Enbrel Etanercept the new
wonder drug for psoriasis?
Deaths caused by Enbrel
Etanercept. New warnings issued
 Again,
Enbrel Etanercept, a drug has been released so rapidly that
its full side effects had not yet become apparent. After
several possible deaths relating to the use of Enbrel
Etanercept the FDA has released the following statement, the
manufacturer has also updated its
warning insert supplied with the dangerous drug.
phototherapy remains the best
proven, medically recognised treatment for psoriasis.
Get legal advise regarding injury or death caused
by Enbrel
May 10, 1999, The FDA writes to all doctors warning about
higher incidences of serious infection, including sepsis,
associated with the use of Enbrel Etanercept.
May 10, 1999, The FDA warning about Enbrel Etanercept
cautions that adverse event reports indicate that certain
patients receiving Enbrel therapy developed serious
infections, including sepsis. Several Enbrel patients died
from their infections.
October 10, 2000, The FDA writes to all doctors warning of
the risks of multiple sclerosis and other central nervous
system (CNS) disorders, as well as pancytopenia and aplastic
anemia associated with the use of Enbrel Etanercept.
Enbrel, a genetically engineered protein, was approved to
treat patients with symptoms of moderate to severe, active
RA who have not responded well to other treatments. It can
significantly reduce pain and swollen joints in people
disabled with RA, an autoimmune disease that affects more
than two million Americans. The FDA is advising physicians
about new safety concerns regarding the use of Etanercept
(Enbrel), a product recently approved to treat moderate to
severe rheumatoid arthritis (RA). New post marketing reports
indicate that certain patients receiving Enbrel have
developed serious infections, including sepsis, and that
several of these patients have died from their infections.
Since the drug's approval, 30 of the estimated 25,000
patients treated with Enbrel are reported to have developed
serious infections, including sepsis. Six of these patients
died within two to sixteen weeks after starting treatment. A
number of these RA patients had a history of chronic or
recurrent infections, pre-existing infections, diabetes, or
other conditions that predisposed them to infections.
If you have experienced severe side effects due to this
medication, seek an attorney, or find a firm devoted to
class actions against the manufacturer of Enbrel (source,
American Legal Database.)
This is the retyped text of a letter from Immunex
Corporation. Contact the company for a copy of any
referenced enclosures.
May 10, 1999
Important Drug Warning
Dear Healthcare professional:
This communication is to inform you of important
post-marketing safety information for ENBREL ® (Etanercept),
a new treatment for moderate to severe rheumatoid arthritis.
Some of this safety information was already described in the
package insert. The new information provides additional data
on serious infections reported with the use of ENBREL. Over
the five month period following the drug's approval in
November 1998, thirty of the estimated 25,000 patients
treated with ENBREL are reported to have developed serious
infections including several with sepsis. Six of these
patients died within two to sixteen weeks after initiation
of treatment. In addition to their rheumatoid arthritis, a
number of these patients had a history of chronic or
recurrent infections, pre-existing infections, diabetes
mellitus or other conditions that predisposed them to
infections. Infections, including serious infections, are
more common in the rheumatoid arthritis population than in
the general public.
Based on the current information, we ask you to consider
the following recommendations regarding the use of ENBREL.
patients who develop a new infection while undergoing
treatment with ENBREL should be monitored closely. Treatment
with ENBREL should be discontinued in patients with serious
infections, or sepsis.
Treatment with ENBREL should not be initiated in patients
with active infections including chronic or localized
infections. Physicians should exercise caution when
considering the use of ENBREL in patients with a history of
recurring infections or with underlying conditions, which
may predispose patients to infections such as advanced or
poorly controlled diabetes.
The Warnings, precautions, and Adverse Events sections of
the labelling for ENBREL have been revised to incorporate
this new information and these revised sections are included
in the attached sheet.
A revised package
insert is enclosed. Should you have questions regarding
the use of ENBREL, please call Wyeth-Ayerst at 1
800-934-5556.
Healthcare professionals should report any serious adverse
events possibly associated with the use of ENBREL to
Wyeth-Ayerst at 1 800-934-5556. Alternatively, this
information may also be reported to FDA's MedWatch reporting
system by phone (1-800-FDA-1088), Fax (1-800-FDA-0178), via
the MedWatch website at www.fda.gov/medwatch, or by mail
(using postage-paid form) to MedWatch, HF-2, 5600 Fishers
Lane, Rockville, MD 20852-9787. Health professionals and
consumers should use the Form 3500 for adverse event/product
problem reporting.
Revised Sections for ENBREL ® (Etanercept) package Insert
WARNINGS
IN POST MARKETING REPORTS, SERIOUS INFECTIONS AND SEPSIS,
INCLUDING FATALITIES, HAVE BEEN REPORTED WITH THE USE OF
ENBREL. MANY OF THESE SERIOUS EVENTS HAVE OCCURRED IN
PATIENTS WITH UNDERLYING DISEASES THAT IN ADDITION TO THEIR
RHEUMATOID ARTHRITIS COULD PREDISPOSE THEM TO INFECTIONS.
PATIENTS WHO DEVELOP A NEW INFECTION WHILE UNDERGOING
TREATMENT WITH ENBREL SHOULD BE MONITORED CLOSELY.
ADMINISTRATION OF ENBREL SHOULD BE DISCONTINUED IF A PATIENT
DEVELOPS A SERIOUS INFECTION OR SEPSIS. TREATMENT WITH
ENBREL SHOULD NOT BE INITIATED IN PATIENTS WITH ACTIVE
INFECTIONS INCLUDING CHRONIC OR LOCALIZED INFECTIONS.
PHYSICIANS SHOULD EXERCISE CAUTION WHEN CONSIDERING THE USE
OF ENBREL IN PATIENTS WITH A HISTORY OF RECURRING INFECTIONS
OR WITH UNDERLYING CONDITIONS WHICH MAY PREDISPOSE PATIENTS
TO INFECTIONS SUCH AS ADVANCED OR POORLY CONTROLLED
DIABETES. (SEE PRECAUTIONS, ADVERSE REACTIONS, INFECTIONS).
PRECAUTIONS
Immunosuppression
The possibility exists for anti-TNF therapies, including
ENBREL, to affect host defences against infections and
malignancies since TNF mediates inflammation and modulates
cellular immune responses. In a study of 49 patients with RA
treated with ENBREL, there was no evidence of depression of
delayed-type hypersensitivity, depression of immunoglobulin
levels, or change in enumeration of effecter cell
populations. The impact of treatment with ENBREL on the
development and course of malignancies, and active and/or
chronic infections is not fully understood (see WARNINGS,
ADVERSE REACTIONS, Infections and Malignancies). The safety
and efficacy of ENBREL in patients with immunosuppression or
chronic infections have not been evaluated.
ADVERSE REACTIONS
Infections
Upper respiratory infections ("colds") and sinusitis were
the most frequently reported infections in patients
receiving ENBREL or placebo. In placebo-controlled trials,
the incidence of upper respiratory tract infections was 16%
in the placebo treatment group and 29% in the group treated
with ENBREL; and 0.68 events per patient year in the placebo
group and 0.82 events per patient year in the group treated
with ENBREL when the longer observation of patients on
ENBREL was accounted for.
In placebo-controlled trials evaluating ENBREL, no
increase in the incidence of serious infections was observed
(1.3% placebo, 0.9% ENBREL). In open-label and
placebo-controlled trials, 22 serious infections were
observed in a total of 745 subjects exposed to ENBREL,
including: pyelonephritis, bronchitis, septic arthritis,
abdominal abscess, cellulitis, osteomyelitis, wound
infection, pneumonia, foot abscess, leg ulcer, diarrhoea,
sinusitis, and sepsis. Serious infections, including sepsis
and death, have also been reported during post-marketing use
of ENBREL. Some have occurred within a few weeks after
initiating treatment with ENBREL. Many of the patients had
underlying conditions (e.g., diabetes, congestive heart
failure, history of active or chronic infections) in
addition to their rheumatoid arthritis. See WARNINGS. Data
from a sepsis clinical trial not specifically in patients
with RA suggest that Enbrel Etanercept treatment may
increase mortality in patients with established sepsis.
Immunex Corporation
51 University Street, Seattle, WA 98101
206-587-0430
phototherapy remains the best
proven, medically recognised treatment for psoriasis.
Reprinted from an FDA public warning advisory.
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