Clinical Pharmacology

New molecular entity: FDA approved Ivacaftor, a treatment of cystic fibrosis for patients with a G551D mutation in the CFTR gene

A recent study indicated that publicly reporting quality data to CMS has not lead to a reduction in mortality.

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

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.

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.

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).

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

Recent FDA Approvals (through April 2012) related to (Johnson & Johnson, AstraZeneca, Affymax, Takeda Pharmaceutical, Teva Pharmaceutical Industries, Avioq, Hope Pharmaceuticals, Novo Nordisk, Avid Radiopharmaceuticals)

A report for the American College of Cardiology's Scientific Session & Expo

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.

FDA has issued a safety alert, warning patients, caregivers, and healthcare professionals about the dangers of accidental exposure to and improper storage and disposal of fentanyl patches.

As many as 80% of patients who are candidates for preventive treatments for migraine headaches could be helped by these treatments, the author of new guidelines issued by the American Academy of Neurology told Formulary.

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.

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.

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 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.

Fibromyalgia patients taking pregabalin had significant improvements in sleep and decreased daily pain, according to a new study published in the April 2012 issue of Arthritis Care & Research.

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.

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.

Aspirin can reduce the risk for cancer-related mortality and can reduce or prevent the risk for distant metastasis, according to 3 new studies published online by The Lancet and The Lancet Oncology.

Daily supplementation with antioxidants, vitamins E and C, and alpha acid, did not improve memory function in patients with Alzheimer?s disease, according to a new study.

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.

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.

Amneal Pharmaceuticals has launched escitalopram oxalate oral solution in 5 mg/5 mL strength, the first generic of antianxiety/antidepressant Lexapro (Forest) in liquid form on the market

FDA approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause

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.

Diacetylmorphine, or heroin, may be a more effective treatment than methadone for people with relapsing chronic opioid dependence, according to a study published in the Canadian Medical Association Journal.

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.

Clinical pharmacists were instrumental in reducing errors in patients' physician-acquired medication histories, according to a study published online on March 13 in the Annals of Pharmacotherapy.