Formulary Watch |

Black box warnings accelerate reduced antipsychotic use in dementia

The rate of decline in the use of atypical antipsychotics in outpatients with dementia accelerated following a black box warning by FDA, according to a multicenter study of national Veterans Affairs data.

TXA reduces death from bleeding in trauma patients

Tranexamic acid reduces the risk of death from bleeding without increasing the risk of vascular occlusive events or the need for surgical intervention in patients with acute traumatic injury, according to a review published in the 2011 Cochrane Database of Systematic Reviews.

FDA warns against terbutaline for preterm labor

FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor because of the risk for serious maternal heart problems and death.

Merck Serono pulls European application for oral MS drug Movectro

Merck Serono Europe informed the European Medicines Agency that it was withdrawing its marketing authorization application for oral cladribine (Movectro), 10-mg tablets, intended for the treatment of relapsing-remitting multiple sclerosis.

Forest to acquire Clinical Data

Forest Laboratories $1.2 billion acquisition of Clinical Data, the developer of Viibryd (vilazodone HCl) for the treatment of adults with major depressive disorder, is expected to allow Forest to leverage its existing presence in the antidepressant category.

FDA approves Corifact to prevent bleeding in people with rare genetic defect

FDA has approved Corifact (CSL Behring), the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

FDA fast tracks Vascugel

FDA has granted fast-track designation to a novel endothelial cell-based therapy (Vascugel, Pervasis) for the prevention of hemodialysis access failure in patients with end-stage renal disease.

Herpes zoster vaccine on back order

Less than 1 month after the Centers for Disease Control and Prevention?s Advisory Committee on Immunization Practices recommended that most Americans aged 60 years and older get vaccinated to prevent herpes zoster, the vaccine (Zostavax, Merck) is on back order.

Rosiglitazone label and medication guide updated with cardiovascular risks

FDA has announced that the physician labeling and patient medication guide for rosiglitazone (Avandia, GlaxoSmithKline) have been changed to include information on cardiovascular risks (including death) of this agent.

ACIP revises adult immunization schedule for 2011

The Advisory Committee on Immunization Practices announces several changes to the recommended adult immunization schedule for 2011.

Variations in DMARD receipt exist in Medicare managed care patients with RA

An analysis of data from more than 90,000 Medicare managed care enrollees who received care for rheumatoid arthritis found that more than one-third did not receive the recommended treatment with a disease-modifying antirheumatic drug, and that receipt varied by demographic factors, socioeconomic status, geographic location, and health plan, according to a study in JAMA.

Oseltamivir oral suspension on back order due to increased demand

Oseltamivir phosphate oral suspension (Tamiflu) is on back order due to increased demand, manufacturer Genentech announced.

Sanofi-aventis to acquire Genzyme

The $20.1 billion acquisition of Genzyme by Sanofi-aventis will allow Sanotif-aventis to expand its footprint in biotechnology and give it an edge in the market for drugs for rare diseases, according to experts.

Zinc may shorten common cold

Zinc, in lozenge or syrup form, is beneficial in reducing the duration and severity of the common cold in healthy people, when taken within at least 24 hours of onset of symptoms, according to a new report published in the Cochran Library.

FDA issues CRL for Contrave

FDA has issued a complete response letter for Orexigen's and Takeda's Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

FDA approves drug to prevent premature births

FDA has approved hydroxyprogesterone caproate injection (Makena [formerly known as Gestiva], Hologic and KV Pharmaceutical Co.), the first drug to help prevent premature delivery before 37 weeks in women who have had at least 1 previous preterm birth.

FDA approves vaccine for meningococcal disease in children

FDA has approved a vaccine for preventing meningococcal disease in children.

Vaccine may help patients avoid herpes zoster recurrence

Recurrences of herpes zoster may be more common in immunocompetent adults than once thought, according to a study published in the February issue of Mayo Clinic Proceedings, as reported in Newswise.

Escitalopram reduces number and severity of menopausal hot flashes

Escitalopram, a selective serotonin reuptake inhibitor, at doses of 10 or 20 mg/d significantly reduced hot flash frequency and severity compared with placebo, according to a recent multi-center, double-blind study.

FDA approves gabapentin once-daily for post-herpetic neuralgia

FDA has approved gabapentin (Gralise, Depomed and Abbott Products) tablets for once-daily treatment of post-herpetic neuralgia.

Analgesic medication errors, including prescribing errors, common but preventable

Medication errors involving analgesics, including mistakes in prescribing, are a major contributor to suboptimal therapeutic outcomes and preventable adverse patient events, according to a study published in the Journal of Pain, reported Newswise.com.

ACIP revises guidelines for influenza vaccination

The Centers for Disease Control and Prevention?s Advisory Committee on Immunization Practices has issued revised guidelines for vaccinating patients against influenza, reported Medscape Medical News.

Eisai receives CRL for GERD drug

FDA has issued a complete response letter to Eisai for its rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive GERD, and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.

FDA issues CRL for obesity treatment due to concerns about cardiovascular safety

FDA has issued a complete response letter for Orexigen?s and Takeda?s Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

Fluzone linked with increase in febrile seizures in young children

An increase in febrile seizures in children following vaccination with Fluzone warrants further investigation, according to a report from FDA.

Formulary Digital Edition February 2011

Contraceptive treatments: A review of current hormone options and newer agents for women; Focus on dabigatran; Agents in late-stage development for the treatment of cystic fibrosis.

Drug Watch: Cystic fibrosis (PDF) (February 2011)

Agents in late-stage development of cystic fibrosis

FDA Pipeline Preview, February 2011 (Afrezza, Nuvigil, Opana ER, Liprotamase, Erwinaze, Telaprevir, SNS01-T, XL184, QLT091001, Fidaxomicin)

Recent FDA action (through, January 2011) related to Afrezza, Nuvigil, Opana ER, Liprotamase, Erwinaze, Telaprevir, SNS01-T, XL184, QLT091001, Fidaxomicin.

Dabigatran: A new orally available anticoagulant for prevention of strokes and thrombosis in patients with atrial fibrillation

Dabigatran etexilate (Pradaxa) was approved by FDA for the prevention of stroke and thrombosis in patients with atrial fibrillation.

FDA announces ongoing safety review of recombinant human growth hormone and possible increased risk of death

FDA released a safety communication to inform prescribers and patients about a possible increased risk of death in persons with certain kinds of short stature treated with recombinant human growth hormone (also known as somatropin).