Remicade Creates Higher Risk Of Lymphoma

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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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