Formulary Watch |
All News - Page 179
FDA posts quarterly drug safety report
October 14, 2008
FDA announced that the agency has posted on its website a report listing drugs that are being investigated for potential safety concerns.
Case of PML reported in efalizumab-treated patient
October 14, 2008
Genentech informed healthcare professionals that a 70-year-old patient who has been treated with efalizumab (Raptiva) for chronic psoriasis for >4 years has developed progressive multifocal leukoencephalopathy (PML), a rare, progressive disease of the central nervous system that is usually fatal.
Tiotropium improves long-term lung function in COPD
October 14, 2008
In the Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial, tiotropium therapy for patients with chronic obstructive pulmonary disease (COPD) was associated with long-term improvements in lung function, quality of life, and COPD exacerbations. The therapy did not, however, significantly reduce the rate of decline in forced expiratory volume in 1 second (FEV1) compared with placebo.
Formulary Digital Edition October 2008
October 1, 2008
Rational approaches to the treatment of mixed dyslipidemia; Focus on eltrombopag; Drug Watch: Agents in late-stage development for the treatment of hepatitis B and C virus infections
License Agreement (PDF)
October 1, 2008
Completion of this licensing agreement transferring copyright ownership to Formulary, is required and has to be signed by all article coauthors (a separate form for each author/coauthor of a single manuscript, each showing an original signature is required). The copyright form must not include any written notations other than the original written and printed signature of the author and date. This form should be mailed [not emailed or faxed] to Formulary when the article is submitted for publication consideration.
Drug Watch: Agents in late-stage development for the treatment of hepatitis B and C virus infections (October 2008) (PDF)
October 1, 2008
Drug Watch: Agents in late-stage development for the treatment of hepatitis B and C virus infections (October 2008)
Congress to consider changes to Medicare Part D drug plans
October 1, 2008
Even though the Medicare prescription drug benefit has provided access to medications at less-than-anticipated cost to the government-and lower out-of-pocket spending for seniors-many Democrats and consumer advocates want to overhaul the program. Critics contend that the federal government can negotiate prices with pharmaceutical companies that are lower than those obtained by private insurers operating prescription drug plans (PDPs), and some reformers charge that the program is too complex and confusing for elderly beneficiaries, pointing particularly to the infamous "donut hole" that is affecting more Medicare patients than anticipated.
ARBs demonstrate no beneficial effect on mortality in patients with heart failure
October 1, 2008
A systematic search of the literature published in the International Journal of Clinical Practice demonstrated that angiotensin receptor blockers (ARBs) used as monotherapy or in combination with angiotensin-converting enzyme (ACE) inhibitors are not associated with a beneficial effect on mortality in patients with heart failure (HF).
Labeling updates and warnings through October 2008 for adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), and rituximab (Rituxan)
October 1, 2008
Labeling updates and warnings through October 2008 for adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), and rituximab (Rituxan).
Ipratropium associated with increased risk of death in patients with COPD
October 1, 2008
A nested case-control analysis published in the Annals of Internal Medicine demonstrated an increased risk of all-cause and cardiovascular mortality among patients with recently diagnosed chronic obstructive pulmonary disease (COPD) treated with ipratropium.
FDA Pipeline preview, October 2008 (vernakalant, doripenem, custirsen, droxidopa, amrubicin, dronedarone, imatinib)
October 1, 2008
Recent FDA action (through October 2008) related to vernakalant, doripenem, custirsen, droxidopa, amrubicin, dronedarone, and imatinib.
Eltrombopag: A TPO receptor agonist for the treatment of chronic idiopathic thrombocytopenic purpura
October 1, 2008
Eltrombopag is a TPO receptor agonist that is currently pending FDA approval for the treatment of ITP. This agent has been granted orphan drug and priority review status. In May 2008, the Oncology Drugs Advisory Committee unanimously agreed that eltrombopag demonstrates a favorable risk:benefit profile for the short-term treatment of chronic ITP.
FDA actions in brief, October 2008 (Cancidas, Aloxi, Vidaza)
October 1, 2008
Recent FDA approvals and indications (through October 2008) related to Cancidas, Aloxi, and Vidaza.
Romiplostim (Nplate): Thrombopoietin mimetic peptibody approved for the treatment of chronic ITP
October 1, 2008
New biologic: Romiplostim (Nplate), a thrombopoietin mimetic peptibody, was approved on August 22, 2008, for the treatment of chronic ITP.
Tetrabenazine (Xenazine): Monoamine depleter approved for the treatment of chorea associated with Huntington's disease
October 1, 2008
New molecular entity: Tetrabenazine (Xenazine), a monoamine depleter, was approved on August 15, 2008, for the treatment of chorea associated with Huntington's disease.
Rational approaches to the treatment of mixed dyslipidemia
October 1, 2008
This article reviews the role of individual therapeutic agents and combination therapies that can be used for the treatment of mixed dyslipidemia.
Comparative effectiveness research legislation likely to raise drug pricing issues
September 1, 2008
The Comparative Effectiveness Research Act of 2008 would establish the Health Care Comparative Effectiveness Research Institute as a private, nonprofit, nongovernmental entity that would contract with government agencies and private research organizations to conduct systematic reviews, observational studies, and randomized controlled clinical trials to obtain evidence regarding the clinical effectiveness of therapies and treatments.
Primary androgen deprivation therapy does not prolong survival in most patients with prostate cancer
September 1, 2008
Primary androgen deprivation therapy (PADT), the second most common treatment for localized prostate cancer following prostatectomy, is no more effective than conservative medical management for prolonging survival in most older patients with prostate cancer.
Labeling updates and warnings through September 2008
September 1, 2008
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)
Rofecoxib, valdecoxib associated with increased risk of stroke
September 1, 2008
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).
Potentially inappropriate medication use in hospitalized older adults: A DUE using the full Beers criteria
September 1, 2008
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
September 1, 2008
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
September 1, 2008
Generic drugs approved by FDA (through September 2008) including nisoldipine extended-release tablets and divalproex delayed-release tablets
FDA Pipeline preview, September 2008
September 1, 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
September 1, 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
September 1, 2008
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)
September 1, 2008
Drug Watch: Agents in late-stage development for the treatment of types 1 and 2 diabetes mellitus (September 2008)
Formulary Digital Edition September 2008
September 1, 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
