Latest Fda Approved Drugs Information Systems

FDA approved vismodegib (ERIVEDGE Capsule, Genentech, Inc.) for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation. (January 30, 2012) More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm289571.htm

Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic). Erivedge, reviewed under the agency’s priority review program, is the first FDA-approved drug for metastatic basal cell carcinoma. Erivedge was reviewed under the FDA’s priority review program that provides for an expedited six-month review of drugs that may offer major advances in treatment. The drug is being approved ahead of the March 8, 2012 prescription user fee goal date. Basal cell carcinoma is generally a slow growing and painless form of skin cancer that starts in the top layer of the skin (epidermis). The cancer develops on areas of skin that are regularly exposed to sunlight or other ultraviolet rad...

Clinical Context In the United States, diabetes has been diagnosed in nearly 19 million people. It is a chronic illness that requires continuing medical care and ongoing patient self-management education and support to prevent acute complications and to reduce the risk for long-term complications. The American Diabetes Association (ADA) has provided annual diabetes recommendations that include screening, diagnostic, and therapeutic actions that may affect health outcomes in people with diabetes. The aim of the Standards of Medical Care in Diabetes—2012 recommendations was to provide clinicians, patients, researchers, payers, and other interested individuals with components of diabetes care, general treatment goals, and tools to evaluate the quality of care. The summary of revisions for the 2012 report is provided. Study Synopsis and Perspective A new standards of care statement from the ADA addresses screening, diagnostic, and treatment interventions known or thought to improv...

Clinical Context Aspirin is used for a wide variety of indications, and an analysis of randomized trials by Rothwell and colleagues, which was published in the January 1, 2011, issue of the Lancet , found that aspirin was effective in reducing the overall risk for death from cancer. Aspirin was particularly effective in reducing the risk for death from gastrointestinal tract cancer, and longer duration of aspirin therapy was associated with greater reductions in cancer mortality risks. However, the dose of aspirin did not appear to affect this outcome. Nonetheless, the current study by Ray and colleagues notes that many reviews have failed to provide a balance between the risks and benefits of aspirin as primary preventive therapy. The authors address this issue, and their findings are described in the Study Highlights section. Study Synopsis and Perspective A new meta-analysis said to provide "the largest evidence to date regarding the wider effects of aspirin treatment ...

At least 36 people with cardiovascular problems have died in a Lahore hospital over the past three weeks because of faulty drugs, Pakistani officials say. Police have arrested the owners of two local pharmaceutical firms that supplied the drugs to the government-owned Punjab Institute of Cardiology. Neither of the two firms have commented on the allegations. Doctors believe one or more of at least four drugs given to patients at the institute directly led to their deaths. The drugs were purchased at competitive rates and were allegedly offered to patients free of cost. "More than 100 patients brought to various hospitals in Lahore for suspected drug reactions have all been recently under treatment at Punjab Institute of Cardiology, and were given these drugs," Punjab provincial Health Secretary Jehanzeb Khan said on Monday. Dr Javed Ikram of the Allama Iqbal Medical College - one of the biggest medical colleges in the country - told the BBC that the drug reaction was ...

Eating fried food may not be bad for the heart, as long as you use olive or sunflower oil to make it, experts say. They found no heightened risk of heart disease or premature death linked to food that had been cooked in this way. But the investigators stress that their findings, from studying the typical Spanish diet in which these "healthy" oils are found in abundance, do not apply to lard or other cooking oils. So traditional fry ups should not be the order of the day, bmj.com reports. When food is fried it becomes more calorific because the food absorbs the fat of the oils. And experts know that eating lots of fat-laden food can raise blood pressure and cause high cholesterol, which are risk factors for heart disease. For the study, the researchers at the Autonomous University of Madrid surveyed 40,757 adults about their diet. The participants were asked about what types of food they ate in a typical week and how that food was prepared and cooked. None of the adu...

The death rate from heart attacks in England has halved in the last decade, says an Oxford University study. The research, published in the British Medical Journal, looked at more than 800,000 men and women who suffered heart attacks between 2002 and 2010. They found that fewer heart attacks occurred in later years and, of those that did occur, fewer were fatal. Researchers say improvements in NHS care and better prevention measures have contributed to the decline. The Oxford researchers used national hospital and mortality data to analyse 840,175 men and women in England who had suffered a total of 861,134 heart attacks over eight years. Comparing 2002 with 2010, they found death rates falling by 50% in men (78.7 per 100,000 population to 39.2) and by 53% in women (37.3 per 100,000 to 17.7). A declining mortality rate was also seen in all age groups and for both sexes. Focus on youngest The research on bmj.com concluded that just over half of the decline in deaths can be ...

Oral human papillomavirus (HPV) infection is more common among men than women, leading to an increased risk for men of head and neck cancers, a US study suggests. The Journal of the American Medical Association (JAMA) study assessed around 5,500 people aged 14 to 69. Around 10% of men had oral HPV, compared with 3.6% of women. HPV causes the majority of cervical cancers, as well as genital and anal - and head and neck cancers. Smoking and drinking are significant known risk factors for head and neck cancers. But oral HPV infection increases cancer risk by around 50%, according to the research team from Ohio State University Comprehensive Cancer Center. They say the incidence of head and neck cancers has significantly increased over the last three decades, and HPV has been directly implicated as an underlying cause. The researchers used data from a cross-sectional study as part of the 2009-10 National Health and Nutrition Examination Survey. They all provided a skin cell sample...

It may be possible to detect autism at a much earlier age than previously thought, according to an international team of researchers. A study published in Current Biology identified differences in infants' brainwaves from as early as six months. Behavioural symptoms of autism typically develop between a child's first and second birthdays. Autism charities said identifying the disorder at an earlier stage could help with treatment. It is thought that one in every 100 children has an autism spectrum disorder in the UK. It affects more boys than girls. While there is no "cure", education and behavioural programmes can help. One of the researchers, Prof Mark Johnson from Birkbeck College, University of London, told the BBC: "The prevailing view is that if we are able to intervene before the onset of full symptoms, such as a training programme, at least in some cases we can maybe alleviate full symptoms." His team looked for the earliest signs of autism...

Only eight people out of several thousand who received counterfeit drugs from the NHS in an incident in 2007 have been identified. Of those eight, only three have been informed about the incident, a BBC investigation has learned. 72,000 packs of counterfeit drugs entered the UK supply chain in 2007 but 25,000 remain untraced. The regulator, the MHRA, has said it took swift action in 2007 and issued its "most serious recall notice". A new EU directive will further improve patient safety, it added. In the spring of 2007, the Medicines and Healthcare products Regulatory Agency (MHRA) issued an emergency recall of drugs which had been identified as counterfeit. Those recalled included batches of the prostate cancer drug Casodex; of a drug used to treat heart complaints called Plavix; and of Zyprexa, which is used to control the symptoms of schizophrenia. The MHRA successfully seized 40,000 packs before they were distributed to pharmacies but 25,000 reached chemists acros...

  This is the Medscape Neurology Minute. I am Dr. Alan Jacobs. Researchers from the Albert Einstein College of Medicine in Bronx, New York, [1] have published a study evaluating the effects of treatment with onabotulinumtoxinA on health-related quality of life and headache impact in adults with chronic migraine. The program consisted of a 24-week, double-blind phase, with two 12-week cycles followed by a 32-week open-label phase consisting of 3 cycles. Thirty-one injections of 5 units each, totaling 155 units, were administered to fixed sites. An additional 40 units could be administered as needed. They pooled results of 2 headache questionnaires assessing headache impact and migraine-specific quality of life. After random assignment, 688 patients received onabotulinumtoxinA and 696 received placebo. Mean scores at baseline on the headache-impact and quality-of-life questionnaires were comparable between the 2 groups, and 93% were severely a...

NEW YORK (Reuters Health) Jan 25 - Out in the field, giving ketamine after an initial dose of morphine is more effective than continuing morphine in adults with significant trauma injuries, according to Australian researchers. "Furthermore, adverse events were uncommon in this nonphysician EMS setting," they reported online January 16 in Annals of Emergency Medicine. Dr. Paul Andrew Jennings of Monash University in Melbourne, Victoria, and colleagues note that while morphine is commonly used for acute traumatic pain, it often causes respiratory depression and nausea. Ketamine is appealing for use in the out-of-hospital setting, they explain, because of its analgesic and dissociative properties and its opioid-sparing effect. In addition, they write, "it is purported to allow patients to maintain their pharyngeal reflexes and maintain their own airway, even when fully dissociated." To investigate further, the team conducted a randomized open-label trial involving...

NEW YORK (Reuters Health) Jan 25 - Methylprednisolone does not improve outcomes in newborns undergoing cardiac surgery, and it may increase the risk of infection in some of those infants, an observational analysis suggests. "These data reinforce the need for a large randomized trial in this population," the authors conclude in their report, published online January 23 in Pediatrics. Dr. Sara K. Pasquali, with Duke University Medical Center in Durham, North Carolina, and colleagues explain that corticosteroids are used in pediatric heart surgery to reduce the inflammatory response triggered by cardiopulmonary bypass. But while inflammatory markers are reduced, the clinical benefits are being increasingly questioned. Using a congenital heart surgery database and another that provided data on medication usage, the researchers identified 3,180 newborns who had heart surgery over a five-year period. Twelve percent received methylprednisolone on the day before surgery, 28% rece...

January 27, 2012 (Lahore, Pakistan) — More than 100 people have died in Pakistan and hundreds more have been hospitalized after having received contaminated drugs for heart conditions. And many more people may have been exposed, authorities say. The drugs, given out free by the state, were supplied by the government-run Punjab Institute of Cardiology in Lahore, according to multiple media reports. Patients have experienced a rapid drop in white blood cells and platelets and damage to bone marrow, with bleeding from the nose, mouth, and urinary tract reported. The owners of three pharmaceutical companies suspected of supplying the medicines have been arrested and the factories closed down. Five other companies are said to be subject to legal action. At a press conference earlier this week, Health Secretary Dr Jahanzeb Khan said five different medicines were given to cardiac patients at the Punjab Institute of Cardiology. The drugs implicated included include versions of simvastat...

January 27, 2012 — 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. The new guidelines were published in the January issue of Maturitas . "There is emerging evidence on the widespread tissue effects of vitamin D," write Faustino R. Pérez-Lópeza, MD, PhD, from the Department of Obstetrics and Gynecology, Universidad de Zaragoza, Spain, and colleagues. "Epidemiological and prospective studies have related vitamin D deficiency with not only osteoporosis but also cardiovascular disease, diabetes, cancer, infections and neurodegenerative disease. However the evidence is robust for skeletal but not nonskeletal outcomes where data from large prospective studies are lacking." Based on a literature review and the consensus of expert opinion, the position statement panel concluded that the leading natural...

By Will Boggs MD NEW YORK (Reuters Health) Jan 26 - The risk of bleeding after combined coronary artery bypass graft (CABG) and valve surgery is higher when chronic aspirin therapy is stopped within five days of the operation, compared to when it's stopped at least six days in advance. The finding is from a review of such surgeries done at the Cleveland Clinic in Ohio, reported by Dr. Leslie Cho and colleagues. Dr. Cho told Reuters Health by email that surgeons need to weigh the risk of bleeding vs. the benefit of aspirin before combined CABG/valve surgery. "For example, if the patient has a drug-eluting stent and needs surgery, continuing aspirin makes sense,' Dr. Cho said. "However, if the patient is at high risk of bleeding" - because of anemia or older age, or because the surgery is a redo, for example - "then holding aspirin makes sense." The data, from 1,963 patients on chronic aspirin therapy who underwent nonemergent CABG/valve surgery, we...

NEW YORK (Reuters Health) Jan 24 - After a month of using vilanterol, an investigational long-acting beta-2-agonist (LABA) that's inhaled once a day, patients with moderate to severe chronic obstructive pulmonary disease (COPD) had significant improvements in forced expiratory volume in 1 second (FEV1). "The 25 mcg and 50 mcg doses of vilanterol appear to offer the greatest clinical benefit without any safety concerns," the authors reported online January 12 in Chest. Dr. Nicola A. Hanania, with Baylor College of Medicine in Houston, Texas, and colleagues note that once-daily dosing of a LABA could improve patient compliance. To assess dose response, efficacy and safety, the researchers enrolled 602 patients with moderate-severe disease and randomly assigned them to 3.0, 6.5, 12.5, 25, or 50 mcg vilanterol, or placebo, inhaled once daily for 28 days. The main outcome measure was the change in trough FEV1 from baseline to the end of the study. The 25 and 50 mcg doses ...

HIV positive mothers can be a viral infection to protect their children, if they get antiretroviral drugs during pregnancy.  However, even these drugs to prevent the spread of this disease are children, they may cause cleft lip and palate and other birth defects.  A new study published in the Journal craniofacial cleft palate in January, will investigate the interaction between antiretroviral prophylaxis and cleft lip and palate. To establish a drug and use the "report odds than the potential link between birth defects, the researchers studied five years of data from the U.S. Food and reporting system, Drug Administration of adverse events  (AERS), pharmacovigilance database publicly available sources. Antiretroviral drug therapy is to reduce the 15-25% of children the risk of transmission of HIV from mother to less than 1%, but even this success rate is now as a standard treatment with antiretroviral drugs, drugs not classified  as safe as a class of drugs, the saf...

In   the   U.S. ,   Keppra ,   Enbrel,   of   ®   has   been approved   for   the   adjuvant treatment of   adults and 4 - year - old   children and   partial   seizures   of epilepsy .   But   cord blood   has recently announced   the   U.S. Food and Drug   Administration (FDA)   has approved   to   reduce   the   age limit , including age   from   1   month-old baby   and   older   with epilepsy . Professor ,   Dr.   Iris   Loew   -   Friedrich ,   Chief Medical Officer   and Executive Vice President   cord blood   
   statement : Leaders   as   epilepsy   cord blood   has the responsibility   to   develop effective drugs   to   address   unmet   medical needs   in young children , we   continued   developmen...