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Enbrel Etanercept the new wonder drug for psoriasis?

Deaths caused by Enbrel Etanercept. New warnings issued

Enbrel Etanercept psoriasis drugAgain, 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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