The commonly used pain reliever-acetaminophen-causes a significant increase in blood pressure in patients with pre-existing coronary artery disease, according to a randomized controlled trial published ahead of print in the October 18, 2010, Circulation.
Removal of marketed unapproved drugs (MUDs), such as that with oral colchicine, is part of FDA's Unapproved Drugs Initiative (launched in 2006).
Throughout 2010, Formulary's "Focus on" articles have examined 10 newly approved or investigational drugs of interest to pharmacy and therapeutics (P&T) committee members. Because many readers have said that they frequently refer to this column when making formulary decisions for hospitals, health systems, or managed care organizations, the editors have compiled this review of these agents, along with updates on the regulatory status of each.
Patients with systolic heart failure and mild symptomatology [New York Heart Association class II] taking the mineralocorticoid receptor antagonist-eplerenone-experienced a 37% reduction in death from cardiovascular causes or first hospitalization for heart failure, researchers demonstrated in a new study.
The new House leaders are gearing up for a vote to repeal health reform early next year. Such a move, though, is expected to be largely symbolic, as it's unlikely to pass the Senate or to override Obama's veto pen.
New molecular entity: Fingolimod (Gilenya) has recently been approved by FDA to treat patients with relapsing forms of MS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Generic drugs approved by FDA (through November 2010): Zafirlukast tablets and Desloratadine tablets
Specialty pharmaceuticals are expected to eventually replace non-specialty agents for the management of various conditions, including gout, lupus, diabetes, and hypercholesterolemia.
Azilsartan medoxomil (TAK-491), the prodrug form of azilsartan (TAK-536), is an ARB under review for FDA approval for the treatment of hypertension.
Rivaroxaban, an oral direct Factor Xa inhibitor given once daily was superior to warfarin in reducing the risk of stroke and non-central nervous system systemic embolism in patients with AF, with comparable rates of bleeding in the pre-specified on-treatment population, according to results from the ROCKET AF study.
About half of the top non-specialty drugs will become generic within the next 5 years, therefore the trend is for pharmaceutical companies to search and "co-develop" agents rather than investing large amounts of dollars in "R&D."
New molecular entity: Dabigatran etexilate (Pradaxa) was approved for stroke prevention in atrial fibrillation.
The outcomes associated with treating patients with chronic myelogenous leukemia improved dramatically when FDA approved imatinab. Subsequently, newer agents in the same therapeutic class have been approved, and early clinical studies suggest that they may become the new standard of care.
Recent FDA action (through, November 2010) related to Ezogabine, Solesta, Dutasteride, Finasteride, Octaplex, SF1126, MP4CO, Ensituximab, Naloxone, CBLB502.
Recent FDA Approvals (through November 2010) related to Xgeva, Kombiglyze XR, Egrifta, Baclofen injection, Vyvanse, Halaven, Nexterone, Axiron
FDA, in conjunction with Takeda Pharmaceuticals and researchers from the University of Pennsylvania and Kaiser Permanente Northern California, reported 5-year interim results of an ongoing, 10-year epidemiological study designed to evaluate whether pioglitazone (Actos) is associated with an increased risk of bladder cancer.
New molecular entity: Drospirenone/ethinyl estradiol/levomefolate calcium (Beyaz) was approved to treat symptoms of premenstrual dysphoric disorder and moderate acne in women at least 14 years of age, and to supplement folate levels in women wishing to use oral contraception.
Aspirin taken for several years and at doses ?75 mg a day was found to result in both a reduced 20-year risk of colorectal cancer incidence and mortality, according to an analysis published ahead-of-print on the Lancet website.
The worst case scenario for health plans would be if the planned expansion of healthcare coverage under the Patient Protection and Affordable Care Act evaporates, leaving insurers with added fees, onerous market regulations and fewer customers
A decade ago, health plans barely raised an eyebrow at specialty pharmaceuticals, however, this under-the-radar segment began to explode
The cost of chronic obstructive pulmonary disorder in terms of medical bills and lost productivity totals $50 billion a year, making it a condition payers can't afford to ignore.
Only about one in five respondents said their company has a program in place to analyze the impact of the Patient Protection and Affordable Care Act on their health benefits
With existing data and the tidal wave of data to come, care management can achieve significant improvements
Exchanges will be at the center of the individual and small group markets in the states and their impact is projected to be transformational
Data flows among primary care physicians, specialists and other providers, theoretically providing access to complete clinical information
One concept that Republican and Democratic legislators should be able to agree on is value-based benefit design
Seniors are satisfied with the current program (84%) because they believe it offers good value for the cost
After a 12-year upward trend, vaccination rates among children enrolled in commercial HMO insurance plans dropped almost four percentage points this year
Few plan organizations are whole-heartedly in favor of the Patient Protection and Affordable Care Act. In fact, there might be just one--the Association for Community Affiliated Plans
Behavioral health issues are garnering attention in California, and the increasing overlap of primary care and mental health has prompted a new collaboration