Formulary Watch

Managed care and hospital decision-makers are in a key position to “move the needle” at the system level on improving adult immunization coverage rates in the United States.

After six years on the job, FDA commissioner Margaret Hamburg, MD, is resigning from her position. Her tenure has ushered in personalized medicine and faster approval of several drug classes.

Non-medication strategies were effective in hospital patients with delirium, according a new study published in the February 2 edition of the JAMA Internal Medicine.

FDA has approved olopatadine hydrochloride ophthalmic solution (Pazeo, Alcon, a division of Novartis) 0.7% for the treatment of ocular itch relief related to eye allergies.

Ibrance is a potent and selective inhibitor of cyclin-dependent kinases (CDKs) 4 and 6, which complex with a regulatory protein, called cyclin, to control cancer cell cycling. The FDA has approved it for use in the treatment of metastatic breast cancer.

FDA approved TissuGlu (Cohera Medical Inc.), the first tissue adhesive approved for internal use.

Diabetic non-smokers taking metformin have a lower lung cancer risk compared with those who do not take metformin, according to a study published in Cancer Prevention Research.

Given the spending growth projections for biologics, successful managed care organizations must find a way to ensure appropriate adoption of biosimilars, according to a study published in Health Affairs’ February issue.

Many patients hospitalized with severe heart failure are receiving potentially harmful treatment with intravenous fluids, according to a Yale-led study, published in the Journal of the American College of Cardiology (JACC): Heart Failure

The first-in-class combined medication for improving glycemic control in adults with type 2 diabetes has been approved by FDA.

FDA actions in brief, priority review, breakthrough designations, orphan drug designations

More than one-third of reproductive-aged women enrolled in Medicaid, and more than a quarter of those with private insurance, filled a prescription for an opioid pain medication each year during 2008 to 2012, according to a recent report in Morbidity and Mortality Weekly Report (MMWR).

FDA approved lisdexamfetamine dimesylate (Vyvanse, Shire) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (BED) in adults, shown to significantly reduce the mean number of binge days per week.

Statin treatment reduces the risk of cardiovascular disease in women, according to a large international study, published in The Lancet.

Hydrocodone bitartrate (Hysingla ER, Purdue Pharma) extended-release tablets CII is now commercially available.

FDA has approved the antiretroviral Prezcobix (darunavir 800 mg/cobicistat 150 mg, Janssen Therapeutics) for the treatment of human immunodeficiency virus 1 (HIV-1).

FDA has approved expanded use of ibrutinib for the treatment of Waldenstroms Macroglobulinemia.

FDA's process for approving drugs and devices is speeding up, according to a PricewaterhouseCoopers (PwC) Health Research Institute report.

Patients perceptions of drug cost may affect how they benefit from the drug, even when receiving a placebo.

A large study links a significantly increased risk for developing dementia, including Alzheimers disease, to taking commonly used medications with anticholinergic effects at higher doses or for a longer time, according to a study published in JAMA Internal Medicine. Many older people take these medications, which include nonprescription diphenhydramine (Benadryl).

FDA approved ferric pyrophosphate citrate (Triferic, Rockwell Medical Inc.) for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.

FDA approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules, Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA) to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.

FDA has approved parathyroid hormone (Natpara, NPS Pharma) once-daily injection to control hypocalcemia in patients with hypoparathyroidism.

Celiac disease occurs due to a genetic intolerance to dietary ingested gluten peptides. This initiates an immune response, predominantly in the small bowel, that results in malabsorption and associated symptoms including chronic diarrhea with weight loss, steatorrhea, postprandial abdominal pain, and bloating.

Approximately one-third of patients on a novel oral anticoagulant (NOAC) received inappropriate dosing based on indication, renal function, or concomitant interacting medications during hospitalization in the intensive care unit, typically for stroke prevention in atrial fibrillation, according to data presented at the Society of Critical Care Medicine meeting in Phoenix.

It is important to ensure established migraine medications are available for the patients who need them, according to a new study published in the January issue of Headache.

FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of moderate-to-severe plaque psoriasis.