Drug Pipeline

The American College of Physicians (ACP), American College of Chest Physicians (ACCP), American Thoracic Society (ACT), and the European Respiratory Society (ERS) have issued updated recommendations to the 2007 ACP clinical practice guideline on diagnosis and management of stable chronic obstructive pulmonary disease (COPD). The new recommendations were published in Annals of Internal Medicine.

Young adults treated with a statin after a first ischemic stroke of undetermined cause were 77% less likely to suffer subsequent vascular events, according to a recent study published in Neurology.

Thirty-two products recently have had label changes to the boxed warnings, contraindications, and warnings sections, according to the FDA.

FDA is warning consumers in the United States not to use an emergency birth control medicine labeled as Evital. According to a recent press release from the agency, Evital has not been approved by FDA, and the product may be a counterfeit version of the morning-after pill. It may not be safe or effective in preventing pregnancy.

The Board of Trustees of the Foundation for Managed Care Pharmacy (FMCP), the educational and philanthropic arm of the Academy of Managed Care Pharmacy (AMCP), has announced the appointment of 4 new FMCP Trustees.

The results of pilot programs focused on increasing international regulatory collaboration among the agencies that aim to enhance drug quality and safety globally, have been released by FDA together with its European and Australian counterparts.

American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the retail/hospital level. The company initiated the product recall because some vials may not maintain potency throughout their shelf-life.

FDA issued a warning this week that chronic high doses (400 mg/day to 800 mg/day) of fluconazole (Diflucan) during the first trimester of pregnancy may be associated with specific birth defects in infants. However, the risk does not appear to be associated with a single, low dose of fluconazole (150 mg), which is used to treat vaginal yeast infection (candidiasis), according to the Safety Alert released August 3.

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

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 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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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

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.

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.

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.

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