Labeling updates and warnings through September 2008 for intramuscular naltrexone (Vivitrol) and for simvastatin (Zocor; generic simvastatin), ezetimibe/simvastatin (Vytorin), and niacin extended-release/simvastatin (Simcor) when used concurrently with amiodarone (Cordarone; Pacerone; generic amiodarone)
A retrospective cohort study published in the journal Stroke demonstrated an increased risk of stroke among users of rofecoxib and valdecoxib but not among users of other nonsteroidal anti-inflammatory drugs (NSAIDs).
The purpose of this drug use evaluation was to report potentially inappropriate medication use, as defined by the full Beers criteria.
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.
Generic drugs approved by FDA (through September 2008) including nisoldipine extended-release tablets and divalproex delayed-release tablets
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.
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
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)
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
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)
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.
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.
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.
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.
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).
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.
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, 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.
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).
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.
Recent FDA approvals and indications (through August 2008) related to Concerta, Avodart, Prandimet, Trivaris, Reclast, Requip XL, Aciphex, Aptivus, Kinrix, Pentacel, and Durezol.
New indication: Duloxetine (Cymbalta), an SSNRI, was approved on June 13, 2008, for the management of fibromyalgia
Generic drugs approved by FDA (through August 2008) including risperidone tablets.
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.
