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Amgen & Wyeth - IMPORTANT DRUG WARNING 3/14/08
Amgen & Wyeth - Enbrel DRUG WARNING for Subcutaneous Injection
Injured By Enbrel?
The FDA approved Enbrel (Generic: Etanercept), which is used to treat Rheumatoid Arthritis, on June 6, 2000. Enbrel is a popular drug used by over 70,000 Rheumatoid Arthritis patients in the United States. On October 17, 2000, Immunex Corp. the manufacturer of Enbrel stated that the drug might cause serious blood reactions and stimulate nervous system disorders. Reports of 10 such incidences, half of which were fatal, prompted this action by Immunex.The central nervous system disorders that Enbrel patients encountered include Multiple Sclerosis, Myelitis and Optic Neuritis, Pancytopeni and Aplastic Anemia. In a public statement in October 2000, Immunex commented that, "In the majority of these cases, there was a close temporal relationship between the start of treatment with Enbrel and the occurrence of hematological disorders (range two weeks to five months). Since the clinical experience with Etanercept is still limited as this product has only recently been marketed, onset after this period cannot be ruled out."
In Europe, where the drug has been available since February 2000, the European Medicines Evaluation Agency also urged doctors to exercise caution when prescribing the medication. They stressed the need to inform patients about the possible signs and symptoms of blood disorders and infections.
On February 15, 2002 researchers in Chicago reported that four (4) women with Rheumatoid Arthritis developed symptoms of the autoimmune disease Systemic Lupus Erythematosus (SLE) after taking the Enbrel. The patients developed symptoms including face reddening and body rash while taking the drug, but the symptoms disappeared when the drug was halted, according to a research letter in the February 16, 2000 issue of The Lancet.
If you or a loved one took Enbrel and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
EnbrelRSS Feed
Group Calls For Study Of Arthritis Drugs
Jul 1, 2009 | Parker Waichman Alonso LLP
Arthritis and other autoimmune medications have made recent headlines over a variety of issues including links to serious opportunistic fungal infections and cancer. Now, as part of President Barack Obama’s health care overhaul, a review of arthritis medications manufactured by Wyeth, Abbott Laboratories, and Johnson & Johnson (J&J) might warrant some additional scrutiny, reports Bloomberg.com.Recently, we reported that federal regulators ordered the makers of Humira, Cimzia,...
Simponi Carries Risk of Possibly Fatal Fungal Infections
May 29, 2009 | Parker Waichman Alonso LLP
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Humira, Cimzia, Enbrel and Remicade to Bear Stronger Infection Warnings
Sep 4, 2008 | Parker Waichman Alonso LLP
Federal regulators have ordered the makers of Humira, Cimzia, Enbrel, and Remicade to strengthen the existing warnings about opportunistic fungal infections linked to the drugs. At least 45 people are known to have died from such infections. The Food & Drug Administration (FDA) ordered the new labeling under authority it was granted with the passage of the Food and Drug Administration Amendments Act of 2007.Humira, Cimzia, Enbrel and Remicade are known as tumor necrosis factor...
Despite Enbrel Risks, FDA Panel Recommends it for Psoriasis in Children
Jun 19, 2008 | Parker Waichman Alonso LLP
A Food & Drug Administration (FDA) advisory panel has recommended that the agency approve Enbrel to treat moderate-to-severe psoriasis in children, despite concerns that the drug has been linked to cancer and serious infections, including tuberculosis. Enbrel is already approved to treat psoriasis and rheumatoid arthritis in adults and juvenile arthritis in children.Enbrel is made from a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance...
Enbrel Infection Risk Cited
Jun 16, 2008 | Parker Waichman Alonso LLP
Enbrel has been linked to sometimes deadly infections when administered to children, casting doubts that the Food & Drug Administration (FDA) will approve the Amgen and Wyeth drug to treat severe psoriasis in children. Enbrel is already approved to treat psoriasis and rheumatoid arthritis in adults and juvenile arthritis in children. Enbrel is made from a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance made by the body’s...
Enbrel
Quick Facts
Enbrel Reference Guide
Generic Name
Etanercept
Date Approved
June 6, 2000
Manufacturer
Immunex
Status
3/14/08 warning
On the market
Approved Uses
Rheumatoid Arthritis
Off Label Uses
Psoriasis
Serious Side Effects
Multiple Sclerosis
Lymphoma
Tuberculosis
Lupus
Bacterial Sepsis
Related Topics
Arava
Remicade
Defective Drugs
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