Latest Fda Approved Drugs Information Systems

A more than 10-fold increase in methicillin-resistant Staphylococcus aureus  (MRSA) infections drove a surge in pediatric  Staphylococcus -associated hospitalizations that peaked in 2006, according to an analysis of 25 years of pediatric hospital discharge data in California. The study, published online December 12 in  Emerging Infectious Diseases , found that children hospitalized for staphylococcal infections had longer hospital stays and higher mortality risk than children hospitalized for other causes. Kathleen Gutierrez, MD, associate professor, Stanford University School of Medicine, California, and colleagues examined the hospital discharge data from 1985 to 2009 for 140,265 children and found that the number of staphylococcal infections rose from 49 per 100,000 children to a peak of 83 per 100,000 children in 2006 before falling to 73 per 100,000 in 2009. The records came from the California Office of Statewide Health Planning and Development, which maintains a hospital di

Many ophthalmologists have made efforts to trim patient expenses but some may not be aware of therapeutically equivalent, cheaper alternatives for treating diabetic macular edema (DME). Using results from various multicenter, prospective trials, William E. Smiddy, MD, professor of ophthalmology at the Bascom Palmer Eye Institute in Miami, Florida, concluded that some DME eyes could be effectively treated with less expensive options, yielding cost savings ranging from 40% to 88%. His findings,  published  in the December issue of Ophthalmology , suggest that pseudophakic patients and those with visual acuity (VA) worse than 20/200 experience similar outcomes when treated with intravitreal corticosteroids or the more expensive anti-VEGF agents. In contrast, patients with better vision (VA > 20/32) have only been included in laser trials and thus should receive that treatment. In addition, certain treatment regimens may be equally effective whether administered with "trea

ATLANTA, Georgia — The investigational agent quizartinib (Astellas/Ambit) has shown unprecedented activity in patients with relapsed and refractory acute myeloid leukemia (AML) in a phase 2 clinical trial. On the basis of these results, larger phase 3 clinical trials with the drug are being planned, according to Astellas/Ambit. Patients with AML can develop many different genetic mutations, but one of the most threatening is  FLT3  internal tandem duplications (ITD), which makes the leukemia even more aggressive and typically leads to resistance to standard chemotherapy. This mutation develops in 34% of AML patients and is associated with more rapid relapse and reduced overall survival, explained lead author Mark Levis, MD, PhD, associate professor of oncology, pharmacology, and medicine at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine in Baltimore, Maryland. "Quizartinib is the first and only single-agent drug that has produced a clinical benefi

Pertuzumab (  Perjeta , Roche) for breast cancer has just been given a go-ahead in the first step of the European approval process. The drug was given a positive opinion from the Committee of Medicinal Products for Human Use (CHMP), which is a recommendation for marketing authorization. The next step is actual approval from the European Commission. Pertuzumab  was approved  in the United States earlier this year, costing approximately $188,000. The indication for its use is rather narrow. Pertuzumab, a humanized monoclonal antibody directed against  HER2 , is indicated for use with the first available  HER2 -targeted agent trastuzumab (  Herceptin , Roche), as well as docetaxel, in patients with metastatic or locally recurrent unresectable  HER2 -positive breast cancer who have not received previous  HER2 therapy or chemotherapy for their metastatic disease. According to the CHMP, the benefits of pertuzumab are its ability to improve progression-free survival, overall surviv

PARIS, France — The short-term mortality benefit of using chest compressions only rather than chest compressions plus rescue breathing in the resuscitation of patients with out-of-hospital cardiac arrest appears to be continued in the long term, a new study suggests [1]. The study, published online in  Circulation  on December 10, 2012, was conducted by a team led by  Dr Florence Dumas (Descartes University, Paris, France). They conclude: "The current results provide important evidence that chest-compression alone . . . can achieve better overall prognosis and should be considered the . . . approach for nearly all adult patients for whom dispatchers suspect cardiac arrest." The researchers combined data from two randomized trials comparing chest compression alone or chest compression plus rescue breathing on short-term mortality and ascertained long-term vital status of patients from national and state death records. Results showed that among the 2496 subjects ther

WORCHESTER, Massachusetts  — Innovative researchers have developed a smartphone-based application that allows patients to detect an irregular pulse caused by atrial fibrillation [1]. Two algorithms developed for the application that analyzed signals using an iPhone 4S successfully distinguished atrial fibrillation from sinus rhythm, report investigators. "A number of patients who are referred to us have pretty symptomatic atrial fibrillation," said lead investigator  Dr David McManus  (University of Massachusetts Medical School, Worchester, MA). "So they are highly motivated to keep track of their episodes. We traditionally order Holter monitors and event monitors to capture the coming-and-going episodes of atrial fibrillation. I thought there was a potential role to leverage the fact that everybody has a smartphone and to use that as a means to do a sort of physiological assay of the patient." The results of the study are published online December 7, 2012 i

OAKLAND, California  — Making prescription refills more affordable and easier to obtain may improve adherence to antihypertensive medication, particularly among certain ethnic groups that currently lag behind in terms of compliance, new research shows [1]. "What is new here is that we really did focus on factors we consider to be modifiable through health-system intervention," lead author  Dr Alyce S Adams  (Kaiser Permanente Division of Research, Oakland, CA) told  heart  wire   . She and her colleagues report their findings in a paper published online December 10, 2012 in the  Archives of Internal Medicine .   When we looked at race and added in these issues of copay and mail order pharmacy, we found the difference between blacks and whites in particular--but also between Hispanics and whites--narrowed.   "We found that health-system factors such as medication copay and the use of mail-order pharmacy were both associated with better adherence for all race

ATLANTA, Georgia — New data from a pooled analysis of the EINSTEIN-DVT   and  EINSTEIN-PE   in the treatment of deep venous thrombosis (DVT) or pulmonary embolism suggests that rivaroxaban  (Xarelto, Bayer/ Janssen) is similarly effective in preventing recurrence of venous thromboembolism (VTE) as enoxaparin  followed by a vitamin-K antagonist and may be associated with less bleeding. In addition, subgroup analysis showed reassuring results in specific high-risk populations such as elderly, fragile patients, those with cancer, and those with large clots. The data was presented at the  American Society of Hematology (ASH) 2012 Annual Meeting   by  Dr Harry Buller  (Academic Medical Center, Amsterdam, the Netherlands). He noted that the EINSTEIN-DVT and EINSTEIN-PE trials had identical noninferiority designs comparing oral rivaroxaban (15 mg twice daily for three weeks then 20 mg once daily thereafter for up to 12 months) with enoxaparin for five to 10 days followed by an oral v

The movie  Silver Linings Playbook  has been garnering critical acclaim and numerous award nominations, including today's announcement of 4 nods from the Golden Globes. But how accurately does it portray mental illness, a major theme in the film? Bradley Cooper and Jennifer Lawrence in  Silver Linings Playbook . Source: Snap Stills/Rex/Rex USA At least one psychiatrist says that although he enjoyed the film, he found that it was not an accurate depiction of mental illness. "It was a really nice love story with a Frank Capra ending that was reminiscent of  It's a Wonderful Life, " Michael Blumenfield, MD, president of the American Academy of Psychoanalysis and Dynamic Psychiatry, told  Medscape Medical News. "And it deals with topics not usually seen in a mainstream move," added Dr. Blumenfield, who is also a psychiatrist in Woodland Hills, California, and professor of psychiatry and behavioral sciences at New York Medical College, in Val

AVENTURA, Florida — The problem of prescription pain medication abuse in the elderly is a rapidly growing concern, new research suggests. An epidemiologic study presented here at the American Academy of Addiction Psychiatry (AAAP) 23rd Annual Meeting & Symposium shows that approximately 20% of individuals aged 65 years and older take analgesics several times per week and that rates of abuse or addiction in those with chronic pain is 18%. Furthermore, oxycodone, hydrocodone, and methadone were the drugs that were most often involved in up to 40% of opiate misuse–related deaths. The researchers also found that most of the illicit pain-relieving drugs came from a well-meaning friend or relative. "What happens is that people get prescription pain medications from a friend or a relative, not from a drug dealer on the street. Or they get it from one physician. For instance, the patient goes to the dentist for a root canal or tooth extraction and gets 30 Vicodin.

An advisory panel to the European Medicines Agency (EMA) has recommended the approval of loxapine (  Adasuve , Alexa UK Ltd) for the rapid control of agitation in adult patients with bipolar disorder or schizophrenia. On Thursday, the Committee for Medicinal Products for Human Use announced it had adopted a positive opinion on the drug and recommended that it be granted marketing authorization. A psycholeptic antipsychotic, its efficacy is thought to be mediated through high-affinity antagonist of dopamine D2 receptors and serotonin 5-HT2A receptors. Loxapine binds with noradrenergic, histaminergic, and cholinergic receptors. Its interaction with these systems may influence the spectrum of its pharmacologic effects associated with calming effects and suppression of aggressive behavior. According to the committee's written opinion, the benefits of the drug are its "ability to rapidly reduce the agitation in mild to moderate patients with schizophrenia or bipolar diso

An advisory committee to the European Medicines Agency (EMA) has recommended that nalmefene (  Selincro , H. Lundbeck A/S), a drug for the reduction of alcohol consumption in adult patients with alcohol dependencies who have a high drinking risk level, who are without physical withdrawal symptoms, and who do not require immediate detoxification, be given marketing approval. On Thursday, the Committee for Medicinal Products for Human Use announced that it had adopted a positive opinion and recommended the opioid receptor antagonist be granted marketing authorization. Acute alcohol intake has been shown to result in mesolimbic dopamine release, which can provide positive reinforcement. Nalmefene is thought to counteract these reinforcement effects, thereby reducing alcohol consumption. The most common side effects are "unspecific" and include nausea or dizziness; some patients have reported sleep-related events. The committee also recommended that the drug be prescri