New oral anticoagulants: Their impact on efficacy and safety in patients undergoing total hip and total knee replacement and their influence on postoperative managementMay 1st 2012
With the aging of the US population, elective total hip and knee replacement operations have become more prevalent, and costs to the healthcare system for these procedures are increasing rapidly. This includes costs related to treatment of venous thromboembolism, which may be a consequence of these operations if appropriate postoperative thromboprophylaxis is not administered.
Recent FDA action (through April 2012) related to, Dihydroergotamine, Levadex inhalation aerosol, droxidopa, Northera, Amitriptyline 4% ketamine 2% cream, AmiKet, Afilbercept, ZALTRAP, Nav rAAV8 vector, Carbamazepine, Carbatrol, Vancomycin hydrochloride, Vancocin, Irbesartan, irbesartan-hydrochloriderothiazide, Avapro, Avalide, Fluvastatin, Lescol
FDA updates drospirenone-containing birth control pill labels to emphasize possible increased risk of blood clots in womenMay 1st 2012
Drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills, according to recent FDA observational (epidemiologic) studies.
Statins associated with decreased risk of depressive symptomsMay 1st 2012
Patients with coronary heart disease who used statins were at a decreased risk of depression; whether there is a cause-and effect relationship, however, merits further research, according to a study published online February 21 in The Journal of Clinical Psychiatry.
Apixaban: An orally active factor Xa inhibitor to prevent strokes and systemic embolism in patients with nonvalvular atrial fibrillationMay 1st 2012
Apixiban (Eliquis) is an orally active factor Xa inhibitor. Its manufacturers are seeking FDA approval to market apixaban to reduce risk of stroke and systemic embolism in patients with nonvalvular AF (NVAF).
Exenatide extended-release (Bydureon): A once-weekly treatment (along with diet and exercise) to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settingsMay 1st 2012
New formulation: FDA approved Exenatide extended-release, a once-weekly treatment (along with diet and exercise) to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings
New system transmits CPE data, credits electronicallyApril 27th 2012
The National Association of Boards of Pharmacy, the Accreditation Council for Pharmacy Education (ACPE), and ACPE providers have teamed up to create the CPE Monitor. This new system will allow for the electronic transmission of continuing pharmacy education data.
Lower rates of intracranial hemorrhage seen with PradaxaApril 27th 2012
Twice-daily dabigatran etexilate mesylate (Pradaxa, Boehringer Ingelheim) was shown to be associated with lower rates of fatal and traumatic intracranial hemorrhage compared with warfarin, according to the results of a retrospective subanalysis published online, April 5, in Stroke, the Journal of the American Heart Association.
Backlog of ANDAs could be alleviated with passage of generic drug user fee actApril 20th 2012
Congressional approval of the bipartisan Generic Drug and Biosimilars User Fee Act could eliminate 90% of the backlog of Abbreviated New Drug Applications by 2017, FDA official Russell Wesdyk, BS, MBA, said in a presentation last month.
Generic Vancocin prompts industry speculation of FDA practicesApril 20th 2012
FDA?s approval (April 10) of generic versions of ViroPharma?s antibiotic Vancocin (vancomycin hydrochloride) for the treatment of Clostridium difficile-associated diarrhea, has some industry experts wondering if FDA is trying to speed up the availability of generics or politically favor new company competition in select areas of therapy.
FDA approves pregnancy category change for insulin detemir injectionApril 20th 2012
FDA has approved insulin detemir [rDNA origin] injection (Levemir, Novo Nordisk) pregnancy Category B classification, indicating that when used in pregnant women with diabetes, the injection did not increase the risk of harm to the unborn baby.
FDA approves first quadrivalent flu vaccineApril 20th 2012
FDA approved the first 4-strain influenza vaccine live, intranasal (FluMist Quadrivalent, MedImmune) for the prevention of influenza. The vaccine?s 4 strains (2 type-A and 2 type-B lineages) help provide broad protection against circulating influenza A and B.
Periprocedural dabigatran use is associated with higher major bleeding rate than warfarin, study findsApril 20th 2012
Patients using periprocedural dabigatran had a significantly higher major bleeding rate than those using warfarin, according to a study published online first February 1, 2012, in the Journal of the American College of Cardiology.
Enhanced pharmacist care improves LDL in patients with dyslipidemiaMarch 30th 2012
Enhanced pharmacist care for patients with dyslipidemia improves low-density lipoprotein cholesterol levels, according to a study published in the March issue of Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy.
Study: Texting enhances HIV therapy complianceMarch 30th 2012
Weekly mobile phone text messaging may help patients with human immunodeficiency virus adhere to antiretroviral therapy that is often associated with difficult side effects, according to a study published online March 14 in the Cochrane Database of Systematic Reviews.
Ingenol mebutate gel is effective treatment for actinic keratosis, study showsMarch 23rd 2012
Ingenol mebutate topical gel (0.015% for face and scalp and 0.05% for trunk and extremities) was effective for treating actinic keratoses, a common precursor to sun-related, squamous cell carcinoma, according to a new study.
Alzheimer’s drugs donepezil, memantine show some benefits in studyMarch 23rd 2012
A new study of patients with moderate-to-severe Alzheimer's disease found that extended treatment with donepezil could improve cognition and function for even severe patients; however, experts caution that the benefits of the drug were modest.