Formulary Watch |

Statin therapy: How safe is it?

The National Lipid Association just released a report addressing six safety issues related to statin therapy, including the effects of statins on cognition, diabetes risk, liver function, muscle symptoms, interactions with other drugs, and statin intolerance. The report, published in the Journal of Clinical Lipidology, is an update to a consensus report published by the organization in 2006.

After MI higher dietary fiber intake helps reduce mortality risk

Higher dietary fiber intake among myocardial infarction (MI) survivors lowers the risk of subsequent all cause and cardiovascular mortality, according to a prospective study published April 29 in BMJ.

E-cigarettes may soon be regulated by FDA

The sale of electronic or e-cigarettes may soon be regulated by FDA. Last week the agency proposed a new rule that would extend its authority to cover additional tobacco products, including e-cigarettes.

Singulair as OTC product voted down by FDA

An FDA advisory panel recommended against Merck’s attempt to sell its prescription drug, montelukast sodium (Singulair), as an over-the-counter product for allergy relief in adults only.

FDA approves late-stage lung cancer drug

FDA approved ceritinib (Zykadia, Novartis) for patients with metastatic non-small cell lung cancer (NSCLC).

Examining correlations between pharmaceutical nonadherence and 30-day hospital readmissions

RightCare’s software, based on 10 years of academic and clinical research, has been proven to reduce readmission rates by as much as 35%.

Big Pharma activity heats up

The increase in recent acquisition activity among Big Pharma illustrates different growth strategies, according to industry watchers.

Lorazepam not better at treating children’s epileptic seizures

Lorazepam is not necessarily better at stopping epileptic seizures in children than diazepam, according to a new study published in the April 30 issue of JAMA.

FDA approves Sylvant for rare Castleman’s disease

FDA approved siltuximab (Sylvant, Janssen Biotech) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma.

The role of pharmacists evolving in the team-based approach to medical care

Pharmacists can play an influential role in ensuring patient access to quality health care by both encouraging and enhancing patient medication adherence and increasing patient knowledge of their disease states and medication therapies.

FDA approves Incruse Ellipta for COPD

FDA approved umeclidinium (Incruse Ellipta, GlaxoSmithKline) once-daily anticholinergic for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

[VIDEO, BLOG] Clinical utility: Reflections on an imperfect science

Assessing the clinical utility of diagnostic testing has always been a complicated undertaking. And as new genetic tests enter the equation, that complexity will only increase. To examine the issues surrounding clinical utility, I’d like to share a quick story.

FDA drug approvals-May

FDA drug approvals, breakthrough designations, fast-track designations, priority review

FDA holds workshop on drug track and trace program

FDA is holding a public workshop on its proposed prescription drug tracking system on May 8-9.

Poorer diets, weight gain associated to statin use

Patients who use statins are consuming more calories and fats than a decade earlier, increasing the risk of obesity, diabetes, and cardiovascular disease, according to a study published online in JAMA Internal Medicine.

Pfizer keen on acquiring AstraZeneca

Pfizer said it offered to buy AstraZeneca for approximately $100 billion. If the deal materializes, it would represent the biggest-ever foreign takeover of a British business and allow Pfizer to pay a lower corporate tax rate of 20%, according to some reports.

Knowledge of MATs can help overcome challenges of opioid abuse

The biggest challenge in tackling opioid abuse is lack of awareness and understanding of addictive diseases generally and specifically opioid use disorders, as well as misinformation and negative perceptions of medication-assisted therapies (MATs), according to a recent opinion article published in the New England Journal of Medicine.

Post-discharge pharmacist follow-up as important as pre-discharge med review

Pharmacists who contacted high-risk patients within 72 hours of discharge from Massachusetts General Hospital, Boston, found more than half of the patients had medication-related issues. In a different group of high-risk patients who had received inpatient interventions, 35% of patients were found to have issues after a pharmacist reviewed their medications just prior to discharge, according to Laura Carr, PharmD.

Pharmacists manage stroke recovery more effective than nurses

Pharmacist-led care with prescribing authority substantially improved risk factors at 6 months among stroke survivors than nurse case managers who monitored patients and provided feedback to their primary care physicians, according to a report published in the Canadian Medical Association’s journal, CMAJ.

First HPV test for primary cervical cancer screening approved by FDA

FDA approved the first HPV DNA test for women aged 25 years and older that can be used alone to help a healthcare professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can offer information about the patient’s risk for developing cervical cancer in the future.

FDA approves advanced stomach cancer drug

FDA approved ramucirumab (Cyramza, Eli Lilly) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma.

Community factors may be tied to hospital readmissions

Community factors may be linked to hospital readmission rates, according to a study published in Health Services Research.

FDA warns of possible neurologic problems after epidural corticosteroid injections

FDA is requiring that drug labels for injectable corticosteroids used to treat neck and back pain must be updated to include a warning of rare but serious adverse events, including vision loss, stroke, paralysis, and death, according to a recent FDA drug safety communication.

Quality initiative helps lower risk of bleeding, death after stroke

Implementation of a quality initiative has been linked to improvement in the time to treatment and a lower risk of in-hospital death, intracranial hemorrhage (bleeding in the brain), and an increase in the portion of patients discharged to their home, according to a study in the April 23/30 issue of JAMA.

Report: Reduction seen in managed care organization drug trend

Managed care organizations (MCOs) experienced a 1.7% drug overall trend, a 10.5% reduction from 2012 to 2013, according to Catamaran’s 2013 Drug Trend data. In 2012, MCO trend was 1.9%.

FDA approves once-weekly GLP-1 injectable for type 2 diabetes

FDA approved albiglutide (Tanzeum, GlaxoSmithKline), a once-weekly subcutaneous injectable for the treatment of adults with type 2 diabetes. It helps to improve glycemic control, along with diet and exercise.

Too many kids given codeine in ERs despite risks

Despite strong FDA warnings against its use in adolescents, a new study suggests that codeine is prescribed for children during at least 500,000 emergency room (ER) visits each year.

FDA approves first sublingual allergen immunotherapy tablet for treatment of short ragweed pollen allergies

FDA approved Short Ragweed Pollen Allergen Extract (Ragwitek, Merck) the first sublingual allergen extract to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults aged 18 years through 65 years.

FDA approves Arzerra in combination with chlorambucil for patients with CLL for whom fludarabine-based therapy is considered inappropriate

FDA has approved a new indication for ofatumumab (Arzerra, GlaxoSmithKline and Genmab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

Ledipasvir-sofosbuvir combination achieves 90% cure rate for HCV patients without cirrhosis

An 8-week regimen of ledipasvir-sofosbuvir was highly effective (>90% cure) in non-cirrhotic HCV patients with genotype infection, and adding ribavirin or extending treatment to 12 weeks did not significantly improve the results, according to a study published in the New England Journal of Medicine.