Clinical News

FDA has announced more conservative dosing recommendations for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease (CKD) because of increased risk of cardiovascular events such as stroke, thrombosis, and death.

FDA published an online safety communication on June 15, informing prescribers and patients that pioglitazone (Actos, Takeda Pharmaceuticals America Inc., Deerfield, Illinois) use may be associated with a 20% to 40% increased hazard of new bladder cancer.

A new labeling system improves the syringe preparation workflow by automatically printing full-color labels compliant with American Society of Anesthesiologists and containing all The Joint Commission required elements, announced a statement issued by the manufacturer.

FDA announced reports of medication errors involving risperidone (Risperdal, Johnson & Johnson) and ropinirole (Requip, GlaxoSmithKline), noting that in some cases, patients who took the wrong medication needed to be hospitalized, according to a Medication Safety Announcement released June 13.

Novo Nordisk recently sent a letter to healthcare professionals, reminding them about the potential risks of thyroid C-Cell tumors and acute pancreatitis associated with Victoza.

FDA announced new testing and labeling requirements for OTC sunscreen products that will help manufacturers better indicate those that when used with other sun protection measures reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn, according to a news release issued by the agency.

Physicians should limit the use of 80-mg simvastatin due to an increased risk of myopathy, according to a recent FDA consumer update and a corresponding news release.

The risk of major congenital malformations increases dose-dependently with 4 common antiepileptic drugs, according to the results of a study published online June 5 in The Lancet Neurology.

Are surgeons at your hospital using recombinant factor VIIa to control bleeding? If so, they are probably not helping patients and could be harming them.

An accurate understanding of the effectiveness of medications, which guides decisions about their optimal use, depends on a critical appraisal of published literature, according to Alvin Goo, PharmD. Goo is a clinical pharmacist with Harborview Medical Center and clinical associate professor, University of Washington School of Pharmacy and Family Medicine, Seattle.

Drug Topics visits one-on-one with Mary Relling, PharmD, chair of pharmaceutical sciences at St. Jude Children's Research Hospital, who has devoted her career to finding better treatment options for childhood leukemia patients.

A meta-analysis of studies on recurrent venous thromboembolism; updated guidelines for management of atrial fibrillation; a meta-analysis of studies comparing generic and branded warfarin

FDA has approved azilsartan medoxomil 40-mg and 80-mg tablets for the treatment of hypertension, either alone or in combination with other antihypertensive agents. FDA has also approved roflumilast as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations (not the relief of acute bronchospasm).

Nearly 20% of young adults in the United States may have high blood pressure, according to the National Longitudinal Study of Adolescent Health, an analysis sponsored by the National Institutes of Health and published online in Epidemiology.

FDA is warning consumers and healthcare professionals about antimicrobial drugs that are being marketed as dietary supplements.

Medication use among pregnant women is widespread and increasing, according to a recent study from the Boston University School of Public Health in Boston.

Early commencement of oral antiretroviral therapy by men and women infected with HIV substantially reduced the risk that they would transmit the virus to their uninfected sexual partners, according to findings from a large multinational clinical study conducted by the HIV Prevention Trials Network.

Allergic rhinitis patients are likely to have sleep disturbances and are not likely to be satisfied with the nasal sprays on the market, according to the new Nasal Allergy Survey Assessing Limitations 2010 study.

Proton pump inhibitors are associated with a 29% increased risk of fracture, including a 31% increased risk of hip fracture and a 54% increased risk of vertebral fracture, according to a study published in the May/June 2011 issue of Annals of Family Medicine.

There is no safe therapeutic window of time for using NSAIDs in patients with prior myocardial infarction. Even short-term treatment with most NSAIDs appears associated with increased risk of death and recurrent MI, reported a study published in Circulation.

ASHP names Abramowitz EVP and CEO-designate

For the fourth consecutive year, diabetes therapy topped the list of contributors to drug use trends in therapeutic categories, contributing 16.1% to overall growth in drug spending in 2010 due to an increasing number of patients, according to the recently released 2011 Medco Drug Trend Report, which tracks utilization and spending.

The National Lipid Association kicked off, "FH: It's Relative-Know Your Family Cholesterol History," a public health campaign about familial hypercholesterolemia, on May 18.

Makers of OTC single-ingredient pediatric liquid acetaminophen will convert these products to just 1 concentration, according to the Consumer Healthcare Products Association.

APhA's white paper focusing on improving REMS programs and designing a system that maximizes patient safety while minimizing burdens on the healthcare system was published in the May/June issue of the Journal of the American Pharmacists Association.

Antibiotic use is rising at Veterans Affairs medical facilities across the country, according to study findings released recently at the annual meeting of the Society for Healthcare Epidemiology of America in Dallas.

A roundup of reports on risk of recurrent venous thromboembolism; direct factor Xa inhibitors; and managing clopidogrel hypersensitivity

As part of an overall federal strategy on the prescription drug epidemic, FDA announced in late April that it will require a Risk Evaluation and Mitigation Strategy for all long-acting and extended-release opioids.

A 2-year study found that a pharmacy-directed anticoagulation service boosted the quality and efficiency of care for heparin-induced thrombocytopenia in patients using direct thrombin inhibitors.

Readers speak out about the 15-minute Rx, antibiotic stewardship, and MTM.