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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.
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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...

Humira, Enbrel, Remicade Being Investigated for Cancer Link

Jun 4, 2008 | Parker Waichman Alonso LLP
Humira and other drugs used to treat autoimmune disorders are being investigated by federal regulators amid concern that they might be linked to cancer in children and young people. The drugs are known as tumor necrosis factor (TNF) blockers, and are used to treat various forms of arthritis including juvenile idiopathic arthritis and Crohn's disease.In addition to Humira, which is made by Abbott Laboratories, four other TNF blockers are currently on the market in the US.  They are Enbrel,...

Enbrel Black Box Warns of Tuberculosis Risk

May 1, 2008 | Parker Waichman Alonso LLP
Enbrel, a drug used to treat psoriasis that has been associated with serious infections, including tuberculosis in some patients.  Enbrel's labeling will now carry the Food & Drug Administration's (FDA) strictest safety notice, a black box warning.Enbrel, manufactured by Amgen and Wyeth, 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 immune system called TNF. People with an immune disease, such...

More Trouble for Amgen, as Enbrel Gets Stronger Infection Warnings

Mar 18, 2008 | Parker Waichman Alonso LLP
Enbrel, a popular treatment for rheumatoid arthritis and psoriasis, is getting stronger warnings about serious infections associated with its use.  Yesterday, Amgen and Wyeth added the strongest U.S. Food and Drug Administration (FDA) warning—the “black box”—to the prescribing information Enbrel. The warning will highlight the risk of infections, including tuberculosis.  The information, which is currently in boldface, must now be highlighted inside a boxed...

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