Alteplase demonstrated to be safe and effacious for use in treatment of stroke within 3 hours of onset, according to a large multicenter, observational study.
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Treament of hypertension with a polypill is more effacious than single-drug treatment, according to a randomized, controlled, open-label trial.
Results of a double-blind, randomized, contolled trial of vildagliptin versus rosiglitazone demonstrate similar efficacy and tolerability in patients with type 2 diabetes.
Pulmonary arterial hypertension (PAH) is a disease state characterized by vascular narrowing and increased pulmonary vascular resistance. Physical symptoms, which may include fatigue or weakness, exertional dyspnea, and peripheral edema, are often nonspecific and can mimic more common disorders encountered in clinical practice. Healthcare professionals have been limited in which medications could be used to treat this condition because clinical data have been scarce. Recently, multiple new classes of medications, many of which are very costly, have become available; these agents offer physicians more therapeutic options for the treatment of PAH. Managed-care organizations have been challenged with suggesting the appropriate place in therapy for these new agents, as well as ensuring their safe and cost-effective utilization. This review summarizes the data available for the drugs used to treat PAH, with the goal of helping organizations to make appropriate decisions regarding the proper use of these agents.
Briefs of FDA actions related to medication safety and reliability (ie, boxed warnings, dear healthcare provider letters)
A large retrospective cohort study demonstrated an increased risk of suicide with use of the antidepressant venlafaxine.
In a large, population-based, case-control study, rofecoxib and celecoxib were associated with an excess risk of acute myocardial infarction (MI) in patients with a history of MI.
First-time generic drug approvals: Nadolol/bendroflumethiazide and ciprofloxacin
The latest FDA action (through May 2007) related to armodafinil (Nuvigil), tacrolimus (Prograf), sipuleucel-T (Provenge), Etoricoxib (Arcoxia), AZD-103/ELND005 (Transition), rNAPc2, Satraplatin, and Ganciclovir
Levetiracetam (Keppra) is now approved by FDA as an antiepileptic agent for adjunctive therapy in treatment of primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy.
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HepaGam B, a solution of hepatitis B immune globulin (human), is now approved by FDA for the prevention of hepatitis B recurrence after liver transplantation in HBsAg-positive patients.
The combination of sitagliptin/metformin is now approved by FDA to improve glycemic control in adult patients with type 2 diabetes mellitus.
All authors contributing manuscripts for consideration for publication in Formulary must disclose any real or apparent conflicts of interest due to affiliation with any company or manufacturer whose products are mentioned in the article they author.
A review of agents in late-stage development for the treatment of gastrointestinal disorders (April 2007).
Chronic kidney disease (CKD) affects 20 million Americans, and an additional 20 million are at increased risk for developing CKD. Anemia is a common complication in patients with CKD. Continuous erythropoiesis receptor activator (CERA) is a new erythropoiesis-stimulating agent (ESA) that is undergoing FDA review for the treatment of anemia in patients with CKD, including in those undergoing dialysis.
The need to reauthorize the Prescription Drug User Fee Act (PDUFA) before it expires September 30, 2007, has set the stage for congressional action on broader legislation to improve the handling of drug safety issues. Bills under consideration aim to expand FDA oversight by establishing new requirements for postmarket risk assessment, for posting active clinical trials and resulting study data, and for completing postmarket studies.
We propose using the results of pharmacodynamic Monte Carlo simulation studies as a surrogate marker for potential efficacy of antibiotic dosage regimens and applying these end points to the calculation of an incremental cost-effectiveness ratio (ICER).
One of the numerous factors shaping pharmacy and therapeutics (P&T) committees' operations and decisions is the push for electronic health information systems, including electronic prescribing (e-prescribing). E-prescribing is expected to help prescribers comply with plan formularies and formulary policies.
In patients with metastatic renal cell carcinoma, treatment with sunitinib yields longer progression-free survival rates and a better health-related quality of life than does the standard treatment, interferon alfa therapy, according to the results of a phase 3 trial published in the New England Journal of Medicine (NEJM). A total of 750 patients aged ≥18 years participated in this international, multicenter, randomized trial.
Maintaining treatment with imatinib as initial therapy in patients with chronic myeloid leukemia (CML) may yield positive outcomes, including increased overall survival to ≥5 years, according to a study published in the New England Journal of Medicine (NEJM). The follow-up study of the International Randomized Study of Interferon and ST1571 (IRIS), a multicenter, international, randomized, phase 3 trial, included patients aged 18 to 70 years diagnosed with Ph-positive CML in chronic phase within 6 months before the start of the study.
In a randomized double-blind, parallel- group trial, salmeterol plus fluticasone failed to reduce all-cause death in patients with moderate, severe, or very severe chronic obstructive pulmonary disease (COPD) compared with each of the agents alone or placebo. The results of the Towards a Revolution in COPD Health (TORCH) trial were published in the New England Journal of Medicine (NEJM).
Healthcare professionals assembled at the 56th Annual Scientific Session of the American College of Cardiology (ACC) from March 24 to 27, 2007, in New Orleans, La, to exchange information and updates about new and continuing research in cardiovascular disease.
A discussion of FDA-requested boxed warnings and medication labeling changes
The rate of anticoagulant-associated intracerebral hemorrhage has increased dramatically since 1988, according to an observational study published in the journal Neurology. Researchers identified all patients hospitalized with first-ever intracerebral hemorrhage (ICH) in the 5-county Greater Cincinnati, Ohio/Northern Kentucky area during 3 unique time periods.
A discussion of new FDA-approved indications and formulations of drugs
A discussion of generic drugs recently approved by FDA
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