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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
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...
Enbrel Marketing Focus of New Jersey Amgen Probe
Jan 18, 2008 | Parker Waichman Alonso LLP
The marketing of Enbrel is the now the subject of an investigation by the New Jersey Attorney General’s Office. The Enbrel probe will look into allegations that Amgen, the maker of the psoriasis drug, instructed Enbrel sales representatives to violate patient confidentiality rules and engage in the illegal promotion of off-label uses of the drug in an effort to increase sales. According to a press release from the New Jersey Attorney General, a subpoena was issued...
Enbrel Marketing Scheme Violated HIPAA, Former Amgen Employees Claim
Jan 11, 2008 | Parker Waichman Alonso LLP
Two former Amgen employees are charging that the drug maker engaged in illegal marketing practices in an attempt to increase sales of the drug Enbrel. The former Amgen salespeople claim that they were encouraged by the company to illegally access patient records to induce insurance carriers to pay for Enbrel, an extremely pricey drug.According to the drug’s website, Enbrel is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance made by...
Arthritis Drug Enbrel Linked to Serious Side-effects
Oct 17, 2000 | ArthritisSupport.com
Enbrel, (etanercept) used by more than 70,000 rheumatoid arthritis patients in the United States, may be responsible for serious blood reactions and stimulate nervous system disorders. Reports of ten occurrences, half of which were fatal, have led the drug’s manufacturer, Immunex Corp., to issue a cautionary statement about Enbrel’s use. The company warned that a few patients using Enbrel have been diagnosed with neurological and hematological disorders. In a letter to healthcare...
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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