute and chronic moderate-to-severe pain.
Breaking news: FDA calls for changes in ESA dosing for patients with chronic kidney disease
June 28, 2011
FDA has announced more conservative dosing recommendations for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease (CKD) because of increased risk of cardiovascular events such as stroke, thrombosis, and death.
Crizotinib shows early promise as treatment for ALK+ NSCLC
June 24, 2011
Crizotinib demonstrated an association with a sharp increase in survival rates for patients with advanced non-small cell lung cancer with an anaplastic lymphoma kinase positive genetic alteration, according to the results of a study presented at the annual meeting of the American Society of Clinical Oncology.
FDA warns of adverse cardiovascular events associated with varenicline, notes label change
June 24, 2011
Safety information regarding varenicline will be added to the Warnings and Precautions section of the label and to the patient Medication Guide because smoking cessation aid varenicline may be associated with an increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.
FDA alerts pharmacists to risperidone, ropinirole mix-ups
June 24, 2011
FDA announced reports of medication errors involving risperidone and ropinirole in which some patients who took the wrong medication needed to be hospitalized.
Higher-dose antiepileptics increase risk of congenital malformations
June 24, 2011
Study shows that several common antiepileptic drugs pose the risk of major congenital malformations and that risk increases dose-dependently.
FDA revises labels, recommends limiting simvastatin dosing
June 24, 2011
FDA announced changes to safety labels for simvastatin, Vytorin, and Simcor, including dosing recommendations and is advising physicians to limit the use of 80-mg simvastatin due to an increased risk of myopathy.
CDER to transition Office of Compliance to Super Office
June 17, 2011
The Center for Drug Evaluation and Research recently announced that it will elevate the Office of Compliance to a Super Office to continue to ensure the safety, quality, and integrity of drugs in America, according to a memo from CDER Director Janet Woodcock.
BUD/FORM maintenance and reliever therapy effective asthma control
June 17, 2011
Budesonide/Formoterol maintenance and reliever therapy is an effective option for patients requiring treatment adjustments across Steps 2 to 4 of the Global Initiative for Asthma guidelines, according to the results of a study published online, June 2 in Respiratory Research.
