- Trasylol (aprotinin injection)
[UPDATE 05/14/2008] Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.
[Posted 11/05/2007] FDA announced that, at the agency’s request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol (aprotinin injection), a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study’s researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.
Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. However, understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol. There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.
Previous MedWatch Alert:
Trasylol Deaths & Injuries – Drug Side Effects and Recall
Thought to be the next billion-dollar drug for pharmaceutical giant Bayer, Trasylol was designed to control bleeding during heart surgery. As early as the 1980s, warnings from drug researchers indicated that the drug may cause deadly side effects. However, these reports did not derail Bayer’s tenacious pursuit of FDA approval and worldwide distribution of Trasylol. The negligent release of Trasylol despite health warnings has caused thousands of patients worldwide to suffer serious injury and/or death. The personal injury lawyers and wrongful death attorneys at Phillips & Associates are dedicated to helping injured victims and their families file lawsuits against Bayer in order to obtain justice and rightful financial compensation.
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Minta maaf,nak tulis sedikit tentang politik malaysia,SEBAB TEKANAN BILA TENGOK BERITA SEKARANG…….
PERHATIAN TO DAP DAN PARTI PEMBANGKANG dan JUGA PEMIMPIN BN.
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DAN ENCIK KARPAL,
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SEMAKIN BENCI DENGAN KARENAH KEBODOHAN(KETIDAKPANDAIAN)POLITIK MALAYSIA SEKARANG.
SILA PASTIKAN BOTOL LABEL UBAT ANDA TIDAK MENGANDUNGI BAHAN INI
Drug Information Heparin Update
The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement. Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used. There have been many reports of deaths associated with allergic or hypotensive symptoms after heparin administration. Please see FDA link at
We ask that health professionals and facilities please review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all of the recalled heparin products have been removed and are no longer available for patient use.
In addition, FDA would like to inform health professionals about other types of medical devices that contain, or are coated with, heparin. To read this update, and to learn how to report these problems to FDA, please go to: http://www.fda.gov/cdrh/safety/heparin-healthcare-update.html. Please report to FDA adverse reactions associated with these devices, as well as any reactions associated with heparin or heparin flush solutions.
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BERMINAT UNTUK MENCUBA?
ZAIDAH WINNERS4LIFE MELAKA.
Rob Robertson, MD – “Transfer factors are tiny protein molecules that are produced by immune cells called T-cells. It allow the immune system to remember conditions for which immunity has already been established. When a person has been infected, for example, with chicken pox in childhood, their body develops a memory of that illness, and prevents the person from becoming re-infected with it later in life. In the future, the specific immune transfer factor molecule for chicken pox will endow the immune system with the exact ‘blueprint’ of what chicken pox looks like, and the body will be able to quickly recognize and respond to any possible re-infection. Many of these transfer factors – or “immune memory molecules,” were introduced to us from our mother’s milk or colostrum, which is the richest source of concentrated transfer factors known to scientists. Transfer factors in colostrum have the sole purpose of transferring immunity from the mother to the baby’s immature immune system. All mammals produce transfer factor, but scientists prefer to work with chicken and normal bovine colostrum. A healthy cow already produces millions of different transfer factors, but when the cow comes into contact with a pathogen such as a virus, it produces a new transfer factor for that specific virus or pathogen. For individuals challenged by specific pathogens – such as those suffering with chronic illnesses like Chronic Fatigue Syndrome, supplementation with the appropriate transfer factor molecule may provide the ‘missing link,’ thereby allowing the immune system to target and destroy the offending pathogen, and mitigate the symptoms of the disease.” Dr. Robertson is a former Emergency Room Physician. He received his medical degree from the University of Louisville School of Medicine in 1974. He served as the Director of Emergency Services at Western Baptist Hospital in Paducah, KY.
In 1949, Dr. H. Sherwood Lawrence made a revolutionary discovery while studying tuberculosis. He determined that an immune response could be transferred from a donor to a recipient by injecting an extract of white blood cells (leukocytes) from a previously infected, now healthy, subject into a newly infected patient. He found that this extract contained a factor capable of transferring immunity. He named the substance “transfer factor.”
Dr. Lawrence’s discovery came in the midst of the discovery and use of antibiotics. Transfer factors have been used throughout the antibiotic age in different regions of the world such as China, Poland, Italy and others, but never have been available commercially due to the lack of technology.
In the fifty years since Lawrence’s pioneering work, an estimated $40,000,000 has been spent on research resulting in over 3,000 published scientific papers documenting the benefits of transfer factors. The world’s leading scientists and physicians have established the safety and remarkable immune system benefits of transfer factors. The processing methods that allow for large-scale extraction of transfer factors have only recently been perfected and a commercial product has only been available within the last few years.
Greg B. Wilson, Ph.D. and James B. Daily, Jr., Ph.D. – “Transfer factors are small molecular messengers produced by immune T lymphocytes. The message they provide is a specific description of an invading pathogen. Using transfer factors, immune T lymphocytes can transfer the ability to recognize and invading pathogen to previously naïve lymphocytes. In other words, one T lymphocyte tells another what the enemy looks like so that a coordinated attack can be mounted.” Learn more: Transfer Factors & Immunity
Duane Townsend, MD – “I’m a cancer physician. I primarily treat female cancer, and certainly encourage my patients who are undergoing chemotherapy and radiation therapy to take transfer factors. It helps to modulate the immune system. I have patients with chronic herpes infections who are taking transfer factors on a regular basis, and it’s reducing the number of outbreaks. I’ve also had patients with chronic yeast infections, and the transfer factors have reduced their infections as well. Transfer factors are science-based with excellent data from a variety of researchers.” Dr. Townsend has had more than 32 years of distinguished experience in the medical field. He pioneered a surgical technique for the treatment of pre-malignant disease of the uterine cervix. In addition, he has authored more than 90 scientific papers in peer review journals as well as over 15 chapters in research books.
Kenneth Bock, MD – “Because transfer factors can function as immune system modulators, they can help to restore immune system balance in many types of clinical situations.”Kenneth Bock, MD, best selling author on immune system modulation.
Richard Bennett, PhD – “The immunity provided by transfer factors is long lived and can help all ages who are suffering from a variety of ailments or those who want to stay well. The unfolding events surrounding Severe Acute Respiratory Syndrome, (SARS) is yet another painful reminder that we live in a crowded world where continents are only a plane ride away. The SARS epidemic is only one of an ongoing series of new emerging diseases. Our best global and personal strategy is to do all in our power to ensure and support our unique abilities of disease resistance and immunity” Dr. Bennett is an Infectious Disease Microbiologist ? Immunologist, who is enjoying retirement from a 21-year career with the University of California where he specialized in food and water quality and safety. He received his Doctorate in Comparative Pathology from the University of California, Davis. He has an extensive background in milk quality and disease control, water resource policy, food safety, public policy of natural resources, etc. He has also served as an advisor for the FDA and USDA.
Rob Robertson, MD – “I believe transfer factors are, without a doubt, the greatest discovery of the century in supporting and modulating the immune system. I believe a strengthened immune system will be the primary way to stay well in the future. This nutrient can affect the immune system like nothing else can. I sincerely believe everyone needs to consume this product. There is no other product in a nutritional substance, nor a drug, that has this kind of power and ability to affect our immune system. With the increase of killer viruses, mutated germs, super-resistant germs, and food contaminations, our only hope and defense, must lie within our own immune system.” Dr. Robertson is a former Emergency Room . He received his medical degree from the University of Louisville School of Medicine in 1974. He served as the Director of Emergency Services at Western Baptist Hospital in Paducah, KY..
Transfer Factor’s Influence on Our Health
Although the primary role of transfer factors is to regulate many functions of your body, transfer factors influence many other aspects of your health and aging process. Studies have suggested, that transfer factors affect oxidation at the cellular level. Much more so than what consuming antioxidants can accomplish. Transfer factors are not antioxidants, but, they regulate the available levels of the body’s natural antioxidants; glutathione, catatase and ascorbate acid.
Patients consuming transfer factors experienced a 19% reduction in protein oxidation and greater than a 44% decrease in lipid oxidative damage. Collectively, these individual effects resulted in an 18% increase in cell stability and integrity. This is a major discovery! You cannot achieve these results by consuming any amount of any antioxidant. Transfer factors achieve these results through regulation by communicating with antioxidant producing properties within cells. This can have a major impact on your health and premature aging.
Another major discovery was up to a 150% increase in enzymatic detoxification. Every cell in your body must detoxify every day for good health. This is another major benefit to good health and less premature aging. Transfer factors influence many different immune system cells and molecules that have dual roles in our health and aging process. For example macrophages are important in the distruction and recognition process of germs that enter your body. Also macrophages secrete a chemical that create fibroblast that are important in the birth of new cells.
Another area of importance is inflammation. Hyper inflammation influences our health and aging process. Other nutrients are promoted for inhibiting the COX-2 enzyme that causes inflammation. There are many body chemicals, cells and molecules that create inflammation through different pathways in your body. Transfer factors appear to influence and regulate many of these pathways. The following are a list of various factors that are involved in creating inflammation:
TNF-a tumor necrosis factor-alpha
Interleukin 17 (IL-17)
Bird Flu: Cell mediated immunity to meet the avian influenza A (H5N1) challenge “Avian influenza A subtype H5N1 virus with its recombination potential with the human influenza viruses presents a threat of producing a pandemic. The consensus is that the occurrence of such a pandemic is only a matter of time. This is of great concern, since no effective vaccine is available or can be made before the occurrence of the event. We present arguments for the use of cell mediated immunity for the prevention of the infection as well as for the treatment of infected patients. Transfer factor (TF), an immunomodulator of low molecular weight capable of transferring antigen-specific cell mediated immune information to T-lymphocytes, has been used successfully over the past quarter of a century for treating viral, parasitic, and fungal infections, as well as immunodeficiencies, neoplasias, allergies and autoimmune diseases. Moreover, several observations suggest that it can be utilised for prevention, transferring immunity prior to infection. Because it is derived from lymphocytes of immune donors, it has the potential to answer the challenge of unknown or ill-defined pathogens. Indeed, it is possible to obtain an antigen-specific TF preparation to a new pathogen before its identification. Thus, a specific TF to a new influenza virus can be made swiftly and used for prevention as well as for the treatment of infected patients.” Immunotherapy Module, Department of Urology and Nephrology, S. Orsola-Malpighi Hospital, Via P. Palagi 9, Bologna 40138, Italy. firstname.lastname@example.org
Effect of long-term therapy with transfer factor in rheumatoid arthritis. Specific immunotherapy with transfer factor (TF) was used in a chronic experiment in a group of 50 female patients with rheumatoid arthritis (RA) stage I-III. The patients were followed up for 24 months, clinical and biologic examinations being repeated every 3 months. In this period the patients received beside the basic nonsteroid antiinflammatory therapy, one unit TF every week over a period of 6 months then one until TF every month (10 patients) to the end of experiment. Of the 50 patients 15 (30%) did not respond to the therapy and the experiments had to be interrupted after 6 months. Excellent, very good and good results were obtained in 35 patients (70%). In 12 patients the response was good but the dose of TF had to be increased to two units/week in the first 6 months. In 13 patients the results obtained were very good and therapy with nonsteroid products + TF was continued even after the first 6 months. In 10 patients with RA stage I the results obtained were excellent and after 6 months the nonsteroid therapy could be interrupted and the therapy was continued only with one unit TF every month. The study confirmed the fact that specific immunotherapy with TF represents an important adjuvant in the treatment of rheumatoid arthritis (RA)
The Russian scientists who conducted this study found the results to be exceptional and requested further information so their results could be published in professional journals. One scientist stated: “The 4Life sample [4Life Transfer Factor Plus Advanced Formula] activated NK cell activity more than the Interleukin-2 (IL2) drug used as the standard. Here, we now refer to your sample as the Golden Interleukin,” said Dr. Kisielevsky, Russian Academy of Medical Sciences. These outstanding test results are certain to be reflected in human health through an increase in immune effectiveness, leading to improved overall health. People around the world can be confident in the ability of 4Life Transfer Factor Advanced Formula and 4Life Transfer Factor Plus Advanced Formula to more effectively modulate immune system function, making it more response “able” and to provide broad-spectrum support that is unmatched in any other health supplement today.
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PENGETAHUAN UMUM BERKENAAN KENCING MANIS DAN TINDAKAN YANG PERLU DI LAKUKAN OLEH SEMUA ORANG DI MALAYSIA.
Diabetes Action Now, an initiative of the World Health Organization and the International Diabetes Federation
“The world is facing a growing diabetes epidemic of potentially devastating proportions. Its impact will be felt most severely in developing countries. The World Health Organization and the International Diabetes Federation are working together to support ongoing initiatives to prevent and manage diabetes and its complications, and to ensure the best quality of life possible for people with diabetes worldwide. Together we are helping to provide countries with the means to face the challenges that lie ahead. It is time for “Diabetes Action Now”.
Dr Robert Beaglehole, World Health Organization
What is diabetes?
Diabetes is a chronic condition that occurs when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Hyperglycaemia and other related disturbances in the body’s metabolism can lead to serious damage to many of the body’s systems, especially the nerves and blood vessels.
There are two basic forms of diabetes: Type 1: people with this type of diabetes produce very little or no insulin. Type 2: people with this type of diabetes cannot use insulin effectively. Most people with diabetes have type 2.
A third type of diabetes, gestational diabetes mellitus (GDM), develops during some cases of pregnancy but usually disappears after pregnancy.
People with type 1 diabetes require daily injections of insulin to survive. People with type 2 diabetes can sometimes manage their condition with lifestyle measures alone, but oral drugs are often required, and less frequently insulin, in order to achieve good metabolic control.
Common symptoms of type 1 diabetes include: excessive thirst; constant hunger; excessive urination; weight loss for no reason; rapid, hard breathing; vision changes; drowsiness or exhaustion. These symptoms may occur suddenly.
People with type 2 diabetes may have similar, but less obvious, symptoms. Many have no symptoms and are only diagnosed after many years of onset. As a consequence, almost half of all people with type 2 diabetes are not aware that they have this life-threatening condition.
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