Latest Fda Approved Drugs Information Systems

The U.S. Food and Drug Administration (FDA) is clarifying dosing and warning recommendations for the drug Celexa (citalopram hydrobromide). There is the possibility that high doses of the antidepressant can cause dangerous abnormalities in the electrical activity of the heart.

Castellini Company LLC is recalling certain jalapeno peppers distributed from its Wilder, Kentucky facility because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

March 28, 2012 (San Francisco, California) — Prostatic artery embolization relieved the symptoms of benign prostatic hyperplasia in 2 studies presented here at the Society of Interventional Radiology 37th Annual Scientific Meeting. The novel procedure, which has been tried in only 2 centers in the world, offers an alternative to transurethral resection of the prostate (TURP), with potentially fewer adverse reactions. "This could mean that more men have a chance at getting their lives back," said researcher Francisco Cesar Carnevale, MD, PhD, professor and chief of the interventional radiology section at University of São Paulo in Brazil, in a statement. "We're very happy," Dr. Carnevale told Medscape Medical News . "It's a feasible, effective, safe procedure." In prostatic artery embolization, surgeons use microcatheters to place resin beads in the arteries that supply the prostate. The constricted blood flow causes the prostate to shrink, rel

March 28, 2012 (New York, New York) — In vitro data on a next-generation hepatitis C virus (HCV) NS3/4A protease inhibitor garnered considerable interest here at the International Conference on Viral Hepatitis 2012. MK-5172, being developed by Merck & Co, demonstrated "potent activity" against the majority of primary first-generation protease inhibitor resistance-associated variants (RAVs) in biochemical and cell-based phenotype assays, reported Richard J. Barnard, PhD, from Merck & Co. MK-5172 also inhibited patient-derived NS3 proteases across HCV genotypes and retained activity against HCV proteases isolated from 5 patients with vaniprevir RAVs. In his presentation, Dr. Barnard noted that virologic failure with first-generation protease inhibitors is often associated with the emergence of RAVs; it is important that next-generation molecules are pangenotypic and active against first-generation protease inhibitor RAVs. "MK-5172 fulfills the profile expected

March 28, 2012 — The US Food and Drug Administration (FDA) has approved a new test designed to detect antibodies to viruses in donors of human serum and plasma. The viruses are associated with several diseases, including some forms of leukemia and neurologic diseases. The Avioq HTLV-I/II Microelisa System is the only test now available that can be used to both screen the blood supply for antibodies to human T-lymphotropic virus type I (HTLV-I) and human T-lymphotropic virus type II (HTLV-II) and help diagnose infection with these viruses, the FDA said in a statement. "Since 2008, there has been only one FDA-licensed donor screening test available for detection of antibodies to HTLV," Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, said in an agency news release. "Today's approval provides an additional test for HTLV, providing greater flexibility to blood establishments and helping to assure the safety of the blood suppl

March 28, 2012 (Orlando, Florida) — Children who undergo a prolonged trial of sublingual immunotherapy (SLIT) before undertaking oral immunotherapy (OIT) for milk allergy have fewer treatment-related symptoms, particularly severe ones, than those on OIT alone, according to a study reported here at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2012 Annual Meeting. "We found that prolonged SLIT before OIT improved safety and reduced severe symptoms but did not eliminate all symptoms." There was also no difference in food-challenge thresholds, reported Shannon Seopaul, a research assistant at Johns Hopkins University in Baltimore, Maryland. "At this time, we can't say that prolonged SLIT before OIT is any more effective than OIT itself." The study was part of a larger study that compared SLIT alone with SLIT followed by OIT ( J Allergy Clin Immunol . 2012;129:448-455). Patients (median age, 8 years) were randomized to SLIT (goal, 7 mg daily) or

March 29, 2012 — Patients who take the antibiotic rifaximin for irritable bowel syndrome (IBS) with diarrhea are far less likely to stop using the drug because of adverse effects than patients taking 2 other common IBS treatments, according to a study by Eric Shah, MBA, from the School of Medicine at the Texas Tech University Health Sciences Center in Lubbock. The study was published online March 26 and in the April print issue of the American Journal of Medicine . A research team led by Mark Pimentel, MD, from the GI Motility Program at the Cedars-Sinai Medical Center in Los Angeles, California, reviewed 26 clinical trials of drugs for IBS with diarrhea and for IBS with constipation. In forms of IBS with diarrhea, the review found that patients experienced fewer adverse effects from the antibiotic rifaximin than patients who used tricyclic antidepressants or stool-slowing alosetron. For every 2.3 and 2.6 patients who benefited from antidepressants or alosetron, respectively, 1 had