Diabetic peripheral neuropathy, one of the most common late complications of diabetes, is associated with decreased quality of life and increased morbidity. The pathophysiology of diabetic neuropathy (DN) is multifactorial, contributing to ischemic and painful events and neuronal damage.
The labeling for darbepoetin alfa (Aranesp, Amgen) and epoetin alfa (Epogen, Amgen and Procrit, Ortho Biotech) was revised to include information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with the agents. This has been reported predominantly in patients with chronic renal failure receiving these products by subcutaneous administration.
In an observational study of patients with type 2 diabetes being treated for heart failure, researchers found that metformin—whether used alone in vulnerable patients or in combination—is associated with lower mortality, less morbidity, and fewer hospitalizations compared with sulfonylurea monotherapy. The study, conducted in Canada, was published in Diabetes Care.
This dual-acting antidepressant is believed to exert its effect through the inhibition of neuronal serotonin and norepinephrine reuptake. Venlafaxine was approved on November 18, 2005, for the treatment of panic disorder, with or without agoraphobia, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
The injectable antibiotic ertapenem (Invanz, Merck) was approved by FDA to treat moderate-to-severe complicated foot infections due to indicated pathogens in patients who have diabetes without osteomyelitis
Thalidomide (Thalomid, Celgene) as a treatment for multiple myeloma
The epidermal growth factor receptor (EGFR) is expressed on the surface of normal cells and cancer cells, and erlotinib inhibits the intracellular phosphorylation of tyrosine kinase associated with EGFR.
Review of agents in late-stage development for the treatment of asthma (November 2005).
In response to the emerging threat of pandemic (avian) influenza, FDA has announced the formation of a Rapid Response Team to ensure that antiviral drugs are available to citizens in the United States if they are needed. While avian flu has not emerged in this country, the team will help ensure an adequate supply of treatments, such as oseltamivir (Tamiflu, Roche) and other anti-influenza drugs, for stockpiling in the event there is an outbreak in the United States.
In an effort to meet the administration's goal of expanded electronic government, FDA is requiring drug manufacturers to submit prescription drug label information to the agency in a new electronic format. This electronic format will allow healthcare providers and consumers to more easily access the product information found in package inserts for all approved medications in the United States.
The future leadership of FDA remains highly uncertain following the unexpected resignation of commissioner Lester M. Crawford, DVM, PhD, in September. Andrew C. von Eschenbach, MD, director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH), was named acting FDA commissioner, but conflict arose initially because Dr von Eschenbach wanted to retain a leadership role at NCI while also taking the helm of FDA. Although he handed over day-to-day leadership of NCI to a deputy, that move failed to fully appease critics concerned about conflicts of interest in advocating for speedy access to new cancer treatments while overseeing the safety and effectiveness of those therapies. Department of Health & Human Services (HHS) secretary Michael Leavitt has indicated that Dr von Eschenbach is not likely to get the top job at FDA on a permanent basis.
Men who have used 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors to reduce their cholesterol levels may be at less risk of developing prostate cancer, according to a case-control study published in the American Journal of Epidemiology.
Results from a 6-month, phase 3b/4 study of eszopiclone (Lunesta, Sepracor) in adult patients with chronic insomnia demonstrated that nightly use of eszopiclone 3 mg resulted in statistically significant improvements (P<.0001) compared with placebo in patient-reported measures of sleep latency (onset of sleep), sleep maintenance, total sleep time, and sleep quality. These results were announced in late September at the American Neurological Association (ANA) Annual Meeting in San Diego, Calif.
Eszopiclone (Lunesta, Sepracor), a novel, non-benzodiazepine sleep aid, shows significant value in the treatment of insomnia associated with menopause, said Claudio N. Soares, MD, PhD, at the North American Menopause Society's 16th annual meeting in San Diego, Calif.
Results from a phase 3 clinical study demonstrate that a novel transdermal estradiol gel (Bio-E-Gel, BioSante) represents a major improvement in low-dose estrogen therapy, significantly reducing the frequency and severity of hot flashes in menopausal women in a dose-dependent manner at all 3 doses studied, with the low dose being identified as the lowest effective approach, stated James A. Simon, MD, at the North American Menopause Society's 16th annual meeting in San Diego.
Quetiapine (Seroquel, AstraZeneca), olanzapine (Zyprexa, Lilly), and risperidone (Risperdal, Janssen) are equally effective in patients experiencing first episode psychosis, according to data presented in late October during the Breaking News session at the European College of Neuropsychopharmacology (ECNP) Congress.
In a "real-world" setting, drug-eluting stents are clinically superior to bare metal stents, but their use is currently cost-effective only in high-risk subsets of patients, according to results from BASKET (Basel Stent Kosten Effektivit?ts Trial).
A single IV bolus of enoxaparin (Lovenox, Aventis) is just as effective as and associated with less bleeding than unfractionated heparin in patients undergoing elective PCI, said Gilles Montalescot, MD. Dr Montalescot was lead investigator of STEEPLE (Safety and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients), the results of which were announced during the the ESC Congress 2005 in Stockholm, Sweden.
USP has been awarded a cooperative agreement with the Centers for Medicare and Medicaid Services (CMS) to revise the Part D Prescription Drug Benefit Model Guidelines.
While Hurricane Katrina has disrupted healthcare for millions of people, one beneficial outcome may be more public and private efforts to develop a national electronic health records (EHR) system.
Children suffering from acute exacerbation of asthma can expect levalbuterol (Xopenex, Sepracor) (LEV) to produce results that are no better-yet are more costly-than racemic albuterol (RAC), according to a study published in Pediatric Emergency Care.
ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) possess a similar and significant ability to reduce the development of new-onset type 2 diabetes among patients with hypertension, coronary artery disease, and heart failure, according to a meta-analysis study published in Diabetes Care.
In other drug safety news, FDA has announced the selection of Gerald J. Dal Pan, MD, MHS, as director, Office of Drug Safety in the Center for Drug Evaluation and Research (CDER). Dr Dal Pan, selected from a strong field of candidates as part of a nationwide search, will lead the agency's post-marketing drug safety program.
Program will allow rapid access to population-based data sources tohelp ensure public safety
Judith Cahill, executive director of the Academy of Managed Care Pharmacy (AMCP), gave testimony in early November during FDA's public hearing on direct-to-consumer advertising (DTC) of pharmaceutical products.
