Formulary Watch |
All News - Page 146
Diabetes drug dapagliflozin fails to get approval from FDA
February 10, 2012
FDA declined approval of the diabetes drug dapagliflozin (Bristol-Myers Squibb and AstraZeneca), based on the recommendations of one of its advisory committees.
Single-tablet option approved for treatment of adults with type 2 diabetes
February 10, 2012
FDA has approved linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets, a new tablet that provides a single-tablet treatment option, taken twice-daily, for adult patients who need to control their blood sugar.
Inlyta approved by FDA to treat renal cell carcinoma
February 10, 2012
FDA approved axitinib (Inlyta, Pfizer) to treat patients with an advanced kidney cancer called renal cell carcinoma who have not responded to another drug for this type of cancer.
FDA panel votes against wider use of denosumab for prostate-cancer patients
February 10, 2012
An FDA advisory panel recommended against using denosumab (Xgeva, Amgen) to delay or prevent the spread of castration-resistant prostate cancer at risk for bone metastases.
SSRIs increase risk of falls, injuries for elderly patients with dementia
February 10, 2012
Nursing home residents with dementia who use average doses of selective serotonin reuptake inhibitors (SSRIs) are three times more likely to have a fall resulting in injury compared with those who don’t use SSRIs, according a study published online January 18 in the British Journal of Clinical Pharmacology
Study: Emergency visits increase risk of infections for long-term care residents
February 10, 2012
There was an increased risk of acute infection among long-term care residents who visited hospital emergency departments, according to a study published online January 23 in the Canadian Medical Association Journal.
Researchers warn of IV acetaminophen dosing errors
February 10, 2012
Researchers are warning pediatricians, pediatric hospitalists and intensivists of the potential for intravenous acetaminophen dosing errors, especially in young patients under 2 years old.
FDA extends approval for Vyvanse to treat adult ADHD
February 8, 2012
FDA has approved lisdexamfetamine dimesylate (Vyvanse, Shire) capsules, (CII) as a maintenance treatment for adults with ADHD. Vyvanse was already approved as a treatment for ADHD in patients aged 6 to 17 years.
FDA grants priority review to GI agent for controlling diarrhea in HIV/AIDS patients
February 7, 2012
FDA has granted priority review to crofelemer 125-mg tablets (Salix Pharmaceuticals) for the control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART).
FDA approves tablets for adult patients with type 2 diabetes
February 6, 2012
FDA has approved (linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets, which combine the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueto provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar.
FDA approves update to Gleevec label, extending treatment to certain GIST patients
February 6, 2012
Following a priority review, FDA has approved an update to imatinib mesylate (Gleevec, Novartis) tablets? label to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial.
FDA approves extended-release tablets for type 2 diabetes
February 3, 2012
FDA approved sitagliptin and metformin hydrochloride (HCl) extended-release (Janumet XR, Merck) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.
Hospitals, healthcare facilities urged to require staffs to get flu shots
February 3, 2012
Hospitals and healthcare facilities should require all employees to get an annual flu shot, a group representing many of the nation?s largest employers emphasized again at a press conference Wednesday in Washington, DC.
FDA approves vismodegib for treating basal cell skin cancer
February 3, 2012
FDA has approved vismodegib (Erivedge, Curtis and Genentech, a member of the Roche Group) for the treatment of adult patients with basal cell carcinoma, the most common type of skin cancer.
ACP groups will used cloud-based system for diabetes project
February 3, 2012
State chapters of the American College of Physicians will soon begin a diabetes pilot project using a cloud-based health system.
High-normal BP in middle-aged men linked to atrial fibrillation later in life
February 3, 2012
Upper-normal blood pressures in otherwise healthy middle-aged men are long-term predictors of incident atrial fibrillation in older age, according to a study that appeared online January 17 in Hypertension.
ASSERT links pacemakers with increased risk of ischemic stroke
February 3, 2012
Sub-clinical atrial tachyarrhythmias without clinical atrial fibrillation occurred frequently in patients with pacemakers and were associated with a significantly increased risk of ischemic stroke or systemic embolism, according to a recent study.
Study: Furosemide-induced high urine output reduces risk of CIN
February 3, 2012
Furosemide-induced high urine output with matched hydration significantly reduced the risk of contrast-induced nephropathy in patients with chronic kidney disease undergoing a coronary procedure, according to a new study.
FDA approves Bydureon, first once-weekly treatment for type 2 diabetes
February 2, 2012
FDA has approved exenatide extended-release for injectable suspension (Bydureon, Amylin and Alkermes) ? the first once-weekly treatment for type 2 diabetes.
American Academy of Neurology and International League against Epilepsy release guidelines for the use of antiepileptic drugs in patients with HIV/AIDS
February 1, 2012
Clinicians are urged to be cautious when selecting an antiepileptic drug (aeD) for patients with HIV/AIDS, according to new evidence-based guidelines developed by the American Academy of Neurology (AAN) and the International League Against Epilepsy (ILae).
AMERICAN COLLEGE OF RHEUMATOLOGY: Tocilizumab responses durable to 2 years in juvenile idiopathic arthritis
February 1, 2012
In patients with severe, refractory, persistent systemic juvenile idiopathic arthritis (JIA), long-term treatment with tocilizumab induces significant, durable responses with acceptable toxicity, according to results from a multicenter phase 3 trial presented at the annual scientific meeting of the American College of Rheumatology, Chicago.
FDA Actions in Brief February 2012 (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)
February 1, 2012
Recent FDA Approvals (through January 2012) related to (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)
FDA adverse drug events app for public health crises could expand to more general adverse event reporting
February 1, 2012
Prompted by the 2009 H1N1 influenza outbreak, FDA has announced plans to create a mobile app that will help it gather information and send out alerts about adverse reactions to experimental medications prescribed during public health crises.
FDA modifies REMS for 2 platelet-booster drugs
February 1, 2012
In December, FDA announced changes to Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs romiplostim (Nplate) and eltrombopag (Promacta).
Health reform promises expanded drug coverage through ACOs, exchanges, value-based initiatives
February 1, 2012
Last month, economists in the Department of Health and Human Services (HHS) reported a big slow-down in healthcare spending for 2010. Outlays rose only 3.9% to $2.6 trillion, largely because the recession and unemployment reduced healthcare coverage and prompted people to skip doctor visits. Spending on prescription drugs increased at a record low 1.2% to $259.1 billion, as utilization stagnated, more generics replaced old blockbusters, and fewer new drugs came on the market.
FDA advisory panel recommends stronger warning for drospirenone-containing birth control
February 1, 2012
An FDA advisory panel has recommended that some oral contraceptives may need stronger warning labels, according to recent reports.
Rivaroxaban reduces combined risk of cardiovascular death, myocardial infarction, or stroke in ACS patients
February 1, 2012
An estimated 1.2 million Americans are discharged from a hospital with a diagnosis of acute coronary syndrome (ACS) each year. Now, a new randomized controlled trial dubbed "ATLAS ACS 2" (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome), is suggesting rivaroxaban may reduce the risk of the composite end point of death from cardiovascular causes, myocardial infarction, or stroke in patients with a recent ACS, but at a cost of increased major bleeding.
