A meta-analysis published in the Journal of the American Medical Association demonstrated an association between antidepressants and improvements in pain, depression, fatigue, sleep, and health-related quality of life (HRQOL) in patients with fibromyalgia syndrome (FMS).
Not so long ago, medically underserved rural communities had only limited options, if any, when need arose for healthcare services and pharmaceutical support. That situation is finally changing, as necessity and technology converge in emerging applications of telepharmacy, the delivery of pharmaceutical care by means of telecommunications and information technologies to patients at a distance from large, usually urban tertiary healthcare centers.
Several blockbuster drugs will fight to hold onto their top spots in 2009 as new products come before FDA for marketing approval, reported Brian W. Kolling, PharmD, at a recent meeting of the Academy of Managed Care Pharmacy (AMCP) in Kansas City, Mo. Key therapies to watch as they move through the pipeline include medications for cardiovascular (CV) disorders, central nervous system (CNS) disorders, respiratory disease, and diabetes.
Outpatient pharmacologic management of ACS using antiplatelet therapy; Focus on sugammadex; Drug Watch: Agents in late-stage development for the treatment of depression and generalized anxiety disorder
New molecular entity: Eltrombopag (Promacta), a TPO receptor agonist, was approved on November 20, 2008, for the treatment of thrombocytopenia in patients with chronic ITP.
Recent FDA action (through January 2009) related to ceftobiprole, oblimersen, motavizumab, rufinamide, febuxostat, telavancin, and ecallantide
Generic drugs approved by FDA (through January 2009) including rocuronium injection and budesonide inhalation suspension
Recent FDA approvals (through January 2009) related to Banzel, tapentadol, synthetic conjugated estrogens-A, and Ranexa
Acute coronary syndrome (ACS) encompasses a series of heart conditions associated with myocardial ischemia.
Sugammadex is a novel, first-in-class, selective relaxant binding agent that encapsulates the nondepolarizing aminosteroid muscle relaxants rocuronium and vecuronium, reversing and preventing their neuromuscular block (NMB) action. Clinical trials have demonstrated that sugammadex is effective in reversing both rocuronium- and vecuronium-induced NMB, and the agent has been well tolerated in studies.
Agents in late-stage development for the treatment of depression and generalized anxiety disorder
The Federal Court of Appeals for the First Circuit in a 2 to 1 decision held that New Hampshire's Prescription Information Law "that among other things prohibited certain transfer of physicians' prescribing histories for use in detailing" regulates conduct, not speech, thereby removing "the challenged portions of the statute from the proscriptions of the First Amendment."
FDA announced that the agency is evaluating data from a clinical study in which all-cause mortality was increased among patients treated with tinzaparin (Innohep, Celgene) versus patients treated with unfractionated heparin (UFH).
FDA informed healthcare professionals that the agency is evaluating data regarding a potentially increased risk of serious skin reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis, in association with phenytoin (Dilantin, Pfizer; Phenytek, Mylan; generic phenytoin) or fosphenytoin (Cerebyx, Pfizer; generic fosphenytoin) treatment in Asian patients who are positive for the human leukocyte antigen allele HLA-B*1502.
Rosiglitazone was associated with an increased risk of all-cause mortality and congestive heart failure (CHF) compared with pioglitazone in an inception cohort study of patients aged >65 years. Patients treated with rosiglitazone or pioglitazone demonstrated similar rates of myocardial infarction (MI) and stroke. These results were published in the Archives of Internal Medicine.
Patients with chronic hepatitis C virus (HCV) infection who have not responded to previous treatment with pegylated interferon alfa-2a (peginterferon) and ribavirin do not demonstrate a reduced rate of disease progression when they undergo long-term treatment with pegylated interferon alfa-2a compared with untreated patients. These results were published in the New England Journal of Medicine.
Evidence supports the clinical equivalence of generic and brand-name cardiovascular drugs, according to a meta-analysis published in the Journal of the American Medical Association. Despite this evidence, more than half of the editorials discussing the issue of generic interchangeability that were assessed in this analysis do not support generic substitution for brand-name cardiovascular drugs.
Clinical news updates from the 2008 American Heart Association Scientific Sessions; Preferential formulary listing of a proton-pump inhibitor; Drug Watch: Agents in late-stage development for the treatment of multiple sclerosis
New molecular entity: Fesoterodine (Toviaz), a muscarinic receptor antagonist, was approved on October 31, 2008, for the treatment of overactive bladder
Second-generation antidepressants generally have equivalent efficacy, according to a review published in the Annals of Internal Medicine. Although these agents demonstrate similar response rates, differences in onset of action or side effects may affect prescribing decisions.
Labeling updates and warnings through December 2008 for efalizumab and bisphosphonates
Treatment with bevacizumab is associated with a significantly increased risk of venous thromboembolism, according to a meta-analysis published in the Journal of the American Medical Association.
During his campaign for the presidency, President-elect Barack Obama stated that all Americans have a right to healthcare and that he will expand coverage for the uninsured. Many voters cited healthcare as a key election issue; however, the need to address a rising unemployment rate and low economic growth may force Obama to seek more limited changes in the near future.
Among the new data presented at the 2008 AHA Scientific Sessions were the results of JUPITER, as well as a phase 2 study of rivaroxaban and an observational study of DES versus BMS in diabetics.
Recent FDA action (through December 2008) related to denileukin, ferumoxytol, cetuximab, HQK-1001, ALD-101, NTX-010, and RTA 402
Generic drugs approved by FDA (through December 2008) including levetiracetam tablets, dorzolamide/timolol ophthalmic solution, and dorzolamide ophthalmic solution
