Latest Fda Approved Drugs Information Systems

Wegmans Food Markets, Inc. is recalling prepared foods that contain chopped/diced white onions as an ingredient because the onions have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

July 30, 2012 (New Orleans, Louisiana) — There are major challenges to increasing underrepresented minorities in medicine, among them the new Medical College Admissions Test (MCAT) that is scheduled to be introduced in 2015, according to Brenda E. Armstrong, MD, dean of admissions at the Duke University School of Medicine, in Durham, North Carolina. "The new MCAT is a monster exam," said Dr. Armstrong in a keynote address here at the National Medical Association 2012 Annual Convention and Scientific Assembly. Dr. Armstrong is also professor of pediatrics and pediatric cardiovascular medicine at Duke. The test, she noted, will not only ask far more about the field of natural sciences, it will also ask about aspects of psychosocial health, the humanities, and other nonmedical issues. New Test Items The recommendations of the M5 Committee of the Association of American Medical Colleges (AAMC) describe 4 test sections: biological and biochemical foundations of living s...

July 27, 2012 — The US Food and Drug Administration has approved prednisone delayed-release tablets ( Rayos , Horizon Pharma) at the 1-, 2-, and 5-mg doses for rheumatoid arthritis (RA). The agency also approved Rayos for polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease. The approval was based on new data indicating that the pharmacokinetics of delayed-released prednisone tablets are comparable to those of immediate-release prednisone. According to a company written release, the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials helped demonstrate the efficacy of this agent. The trials were  reported on  by  Medscape Medical News  in November 2010. "The CAPRA-2 trial demonstrated that people with moderate to severe RA treated with Rayos experienced a statistically significant improvement in ACR20 response criteria compared to placebo," the company states, while the overa...

July 30, 2012 (Washington, DC) — Two studies presented here at the AIDS 2012: XIX International AIDS Conference indicate that it is possible for "elite controllers" to discontinue antiretroviral therapy (ART) for the treatment of HIV after the virus drops below undetectable viral levels. Elite controllers are people infected with HIV who do not progress to full-blown AIDS. The key is early detection and early treatment, Asier Sáez-Cirión, MD, from the Institut Pasteur in Paris, France, told meeting attendees. Dr. Sáez-Cirión and colleagues conducted the Virological and Immunological Studies in Controllers After Treatment Interruption (VISCONTI) trial of 12 patients with HIV whose infections had been controlled for a median of 76 months (but for as long as 84 months) after interruption of 3 years of treatment with highly active antiretroviral therapy initiated in the first 10 weeks after infection (the VISCONTI patients). Circulating resting CD25, CD69, HLADR, and C...

July 27, 2012 (Washington, DC) — "The paradigm for use of antiretroviral therapy has shifted; treatment and prevention have converged," a panel from the International Association of Physicians in AIDS Care (IAPAC) announced here at AIDS 2012: XIX International AIDS Conference. The foundation of the approach requires treatment as soon as HIV-positivity is established and the use of preexposure prophylaxis, said José M. Zuniga, PhD, MPH, a member of the IAPAC from Washington, DC. "Successful treatment as prevention will require higher levels of HIV testing, enhanced linkage to and retention in care, access to quality treatment, adherence support, and new ways to monitor coverage and treatment," reports the IAPAC panel in its  consensus statement . Julio Montaner, MD, director of the British Columbia Center for Excellence in HIV/AIDS, chair in AIDS research and head of division of AIDS at the University of British Columbia in Vancouver, Canada, and past-presid...

July 27, 2012 — An advisory committee to the US Food and Drug Administration (FDA) voted July 26 to recommend ocriplasmin ( Jetrea , ThromboGenics, Inc) 125 μg intravitreal injection for the treatment of symptomatic vitreomacular adhesions (sVMAs), including macular hole. The committee voted unanimously to recommend approval of ocriplasmin for the treatment of VMAs, and 7 to 3 in favor of recommending approval for treatment of macular holes. "I thought the anatomic data was very favorable," Stephen S. Feman, MD, MPH, a professor at Saint Louis University School of Medicine in Missouri and voting committee member, said during the advisory meeting. Symptomatic VMAs result from incomplete separation of the vitreous from the macula and can be progressive and result in blindness. At this time, the only treatment option is vitrectomy, a major surgical procedure that is usually postponed until late in the disorder because of the potential risks and difficult recovery period. ...

uly 27, 2012 — When the Centers for Medicare and Medicaid Services (CMS) announced on July 6 that it intended to substantially slash reimbursements for a broad range of specialists to underwrite the expense of raising payments for primary care physicians by up to 7%, ophthalmologists were among the specialists who emerged largely unscathed. Ophthalmologists generate a significant amount of revenue through the same evaluation and management codes that primary care physicians use. By directing more money into those codes to boost pay for primary care physicians during the last 15 years, the CMS also has increased Medicare reimbursements to ophthalmologists. In this new proposed rule, CMS increased reimbursements to ophthalmologists by 1%, says William Rich III, MD, who practices at Northern Virginia Ophthalmology Associates in Falls Church, Virginia, and is medical director of health policy at the American Academy of Ophthalmology. The eye specialists had been slated for a 2% increa...

July 27, 2012 — Robert S. Ledley, DDS, the trailblazing dentist who invented the first practical whole-body computed tomography (CT) system and alerted researchers to the potential of computers in medicine, has died in Kensington, Maryland. He was 86 years old. Born in Flushing Meadows, New York, on June 28, 1926, Dr. Ledley earned his DDS at the New York University College of in Dentistry in 1948. Dr. Robert S. Ledley The dental degree was intended to provide a reliable source of income to support Dr. Ledley's budding interest in theoretical physics. Work toward a master's degree in physics at Columbia University in 1949 brought him into contact with Nobel laureates Hans A. Bethe and Enrico Fermi. Isidor Rabi, who conducted key experiments for the future development of magnetic resonance imaging, headed Columbia's physics department at the time. Dr. Ledley gained professional prominence in the 1950s and 1960s as an early advocate for computers in medicine an...

July 27, 2012 — The most important risk factor for the development of basal cell carcinoma (BCC) is a prior history of the disease, according to an analysis of data from a study of more than 1100 people at high risk for the disease. In addition, for the first time, a history of eczema has been linked to the disease. Martin Weinstock, MD, professor of dermatology at Brown University and a clinician at the Veterans Affairs Medical Center in Providence, Rhode Island, and colleagues authored the study, which was  published online  July 19 in the Journal of Investigative Dermatology . "Predictors of new BCCs on the face and ears among those at very high risk have not been studied in detail," the authors note. "In an attempt to better define risk factors for future BCCs in an important high-risk group, we studied predictors of BCCs among individuals who had at least two prior keratinocyte carcinomas (KCs) who participated in the Veterans Affairs Topical Tretinoin Ch...

July 27, 2012 — Three measures of blood sugar — glycated hemoglobin (HbA1c) levels, fasting plasma glucose (FPG), and 2-hour β-plasma glucose (2hrPG) — were higher on average in South Asians than white Europeans regardless of other factors associated with glycemic control, according to results from a new  study published  online June 14 and in the August print issue of  Diabetes Care . Samiul A. Mostafa, MBCHB, from the Department of Cardiovascular Sciences, University of Leicester, United Kingdom, and colleagues analyzed screening data from 6040 people aged 40 to 75 years between 2005 and 2009. The data included 1352 South Asians and 4688 white Europeans. The analysis showed HbA1c glucose levels to be significantly associated with ethnicity, FPG, 2hrPG, and homeostasis model assessment of β-cell function ( P  = .001), age and sex ( P  = .01), and fasting insulin and potassium ( P  = .05). When these and other risk factors were adjusted for, South As...

July 27, 2012 — The European Commission has approved the combination pill containing the dipeptidyl peptidase-4 inhibitor linagliptin and metformin hydrochloride for the treatment of adults with type 2 diabetes, alongside diet and exercise. The approval follows a  favorable recommendation  by the European Medicines Agency in May. The linagliptin/metformin combination sold in Europe as  Jentadueto  (Boehringer Ingelheim Pharmaceuticals, Inc, and Eli Lilly & Co) provides a single-tablet option that is taken twice daily. It is intended for patients with type 2 diabetes that is inadequately controlled on their maximal tolerated dose of metformin alone, metformin plus a sulfonylurea, or those already being treated with the combination of linagliptin and metformin. It can be used alone or in combination with a sulfonylurea. As  previously reported  by  Medscape Medical News , the linagliptin/metformin combination was approved by the US Food and ...

July 27, 2012 — Compared with those taking a placebo, almost twice as many patients with multiple sclerosis (MS) prescribed an oral cannabis extract reported relief from muscle stiffness, a new study has found. The cannabis agent also proved better at relieving symptoms of body pain and muscle spasm, and sleep disturbances. Results of the phase 3 Multiple Sclerosis and Extract of Cannabis (MUSEC) study confirm the patient-rated benefits of cannabis on MS symptoms that were found in the earlier  Cannabinoids in Multiple Sclerosis  (CAMS) study, researchers say. "The evidence behind using cannabinoids for symptom relief is pretty strong now, and the MUSEC study is another piece of evidence to support that view; in fact, it's probably the strongest evidence so far," said study lead author John Peter Zajicek, PhD, professor and chair of clinical neurology at the University of Plymouth, United Kingdom (UK). Dr. John Peter Zajicek The study was  published onlin...

July 27, 2012 — Eight weeks of modified yoga exercises led to clinically meaningful improvements in balance in a small pilot study of patients with a history of stroke who completed rehabilitative care. Yoga participants also experienced improvement in motor function, independence, and quality of life. "Yoga is a mind-body approach and thus may fit well into rehab efforts and stroke recovery," Arlene A. Schmid, PhD, who led the study, told  Medscape Medical News . Dr. Arlene A. Schmid "Rehabilitation therapists, such as occupational therapists [OTs], may consider embedding yoga into stroke rehab," added Dr. Schmid, a rehabilitation research scientist at the Roudebush Veterans Administration Medical Center and Indiana University in Indianapolis. The study was  published online  July 26 in  Stroke . "Important Contribution" Reached for comment, Maarten A. Immink, PhD, director of the Human Movement and Clinical Exercise Physiology program ...