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
Legal Help For Victims Affected By Enbrel
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