Edmund's Newsletter October 14, 2008 Issue: #42 Volume 8 Join Our List In This Issue FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland Tamoxifen Chemoprevention Tied To Early Detection Of Breast Cancer Mayo Clinic Collaborates to Advance Crohn's Treatment Hospital for Special Surgery Finds Common Drug Could Help Some Women Have a Healthy Pregnancy Largest Review of Its Kind Associates Anti-inflammatory Drugs with Reduced Breast Cancer Risk C. Difficile and Antibiotics Not Necessarily Linked 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 Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children The U.S. Food and Drug Administration supports the voluntary actions by CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. The FDA continues to assess the safety and efficacy of these products and to revise its OTC monograph (list of approved ingredients and amounts) for these medicines. Although this new labeling is inconsistent with the current monograph, FDA will not object, under the circumstances presented here, to the new label modification stating "do not use in children under 4," which reflects a more restrictive use of the drugs in children. The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist. Over the last year, FDA has been working on several fronts to address the safe use of nonprescription OTC cough and cold medicines in children. Read more..... FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate. BPH is a male disease wherein the prostate gland - located between the bladder, which stores urine, and the urethra, the tube through which urine exits the body - enlarges in men as they age. By age 50, roughly 50 percent of all men suffer from BPH. By age 80, that number jumps to 75 percent. "Benign prostatic hyperplasia can seriously impact the quality of life of men as they age," said George Benson, deputy director, Division of Reproductive and Urological Products, FDA. "This product will provide another treatment option for men suffering symptoms of an enlarged prostate." As men age, their prostate gland enlarges and begins to press against their urethra. This pressure can impede the flow of urine and make it difficult to eliminate it from the body. In the early stages of BPH, the disease can also create a need to urinate more frequently, or cause dribbling after urination. BPH can also lead to an increased risk of urinary tract infections and urinary retention. Urinary retention can damage the kidneys and cause urinary tract infections by mixing urine from the ureter with urine from the bladder that is heavily laden with bacteria. Rapaflo works by blocking the alpha-1 adrenoreceptors in the prostate, bladder, and urethra. By blocking these receptors, this treatment allows the smooth muscle in these tissues to relax, resulting in a reduction in BPH symptoms. Read more..... Tamoxifen Chemoprevention Tied To Early Detection Of Breast Cancer The drug tamoxifen does not prevent or treat estrogen receptor (ER) negative breast cancer, but it can make the disease easier to find, researchers report in the Oct. 1 Journal of the National Cancer Institute. Women at high-risk for breast cancer who took tamoxifen as a preventive measure in a clinical trial and later developed ER-negative breast cancer had a median time to first diagnosis of 24 months, compared with 36 months for those who received placebo, according to a retrospective statistical analysis. While long-term survival has not yet been observed for the trial, that one-year advanced diagnosis is an unexpected and significant finding, said study lead author Yu Shen, Ph.D., professor in The University of Texas M. D. Anderson Department of Biostatistics. "Based on our basic understanding of breast cancer, survival rate is higher when cancer is detected at an earlier stage. Our findings open up a new area of research." "It's a good example of how innovative application of statistical analysis can make a great contribution to better understanding the biological mechanisms of cancer," Shen said. Read more..... Mayo Clinic Collaborates to Advance Crohn's Treatment A study led by Mayo Clinic has found that infliximab (Remicade®)administered alone (monotherapy) or in combination with azathioprine is a more effective treatment for patients with moderate to severe Crohn's disease than azathioprine alone. These findings were presented today at the 2008 American College of Gastroenterology (ACG) Annual Meeting. Crohn's disease is an inflammatory disorder of the gastrointestinal tract that affects an estimated 500,000 people in the United States. Symptoms include abdominal pain, fever, nausea, vomiting, weight loss and diarrhea. Crohn's disease has no known medical cure. One common therapy used to manage the disease is a series of intravenous infusions of infliximab, which blocks tumor necrosis factor, an important cause of inflammation in Crohn's disease. Azathioprine is an orally-administered, small molecule immunosuppressive which has a broad immunosuppressive effect. Read more..... Hospital for Special Surgery Finds Common Drug Could Help Some Women Have a Healthy Pregnancy Hospital for Special Surgery researchers have found that statins may be able to prevent miscarriages in women who are suffering from pregnancy complications caused by antiphospholipid syndrome (APS), according to a study in mice. In this autoimmune syndrome, the body produces antibodies directed at phospholipids, the main components of cell membranes. This news comes from a study published in the October issue of the Journal of Clinical Investigation that is currently online in advance of print. In low risk pregnancies, APS is associated with a nine-fold increase in miscarriage. In high-risk pregnancies (women who have had at least three prior losses), APS is associated with a 90 percent risk of miscarriage. "Statins may work as a treatment for women with APS-induced pregnancy complications," said Guillermina Girardi, Ph.D., associate scientist at Hospital for Special Surgery in New York, who is lead author of the study. "They are drugs that have been shown to be very safe. There are a lot of women who continue to take statins through pregnancy and the drugs have not been shown to produce birth defects." Statins do not increase the risk of bleeding like anticoagulants, the current treatment for patients with APS. Read more..... Largest Review of Its Kind Associates Anti-inflammatory Drugs with Reduced Breast Cancer Risk Analysis of data from 38 studies that enrolled more than 2.7 million women -- the largest of its kind -- by researchers at the University of British Columbia, Vancouver Coastal Health Research Institute, and the University of Santiago de Compostela reveals that regular use of Non Steroidal Anti-Inflammatory Drugs (NSAIDs) is associated with a 12 per cent relative risk reduction in breast cancer compared to non-users. A separate analysis for Aspirin showed a 13 per cent relative risk reduction in breast cancer and an analysis for ibuprofen (Advil) showed a 21 per cent relative risk reduction. The review, published in the U.S. Journal of the National Cancer Institute, alludes to a protective affect against breast cancer. It was conducted by Dr. Mahyar Etminan, assistant professor of medicine at the University of British Columbia, and member of the Vancouver Coastal Health Research Institute, and Bahi Takkouche, professor of epidemiology at the University of Santiago de Compostela in Spain. Read more..... C. Difficile and Antibiotics Not Necessarily Linked A team at the MUHC and the Jewish General Hospital takes a new look at the causal relationship between antibiotic use and C. difficile infections. The latest study by Dr. Sandra Dial from the Research Institute of the MUHC, McGill University, and Attending Staff in the Intensive Care Unit at the Jewish General Hospital, questions the assumption held by a vast majority of medical professionals that Clostridium difficile (C.difficile) infections are essentially always preceded by antibiotic use. This finding could have a major impact on how patients with diarrhea are evaluated upon their admission to the hospital. This study will appear in the October 6 issue of the Canadian Medical Association Journal (CMAJ). The researchers analyzed only C. difficile infections acquired outside the hospital by patients aged 65 or older, and serious enough to require a hospitalization. Patients with hospital-acquired C.difficile infections were excluded because of the increased risk of infection and antibiotic use in the hospital environment. Their results show that 53% of the patients studied had not been exposed to antibiotics during the 45 days preceding their C.difficile-related hospitalisation. A rate that decreased to 46% when the pre-hospitalization timeframe analysed was extended to 90 days. "These figures show that approximately 50% of community-acquired C. difficile infections are not related to antibiotic use," explained Dr. Dial. "While antibiotic use indeed plays an important role, other factors are likely to also be important. But we still need to determine what these other risk factors are." Read more..... Believe it or not Med Student Plotted Sex Slave "Family" A Pennsylvania medical student who allegedly planned to assemble a "family" of female sex slaves that would reside with him on a farm or island was arrested yesterday on federal child pornography charges. Jeremy Noyes, 30, was nabbed after illicit images were found in one of his e-mail accounts, according to an FBI affidavit filed in U.S. District Court in Erie. Investigators searched Noyes's Yahoo and Gmail accounts after an ex-girlfriend (and fellow student at the Lake Erie College of Osteopathic Medicine) told agents of his "sexual interest in children." The woman, Elizabeth Fleming, also provided agents with e-mails in which Noyes, pictured at right, described his bizarre plan to start a "new society." That correspondence included details of Noyes's contact with a New Zealand woman named Alex who planned to move to the U.S. with her four-year-old daughter Abby. Like Fleming, Noyes met the New Zealand woman on collarme.com, a web site for bondage and S&M devotees. According to the FBI affidavit, a copy of which you'll find below, during an online chat Noyes coached the woman "on the proper ways to prepare Abby for sexual activity." Fleming told investigators that while attending a medical conference in March, Noyes told her that "his long term intent was to assemble a 'family' of female sex slaves that would begin with Alex and Abby." Noyes allegedly intended to impregnate the child "between the ages of eight and fourteen and then continue to breed the future offspring that would result from his plan," according to the affidavit. "Noyes intends to buy a farm or an island where he could put his new society together," reported FBI Agent Thomas Brenneis. Noyes, charged with two child porn counts, is being held in the Erie County jail in advance of a detention hearing scheduled for Thursday. If convicted of the felonies, he faces a mandatory minimum of five years in prison on each count (and a maximum of 20 years per charge). 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. 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