Formulary Watch |

Error rates for computer-generated prescriptions vary significantly

About 1 in 10 computer-generated prescriptions includes at least 1 error, and one-third of those has potential for harm, which is consistent with the error rate for paper-written prescriptions, according to a new study published online June 29 in the Journal of the American Medical Infomatics Association.

Texting program improves smoking cessation rates

A smoking cessation program in which participants received mobile phone motivational text messages significantly improved smoking cessation rates at 6 months and the method should be considered for inclusion in smoking cessation services, according to a study published June 29 in The Lancet.

CDC revises recommendations for postpartum contraception

The US Centers for Disease Control and Prevention (CDC) has released revised recommendations for postpartum contraceptive use based on an assessment of new evidence, according to an article published in the July 8 issue of Morbidity and Mortality Weekly Report.

REMS required for belatacept

Patients treated with belatacept (Nulojix) are at an increased risk for developing 2 potentially fatal complications: post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) and progressive multifocal leukoencephalopathy (PML), according to a recent Safety Alert. The risk of PTLD is higher for transplant patients who have never been exposed to Epstein-Barr virus (EBV), and therefore is indicated for use only in transplant patients who are EBV seropositive.

FDA approves new oral antiplatelet agent ticagrelor

FDA has approved ticagrelor (Brilinta, AstraZeneca) tablets to reduce the rate of heart attack and cardiovascular death in adult patients with acute coronary syndrome.

FDA approves vaccines for the 2011 to 2012 influenza season

FDA has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the 6 manufacturers licensed to produce and distribute influenza vaccine for the United States.

Tamiflu for oral suspension label revised, reflects new concentration

The concentration of the influenza drug oseltamivir phosphate (Tamiflu, Genentech) for oral suspension has been reduced from 12 mg/mL to 6 mg/mL to reduce the possibility of prescribing and dosing confusion that can lead to medication errors, according to FDA.

Use of nesiritide doesn't help or hinder, study shows

Nesiritide cannot be recommended in the broad population of patients with acute decompensated heart failure, according to the results of a recent study published in the New England Journal of Medicine.

CDC recommends dual therapy to combat gonorrhea resistance

The Centers for Disease Control and Prevention (CDC) is concerned about the increasing potential in gonorrhea patients for resistance to cephalosporin.

Study links medications with anticholinergic activity to cognitive decline

Medications with anticholinergic activity increase the cumulative risk of cognitive impairment and death, according to findings from a study published online June 24 in the Journal of the American Geriatric Society.

Everolimus breast cancer trial halted early with primary end point met

Novartis announced that it has stopped early its phase 3 trial of everolimus (Afinitor) plus exemestane in women with estrogen receptor-positive locally-advanced or metastatic breast cancer after an interim analysis showed that the primary end point of progression-free survival was met, the company said.

Study demonstrates increased cardiovascular risk associated with varenicline

A recent study raises safety concerns associated with the use of varenicline among tobacco users. Use of the drug was associated with a 72% increased risk of serious adverse cardiovascular events and deserves further investigation, according to results of the study, which was published July 4 in the Canadian Medical Association Journal.

FDA seeks input on proposed policy for diagnostic tests used with targeted drug therapies

FDA has issued a new draft guidance to facilitate the development and review of companion diagnostics ? tests used to help healthcare professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency's policy for reviewing a companion diagnostic and the corresponding therapy.

Multaq phase 3 study halts; increased cardiovascular events cited

Dronedarone (Multaq, Sanofi), which is approved for nonpermanent atrial fibrillation (AF), was being tested on patients with permanent AF. However, that trial, PALLAS (Permanent Atrial fibrillation outcome Study using Dronedarone on top of standard therapy) phase 3b, has been terminated because it was causing increased cardiovascular events.

DMARDs may reduce diabetes risk for patients with RA, psoriasis

Disease-modifying antirheumatic drugs (DMARDs) may lower diabetes (DM) risk in patients with rheumatoid arthritis (RA) or psoriasis, according to a study published in the June 22 issue of the Journal of the American Medical Association.

Qualitest recalls pain-relief tablets due to label mix-up

A voluntary nationwide retail level recall of generic pain-relief tablets combining

SSRIs during first trimester increase risk of congenital anomalies

Exposure to fluoxetine and paroxetine in early pregnancy is associated with a small but established risk of specific cardiac anomalies, according to a study published in the July issue of Obstetrics and Gynecology.

Alternative to NSAIDs should be considered for patients with CAD, hypertension

Chronic self-reported use of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with coronary artery disease (CAD) and hypertension is associated with harmful outcomes and alternative methods of pain relief should be considered, according to a study in the July issue of The American Journal of Medicine.

Breaking news: FDA approves Boostrix to help prevent whooping cough in older adults

FDA has approved Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap); GlaxoSmithKline Biologicals] for use in adults aged 65 years and older for active booster immunization against tetanus, diphtheria, and pertussis (whooping cough). This approval makes Boostrix the first Tdap vaccine approved for use by this age group.

FDA approves first fentanyl nasal spray for the management of breakthrough cancer pain

DA has approved the first and only fentanyl nasal spray (Lazanda, Archimedes) in the United States for the management of breakthrough pain in cancer patients aged 18 years and older who are already receiving opioid therapy to which they are tolerant, for their underlying persistent cancer pain.

FDA panel recommends withdrawing Avastin indication for breast cancer treatment

An FDA advisory panel recommended in late June that Avastin should not be used to treat breast cancer.

Amgen submits application to expand indication for Xgeva

Amgen has submitted a supplemental Biologics License Application to FDA to expand the indication for Xgeva to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases, according to a company press release.

FDA approves tamper-resistant pain drug, Oxecta

FDA granted approval to Pfizer and Acura Pharmaceuticals for a new formulation of oxycodone hydrochloride (HCl) (Oxecta USP Tablets CII) that is designed to be tamper resistant, according to a joint statement from the 2 companies.

FDA approves Xarelto to help prevent DVT in patients undergoing knee- or hip-replacement surgery

FDA has approved rivaroxaban tablets (Xarelto, Janssen Pharmaceuticals), a novel, once-daily, oral anticoagulant for the prevention of deep vein thrombosis, which may lead to a pulmonary embolism in people undergoing knee- or hip-replacement surgery. Xarelto is the only new oral anticoagulant with FDA approval for this indication.

FDA approves only once-daily LABA for COPD

FDA has approved once-daily indacaterol inhalation powder (Arcapta Neohaler, Novartis) 75 µg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma.

Formulary Digital Edition July 2011

Alzheimer's disease: Current treatment options and future developments; Focus on rivaroxaban: a novel oral factor Xa inhibitor to prevent stroke in nonvalvular atrial fibrillation

FDA's Hamburg to make final decision on Avastin's indication for metastatic breast cancer

In the face of dozens of pink-clad demonstrators at the gates of FDA and many heartfelt pleas from women with metastatic breast cancer, an advisory committee to the agency voted unanimously at the end of June to hold firm in its recommendation that approval for Avastin (bevacizumab, Genentech/Roche) for breast cancer be withdrawn.

FDA approves generic Levaquin

FDA approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people aged 18 and older.

New evidence-based guidelines for PDN treatment

In an effort to address the efficacy of various treatment options available to reduce pain and improve physical function and quality of life (QOL) in patients with painful diabetic neuropathy (PDN), a broad literature review was conducted and new guidelines were published online May 17 in Neurology, as well as presented at the American Academy of Neurology Annual Meeting in Honolulu.

FDA calls for changes in ESA dosing for patients with chronic kidney disease

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 the increased risks of cardiovascular events such as stroke, thrombosis, and death.