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Recent FDA action (through November 2012) related to, H5N1 adjuvanted influenza vaccine, Pasireotide, Digoxin immune fab, Etirinotecan pegol, OBI-1, beclomethasone 17, 21-dipropionate, Regorafenib, Trastuzumab emtansine, A4250, Sildenafil

Medication-related adverse events tied to ED visits in the elderly

Adverse drug events in the elderly can be prevented with appropriate monitoring, according to CDC.

From the Academy of Managed Care Pharmacy 2012 Educational Conference: MS specialty drug treatment costs climb to two-thirds of total MS treatment cost

Multiple sclerosis (MS) specialty drug costs now account for more than two-thirds of MS patients' total cost of care, according to a new study presented at the Academy of Managed Care Pharmacy 2012 Educational Conference in Cincinnati, Ohio, in October.

From the Academy of Managed Care Pharmacy 2012 Educational Conference: Patients who adhere to statin regimens are healthier, but higher drug spending makes overall care more costly

Individuals with high cholesterol who stay on their statin medications over a 2-year period are healthier than comparable nonadherent individuals, but the overall cost of their care is slightly higher, according to a new study presented at the Academy of Managed Care Pharmacy 2012 Education Conference, in Cincinnati, Ohio, in October.

Escitalopram reduces the risk of depression in patients with HCV treated with interferon alpha

Pre-emptive therapy with the selective serotonin reuptake inhibitor escitalopram in patients initiating interferon therapy for hepatitis C virus (HCV) without psychiatric risk factors reduced the risk of depression, according to a recent study published in the Annals of Internal Medicine.

FDA Actions in Brief November 2012

Recent FDA Approvals (through November 2012) related to (Tofacitinib, Pfizer, Omacetaxine mepesuccinate, Teva, rivaroxaban, Janssen, darunavir)

Invermectin lotion eliminates head lice with 1 application

Topical ivermectin provided a good degree of cure in patients with head lice infection with 1 simple and easy-to-use application, according to a study published in the November 1 issue of the New England Journal of Medicine.

Aubagio (Teriflunomide)

New molecular entity: FDA approved teriflunomide (Aubagio, Genzyme, a Sanofi-Aventis company), a pyrimidine synthesis inhibitor, for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Analgesics linked to hearing loss in women

Women who regularly took the analgesics ibuprofen or acetaminophen 2 more days per week had an increased risk of hearing loss, according to a recent study published in a recent issue of the American Journal of Epidemiology.

Tudorza Pressair (Aclidinium bromide)

New combination: FDA approved aclidinium bromide (Tudorza Pressair, Forest) for the long-term maintenance treatment of bronchospasm associated with COPD.

2012: A year of novel pharmalogic agents in review

A look at the pharmacologic agents reviewed by Formulary in 2012.

Early therapy with basal insulin does not reduce cardiovascular outcomes in dysglycemic patients

Early initiation of basal insulin did not impact cardiovascular outcomes compared to standard management of glucose in patients with type 2 diabetes or elevated fasting glucose with cardiovascular risk factors.

From the American College of Obstetricians and gynecologists 60th Annual Clinic Meeting: Low-dose contraceptive patch comparable to combination oral contraceptive in safety, tolerability study

A low-dose contraceptive patch is comparable to combination oral contraceptive in a comparative study, according to phase 3 data presented at the American College of Obstetricians and Gynecologists' (ACOG) 60th Annual Clinical Meeting.

Stroke decreases in elderly, but rises in younger patients

Stroke is declining in the elderly but increasing at younger ages, according to research published online in Neurology.

Social value of statins merits actions to broaden treatment, improve adherence, study finds

New evidence suggests that statins generate large survival and health benefits at the population level and shows that the social value of the survival gains are large and go predominantly to consumers, according to a study published in a recent issue of Health Affairs.

Clinical pharmacists' partnership with hospices drives an evolution in PBM services

A look at pharmacist involvement in hospice care.

P&T community ponders economic goals of healthcare reform and pharmacy

Finally, the grueling election is over and healthcare reform is here to stay.

Updated antiplatelet guideline highlights surgical bleeding risk

The Society of Thoracic Surgeons (STS) has updated its clinical practice guideline on use of antiplatelet drugs during heart surgery.

FDA approves cabozantinib to treat rare type of thyroid cancer

FDA has approved cabozantinib (Cometriq, Exelixis and AstraZeneca) for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

Study: Similar safety, efficacy with dabigatran versus warfarin in diabetic patients with Afib

Patients with nonvalvular atrial fibrillation (NVAF) who also have diabetes experienced similar safety and efficacy with dabigatran etexilate mesylate (Pradaxa) 150 mg or dabigatran 110 mg relative to warfarin, in comparison to patients without diabetes who have NVAF, according to data presented at American Heart Association's Scientific Sessions 2012.

Antipsychotic drugs improve life expectancy for schizophrenia patients

Individuals with schizophrenia are significantly more likely to live longer if they take their antipsychotic drugs on schedule, avoid extremely high doses, and also regularly see a mental health professional, according to results of a Johns Hopkins study, published in Schizophrenia Bulletin.

FDA panel votes against making oxybutynin transdermal patch OTC

An FDA advisory panel voted against making oxybutynin transdermal patch (Oxytrol, Merck and Watson Pharma) available over-the-counter (OTC) for overactive bladder (OAB) in women, Medpage Today reported.

FDA approves first cell-culture vaccine for seasonal influenza

FDA approved Influenza Virus Vaccine (Flucelvax, Novartis Vaccines, the first cell-culture-derived vaccine, for individuals aged 18 years of age and older

No big surprises in ACA insurance regulations

The Obama administration moved ahead to implement provisions in the healthcare law that would make it illegal for insurance companies to deny coverage for those with pre-existing conditions. Other provisions of the Affordable Care Act (ACA) also would make it easier for consumers to compare health plans and easier for employers to promote and encourage employee wellness.

Best tocolytic therapy options outlined for preterm delivery

Prostaglandin inhibitors, such as celecoxib (Celebrex, Pfizer) and indomethacin (Indocin, Merck and Lundbeck) and calcium channel blockers, such as nifedipine and nicardipine (Cardene, Cornerstone Therapeutics) had the highest probability of delaying premature labor by 48 hours and improving maternal and neonatal outcomes, according to a systemic review and network meta-analysis published in a recent issue of BMJ.

Low back pain may be difficult to self-manage, study says

Low back pain may be difficult to self-manage, study says Self-management has small effects on pain and disability in people with low back pain, according to a study published online in Arthritis Care & Research.

Direct renin inhibitor adjunct not helpful in T2DM patients at high risk for CV, renal events

The direct renin inhibitor aliskiren, added to standard therapy with renin-angiotensin system blockade, in patients with type 2 diabetes who are at risk for cardiovascular and renal adverse events was not useful at lowering these events and may even be harmful, according to an online study published in the New England Journal of Medicine.

Statins may lower risk of cancer-related mortality

Patients with cancer who use statins regularly may have a lower risk of cancer-related mortality, according to a study published November 8 in the New England Journal of Medicine.

Study: Sleep deprivation may cause insulin resistance in adipocytes

Sleep restriction may contribute to poor health, including an increased risk for insulin resistance, type 2 diabetes, and obesity. In addition, fewer hours of sleep can adversely affect molecular metabolic pathways in peripheral human adipocytes, according to a clinical study published in the October issue of Annals of Internal Medicine.

Medication use for normal aging conditions overtake costs of treating most chronic diseases

Prescription-drug treatment regimens for conditions are a normal part of aging are now costing the nation more than many serious and potentially life-threatening disease, according to new research from Express Scripts.