Remicade Creates Higher Risk Of Lymphoma,

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>

> 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.

>

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