Edmund's Newsletter December 2, 2008 Issue: #49 Volume 8 Join Our List In This Issue FDA Approves New Drug to Alleviate Moderate to Severe Pain FDA Approves New Drug to Treat Severe Form of Epilepsy Researchers Identify How Binge Drinking May Drive Heart Disease Selenium May Slow March Of AIDS Asthma Over-Diagnosed In One Third Of Canadian Adults, Study Suggests Experimental TB Drug Explodes Bacteria from the Inside Out 14 Drugs Identified As Most Urgently Needing Study For Off-Label Use Believe It Or Not News From MedWatch Recently Approved Drugs/Indications FDA Recalls and Safety Alerts in the Past 60 Days Drug Shortages Quick Links Edmund's Blog Edmund's Newsletter Edmund's Web Page Past Issues SPECIAL THANKS TO Michael R. Cohen President The Institute for Safe Medication Practices and Dr. Stephen Barrett Quackwatch Some links in Edmund's Newsletter will point to a page that requires registration.  In all cases the most you will have to do is fill out a simple form to enroll as a member.  In no case will I point you to a site that requires payment to view the page. PRAY FOR PEACE © 2001,2002, 2003, 2004, 2005, 2006, 2007 Join Our List FDA Approves New Drug to Alleviate Moderate to Severe Pain The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg. "This approval offers health care professionals an additional choice for treating moderate to severe acute pain," said John Jenkins, M.D., director of the office of new drugs in the FDA's Center for Drug Evaluation and Research. Tapentadol acts in two ways, opioid (narcotic) and non-opioid. It affects the brain and body primarily by activating opioid receptors in the brain, spinal cord and gastrointestinal tract. In addition, Tapentadol inhibits the reuptake of the brain chemical norepinephrine which possibly has an analgesic effect. Read more..... FDA Approves New Drug to Treat Severe Form of Epilepsy The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome. "This approval offers another treatment option for patients who suffer from these debilitating, severe seizures," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. Lennox-Gastaut syndrome is a severe form of epilepsy that usually begins before 4 years of age, and can be caused by brain malformations, severe head injury, central nervous system infection and inherited degenerative or metabolic conditions. In 30-35 percent of cases, no cause can be found. Patients may have periods of frequent seizures mixed with brief, relatively seizure-free periods; and suffer from varying types of seizures including tonic (stiffening of the body, upward deviation of the eyes, dilation of the pupils, and altered respiratory patterns), atonic (brief loss of muscle tone and consciousness, causing abrupt falls), atypical absence (staring spells), and myoclonic (sudden muscle jerks). Most children with Lennox-Gastaut syndrome experience some degree of impaired intellectual functioning or information processing, along with developmental delays and behavioral disturbances. Read more..... Researchers Identify How Binge Drinking May Drive Heart Disease As the holidays arrive, a group of researchers has identified the precise mechanisms by which binge drinking contributes to clogs in arteries that lead to heart attack and stroke, according to a study published today in the journal Atherosclerosis. The works adds to a growing body of evidence that drinking patterns matter as much, if not more, to risk for cardiovascular disease than the total amount consumed. According to the National Institute on Alcohol Abuse and Alcoholism (NIAAA), going on a "binge" means having five or more drinks for men, and four or more drinks for women, in two hours. Many studies suggest that an irregular pattern of heavy drinking brings about a two-fold increase in risk for a fatal heart attack, even as moderate drinking has been shown to reduce risk (the red wine effect). About 65 percent of Americans drink alcohol, with 15 percent reporting binge patterns in a national survey of problem drinkers. Alcoholic beverages contain ethanol, which is mostly converted into acetaldehyde once in the human system at "binge" levels, with the levels of acetaldehyde remaining high for many hours after the binge has ended. The current study clarified for the first time that binge levels of acetaldehyde cause an important type of immune cell, the monocyte, to become better able to stick to blood vessel walls, an important step in initiating atherosclerotic disease. Clarifying these mechanisms promises to empower the design of new treatments to counter the effects when combined with lifestyle change, researchers said. Read more..... Selenium May Slow March Of AIDS Increasing the production of naturally occurring proteins that contain selenium in human blood cells slows down multiplication of the AIDS virus, according to biochemists. "We have found that increasing the expression of proteins that contain selenium negatively affects the replication of HIV," said K. Sandeep Prabhu, Penn State assistant professor of immunology and molecular toxicology. "Our results suggest a reduction in viral replication by at least 10-fold." Selenium is a micronutrient that the body needs to maintain normal metabolism. Unlike other nutrients, which bind to certain proteins and modulate the protein's activity, selenium gets incorporated into proteins in the form of an amino acid called selenocysteine. These proteins -- selenoproteins -- are especially important in reducing the stress caused by an infection, thereby slowing its spread. Read more..... Asthma Over-Diagnosed In One Third Of Canadian Adults, Study Suggests Asthma may be overdiagnosed in countries like Canada, suggests a longitudinal study of 540 obese and non-obese adults that found approximately one third of Canadians with physician-diagnosed asthma do not have asthma when objectively tested. Asthma rates have increased in Canada and the US by 75% between 1980 and 1994, and studies suggest a possible link between obesity and asthma. In North America, obese adults are twice as likely to be diagnosed with asthma by a physician as non-obese adults. However, the "study found that 30% of adults recruited from the community who had been diagnosed with asthma by a physician had no evidence of asthma when their medications were tapered and when there were evaluated with serial assessments of symptoms, lung function and bronchial provocation tests," state Dr. Shawn Aaron from the Ottawa Health Research Institute and coauthors. "Overdiagnosis, or misdiagnosis, of asthma in Canada seems to be very common, but obese adults are not more likely to be overdiagnosed compared to normal weight adults." Read more..... Experimental TB Drug Explodes Bacteria from the Inside Out An international team of biochemists has discovered how an experimental drug unleashes its destructive force inside the bacteria that cause tuberculosis (TB). The finding could help scientists develop ways to treat dormant TB infections, and suggests a strategy for drug development against other bacteria as well. A report describing the research, led by Clifton E. Barry, III, Ph.D., of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is published in the Nov. 28 issue of Science. Dr. Barry's collaborators included scientists from NIAID and from the Novartis Institute for Tropical Diseases in Singapore. One-third of the world's population is infected with Mycobacterium tuberculosis (M. tb), the bacteria that cause TB. "Currently, there are no drugs available that specifically target latent tuberculosis infections in which bacteria are present but are not actively dividing," notes NIAID Director Anthony S. Fauci, M.D. "Dr. Barry and his colleagues have now given us a detailed picture of how the candidate TB drug PA-824 is metabolized inside Mycobacterium tuberculosis. Their discovery is a promising step towards developing effective drugs against latent TB as well as other bacteria." Read more..... 14 Drugs Identified As Most Urgently Needing Study For Off-Label Use Physicians and policy-makers know that drugs are frequently prescribed to treat certain diseases despite a lack of FDA approval - a practice known as off-label prescribing. Yet they say the problem is so big they don't know how to begin tackling it. But a potential game plan now exists. In a paper published in the December issue of Pharmacotherapy, a group of researchers has developed a list of 14 widely prescribed medications most urgently in need of additional study to determine how effective and safe they are for their off-label uses. Antidepressants and antipsychotics are the most prominent classes of drugs on the list, which specifically targets drugs that have high levels of off-label use without good scientific backing. "Off-label prescribing means that we're venturing into uncharted territory where we lack the usual level of evidence presented to the FDA that tells us these drugs are safe and effective," said Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, who is the senior author of the study. "This list of priority drugs might be a start for confronting the problem of off-label use with limited evidence." Read more..... Believe it or not Accused drunk driver ends up running over himself A 21-year-old man was accused of driving drunk and leading police on a chase that finally ended with him running over himself. The man was treated for minor injuries at a Santa Fe hospital and booked in to the Sandoval County detention center on charges of aggravated driving while intoxicated, fleeing a police officer, careless driving and two other outstanding traffic warrants. A tip to the state's DrunkBuster hot line Sunday afternoon alerted authorities to a possibly drunken driver. State Police Officer Grace Romero spotted the man's pickup truck swerving across both lanes of a highway, driving slowly and then fast. He refused to stop. After narrowly missing other vehicles, police said the suspect drove through a ditch and a barbed-wire fence before stopping. He tried to put the truck into park, but it ended up in reverse. Police said the man fell from his open door and both of his legs were run over by the front driver's side tire. News From MedWatch Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by  CLICKING HERE   Recently Approved Drugs/Indications Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs by CLICKING HERE   FDA Recalls and Safety Alerts in the Past 60 Days: To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE   Drug Shortages: As many of you are aware, many drugs in the US are either unavailable or in short supply.  To view a list of these drugs CLICK HERE   Recommend Edmund's Newsletter Edmund's Newsletter is published for only one reason and that is expand our knowledge base, join people together with like minds and to disseminate valuable information. If you feel this newsletter is of worth, please pass it along to your friends and colleagues. As you probably know, word of mouth is the best form of advertising! So, to help spread the word about Edmund's Newsletter, I set up an easy-to-use form for you to use. Feel free to recommend my newsletter to a friend, family member, or colleague! Send as many recommendations as you want; there's always room for another subscriber! Thank you Edmund