June 17th 2021
The COX-2 inhibitor Anjeso, a faster-acting injectable formulation of meloxicam, reduces opioid use after surgery.
November 18th 2014
June 13th 2013
June 12th 2013
FDA, international counterparts report progress on drug inspection collaboration
August 12th 2011The 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 recalls Vasopressin Injection, USP
August 12th 2011American 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 warns fluconazole in early pregnancy may cause birth defects
August 12th 2011FDA 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.
First pharmacist-focused session coming to AHA Scientific Sessions 2011
August 5th 2011Over 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
August 5th 2011PriCara 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
August 5th 2011More 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
August 5th 2011A 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
August 5th 2011Improving 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.
Error rates for computer-generated prescriptions vary significantly
July 29th 2011About 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
July 29th 2011A 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
July 29th 2011The 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.
Tamiflu for oral suspension label revised, reflects new concentration
July 22nd 2011The 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.
Study links medications with anticholinergic activity to cognitive decline
July 22nd 2011Medications 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
July 22nd 2011Novartis 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
July 22nd 2011A 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.
DMARDs may reduce diabetes risk for patients with RA, psoriasis
July 15th 2011Disease-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.
Alternative to NSAIDs should be considered for patients with CAD, hypertension
July 15th 2011Chronic 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
July 11th 2011FDA 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.
Amgen submits application to expand indication for Xgeva
July 8th 2011Amgen 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.
New evidence-based guidelines for PDN treatment
July 1st 2011In 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
July 1st 2011FDA 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.