Formulary Watch |

Office of Generics Drugs reorganizes for greater efficiency

The Office of Generics Drugs (OGD) has been reorganized to improve coordination, communication, efficiency, and to enhance the Office?s ability to assure that all generic drugs are safe, effective, high quality, and interchangeable to the brand name drug product/reference listed drugs, according to The Center for Drug Evaluation and Research (CDER), part of FDA.

Transcept receives CRL from FDA for low-dose zolpidem tartrate formulation

FDA has issued a Complete Response Letter (CRL) for Intermezzo (zolpidem tartrate sublingual tablet, Transcept Pharmaceuticals).

First pharmacist-focused session coming to AHA Scientific Sessions 2011

Over the past 3 decades, pharmacists have become integrated members of multidisciplinary teams. To recognize the value of the role of pharmacists in improving patient outcomes and safety in cardiac care, the American Heart Association (AHA) will offer pharmacists a session focused specifically on them at this year?s AHA Scientific Sessions in Orlando, Fla.

PriCara, Ortho-McNeil now named Janssen Pharmaceuticals

PriCara and Ortho-McNeil, divisions of Ortho-McNeil-Janssen Pharmaceuticals, will operate under the name Janssen Pharmaceuticals, the family of companies announced this week. The change, effective immediately, is part of a global effort to unite the Janssen Pharmaceutical Companies around the world under a common identity and to increase collaboration, the statement said.

Novartis reports phase 3 results of Afinitor study

More than one-third of patients treated with everolimus (Afinitor) tablets had a 50% or greater reduction in the size of non-cancerous brain tumors associated with tuberous sclerosis complex (TSC) versus 0% who were treated with placebo, according to a company statement from the drug?s manufacturer Novartis.

IOM report recommends 8 preventive women's health services

A new report from the Institute of Medicine (IOM) recommends that 8 preventive health services for women will be added to the services that health plans will cover at no cost to patients under the Patient Protection and Affordable Care Act of 2010 (PPACA).

Poor glycemic control linked to potential risk for heart failure

Improving glycemic control may help prevent heart failure, according to a recent study published in The Lancet. The study enrolled at 20,985 patients with type 1 diabetes to assess variables associated with cardiovascular disease, including age, sex, duration of diabetes, HbA1c, body mass index, systolic and diastolic blood pressure, LDL and HDL cholesterol, and smoking status.

FDA approves subcutaneous formulation of abatacept for treatment of RA

FDA has approved a subcutaneous (SC)formulation of abatacept (Orencia, Bristol-Myers Squibb) for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA). It is the first biologic available in both SC and intravenous formulations for the treatment of RA.

FDA postpones new Prevnar ruling to January 2012

FDA has issued a 90-day extension of the action date for Pfizer?s Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults 50 years of age and older.

Methylene blue linked to serious CNS reactions

FDA has received reports of serious central nervous system reactions when methylene blue is given to patients taking serotonergic psychiatric medications.

Formulary Digital Edition August 2011

Treatment of chronic hepatitis C: The new standard of care for the future; Focus On Fidaxomicin: New therapy for Clostridium difficile-associated diarrhea

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.