FDA has approved gabapentin enacarbil (Horizant Extended-Release Tablets, GlaxoSmithKline and XenoPort), a once-daily treatment for moderate-to-severe restless legs syndrome, also known as Ekbom disease. It is the first medication in its class to be approved for this condition.
The number of people treated in U.S. hospitals for illnesses and injuries from taking medicines increased 52%-from 1.2 million to 1.9 million-between 2004 and 2008, according to an April 2011 report from the Agency for Healthcare Research and Quality.
An estimated 9 million working-age adults became uninsured in the last two years, according to the Commonwealth Fund 2010 Biennial Health Insurance Survey.
Using clinical analytics to lower clinical costs emerged as the top drivers for payers for using and analyzing clinical data, according to an HIMSS Analytics whitepaper.
CaroMont Health, based in Gastonia, NC, and Blue Cross and Blue Shield of North Carolina (BCBSNC) have announced a collaborative arrangement to offer patients a new health care delivery and reimbursement model for knee replacements.
A survey of 321 seniors 65 and older revealed that 61% think the healthcare reform bill has weakened Medicare in the year since it became law.
FDA has approved peginterferon alfa-2b (Sylatron, Merck) for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.
Patients with inflammatory rheumatic disease may need 2 doses of adjuvanted split influenza A vaccine to elicit the same antibody response as healthy individuals, reported a recent Swiss study published in Arthritis & Rheumatism.
The anticholinergic drug tiotropium is more effective than the ?2-agonist salmeterol in preventing exacerbations in patients with moderate-to-very-severe chronic obstructive pulmonary disease, according to a multicenter European study published in the New England Journal of Medicine.
Clopidogrel hypersensitivity, which affects 6% of patients, can be successfully treated using short-course corticosteroids and antihistamines without interrupting drug therapy, reported researchers at Jefferson Medical College in Philadelphia.
Combining angiotensin-converting-enzyme inhibitors with angiotensin-receptor blockers is associated with increased risk of adverse renal outcomes, according to a recent study published in the Canadian Medical Association Journal.
FDA said it wouldn't take action against compounding pharmacies that continue to supply 17 alpha hydroxyprogesterone caproate (Makena, KV Pharmaceutical, Ther-Rx).
The use of high-dose clopidogrel compared with use of standard-dose clopidogrel does not reduce the incidence of death from cardiovascular causes, nonfatal myocardial infarction, or stent thrombosis among patients with high on-treatment reactivity after percutaneous coronary intervention with drug-eluting stents, according to a recent multicenter study published in the Journal of the American Medical Association.
Naproxen/esomeprazole magnesium (Vimovo, AstraZeneca and Pozen) 500/20-mg delayed-release tablets was generally well tolerated in osteoarthritis patients requiring daily NSAID therapy who were at risk for NSAID-associated ulcers, according to an open-label, multicenter phase 3 study.
5?-reductase inhibitors may cause persistent erectile dysfunction, depression, and loss of libido, even after discontinuing use, in men being treated for systems of benign prostatic hyperplasia and androgenetic alopecia, according to a literature review published in the March 2011 issue of The Journal of Sexual Medicine.
Patients with systemic lupus erythematosus are commonly nonadherent to therapy, according to a recent study published in the March 2011 issue of Arthritis Care & Research.
The risk of fracture is unlikely in patients taking short-term, low-dose proton pump inhibitors, according to a review of available safety data by FDA.
FDA has approved an expanded age indication for Zoster Vaccine Live, (Zostavax, Merck) for the prevention of herpes zoster, commonly known as shingles, in adults ages 50 years and older.
Evidence supports metformin as a first-line agent to treat type 2 diabetes, according to a study in the March 14, 2011, online edition of the Annals of Internal Medicine.
FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.
Prescription proton pump inhibitors may cause hypomagnesemia if taken for prolonged periods of time (in most cases longer than 1 year), according to FDA.
FDA notified healthcare professionals of serious health risks that have been reported in premature babies receiving lopinavir/ritonavir (Kaletra, Abbott) oral solution.
Agents in late-stage development for the treatment of type 1 diabetes.
Available evidence reviewed by FDA does not suggest abacavir is associated with an increased risk of myocardial infarction, according to an updated safety communication released March 2011.
FDA notified healthcare professionals of serious health risks that have been reported in premature babies receiving lopinavir/ritonavir (Kaletra, Abbott) oral solution.
Generic drugs approved by FDA (through March 2011): Docetaxel and Zidovudine
FDA "...does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products," according to a statement.
FDA recently announced that the 'Pregnancy' sections of labeling for all antipsychotic medications will now have to include wording about the potential risk for extrapyramidal side effects and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.
There's growing uncertainty about how the Obama healthcare reform program will be implemented, and how proposed changes will affect biomedical product development and coverage of prescription drugs.
Investigators question whether the thiazide diuretic, hydrochlorothiazide, should be used as commonly as it is for treating hypertension, according to a report published in a recent edition of the Journal of the American College of Cardiology.
