Edmund's Newsletter June 10, 2008 Issue: #24 Volume 8 Join Our List In This Issue Two Diabetes Trials Shed a Little Light On Deaths Protein Found To Promote Antibiotic Resistance In A Common Food-borne Pathogen FDA Announces New Labeling Changes for Regranex FDA Announces Limited Return of Heartworm Drug to U.S. Market Researchers Find Drug That Stimulates Immune System to Fight Prostate Cancer Estrogen Helps Drive Distinct, Aggressive Form of Prostate Cancer Long-term Pesticide Exposure May Increase Risk of Diabetes 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 Two Diabetes Trials Shed a Little Light On Deaths Researchers who compared two diabetes trials said on Friday they are getting some insight into why patients in one were more likely to die after aggressive treatment, while patients in another were not. Weight gain, the use of multiple drug combinations and perhaps even getting blood sugar too low, too fast may all have been factors in causing early deaths, experts said. The trials, one in the United States and Canada and the other in Australia, were both designed to measure the benefits of using drugs to dramatically lower blood sugar in diabetes. But the American trial, called Accord, was halted in February after researchers found patients were more likely to die with more treatment. Results from the Australian trial, called Advance, showed the treatment reduced the risk of kidney disease by one-fifth without increasing the risk of death. "These findings reinforce that blood glucose lowering in diabetes is safe and has an important role to play in the prevention of serious complications," said Dr. Anushka Patel of the University of Sydney, who presented findings from the study at the American Diabetes Association meeting in San Francisco. Read more..... Protein Found To Promote Antibiotic Resistance In A Common Food-borne Pathogen Researchers from Iowa State University have identified a novel factor that promotes the development of antibiotic resistance in a bacterial pathogen. The study explains that Mfd, a protein involved in DNA transcription and repair, plays an important role in the development of fluoroquinolone resistance in Campylobacter, a bacterial pathogen commonly associated with food poisoning in humans. Development of antibiotic resistance in Campylobacter, especially to fluoroquinolone (a broad-spectrum antimicrobial), compromises clinical therapy and poses a public health threat. Previous studies have revealed that Campylobacter is highly mutable to antibiotic treatment and the number of fluoroquinolone-resistant Campylobacter is greatly increased in many regions of the world. But it has not been clear why Campylobacter is able to mutate at such a high frequency. Using various molecular tools, the research team from the College of Veterinary Medicine, led by Dr. Qijing Zhang, has found that Campylobacter increases the production of Mfd in the presence of a fluoroquinolone antibiotic. Elimination of Mfd from Campylobacter resulted in 100-fold reduction in the rate of emergence of mutants resistant to fluoroquinolones. Without Mfd, the development of fluoroquinolone-resistant Campylobacter under antibiotic treatment is significantly reduced. Read more..... FDA Announces New Labeling Changes for Regranex The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. The WARNINGS section of the product has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for the revised label. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed. The results were consistent with no overall increase in cancer incidence among the patients exposed to Regranex. However, there was a five-fold increased risk of cancer mortality in the group exposed to three or more tubes of Regranex. "In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," said Susan Walker, M.D., director of the Division of Dermatological and Dental Products. "Regranex is not recommended for patients with known malignancies." Read more..... FDA Announces Limited Return of Heartworm Drug to U.S. Market The U.S. Food and Drug Administration (FDA) today announced a limited return of a reformulated heartworm prevention drug for dogs, which had been withdrawn because of serious, life-threatening adverse reactions, including loss of appetite, lethargy; vomiting, seizures, difficulty walking, jaundice (a yellowish appearance); and bleeding disorders, allergies, convulsions, followed in some cases by death. ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs, NADA 141-189, manufactured by Fort Dodge Animal Health, Overland Park, Kan., is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. "This is the first veterinary drug to be marketed under a risk minimization and restricted distribution program. Numerous drugs for use in people have been successfully marketed under similar programs," said Bernadette Dunham, D.V.M., Ph.D., director, FDA's Center for Veterinary Medicine. "While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions." Heartworm disease is a serious and potentially fatal condition for dogs. The parasite that causes heartworm disease is transmitted through the bite of a mosquito. Read more..... Researchers Find Drug That Stimulates Immune System to Fight Prostate Cancer In a multi-site study, Oregon Health & Science University Cancer Institute researchers have found that a drug called Ipilimumab, also known as MDX-010, works to stimulate the body's own immune system to fight prostate cancer. The drug was found to be effective in study participants with a serious type of prostate cancer - one where the tumor has spread and was resistant to hormonal treatment and, in some cases, also to chemotherapy. Darryl Pape was one of 19 participants in the Oregon Health & Science University Cancer Institute trial. "I was in such bad shape. I couldn't even sit on a plane for more than two hours without a lot of pain. I was praying for some clinical trial that would help," said Pape, 54, of Portland, Ore. Pape was running out of options for his prostate cancer. He was diagnosed almost seven years ago and had tried different cancer drugs, but each only for a while. Last year his cancer count, or prostate specific antigen (PSA), was at a high level -- an indicator that his cancer was growing and spreading and it was not responding to any drugs. Read more..... Estrogen Helps Drive Distinct, Aggressive Form of Prostate Cancer Using a breakthrough technology, researchers led by a Weill Cornell Medical College scientist have pinpointed the hormone estrogen as a key player in about half of all prostate cancers. Estrogen-linked signaling helps drive a discrete and aggressive form of the disease caused by a chromosomal translocation, which in turn results in the fusion of two genes. "Fifty percent of prostate cancers harbor a common recurrent gene fusion, and we believe that this confers a more aggressive nature to these tumors," explains study senior author Dr. Mark A. Rubin, professor of pathology and laboratory medicine, and vice chair for experimental pathology at Weill Cornell Medical College. Dr. Rubin is also attending pathologist at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. "Interfering with this gene fusion - or its downstream molecular pathways - will be crucial in the search for drugs that fight the disease. Based on our new data, we now believe that inhibiting estrogen may be one way of doing so," he says. The findings are published in the May 27 online edition of the Journal of the National Cancer Institute. Dr. Rubin conducted the study while at the Brigham and Women's Hospital and in collaboration with Dr. Todd Golub and other members of the Broad Institute of MIT and Harvard, in Cambridge, Mass. His team is now continuing this line of research at Weill Cornell. Read more..... Long-term Pesticide Exposure May Increase Risk of Diabetes Licensed pesticide applicators who used chlorinated pesticides on more than 100 days in their lifetime were at greater risk of diabetes, according to researchers from the National Institutes of Health (NIH). The associations between specific pesticides and incident diabetes ranged from a 20 percent to a 200 percent increase in risk, said the scientists with the NIH's National Institute of Environmental Health Sciences (NIEHS) and the National Cancer Institute (NCI). "The results suggest that pesticides may be a contributing factor for diabetes along with known risk factors such as obesity, lack of exercise and having a family history of diabetes," said Dale Sandler, Ph.D., chief of the Epidemiology Branch at the NIEHS and co-author on the paper. "Although the amount of diabetes explained by pesticides is small, these new findings may extend beyond the pesticide applicators in the study," Sandler said. Some of the pesticides used by these workers are used by the general population, though the strength and formulation may vary. Other insecticides in this study are no longer available on the market, however, these chemicals persist in the environment and measurable levels may still be detectable in the general population and in food products. For example, chlordane, which was used to treat homes for termites, has not been used since 1988, but can remain in treated homes for many decades. More than half of those studied in the National Health and Nutrition Examination Survey in 1999-2002 had measurable evidence of chlordane exposure. "This is not cause for alarm," added Sandler "since there is no evidence of health effects at such very low levels of exposure." Overall, pesticide applicators in the highest category of lifetime days of use of any pesticide had a small increase in risk for diabetes (17 percent) compared with those in the lowest pesticide use category (0-64 lifetime days). New cases of diabetes were reported by 3.4 percent of those in the lowest pesticide use category compared with 4.6 percent of those in the highest category. Risks were greater when users of specific pesticides were compared with applicators who never applied that chemical. For example, the strongest relationship was found for a chemical called trichlorfon, with an 85 percent increase in risk for frequent and infrequent users and nearly a 250 percent increase for those who used it more than 10 times. In this group, 8.5 percent reported a new diagnosis of diabetes compared with 3.4 percent of those who never used this chemical. Trichlorfon is an organophosphate insecticide classified as a general-use pesticide that is moderately toxic. Previously used to control cockroaches, crickets, bedbugs, fleas, flies and ticks, it is currently used mostly in turf applications, such as maintaining golf courses. Read more..... Believe it or not Chemical plant accident creates laughing gas cloud An accident in a chemical plant Friday created a frightening-looking cloud of "laughing gas," government and emergency officials said. Nobody was reported to be injured - or to be giggling uncontrollably.   The Northern Ireland Department of the Environment said workers at Albion Chemicals Ltd. poured nitric acid into a disposal container that was contaminated, causing a reaction that produced plumes of nitrous oxide. The gas, inhaled as an analgesic, has been known since the late 18th century as "laughing gas." It has a range of medical and industrial uses and is not toxic. Greig Laing, Albion Chemicals' director of human resources at its headquarters in Leeds, England, declined to describe the exact chemicals and reactions involved in the accident. He said the fumes created were "fully controlled," and caused "no injuries and no environmental damage." Belfast police and firefighters launched an emergency plan following first reports of the accident, which suggested an explosion had created a haze of unknown, potentially toxic fumes. Una Devlin, spokeswoman for the Northern Ireland Fire and Rescue Service, said firefighters sprayed the gas plume with water mist and shut off the plant's sewage connections to nearby Belfast Harbor. The operation lasted about three hours. She said fire crews donned full-body protective suits and gas masks as they doused the container, which continued to emit fumes of the gas for more than an hour.  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