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FNIH publishes article aimed to improve medical product safety

FNIH has released 'Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership' in the Annals of Internal Medicine.

CCCS program linked to lower healthcare costs in CAD patients

Among patients with CAD, participating in a secondary prevention program featuring a clinical pharmacy specialist and registered nurse is associated with lower healthcare expenditures, according to research published in the November issue of Pharmacotherapy, HealthDay News reported.

FDA cautions against 2 dietary supplements

FDA has issued warnings regarding 2 products, Man Up Now and Vigor-25, both marketed as natural dietary supplements to enhance male sexual performance.

More reduction in LDL cholesterol lessens vascular events

Further reductions in LDL cholesterol with more intensive statin regimens safely produce definite further reductions in vascular events, even down to very low LDL levels, lower than current targets, according to the results of 2 meta-analyses, as reported Nov. 8 online by The Lancet.

FDA begins process to remove breast cancer indication from Avastin label

FDA is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

Medication improves survival rates in prostate cancer patients

A medication for skeletal-related events in patients with bone metastases was shown to significantly improve bone metastasis-free survival rates in prostate cancer patients, according to a new trial.

FDA panel recommends approval of weight-loss drug

An FDA panel has recommended that the agency approve Orexigen Therapeutics? and Takeda?s obesity drug Contrave (naltrexone SR/bupropion SR). This makes the drug the first in a group of competitors to receive this recommendation, the Associated Press reported.

Wholesale, retail level recalls

In consultation with FDA, McNeil Consumer Health, Division of McNeil-PPC Inc., has initiated a wholesale and retail level recalls.

FDA approves CNS Therapeutics' baclofen injection drug for severe spasticity

CNS Therapeutics announced that FDA has approved baclofen injection (Gablofen) for use in the management of severe spasticity. The drug gives providers an easy-to-administer, cost-effective intrathecal baclofen treatment option, according to the company.

Wholesale, retail level recalls

In consultation with FDA, McNeil Consumer Health, Division of McNeil-PPC Inc., has initiated a wholesale and retail level recalls.

FDA approves CNS Therapeutics' baclofen injection drug for severe spasticity

CNS Therapeutics announced that FDA has approved baclofen injection (Gablofen) for use in the management of severe spasticity. The drug gives providers an easy-to-administer, cost-effective intrathecal baclofen treatment option, according to the company.

FDA approves Vyvanse for treating ADHD in teens

FDA has approved Lisdexamfetamine dimesylate (Vyvanse, Shire) capsules CII for the treatment of ADHD in adolescents aged 13 to 17 years.

Kombiglyze XR tablets approved for the treatment of type 2 diabetes mellitus in adults

FDA has approved saxagliptin and metformin XR (Kombiglyze XR, AstraZeneca and Bristol-Myers Squibb) tablets for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first and only once-a-day metformin XR plus DPP-4 inhibitor combination tablet offering strong glycaemic control across glycosylated hemoglobin levels, fasting plasma glucose and post-prandial glucose.

Combination improves tumor response rates in patients with HER2-positive breast cancers

A combination of lapatinib, trastuzumab, and paclitaxel significantly improved tumor response rates in patients with HER2-positive breast cancers, according to a new study presented at the annual Cancer Therapy and Research Center-American Association for Cancer Research San Antonio Breast Cancer Symposium held recently in San Antonio, Texas.

FDA begins process to remove breast cancer indication from Avastin label

FDA is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

Manufacturer agrees to withdraw propoxyphene from the market

Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon and Darvocet) from the US market at the request of FDA. FDA also has informed generic manufacturers of Xanodyne?s decision, and they will be removing their propoxyphene-containing products from the market as well.

Paricalcitol found to reduce albuminuria in type 2 diabetes

In a multinational, placebo-controlled, double-blind trial, the selective vitamin D receptor activator paricalcitol (Zemplar, Abbott Laboratories), at doses of 1 µg or 2 µg daily, reduced albuminuria in patients with type 2 diabetes, who were already being treated with renin-angiotensin-aldosterone system inhibitors.

FDA approves tesamorelin for HIV patients with lipodystrophy

Canada-based Theratechnologies announced that FDA has approved tesamorelin (Egrifta) to treat HIV patients with lipodystrophy. The condition is associated with many antiretroviral drugs used to treat HIV.

Metformin may lower mortality in patients with diabetes and heart failure

Metformin, either alone or in combination with sulfonylurea, appears to increase 1-year and long-term survival in patients with type 2 diabetes mellitus and chronic heart failure, according to research published in the October 1 issue of the American Journal of Cardiology, HealthDay News reported.

FDA panel recommends approval of weight-loss drug

An FDA panel has recommended that the agency approve Orexigen Therapeutics' and Takeda's obesity drug Contrave (naltrexone SR/bupropion SR). This makes the drug the first in a group of competitors to receive this recommendation, the Associated Press reported.

Therapy Update: Nonanthracycline regimens for adjuvant treatment of operable breast cancer

Nonanthracycline-containing chemotherapy regimens for the adjuvant treatment of operable stage I to III breast cancer are discussed, including efficacy and toxicity results from recent randomized clinical trials comparing anthracycline to nonanthracycline-containing regimens.

FDA panel votes against approving Proscar, Avodart

FDA voted today against approving 2 drugs for the prevention of prostate cancer: finasteride (Proscar, Merck) and dutasteride (Avodart, GlaxoSmithKline).

Formulary Digital Edition December 2010

Focus on 2010: A year of novel pharmacologic agents in review; Azilsartan: A next-generation angiotensin II receptor blocker for the treatment of hypertension; Agents in late-stage development for the treatment of eye diseases

Drug Watch: Eye diseases (PDF) (December 2010)

Agents in late-stage development for the treatment of eye diseases.

Study finds acetaminophen increases blood pressure in patients with coronary artery disease

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.

Greater vigilance needed for unapproved agents; reduce demand for these drugs by reporting adverse events

Removal of marketed unapproved drugs (MUDs), such as that with oral colchicine, is part of FDA's Unapproved Drugs Initiative (launched in 2006).

Focus on 2010: A year of novel pharmacologic agents in review

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.

Eplerenone reduces risk of death and hospitalization in patients with mildly symptomatic heart failure

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.

Political changes in Washington create uncertainty for health reform, drug regulation, biomedical research

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.

Fingolimod (Gilenya): An oral sphingosine 1-phosphate receptor modulator

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.