FDA has approved fluticasone furoate and vilanterol inhalation powder (Breo Ellipta, GlaxoSmithKline and Theravance), an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
Individuals who regularly take statins to reduce high cholesterol will see lower hospitalization rates according to a study presented at the Academy of Managed Care Pharmacy’s 25th Annual Meeting & Expo in San Diego, in April.
Migraine prevention drugs used during pregnancy can cause decreased IQ scores in children born to mothers who take these medications, according to an FDA alert.
Zoster vaccination was associated with a reduction in post-herpetic neuralgia among those who are aged 65 and older, according to a study, published in PLoS Medicine. However, they also found that the use of the shingles vaccine was also very low among certain population groups
Interim data from a phase 2, multicenter, randomized, dose-ranging clinical trial evaluating the safety and antiviral activity of MK-5172 (Merck), for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection, was presented at the 2013 International Liver Congress, 48th annual meeting of the European Association for the Study of the Liver, in Amsterdam.
Data from a meta-analysis of 5 boceprevir (Victrelis, Merck) phase 3 clinical studies was presented at the 2013 International Liver Congress, 48th annual meeting of the European Association for the Study of the Liver, in Amsterdam.
FDA has approved ezetimibe and atorvastatin (Liptruzet, Merck) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet, according to the manufacturer.
A group of doctors and researchers is protesting the high cost of certain cancer drugs and is urging pharmaceutical companies to make changes.
Greater dietary fiber intake is significantly associated with lower risk of first stroke, according to a recent study published in Stroke.
For critically ill adults with multiorgan failure, early supplementation with glutamine or antioxidants does not improve clinical outcomes, and glutamine may increase the mortality rate of this patient population, according to a study published in the April 18 issue of the New England Journal of Medicine.
Women who are 15 years and older will have access to emergency contraceptive Plan B One-Step (levonorgestrel) as an over-the-counter (OTC) medication that will no longer be sold behind the counter, according to the FDA.
FDA has approved Prothrombin Complex Concentrate [Human] (Kcentra, CSL Behring), the first non-activated 4-factor PCC indicated for the urgent reversal of warfarin in patients with acute major bleeding.
Eighteen years of follow-up of the Prostate Cancer Prevention Trial (PCPT) suggests that 7 years of treatment with the 5-alpha-reductase inhibitor finasteride (Proscar) for prostate cancer prevention does not appear to affect mortality but does reduce the risk of a prostate cancer diagnosis.
Older men with metastatic castration-resistant prostate cancer (mCRPC) derive a similar if not superior survival benefit from treatment with enzalutamide as do younger men, according to a post-hoc analysis of the phase III AFFIRM trial.
Autism spectrum disorders (ASD) are complex neurodevelopmental disorders that involve significant social functional impairment and behavioral inflexibility. Autism is the most severe form of ASD and includes significant impairment in communication skills. Treatment of ASD is complex and involves a comprehensive educational interventional plan. Medications are used only as adjuncts, and only in cases in which maladaptive behaviors are severe or life-threatening, or to enable a patient to participate in their behavioral therapies. The most commonly used medications include second-generation antipsychotics (SGAs), selective serotonin reuptake inhibitors (SSRIs), and psychostimulants. Risperidone and aripiprazole are the only medications to carry an FDA indication to treat ASD-related symptoms. There is interest in using newer agents, such as atomoxetine, galantamine, rivastigmine, and memantine, to treat ASD-associated symptoms, but data are lacking to support their use.
Use of tivozanib, an experimental tyrosine kinase inhibitor (TKI) with increased specificity and potency for the vascular endothelial growth factor (VEGF) receptor, as initial targeted therapy for patients with advanced renal cell carcinoma did not translate into improved overall survival compared with sorafenib (Nexavar) in a phase 3 clinical trial.
The standard of care for hepatitis C (HCV) was uprooted in 2011. Prevailing treatment involved a combination of 2 drugs-pegylated-interferon and anti-viral ribavirin-taken for 1 year. Two new protease inhibitors, boceprevir and telaprevir, joined the regimen.
In November 2012, FDA approved tofacitinib (Xeljanz, Pfizer) 5 mg tablets for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have not had an adequate response to methotrexate or are intolerant to methotrexate. Tofacitinib, an oral non-biologic disease-modifying antirheumatic drug (DMARD) can be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. It is contraindicated for use with biologic DMARDs or with immunosuppressive agents, such as azathioprine and cyclosporine.
Medication Reconciliation, “Med Rec” as it has come to be known, is recognized as an important part of the growing practice of medication management and a critical step in improving the care of patients in all settings. Despite the many challenges associated with implementation of a successful Med Rec program, the potential for significant value drives the ongoing effort to find scalable, cost-effective solutions.
Anticoagulation while on docetaxel (Taxotere) chemotherapy is an independent predictor of survival in men with metastatic castration-resistant prostate cancer (mCRPC).
Pipeline preview, FDA actions in brief
Ponatinib (Iclusig; Ariad Pharmaceuticals) is an oral tyrosine kinase inhibitor (TKI) that was approved by FDA on December 14, 2012, for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myelogenous leukemia (CML) that is resistant or intolerant to previous TKI therapy, and for Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (Ph+ALL).
A new multinational study confirms the impact of the recently-approved lung cancer medication, crizotinib, on testosterone. The study was published online first in the April 12, 2013, issue of Cancer.
Prenatal exposure to valproate significantly increased the risk of autism spectrum disorder and childhood autism in the offspring of mothers who took the anti-epileptic agent, according to a study published in the April 24 issue of the Journal of the American Medical Association.
A draft bill that hopes to address regulatory gaps in oversight of pharmaceutical compounding would give the FDA authority to regulate compounding manufacturers that make sterile products without, or in advance of, a prescription and sell them across state lines, according to a statement by the Senate Health, Education, Labor, and Pensions (HELP) Committee.
FDA has issued a Drug Safety Communication indicating that the drug tolvaptan (Samsca, Otsuka American Pharmaceuticals), used in the treatment of electrolyte disturbances, can cause irreversible liver injury with the potential to result in liver transplant or death.
