| | | | | | | | Aliskiren: A novel oral renin inhibitor for the treatment of hypertension
| | | By
James S. Kalus, PharmD, BCPS (AQ CV)
| | | Cardiac function is regulated in part by the renin-angiotensin-aldosterone system, and current cardiovascular therapies work to antagonize this system by inhibiting the generation or action of angiotensin II. Aliskiren is the first drug to be reviewed by FDA in a new class of antihypertensive agents that directly inhibit the action of renin.
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| | | | | | | NSAID use in first trimester may increase risk of congenital anomalies
| | | Women who take prescribed non-steroidal anti-inflammatory drugs (NSAIDs) in early pregnancy, specifically the first trimester, may increase their risk of giving birth to a child with congenital anomalies, especially cardiac septal anomalies, compared with women who do not take NSAIDs during this period, according to a recent study published in Birth Defects Research (Part B).
| | | ADEs responsible for more than 700,000 visits to US emergency departments in 2004 and 2005
| | | Adverse drug events (ADEs) led to the treatment of an estimated 701,547 patients in US emergency departments (EDs) in 2004 and 2005, according to a recent study in the Journal of the American Medical Association (JAMA). Significantly, those patients ?65 years of age were 2 times more likely to have ED treatment for an ADE and approximately 7 times more likely to need hospitalization than their younger counterparts.
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| | | | | | | Clinical news updates from the 2006 AHA Scientific Sessions
| | | The American Heart Association (AHA) Scientific Sessions comprise the world's largest conference for scientists and healthcare professionals focusing on cardiovascular disease. The 2006 AHA Scientific Sessions, which took place Nov. 12–15 in Chicago, Ill, featured invited lectures and investigative reports. The conference included presentations on trials that evaluated investigational therapeutic agents, existing drugs and drug-related devices, and approved agents in alternative regimens or for alternative indications.
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| | | | Telbivudine
| | | Telbivudine was approved on October 25, 2006, for the treatment of chronic hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
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| | | | Infliximab
| | | Infliximab was approved on October 13, 2006, for the reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing, and elimination of corticosteroid use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
| | | Pramipexole
| | | Pramipexole was approved on November 7, 2006, for the treatment of moderate-to-severe primary restless legs syndrome (RLS).
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| | | | Pipeline Preview
| | | Approvable designations; Nonapprovable designation; Fast-track designations; Priority review; Orphan drug designations
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| | | | Effects of evidence-based formulary restrictions at a Veterans Affairs medical center
| | | By
Nathan Herling Moore
| | | The Oklahoma City Veterans Affairs Medical Center restructured its formulary system in 2003, creating a system of restrictive criteria for certain drugs to improve pharmaceutical cost effectiveness by enforcing evidence-based indications in the prescription system. The new criteria-restriction system required the use of formulary drugs as first-line therapy; prescriptions for nonpreferred, criteria-restricted drugs had to be justified by the prescriber at the time of prescription in accordance with the criteria established by the pharmacy and therapeutics (P&T) committee. To determine the effects of the system on cost avoidance and prescriber opinion, we analyzed drug utilization statistics and surveyed prescribers. Analysis demonstrated that the criteria-restriction system was an effective cost-avoidance tool because inappropriate prescriptions for restricted, high-cost drugs were curtailed in favor of lower-cost formulary alternatives. The total cost avoidance observed after placing 15 outpatient drugs in..
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| | | | First-time generic approvals (December 2006)
| | | Oxybutynin extended-release tablets, 15 mg (equiv to Ditropan XL extended-release tablets, 15 mg)
| | | FDA Actions in Brief (December 2006)
| | | Imatinib (Gleevec, Novartis) was approved for relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia, certain forms of myelodysplastic/myeloproliferative diseases, aggressive systemic mastocytosis, hypereosinophilic syndrome and/or chronic eosinophilic leukemia, and unresectable, recurrent, and/or metastatic dermatofibrosarcoma protuberans.
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Resources: 
Formulary archives are now available on ModernMedicine.com, a new online resource designed to meet the evolving needs of physicians.