Latest Fda Approved Drugs Information Systems

Exenatide (Ex-4), a glucagonlike peptide-1 (GLP-1) receptor agonist currently used in the management of type 2 diabetes, could effectively treat drug addiction, including cocaine dependence, new research shows. Investigators at Vanderbilt University in Nashville, Tennessee, found that mice pretreated with the drug seemed to enjoy cocaine less, spending less time in the treatment chamber following cocaine introduction, compared with mice that were not pretreated with Ex-4. "We know that the GLP-1 receptor affects the dopaminergic system and when dopamine neurotransmission is impaired, it leads to hedonic feeding and obesity," study investigator Aurelio Galli, PhD, professor of molecular physiology and biophysics and the Vanderbilt Brain Institute, told  Medscape Medical News . "So providing animals with a GLP-1 agonist activates the GLP-1 receptor and decreases interest in highly palatable food, and we found it also works to decrease the craving for cocaine....

VIENNA, Austria — The new serotonin-norepinephrine reuptake inhibitor (SNRI) levomilnacipran is effective in treating patients with major depressive disorder (MDD), new research suggests. A phase 3 randomized controlled trial (RCT) of more than 700 adults with MDD showed that those treated for 2 months with 40-mg, 80-mg, or 120-mg daily doses of levomilnacipran sustained release (SR) all showed significantly greater symptom improvements than those who received placebo. Although the active medication overall was considered "generally well tolerated," common treatment-related adverse events (AEs) included nausea and hyperhidrosis (especially in the 80-mg dose). Forest Laboratories announced in September that they had submitted a New Drug Application to the US Food and Drug Administration (FDA) for levomilnacipran in the treatment of MDD in adult patients. "This was one of the pivotal trials done to test the efficacy and safety profile of this drug. And it was on...

October 25, 2012 — Over-the-counter eyedrops and nose sprays contain powerful drugs that are poisonous in surprisingly small amounts if swallowed, the FDA warns. Unwary parents often leave these products within easy reach of curious children. From 1997 through 2009, eyedrops injured more than 4,500 children under the age of 5 and nasal sprays injured more than 1,100, according to the U.S. Consumer Product Safety Commission (CPSC). Injury reports show that children can easily open the products, which do not come in child-resistant packages. The drugs are surprisingly powerful. Swallowing less than a fifth of a teaspoon can seriously harm a child, the FDA says. The eyedrops in question soothe redness by causing blood vessels in the eye to constrict. Visine is a popular brand; there are many generic versions. Nose drops work in a similar way, tightening blood vessels in the nose. Afrin, Dristan, and Mucinex are popular brands, and there are many generic versions. The products...

NEW ORLEANS — Although much of the data come from preclinical and observational studies, evidence is mounting that exposure to anesthesia in early childhood may increase the risk for learning disabilities and other forms of neurodevelopmental impairment in adolescence, according to speakers at the American Academy of Pediatrics (AAP) 2012 National Conference and Exhibition. "Concerns regarding the safety of anesthetics in young children have been present within anesthesiology for most of the past decade, and the concern is spreading," said Randall Flick, MD, MPH, associate professor of anesthesiology and pediatrics and chair of pediatric anesthesiology at the Mayo Clinic, Rochester, Minnesota. But, in spite of noticeable trends, he urged pediatricians not to jump to conclusions and change their practices yet. Preclinical Evidence of Neurotoxicity Sulpicio G. Soriano, MD, professor of anesthesia at Harvard Medical School, Boston, Massachusetts, said the scientific e...

LAS VEGAS, Nevada — Bisphosphonates (BPs) are not associated with an increased risk for esophageal cancer, according to a study presented here at the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting and Postgraduate Course. Oral BPs are commonly used to prevent and treat osteoporosis, but they can cause erosive esophagitis when pills become entrapped in the esophagus. Some previous studies had suggested an association between long-term BP use and an increased risk for esophageal cancer, but there were conflicting results. "Some people are concerned that esophagitis might cause inflammation and lead to (cancer)," presenter Saowanee Ngamruengphong, MD, a gastrointestinal fellow at the Mayo Clinic in Jacksonville, Florida, told  Medscape Medical News . The researchers performed a systematic review and meta-analysis of controlled observational studies. MEDLINE was searched from 1950 to 2012, and bibliographies of all retrieved articles were exami...

NEW ORLEANS — A new "autism toolkit" designed to help clinicians diagnose and manage autism spectrum disorders (ASD) and provide resources for the families of these children has been launched by the American Academy of Pediatrics (AAP). Released here at the AAP 2012 National Conference and Exhibition, the second edition of the autism toolkit is entitled  Autism: Caring for Children With Autism Spectrum Disorders: A Resource Toolkit for Clinicians  and includes the latest AAP guidelines on autism screening, surveillance, diagnosis, treatment, and referral. According to the toolkit coeditor Susan E. Levy, MD, University of Pennsylvania School of Medicine, Philadelphia, it provides doctors with tools to help them "be more comfortable in their understanding of the policies put forward by the AAP for evaluating and managing ASD." "We modelled it after the toolkit for attention-deficit/hyperactivity disorder, which has had very good uptake by pediatricians. ...

The US Food and Drug Administration's (FDA's) Radiological Devices Panel of the Medical Devices Advisory Committee has voted 9 to 1 to endorse the  Selenia Dimensions 3-D System With C-View Software Module  (Hologic Inc) as a new option for breast cancer screening, calling it safe and effective, with a favorable risk-benefit ratio. The system was approved by the FDA in 2011 for breast cancer screening and diagnosis. Screening can consist of field digital mammography (FFDM) alone or a combination of FFDM and digital breast tomosynthesis (DBT). The new element being recommended for approval is that the addition of the software module can generate synthetic 2-dimensional images from the DBT data, thus obviating the need for acquiring standard FFDM images. Hologic was asking the FDA to allow the combination of DBT with synthetic 2-dimensaional images to be used as another exam option for screening women for breast cancer. Before voting, the panel discussed a number of q...