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Remicade (Infliximab) Basics
Remicade and Harmful
Side Effects
Rheumatoid Arthritis
and Crohn's Disease
Remicade Lawsuits
and Legal Claims
Other Dangerous RA Treatments: Enbrel
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Other Dangerous Treatments Enbrel
Many other patients with autoimmune diseases such as rheumatoid
arthritis have used Enbrel (etanercept). This drug was approved
by the U.S. Food and Drug Administration in 1998. Like Remicade,
Enbrel was widely promoted its maker as a wonder drug, however
it also has potent and dangerous side effects. The adverse effects
that are known are often serious and can be fatal. Attorneys
believe that many patients have not been fully warned of the
risks of using enbrel and many have suffered serious long term
injury.
Enbrel is a genetically engineered antibody, that works by inhibiting
the natural actions of the body's inflammatory and immune systems.
Enbrel works by inhibiting part of the body's natural defenses
against serious infection called the tumor necrosis factor (TNF).
The suppression of this chemical can lead to serious problems
however.
Although many sufferers of rheumatoid arthritis prescribed Enbrel
have had positive responses, the drug has a dark side. In subsequent
studies Enbrel is reportedly linked to serious infections and
sepsis, nervous system disorders such as multiple sclerosis,
seizures, blood disorders, tuberculosis, SLA, inflammation of
the nerves of the eyes, and death. Other researchers are concerned
about the long-term effects of Enbrel and TNF antagonists in
general both in the dangers of infection, and autoimmune disease.
Within months of approval, reports about Enbrel noted nearly
thirty serious infections and six fatalities. This prompted a
warning letter to be send out to prescribing doctors and added
to the drug label warnings section. The new warnings discussed
infections and sepsis and advised doctors not to use Enbrel to
use caution in patients with a history of recurring infections,
and to stop Enbrel if serious infection arises.
In October 2000, a second warning letter was sent out to doctors
stating that "Rare cases of central nervous system disorders,
including demyelinating disorders such as multiple sclerosis,
myelitis, and optic neuritis; have been reported in patients
with rheumatoid arthritis who have received Enbrel therapy [and
that] rare cases of pancytopenia, including aplastic anemia,
some with a fatal outcome, have been reported in patients with
rheumatoid arthritis who have received Enbrel therapy."
In January 2002, the FDA warned about serious nervous system
problems related to Enbrel, involving demyelination, producing
MS and other conditions; patients were also warned to watch for
vision changes.
Remicade has also been linked to the deaths of congestive
heart failure patients. On October 18, 2001, Centocor, Inc. issued
an "Important Drug Warning" which announced that seven
of one hundred one patients treated with Remicade had died during
ongoing testing, compared to zero deaths among 49 test patients
not using Remicade. The following day, the Food and Drug Administration
revealed Remicade's potentially negative effects on patients
with congestive heart failure. Subsequently, a detailed statement
was issued to physicians describing the reasons for the warning
and recommended treatment changes for patients with congestive
heart failure taking the drug. According to the Centocor, Inc.
it was determined that patients with moderate to severe congestive
heart failure were at higher risk of death or worsening of their
condition while taking Remicade. For congestive heart failure
patients with Crohn's disease or rheumatoid arthritis, Centocor,
Inc. advised against initiating any Remicade therapy.
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