Guest guest Posted October 12, 2004 Report Share Posted October 12, 2004 Frank <califpacific wrote: alternative_medicine_forum From: Frank Sun, 10 Oct 2004 17:03:38 -0700 (PDT) Remicade Creates Higher Risk Of Lymphoma,> > WARNING: Remicade Creates Higher Risk Of Lymphoma, A> Blood Cancer> > By Kathy Eldrid, RN> Oct 8, 2004, 17:43>http://www.earthchangestv.com/secure/2004/printer_4308.php> > NEW YORK> Patients taking the rheumatoid arthritis drug> Remicade may have a higher> risk of lymphoma, a blood cancer, the Johnson & > Johnson admitted on Friday.> > Patients taking its rheumatoid arthritis drug> Remicade for may have a higher> risk of lymphoma, a blood cancer.> > Remicade's label will be revised to warn of a> three-fold increase in the> risk of lymphoma for rheumatoid arthritis patients> taking the drug.> > Although Remicade has been touted as a miracle> product, since its approval,> Remicade is a potent product that has been> associated with such serious and> debilitating side effects. Patients have neither> been warned adequately of> these risks nor of their severity.> > Since its approval, in August of 1998, the warnings> regarding using Remicade> have changed in response to these serious side> effects. In August 15, 2001,> a "Black Box Warning" was added to Remicade's label> warning that> tuberculosis, invasive fungal infections, and other> opportunistic> infections, have been observed in patients receiving> Remicade and that some> of these infections have been fatal. Additionally,> the following a warning> was added to the package insert: Cases of> histoplasmosis, listeriosis,> pneumocystosis and tuberculosis, have been observed> in patients receiving> Remicade. For patients who have resided in regions> where histoplasmosis is> endemic, the benefits and risks of Remicade> treatment should be carefully> considered before initiation of Remicade therapy."> > On October 5, 2001, Centocor sent health care> professionals a letter warning> them tuberculosis, and other serious opportunistic> infections including> histoplasmosis, listeriosis, and pneumocystosis,> have been reported in both> the clinical research and post-marketing> surveillance settings. Some of> these infections have been fatal. The letter refers> the healthcare> professional to the August 15, 2001 revisions to the> labeling for Remicade> including the Black Box Warning. According to the> manufacturer, at least 84> cases of tuberculosis had been reported in patients> using Remicade.> > Less than a week later, on October 18, 2001, a> second drug warning was sent> to Healthcare Professionals, warning them not to> initiate Remicade therapy> in patients with congestive heart failure, to> discontinue Remicade in> patients whose congestive heart failure is worsening> and to consider> discontinuing Remicade in patients with stable> congestive heart failure.> Centocor provides in this letter that "Upon review> of preliminary results of> its ongoing phase 2 trial in 150 patients with> moderate to severe (NYHA> class III-IV) congestive heart failure (CHF), higher> incidences of mortality> and hospitalization for worsening heart failure were> seen in patients> treated with REMICADE, especially those treated with> the higher dose of 10> mg/kg. Seven of 101 patients treated with Remicade> died compared to no> deaths among the 49 patients on placebo.> > On January 2002, the FDA, based upon adverse drug> reactions reports, issued> a warning about serious nervous system problems,> involving demyelinization,> MS and other conditions, associated with the use of> Remicade.> > Centocor, currently warns that there are reports of> serious infections,> including tuberculosis (TB) and sepsis and that some> of these infections> have been fatal.> > Remicade is not related to the arthritis drug Vioxx,> which was pulled off> the market last week by Merck & Co. Inc. after a> study showed it doubled the> risk of heart attack and stroke.> > Remicade's label will be revised to warn of a> three-fold increase in the> risk of lymphoma for rheumatoid arthritis patients> taking the drug, said> Michael Parks, a spokesman for Centocor, the J & J> unit that markets Remicade.> > The change means the drug's safety profile will be> more closely aligned with> that of rival drugs in the same class: Amgen Inc.'s> Enbrel and Abbott> Laboratories Inc.'s Humira. All three drugs block an> inflammation-causing> protein called tumor necrosis factor, or TNF.> > Recent reports from the Food and Drug Administration> indicate that the> arthritis drugs Remicade and Enbrel may cause in> some patients a process> known as demyelination.> > Demyelination is the degeneration of a protective> substance that insulates> nerve axons (fibers) called myelin. In addition to> protecting the axons,> myelin also facilitates transmission of> electrochemical impulses from nerve> to nerve. When nerve axons become demyelinated, this> process is drastically> impaired and neurological impulses slow to a rate> ten times less than> normal. Neurologists frequently compare the loss of> myelin and its effect on> "conductivity" to the loss of insulating material> around an electric wire.> > The Neurological symptoms of demyelination include> confusion, loss of motor> ability, difficulty walking, changes in vision,> muscle weakness, numbness> and possible paralysis.> > During relapses of multiple sclerosis (a well known> type of a demyelinating> disease) patches of demyelinated and inflamed> neurons appear in the central> nervous system (brain and spinal cord.) These> patches are known as lesions.> Oligodendrocytes (the cells that produces myelin)> are also destroyed during> MS relapses.> > The destruction of Oligodendrocytes prevents the> quick rebuilding of myelin> during remissions, a slow down which in turn allows> scar tissue or> "sclerotic" tissue to form in its place. The> sclerotic tissue can not> perform the same tasks as the myelin. These> sclerotic lesions are known as> "plaques" and will appear in multiple places through> out the central nervous> system. In more advanced cases of MS, some of the> nerve axons themselves are> destroyed during relapses.> > The cause of demyelination is still unknown. It is> generally believed that> demyelination involves an autoimmune process. In> other words, during> demyelination a person's immune system attacks his> or her central nervous> system.> > Evidence of this is seen when Acquired Immune System> Cells (T Cells) and> macrophages (mobile white cells that speed up the> process of Demyelination)> are observed at lesions. What exactly triggers this> response of the immune> system is a question that is still being studied.> > The FDA researchers advise that physicians> prescribing either Remicade or> Enbrel should be on the look out for early symptoms> of demyelination such as> difficulty walking, light headedness, confusion, and> blurred vision.> > If such symptoms do occur the drug should be> discontinued immediately and> the patient referred to a neurologist for a complete> examination. The> researchers also advised that physicians treating> patients known to have> multiple sclerosis, other demyelinating diseases or> related symptoms should> consider alternatives to the drugs.> > Some doctors reacting to this recommendation advised> that patients known to> have these conditions should not be prescribed the> drugs under any> circumstances.> > What is Rheumatoid arthritis?> > Rheumatoid arthritis, the most common form of> inflammatory arthritis> affecting approximately one percent of the world's> population, is an> autoimmune disease which causes the body's immune> system to attack multiple> joints leading to pain, swelling and joint damage.> Generally, an autoimmune> disease is a disease where one's immune system> breaks down certain body> tissue. Rheumatoid arthritis primarily affects the> thin membrane that lines> a joint, known as the synovium, and causes it to> thicken and produce> chemical substances that damage the joint's> cartilage, bone and the> supporting soft tissue structures. Although joints> are most commonly> affected, rheumatoid arthritis can also attack the> membranes lining the> blood vessels, heart, and lungs. The hands and feet> are most often affected,> but any joint lined by a membrane may be involved.> Rheumatoid arthritis is> most commonly seen in females in their 20's and 30's> and often first> involves the hands, feet or wrists, but also may> include the ankles, knees,> hips, elbows, shoulders, spine or jaw.> > Some rheumatoid arthritis patients develop hardened> lumps under the skin> called rheumatoid nodules which form on the elbows,> hips, heels, and head.> Rheumatoid arthritis patients are also susceptible> to cartilage and bone> destruction which can render the joint deformed and> immobile. Finally,> rheumatoid arthritis patients may also experience> weight loss, fever,> fatigue, low grade fever, dryness of the eyes, color> changes of the fingers> and toes, dryness of the mouth, and inflammation of> the eyes, heart, lungs> skin and nerves.> > Although it has not yet been determined what causes> rheumatoid arthritis,> researchers suspect heredity plays a determining> role. Ongoing research has> also pointed to the possibility of certain> infections or chemicals as a> possible cause as well as hormones.> > What is Crohn's disease?> > Crohn's disease is a chronic inflammatory disease of> the intestines. It> primarily causes ulcerations in the small and large> intestines, but can> affect the digestive system anywhere between the> mouth and the anus. The> inflammation can cause pain and can make the> intestines empty frequently,> resulting in diarrhea. The disease is found in equal> frequency in men and> women, and usually affects young patients in their> teens or early twenties.> Crohn's disease, in most cases, is a chronic,> recurrent condition with> periods of remission and disease exacerbation.> > Although the precise cause of Crohn's disease has> yet to be determined, it> is suspected to be caused by bacteria which promotes> intestinal> inflammation.> > Symptoms and complications of Crohn's disease> include anemia, diarrhea,> abdominal pain, ulcers, bloody stool, swelling,> cramping, weight loss,> swelling, hemorrhaging, rectal bleeding, bowel> obstruction, fever, poor> absorption of nutrients and bile acids and> inflammation of the large> intestine.> > > Earth Changes TV> Please pass this message or article on to someone else so that they may learn also.Community Newsletters.http://www.alternative-medicine-newsletter.infoCommunity Message Boards.http://www.alternative-medicine-message-boards.info"Do not let either the medical authorities or the politicians mislead you. Find out what the facts are, and make your own decisions about how to live a happy life and how to work for a better world." - Linus PaulingGetting well is done one step at a time, day by day, building health and well being..list or archives: :........ - post:............. alternative_Medicine_Forum digest form:...... -digest individual emails: -normal no email:......... -nomail moderator:........ -owner unsubscribe:...... - Quote Link to comment Share on other sites More sharing options...
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