Formulary Watch |

Potentially inappropriate medication use in hospitalized older adults: A DUE using the full Beers criteria

The purpose of this drug use evaluation was to report potentially inappropriate medication use, as defined by the full Beers criteria.

Alogliptin: A dipeptidyl peptidase-IV inhibitor for the treatment of type 2 diabetes

Alogliptin is a highly selective DPP-IV inhibitor under investigation for the treatment of type 2 diabetes. An NDA for alogliptin was submitted in January 2008, and a response from FDA is expected in the fourth quarter of this year.

First-time generic drug approvals, September 2008

Generic drugs approved by FDA (through September 2008) including nisoldipine extended-release tablets and divalproex delayed-release tablets

FDA Pipeline preview, September 2008

Recent FDA action (through September 2008) related to Immediate-release diclofenac capsules, tocilizumab, sugammadex, topical alprostadil cream, fospropofol, iloperidone, lacosamide, and vascular endothelial growth factor b.

FDA actions in brief, September 2008

Recent FDA approvals and indications (through September 2008) related to Diovan HCT, Exforge, Cleviprex, Eovist, Stavzor, Promus Everolimus-Eluting stent, and Xience V Everolimus-Eluting stent

Tenofovir (Viread): Antiviral agent approved for the treatment of chronic hepatitis B in adults

New indication: Tenofovir (Viread), an antiviral agent, was approved on August 13, 2008, for the treatment of chronic hepatitis B in adults.

Drug Watch: Agents in late-stage development for the treatment of types 1 and 2 diabetes mellitus (September 2008) (PDF)

Drug Watch: Agents in late-stage development for the treatment of types 1 and 2 diabetes mellitus (September 2008)

Formulary Digital Edition September 2008

Potentially inappropriate medication use in hospitalized older adults: A DUE using the full Beers criteria; Focus on alogliptin; Drug Watch: Agents in late-stage development for the treatment of types 1 and 2 diabetes mellitus

Formulary Digital Edition August 2008

Clinical updates from the 68th Scientific Sessions of the American Diabetes Association; Focus on tocilizumab; Drug Watch: Agents in late-stage development for the treatment of type 2 diabetes mellitus

Information for Authors (revised 8/2008) (PDF)

Information for Authors (revised 8/2008) (PDF)

Erythropoiesis-stimulating agents for anemia in older adults

Erythropoietin, a humoral factor produced predominantly in the kidney, stimulates red blood cell production in the bone marrow. Erythropoiesis-stimulating agents (ESAs) have been used for years in the treatment of anemia, with extensive experience and benefits in anemia of chronic kidney disease. Recent data have suggested adverse consequences with use of ESAs, perhaps relating to inappropriate use, and prompting release of guidelines to ensure safe use and maximize benefit. When prescribing ESAs, indications, requirements to monitor laboratory parameters (hemoglobin levels and ferrokinetics), and clinical status need to be stringently followed.

Safety surveillance to transform drug development and oversight

FDA has launched the Sentinel Initiative to expand and improve medical product risk detection and evaluation. Instead of relying on passive, voluntary adverse event (AE) reports sent to FDA by physicians and pharmacists, the agency would be able to detect safety signals much more quickly through links to health information databases containing information about millions of patients.

Raltegravir plus optimized background therapy superior to optimized background therapy alone in treatment of resistant HIV

Two randomized, double-blind, phase 3 clinical trials demonstrated that raltegravir plus optimized background therapy was more effective than optimized background therapy alone in suppressing resistant HIV-1.

Treatment with SSRIs or venlaxafine associated with increased risk of GI bleeding

In a nested, case-control study published in the Archives of General Psychiatry, investigators observed that the use of selective serotonin-reuptake inhibitors (SSRIs) increased the risk of upper gastrointestinal (GI) tract bleeding; this increased risk was also observed with the serotonin and norepinephrine reuptake inhibitor (SNRI) venlafaxine. This risk may be increased when the agents are used concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDs) and decreased when used concomitantly with acid-suppressing agents.

Methotrexate plus etanercept effective in inducing clinical remission in patients with early moderate-to-severe RA

The first phase of a double-blind, randomized, parallel-group, multicenter, outpatient study demonstrated that treatment with the combination of etanercept and methotrexate was more effective in inducing both clinical remission and radiographic nonprogression than methotrexate alone in patients with early moderate-to-severe rheumatoid arthritis (RA).

Addition of aliskiren to losartan provides additional renal protective effects in hypertensive patients with type 2 diabetic nephropathy

A recent multinational, randomized, double-blind, placebo-controlled clinical trial demonstrated that administration of aliskiren provides additional renal protection to patients with hypertension, type 2 diabetes mellitus, and nephropathy who are already receiving optimal antihypertensive therapy and renal protective therapy with the angiotensin receptor blocker (ARB) losartan.

Clinical news updates from the 68th Scientific Sessions of the American Diabetes Association

Among the new data presented at the 68th Scientific Sessions of the ADA were the results of phase 3 trials of the investigational agents liraglutide, ABT-335, saxagliptin, and alogliptin.

Tocilizumab: A humanized anti-IL-6 receptor monoclonal antibody for the treatment of rheumatoid arthritis

Tocilizumab, an investigational agent for the treatment of moderate-to-severe rheumatoid arthritis, is a humanized anti-IL-6 receptor monoclonal antibody. Because tocilizumab contains a mouse monoclonal antibody grafted onto human immunoglobulin, the grafted antibody is less antigenic and has a longer half-life than the mouse antibody. When administered, tocilizumab inhibits IL-6 activity by competing for both the membrane-bound and soluble types of IL-6 receptors, thus eliminating IL-6 transduction into the cell.

Medication safety labeling updates and new warnings, August 2008

Labeling updates and warnings through August 2008 for abacavir (Ziagen) and abacavir-containing agents (Epzicom, Trizivir) and ciprofloxacin (Cipro), ciprofloxacin extended-release (Cipro XR. Proquin XR), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin).

Dronedarone associated with increased mortality in patients with severe heart failure

In the Antiarrhythmic Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA) investigators observed that dronedarone, an anti-arrhythmic agent related to amiodarone, was associated with increased mortality in patients who were hospitalized for symptomatic heart failure (HF) (New York Heart Association [NYHA] class II, III, or IV) and left ventricular systolic dysfunction.

FDA actions in brief, August 2008

Recent FDA approvals and indications (through August 2008) related to Concerta, Avodart, Prandimet, Trivaris, Reclast, Requip XL, Aciphex, Aptivus, Kinrix, Pentacel, and Durezol.

Duloxetine (Cymbalta): SSNRI approved for the management of fibromyalgia

New indication: Duloxetine (Cymbalta), an SSNRI, was approved on June 13, 2008, for the management of fibromyalgia

First-time generic drug approvals, August 2008

Generic drugs approved by FDA (through August 2008) including risperidone tablets.

FDA Pipeline preview, August 2008

Recent FDA action (through August 2008) related to long-acting depot preparation of testosterone, pancrealipase capsules, human papillomavirus (HPV) quadrivalent (types 6, 11, 16, 18) vaccine, recombinant, tolvaptan, etanercept, ustekinumab, and cysteamine hydrocortisone dual-release table.

Bortezomib (Velcade): Antineoplastic agent approved for the initial treatment of multiple myeloma

New indication: Bortezomib (Velcade), an antineoplastic agent, was approved on June 20, 2008, for the initial treatment of multiple myeloma.

Drug Watch: Agents in late-stage development for the treatment of type 2 diabetes mellitus (August 2008) (PDF)

Drug Watch: Agents in late-stage development for the treatment of type 2 diabetes mellitus (August 2008)

Orphan drug program continues to yield treatments for serious conditions

The US orphan drug program has demonstrated that economic incentives and regulatory flexibility can spur development of treatments for small patient populations. Since enactment of the Orphan Drug Act (ODA) in 1983, FDA has approved >300 medicines for approximately 12 million patients around the world. However, there are approximately 6,000 to 8,000 rare diseases, so “we still have a very long way to go,” commented Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), at a May conference commemorating ODA’s 25th anniversary, which was sponsored by the Drug Information Association (DIA).

Update on the diagnosis and treatment of hospital-acquired pneumonia

Hospital-acquired pneumonia (HAP) is a frequently occurring complication of endotracheal intubation and hospitalization that is associated with a significant increase in morbidity, mortality, and cost of care.

Tolvaptan: A novel oral vasopressin V2 receptor antagonist for the treatment of acute decompensated heart failure and hyponatremia

Tolvaptan is an oral selective vasopressin V2 receptor antagonist that works to produce aquaresis (water diuresis without electrolyte excretion) by blocking the effects of AVP. This effect makes tolvaptan a viable treatment option for patients with acute decompensated heart failure (ADHF) and hyponatremia.

First-time generic drug approvals, July 2008

Generic drugs approved by FDA (through July 2008) including fluoxetine capsules and calcipotriene topical solution.