Latest Fda Approved Drugs Information Systems

February 27, 2012 — A novel strain of a swine influenza virus that sickened just 12 individuals in 2011 nevertheless merits continued surveillance because tests indicate that the emerging virus has "pandemic potential" among humans, according to an article published online February 21 in the Proceedings of the National Academy of Sciences. In the tests, ferrets were inoculated with isolates of this novel virus, as well as earlier versions. The viruses efficiently replicated and spread among the ferrets, which resemble humans in terms of lung physiology and susceptibility to influenza viruses, lead author Melissa Pearce, PhD, an associate service fellow at the US Centers for Disease Control and Prevention (CDC), and coauthors write. The swine influenza virus from 2011 is designated A(H3N2)v, with the "v" standing for variant. What accounts for the variance in this particular virus is a gene from the pandemic 2009 influenza A(H1N1) virus that codes for matrix protei...

(Reuters) Feb 27 - U.S. health regulators have rejected a vaginal gel from Watson Pharmaceuticals and Columbia Laboratories aimed at reducing the risk of premature birth, the companies said on Monday. The Food and Drug Administration told the companies that the data was not strong enough to support approval of the Prochieve drug and that they needed to do additional clinical studies, Watson and Columbia said. The decision was not a major surprise after an advisory panel to the FDA recommended in January that the agency reject the drug, already used in some other countries, because there was not enough data to show it worked. The vaginal gel, which contains the hormone progesterone, is meant for women with a short cervix, who have a higher risk of premature birth. "We have formally requested an end-of-review meeting with FDA to determine if a viable path forward can be established for this application," Watson Chief Executive Officer Paul Bisaro said in a statement. A si...

February 28, 2012 (Abu Dhabi, United Arab Emirates) — A telemedicine program in Germany facilitates interaction between internists and ophthalmologists and helps to identify patients at increased risk for cardiovascular events using information from the retina, according to a study presented here at the World Ophthalmology Congress 2012. "The eye mirrors vascular and neurodegenerative diseases," said study presenter Georg Michelson, MD, from the University of Erlangen in Germany. "In particular, retinal microangiopathy correlates with certain systemic diseases such as arterial hypertension, stroke, and diabetes." For instance, retinal vessel-wall thickness, which is increased in stroke, can be seen using a nonmydriatic fundus camera. Dr. Michelson described previous research done by his team, which showed that stroke risk increased 6.35-fold when cotton-wool spots were observed, and increased 4.71-fold with microaneurysms; stroke risk was 4.25-fold higher with blo...

February 27, 2012 — New data from the Framingham Offspring Study cohort suggest that higher dietary intake of the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) may help protect the aging brain. Dr. Zaldy S. Tan Results showed that lower red blood cell (RBC) levels of DHA and EPA in late middle age were associated with smaller brain volumes and a "vascular" pattern of cognitive impairment, even in persons free of clinical dementia. "People with lower blood levels of omega-3 fatty acids had lower brain volumes that were equivalent to about 2 years of structural brain aging," study author Zaldy S. Tan, MD, MPH, from the Easton Center for Alzheimer's Disease Research and the Division of Geriatrics, University of California, Los Angeles, comments in a written statement. This study, Dr. Tan told Medscape Medical News, "adds to the current body of evidence on the beneficial health effects of omega-3 fatty acids." Howev...

February 27, 2012 — Women with dysmenorrhea who take a single high dose of vitamin D suffer much less menstrual pain and have no need of pain medications for any reason for up to 2 months, a new study has found. “To our knowledge, this is the first study investigating the effect of a single high dose of vitamin D in primary dysmenorrhea,” wrote the study authors, led by Antonino Lasco, MD, from the Department of Internal Medicine, University of Messina, Italy. “Our data support the use of cholecalciferol in these patients, especially when exhibiting low plasmatic levels of 25(OH)D [25-hydroxyvitamin D],” they write. The study is published February 27 in the Archives of Internal Medicine. Pain Trigger Dysmenorrhea affects almost one half of menstruating women. The pelvic pain is believed to be triggered by excessive uterine production of prostaglandins, synthesized from omega-6 fatty acids before menses, that control vasoconstriction and uterine contractions. According to the stu...

ISSUE: FDA notified healthcare professionals and medical care organizations about the Class 1 recall of certain lots of these tracheostomy tubes. Difficulty arising from disconnecting accessories from the connectors of the affected tubes may result in excessive force to detach the accessory and the tracheostomy tube may dislodge from the patient. This could lead to serious patient injury or death, especially if no replacement tube is immediately available. BACKGROUND: The Bivona Pediatric, Neonatal and Flextend tracheostomy tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. This product is used in health care facilities and home care environment. Lot Numbers 1631477 through 1923406 are being recalled. The recalled products were manufactured from August 29, 2009 to January 29, 2011. RECOMMENDATION: Consumers who have the affected tubes should identify all affected, unused product in inventory and segregate it to a quarantine location. Con...

ISSUE: Bedford Laboratories announced a nationwide recall of three lots of cytarabine for injection—2066986, 2111675, and 2131148—because vials have a potential risk of a lack of sterility. The risk was determined from a post-release investigation of the manufacturing area. BACKGROUND: Cytarabine in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningeal leukemia RECOMMENDATIONS: Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use the product lots listed for patient care and should immediately quarantine any product for return. Should wholesalers/distributors/retailers still have product which is being recal...

Dr. Jeffrey Gordon wants to treat a new patient with ovarian cancer with Doxil, a chemotherapy drug that's proven highly effective against the disease. But he is unable to obtain Doxil because, like many other potentially lifesaving drugs, it is in short supply. "It's really become a crisis," said Gordon, an oncologist with New London Cancer Center. The Food & Drug Administration announced Tuesday that it would approve importation of a replacement drug for Doxil, called Lipodox. Supplies of Lipodox will end the Doxil shortage within weeks, according to the FDA. The FDA also announced that it has asked other drug companies to begin producing or increase production of Methotrexate, a cancer drug used to treat children with leukemia. The drug is mainly manufactured by Ben Venue Laboratories. Drug availability continues to concern doctors and patients. The FDA currently lists 115 drugs as being in shortage. The list is largely made up of generic injectable drugs, ...

In the short life of Sam Grady, dates are divided into two categories: days that came before the 3-year-old's July 1 diagnosis of leukemia and the days that followed. Before July 1, the Lehigh Township boy loved tearing through the house with his older brother Eli and watching "SpongeBob SquarePants." Since then, he has lost his hair and grown nauseous from his chemotherapy; it took weeks for his parents to adapt to their new reality. His mother, Pauline Grady, said she feared a third time period for Sam: the dates after her son missed taking methotrexate, the medicine essential to his recovery. Doctors at Lehigh Valley Hospital-Muhlenberg in Bethlehem administered the drug to him Monday via spinal tap, but national reserves of the drug were reduced to a two-week supply at the time. "It's worth its weight in gold," Pauline Grady said of the drug. She took a photo of it Monday, not knowing if it was the last time her son would receive a dose of the medi...

WASHINGTON – The battle of the bulge has been a big, fat failure for U.S. drugmakers, but that hasn’t stopped them from trying. For nearly a century, scientists have struggled to make a diet pill that helps people lose weight without side effects that range from embarrassing digestive issues to dangerous heart problems. Earlier this week, a government panel recommended the Food and Drug Administration approve the diet drug Qnexa. The recommendation raises hope the U.S. could approve the first anti-obesity drug in more than a decade. It also highlights how challenging it is to create a pill that fights fat in a variety of people without negative side effects. Even Qnexa was previously rejected over concerns it can cause heart palpitations and birth defects if taken by pregnant women. “Having a drug for obesity would be like telling me you had a drug for the fever,” said Dr. Mitchell Roslin, chief of bariatric surgery at Northern Westchester Hospital in New York. “There can be million...

Your Pharmacist May Hate You: I Have No Idea How This Stayed Under My Radar For ... : You HAVE to let this video run until the talk of Walgreen's starts. Or skip until around 3:25 in: The Colbert Report Get More: Co...

Your Pharmacist May Hate You: Highlights From Recent Pill Counting Action. : I was excited when I first heard of the 15 minute prescription filling guarantee, as the prospect of seeing outer space has always excited m...

Electronic cigarettes, also known as e-cigarettes and electronic nicotine delivery devices, are becoming a popular alternative to cigarette smoking. Sold at mall kiosks, on the Internet, and at some convenience stores, electronic cigarettes allow the user to consume nicotine by simulating cigarette smoking without producing second-hand smoke. An electronic cigarette, which resembles a metallic cigarette, contains flavored, liquefied nicotine encased in a plastic cartridge that is placed into a battery-operated device. When the smoker actuates the button, a vaporized puff of nicotine is released to be inhaled. Despite the seemingly growing popularity of electronic cigarettes, several countries, including Canada, Australia, and Brazil, have banned them. [1] The US Food and Drug Administration (FDA) has issued warnings about the lack of scientific and clinical trial data to support the safety of electronic cigarettes. [2] Yet, many reasons are offered for the use of these devices. Acc...

Abstract Aim: Pharmacists are positioned to provide medication counseling and drug information to patients. This study assessed the knowledge, attitudes and education of over 700 pharmacists concerning pharmacogenetics and pharmacogenetic testing. Methods: A multiquestion, online survey was developed to assess healthcare provider knowledge, attitudes and education concerning pharmacogenetic testing. Results: More than 90% of pharmacists were interested in learning more about pharmacogenetics and testing, with those with less than 10 years of experience were more likely to want web-based continuing education programs. The pharmacists were unlikely to have had formalized education regarding pharmacogenetics, were very likely to rate their knowledge accurately, and were more likely to have a positive attitude about pharmacogenetics if they had received education regarding pharmacogenetics. Conclusion: Most pharmacists were interested in learning more about pharmacogenetic testing.

The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment. Gleevec was originally granted accelerated approval for the treatment of advanced or metastatic GIST in 2002. In 2008 Gleevec received a subsequent accelerated approval for adjuvant use that is for the treatment of patients with GIST who had had potentially curative resection (surgical removal) of GIST tumors, but who were at increased risk for a recurrence. The accelerated approval program provides earlier patient access to promising new drugs while the confirmatory clinical trials are being conducted. Regular approval for the metastatic GIST indication was also granted in 2008. GIST is a rare form of cancer that originates in cell...

January 31, 2012 — The US Food and Drug Administration (FDA) yesterday approved a combination pill containing the dipeptidyl peptidase-4 inhibitor linagliptin and metformin hydrochloride for the treatment of adults with type 2 diabetes. The linagliptin/metformin combination sold as Jentadueto (Boehringer Ingelheim Pharmaceuticals, Inc, and Eli Lilly & Co) provides a single-tablet option that is taken twice daily. It can be used alone or in combination with a sulfonylurea. As previously reported by Medscape Medical News , linagliptin ( Tradjenta ) received FDA approval in May 2011 for improving blood glucose control in adults with type 2 diabetes, either as a stand-alone or in combination with other therapies. In a 24-week, randomized, double-blind, placebo-controlled study involving 791 adults with type 2 diabetes inadequately managed with diet and exercise, linagliptin plus metformin led to reductions in hemoglobin A1c levels of up to 1.7 percentage points. A Matter of Conv...

February 1, 2012 (New Orleans, Louisiana) — The risk of ischemic stroke is greatly elevated in children who seek medical attention for an infection, especially within the first few days following the infection, a new study shows. "It seems to be less an issue of a chronic infection and more an issue of an acute infection transiently increasing a child's risk of stroke," the study's principal investigator, Heather Fullerton, MD, director of the Pediatric Stroke and Cerebrovascular Disease Center, University of California, San Francisco, told Medscape Medical News . "So the risk is probably for a pretty brief period, just a handful of days, then it really seems to taper off." The study was presented here at the International Stroke Conference (ISC) 2012. Dose Dependent Researchers used administrative databases and medical charts to find cases of stroke and infection exposures. Within a cohort of about 2.5 million children who received care in a northern ...

January 31, 2012 — Negative social interactions may increase proinflammatory cytokine reactivity, new research suggests. When chronic, this reactivity has been associated with hypertension, diabetes, coronary heart disease, depression, and some cancers. In a prospective study of more than 100 healthy young adults, stressful or "hostile" interactions during daily living were associated with increased levels of the cytokines IL-6 and soluble receptor for tumor necrosis factor-α (sTNFαRII). Significant levels of increased inflammation were also found after the participants engaged in competitive interactions, such as in school, the workplace, or even for another's attention, but not in leisure-time activities such as sports. "Our findings about negative and competitive interactions were pretty much what we expected. But when we broke down the types of competitive activities, we were surprised that leisure activities didn't fall into this heightened inflammation ...

January 31, 2012 — Laxatives are the answer for many children experiencing bed-wetting, according to a report from Wake Forest University in Winston-Salem, North Carolina. Investigators report that occult megarectum is a commonly overlooked cause of nocturnal enuresis, and that it can be detected simply by an abdominal X-ray and treated with laxatives. Lead author Steve Hodges, MD, assistant professor of urology, and coauthor Evelyn Anthony, MD, from the Department of Radiology at the university, found that 30 children and adolescents aged 5 to 15 years seeking treatment for bed-wetting had large amounts of stool in their rectums, even though they reported having normal bowel habits. The report, published online December 14 in Urology , showed that 3 months of laxative therapy cured 25 patients (83%) of their bed-wetting. The authors note that stool retention reduces bladder capacity (and possibly leads to bladder overactivity) and explains why many therapies aimed at the bladder, ...

January 31, 2012 — The US Food and Drug Administration (FDA) Pediatric Advisory Committee today reviewed safety data on pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), or PCV13 ( Prevnar 13 , Wyeth Pharmaceuticals, Inc). The panel agreed that the estimates of febrile seizure risk need to be further refined but that routine monitoring of the vaccine should continue. The 2-day committee meeting was held in Gaithersburg, Maryland, yesterday and today. Tina Khoie, MD, MPH, a medical officer with the Division of Vaccines and Related Product Applications Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER), FDA, presented an overview of the prelicensure safety data for PCV13. PCV13 was licensed on February 24, 2010, for use in children aged 6 weeks through 5 years of age and is indicated for active immunization for the prevention of invasive disease and otitis media caused by strains of Streptococcus pneumoniae . Prevnar ...

January 31, 2012 — A new study strengthens the association of long-term use of proton pump inhibitors (PPIs) with increased risk for hip fracture in postmenopausal women, particularly those who smoke. PPIs can affect fracture risk by increasing secretion of gastrin, inhibiting calcium absorption, and altering osteoclast function. Use of these drugs to treat indigestion increased when they became available over the counter in the United States in 2003. In May 2010, the US Food and Drug Administration issued a warning about the possible link between extended PPI use and hip fracture and requested further information. The new study, published online January 31 in the BMJ , adds information from nearly 80,000 women to the body of data. Hamed Khalili, MD, from Massachusetts General Hospital, Boston, Massachusetts, and colleagues examined data from the prospective cohort Nurses' Health Study, which provided information on lifestyle and dietary risk factors. The study, which began in ...

Abstract Over 50% of women are believed to be affected by female sexual dysfunction (FSD). When particularly distressful, FSD is known as hypoactive sexual desire disorder (HSDD). In contrast to male sexual dysfunction that has been extensively researched, there is less evidence addressing the treatment of HSDD in women, particularly with regard to the use of androgen therapy. A variety of testosterone products, including oral, injectable, and transdermal preparations, has been prescribed for the treatment of HSDD in premenopausal women, as well as in those with naturally occurring or surgically induced menopause. Although studies have shown some benefit with testosterone supplementation in women with HSDD, conflicting evidence and debate regarding the clinical efficacy of testosterone remain. Because of concern over potential adverse events, additional studies with longer follow-up periods are necessary before use of testosterone in women with HSDD becomes widespread. Initiation of...

February 1, 2012 — Implementation of 2 commercial e-prescribing systems significantly reduced prescribing errors, including serious errors, at 2 Australian hospitals, according to results from a study published online January 31 in PloS Medicine . "Considerable investments are being made in commercial electronic prescribing systems (e-prescribing) in many countries," write lead author Professor Johanna Westbrook, PhD, from the University of New South Wales, Sydney, Australia, and colleagues. However, they note, "Few studies have measured or evaluated their effectiveness at reducing prescribing error rates, and interactions between system design and errors are not well understood, despite increasing concerns regarding new errors associated with system use." These researchers evaluated the effect of 2 commercially available e-prescribing systems on reducing prescribing errors and assessed their propensity for creating new types of errors. The authors looked for ...

Roughly 50%-75% of patients with chronic kidney disease (CKD) have high blood pressure. Therefore, it is important to know which antihypertensive interventions are associated with positive outcomes in these patients. [1,2] The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI™) practice guidelines address the pharmacotherapeutic management of this patient population, compiling the subanalyses of trials that focused on the use of antihypertensive agents in patients with CKD. [2-5] In the setting of arrhythmias, angina, and high-risk cardiovascular disease (CVD), nondihydropyridine (non-DHP) calcium channel blockers (eg, diltiazem and verapamil) are the preferred antihypertensive agents. [2] Because all patients with CKD are classified as being at high risk for CVD, non-DHP calcium channel blockers are indicated along with other antihypertensives. [2] Non-DHPs have shown significant reductions in albuminuria, both alone and in combination with agents t...

Objectives: To describe the various factors that come into play when a breastfeeding mother is taking medications, including use of prescription drugs, over-the-counter medications, recreational drugs, galactogogues, and herbal emedies and to provide a framework used for counseling breast-feeding women. Setting: Community and hospital pharmacy and health care settings. Practice description: Consultative services provided to breast-feeding mothers who had been prescribed or were using medications. Main outcome measures: Use of pharmacokinetic factors, maternal and child factors, a list of questions to ask breast-feeding mothers, and a stepwise approach to counsel breast-feeding mothers on the compatibility of using medications while breast-feeding. Results: By positive intervention of pharmacists and health care providers, up to 1 million breast-feeding mothers, who must use medications, can continue to breastfeed while taking medications. Conclusion: Objectively weighing the ben...

Clinical Context According to the current study by Pérez-Lópeza and colleagues, vitamin D plays a pivotal role in maintaining skeletal health. There are 2 major forms of vitamin D: vitamin D 2 and vitamin D 3 . The major source of D 3 is cutaneous synthesis requiring sunlight exposure, and other sources include gastrointestinal absorption of foods such as fatty fish, eggs and milk. There are 3 categories of hypovitaminosis D: insufficiency, deficiency, and severe deficiency according to the respective cutoff values of 25-hydroxyvitamin D [25(OH)D] levels of 20 to 29.99 ng/mL, below 20 ng/mL, and below 10 ng/mL. This is a review of hypovitaminosis D in postmenopausal women and recommendations to address low levels of vitamin D. Study Synopsis and Perspective A European Menopause and Andropause Society (EMAS) position statement on the role of vitamin D after menopause notes that the recommended daily allowance is 600 IU/day, or 800 IU/day for those 71 years of age or older. Th...

Clinical Context The US Food and Drug Administration (FDA) has approved ivacaftor, the first available treatment targeting the defective cystic fibrosis transmembrane regulator ( CFTR ) protein implicated in the pathophysiology of CF. Specifically, ivacaftor targets the G551D mutation, in which the amino acid aspartic acid substitutes for glycine in position 551. Ivacaftor was designated as an orphan drug because of the rarity of the G551D mutation. CF is the most common fatal genetic disease in white persons, with US prevalence of approximately 30,000. Of these, approximately 4%, or 1200 patients, have the G551D mutation. Study Synopsis and Perspective On January 31, the US FDA approved ivacaftor ( Kalydeco , Vertex Pharmaceuticals, Inc) for patients 6 years and older who have a rare form of CF and carry the G551D mutation in the CFTR gene. Defects in the CFTR gene are the basis of CF. In the G551D mutation, the amino acid glycine in position 551 is substituted with asp...