Latest Fda Approved Drugs Information Systems

May 30, 2012 — In an overwhelming 96 to 1 vote last week, the US Senate approved a bill that, among other things, will help to prevent shortages of lifesaving drugs. However, some experts believe that the bill does not go far enough, even though they see it as an important first step. The bipartisan Food and Drug Administration Safety and Innovation Act (SB-3187) will require drug manufacturers to notify the US Food and Drug Administration (FDA) as soon as they anticipate interruptions in drug production, and 6 months in advance if a product will be discontinued. The bill also authorizes $6.4 billion in user fees over the next 5 years for manufacturers seeking the approval of branded and generic drugs, medical devices, and biotechnology products. It is expected that the House of Representatives will pass a similar bill soon — the FDA Reform Act (HR-5651). The American Society of Hematology (ASH) notes that the Senate bill exempts biologics from all provisions, and is p...

May 29, 2012 (Milan, Italy) — More details of  the phase 3 study  with a new drug for familial hypercholesterolemia (FH),  lomitapide  (Aegerion), showing large reductions in LDL, were presented at the  European Atherosclerosis Society  (EAS)  2012 Congress  last weekend. Limited preliminary results of the study were released last year and reported then by  heart wire   . Lomitapide is one of a cluster of new agents in development that offer the hope of achieving near-normal LDL levels in FH patients. Others include anti-proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9) antibodies in development by Sanofi/Regneron and Amgen and the antisense agent  mipomersen (Genzyme). Presenting the latest data on lomitapide,  Dr Marina Cuchel  (University of Pennsylvania School of Medicine, Philadelphia) said: "These are results that a few years ago we could only dream about in homozygous FH patients." EAS p...

May 26, 2012 (Silver Spring, Maryland)   — More studies of atrial septal defect (ASD) occluders are needed to better understand the incidence and causes of rare life-threatening adverse events related to the devices, an  FDA advisory panel concluded at its May 24 meeting [1]. At the meeting, the agency's  Circulatory System Devices Advisory Committee   had a wide-ranging and complex discussion on how the agency, manufacturers, researchers, and clinicians can better understand why a small number of ASD occluders are malfunctioning and which patients are most at risk for these rare events. "There's a lot we don't know, and this is an opportunity to better define the space. If today has been anything, it's been instructive in how many unanswered questions there are in the field," panel chair  Dr Clyde Yancy  (Northwestern University, Chicago, IL) said. St Jude's  Amplatzer  septal occluder was first introduced to the US market in 2001, followe...

May 29, 2012 (Florence, Italy) — In patients with newly diagnosed type 2 diabetes, genetic differences might influence beta cell functional mass, new research suggests. Sara Bonetti, MD, from the University of Verona and the Azienda Ospedaliera Universitaria Integrata, in Italy, and colleagues presented the findings here at the Joint 15th International Congress of Endocrinology and 14th European Congress of Endocrinology. "This cohort of newly diagnosed type 2 diabetic patients was useful for our purposes because of the absence of the potentially confounding effects of long-lasting antidiabetic treatments and because of the limited impact of duration and severity of hyperglycemia on metabolic phenotypes," Dr. Bonetti told  Medscape Medical News . According to Dr. Bonetti and colleagues, common genetic variability is already known to influence beta cell functional mass in type 2 diabetes, but the way in which this occurs is not clear. To investigate the rol...

May 30, 2012 — A counterfeit version of Adderall (Teva Pharmaceutical Industries) 30 mg tablets being sold on the Internet is unsafe, ineffective, and potentially harmful, the US Food and Drug Administration (FDA) warns. The FDA's preliminary laboratory tests show that the counterfeit tablets contain the wrong active ingredients. Adderall contains dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amephtamine sulfate. In contrast, the counterfeit medication was found to contain tramadol and acetaminophen. Currently on the FDA's drug shortage list, Adderall is in short supply owing to active pharmaceutical ingredient supply issues. Teva continues to release product as it becomes available. The FDA warns that "consumers should be extra cautious when buying their medicines from online sources. Rogue Web sites and distributors may especially target medicines in short supply for counterfeiting." The counterfeit Adderall tablets are...

May 29, 2012 — A coalition of medical societies representing some 100,000 specialists says a well-intentioned federal effort to improve the care of some of the nation's sickest and neediest patients could backfire, in part by cutting provider compensation. The patients in question are roughly 9 million "dual-eligibles" who are enrolled in both Medicare and Medicaid. They represent a disproportionately large share of Medicare and Medicaid spending, in part because they are generally sicker, and also because the 2 programs — each with its own benefits, billing systems, and provider networks — sometimes work at cross-purposes. Under the auspices of the Affordable Care Act, the Center for Medicare and Medicaid Services (CMS) is hatching demonstration projects that would turn over the care of dual-eligibles to state-operated managed care programs. The goal is to improve the lives of these patients, expand their access to care, eliminate duplicated services, and lower co...

May 30, 2012 — Ischemic stroke patients should be included among those deemed to be at high risk for further atherosclerotic coronary events, concludes a new scientific statement from the American Heart Association (AHA) and American Stroke Association (ASA). "This is an important message," Daniel T. Lackland, DrPH, from the Medical University of South Carolina in Charleston, and co-chair of the statement writing group, noted in an interview with  Medscape Medical News . "We've typically recognized that if a patient has heart disease or another condition you often treat them differently, maybe more aggressively," he explained. "But it's been unclear what you do with someone who has had a stroke. Do you treat them differently? This has been a big question for a really long time." "This is a very strong writing team that got together and looked at the evidence and determined that indeed stroke should be recognized as a cardiac risk equi...

May 29, 2012 (Atlanta, Georgia) — Urologists were up in arms over the new guidelines against prostate-specific antigen (PSA) screening here at the American Urological Association (AUA) 2012 Annual Scientific Meeting, and pointed out they have different perspectives than primary care physicians. Many older urologists remember a time when they regularly saw men with advanced prostate cancer at their first urology consult. "It was as if people were drowning all around us," said Ian Thompson, MD, director of the Cancer Therapy & Research Center at the University of Texas Health Science Center at San Antonio, and chair of the AUA prostate cancer guideline panel. When the PSA test came along in the 1980s, urologists saw it as a life preserver that could save patients' lives by detecting prostate cancer at an earlier stage, he said. That might explain why emotions ran so high at the annual meeting, which coincided with the release of the federal guideline recommend...

May 29, 2012 — Exercise or physical therapy, along with vitamin D supplementation, are the best medicine for fall prevention among older adults, according to a report by the US Preventive Services Task Force (USPSTF). The new clinical guideline was  published online  May 28 in the  Annals of Internal Medicine . Virginia A. Moyer, MD, MPH, on behalf of the USPSTF, reported new recommendations for fall prevention among community-dwelling adults aged 65 years and older after reviewing evidence on both the efficacy and possible harm from interventions. Dr. Moyer and colleagues reviewed data on multifactorial clinical assessment, clinical management, clinical education or behavioral counseling, home hazard modification, and exercise or physical therapy. Falls are the leading cause of injury in adults aged 65 years and older, with 30% to 40% of community-dwelling adults older than 65 years falling at least once each year. Among these patients, 5% to 10% incur a fracture,...

OSKRI Corp. of Lake Mills, WI is recalling 3.53 ounce bags of “Peach Granola”, because it may contain undeclared cashews. People who have an allergy or severe sensitivity to cashews and/or other nuts run the risk of serious or life-threatening allergic reaction if they consume these products.

May 28, 2012 (Thessaloniki, Greece) — Despite strict policies regarding the use of antibiotics in treating sore throats in pediatric patients, emergency department physicians commonly prescribe the drugs, particularly to patients younger than 5 years or if the prescribing physician is on a night shift, according to a Belgian study presented here at the European Society of Paediatric Infectious Diseases (ESPID) 30th Annual Meeting. With antibiotic resistance a pressing concern, policies are in place around the world to try to curb overuse, and Belgium is no exception, said lead author Inge Roggen, MD, of the Universitair Ziekenhuis Brussels Department of Emergency Medicine, Belgium. "Every government has different guidelines, but in Belgium, our policy is that if the child is healthy with no other comorbidities, we don't give antibiotics if it is just a sore throat," she said. Dr. Roggen and her team conducted the prospective study in an effort to evaluate adheren...

May 25, 2012 — With any luck, the Memorial Day weekend will bring weather good enough to be slathering on the sunscreen at least every two hours when outdoors. And to know which are the best products to put on your skin during the unofficial start of summer, the May issue of Consumer Reports  rated 18 top-selling sunscreens. The products ranged from SPF 30 to SPF 75+ and were lotions, sprays, or a spray foam. They varied in price from a low of $.59 an ounce to a high of $20.59 per ounce. To judge the performance of each product, sunscreens were tested on people, and the ultraviolet B (UVB) radiation protection was rated before and after swimming in fresh water for up to 80 minutes. Testers also checked whether the product stained clothing. In addition, they did a new "critical wavelength" test required by the FDA to see if the sunscreen truly offered broad-spectrum UVA and UVB protection. UVB radiation is the main cause of sunburn, while UVA rays penetrate deeper, wh...

May 29, 2012 — Use of nonsteroidal anti-inflammatory drugs (NSAIDs) may decrease the risk for developing squamous cell carcinoma (SCC) or malignant melanoma (MM), according to a new population-based, case-control study published online May 29 in  Cancer . Use of NSAIDs overall (>2 prescriptions) was associated with a decreased risk for SCC (incidence rate ratio [IRR], 0.85; 95% confidence interval [CI], 0.76 - 0.94) and MM (IRR, 0.87; 95% CI, 0.80 - 0.95) compared with nonuse (≤2 prescriptions). This was especially true for long-term use (≥7 years) and high-intensity use (>25% prescription coverage during the total duration of use). Although NSAID use was not associated with a reduced risk for basal cell carcinoma (BCC) overall (IRR, 0.97; 95% CI, 0.93 - 1.01), a reduced risk for BCC at sites other than the head was noted with long-term use (IRR, 0.85; 95% CI, 0.76 - 0.95) and high-intensity use (IRR, 0.79; 95% CI, 0.69 - 0.91). "The effect [of NSAIDs] increased with ...

May 28, 2012 — Menopausal hormone therapy (HRT) reduced risk of fractures but increased risk for stroke, thromboembolic events, gallbladder disease, and urinary incontinence, according to a systematic review of articles published after 2002. Whereas estrogen alone decreased the risk for breast cancer, estrogen plus progestin increased risk for probable dementia and breast cancer. This new review,  published online  May 29 in the  Annals of Internal Medicine , will be used to update the US Preventive Services Task Force recommendations. "Menopausal hormone therapy to prevent chronic conditions is currently not recommended because of its adverse effects," write Heidi D. Nelson, MD, MPH, from the Oregon Health & Science University in Portland, and colleagues. "The current indications for use from the U.S. Food and Drug Administration include short-term treatment of menopausal symptoms, such as vasomotor hot flashes or urogenital atrophy, and prevention of osteopo...

May 27, 2012 (Philadelphia, Pennsylvania) — Drugs aimed at halting the molecular destruction of beta cells are likely the next step in the quest to stop the progression of autoimmune type 1 diabetes, according to research presented here at the American Association of Clinical Endocrinologists 21st Annual Meeting and Clinical Congress by a pioneer in the field. "Most of the trials we do in are in recent-onset type 1 diabetes, when there are plenty of beta cells left — probably at least 20%.... If one could preserve them, it would be much easier to control patients; it's like the honeymoon phase," said George Eisenbarth, MD, PhD, executive director of the Barbara Davis Center for Childhood Diabetes and professor of pediatrics, medicine, and immunology at the University of Colorado at Denver School of Medicine. Today, autoantibody testing can predict an individual's risk of developing autoimmune type 1 diabetes, and even the age of onset of the disorder — informat...