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Enbrel and Remicade Companies Sued for Infections and Deaths

 In August one of the first cases was filed against the manufacturer of the biological product, Enbrel (etanercept). Enbrel (etanercept) was approved by the U.S. Food and Drug Administration on November 2, 1998, as a second-line agent for the treatment of juvenile rheumatoid arthritis. At the time Enbrel was co-marketed by Immunex, Corp. (in 2001 Amgen, Inc. bought Immunex Crop. of Seattle and Enbrel for some $16 billion, the largest biotech buyout ever) and Wyeth-Ayerst Pharmaceuticals. Although Enbrel has been touted in the press and through marketing as a wonder "drug", it is a potent product whose long term effects and mechanism of action are not known or fully understood. The adverse effects that are known, are serious and fatal. Patients have neither been warned adequately of these risks nor their severity. 

Embrel Is Injected Subcutaneously
Enbrel Is Injected Subcutaneously Enbrel is a biological product (a genetically engineered antibody), which reduces the actions of chemicals in the body that are involved in inflammatory and immune responses. Specifically, Enbrel inhibits the action of tumor necrosis factor, a component of the body's natural defenses against serious infection. Enbrel is injected subcutaneously twice weekly by trained patient. Although the scientific literature to date demonstrates a positive response by many sufferers of rheumatoid arthritis prescribed Enbrel, in post marketing reports serious infections and sepsis, nervous system disorders such as multiple sclerosis, seizures, blood disorders, tuberculosis, SLA, inflammation of the nerves of the eyes, and fatalities, have all been reported with the use of Enbrel. The long-term effect of TNF antagonists in the development of infection, malignancy and autoimmune disease is currently unknown. 

Serious Infections & Deaths
Serious Infections & Deaths In just the initial five months following licensure of Enbrel, post-marketing reports documented thirty serious infections including six deaths. Subsequently, on May 10, 1999, a "Dear Health Care Professional" letter was sent out which added to the warnings section of the labeling, a warning about infections and sepsis and advised, among other things, not to give if there is a new infection and to use caution if there is a history of recurring infections, and to stop Enbrel if serious infection arises. On October 10, 2000, a second "Dear Health Care Professional" letter was sent out to health care professionals providing inter alia, that "[r]are cases of central nervous system disorders, including demyelinating disorders such as multiple sclerosis, myelitis, and optic neuritis; have been reported in patients with rheumatoid arthritis who have received Enbrel therapy… [and that] rare cases of pancytopenia, including aplastic anemia, some with a fatal outcome, have been reported in patients with rheumatoid arthritis who have received Enbrel therapy." The FDA followed suit, and in January 2002, it issued a warning about serious nervous system problems that could be caused by Enbrel, involving demyelination, producing MS and other conditions; patients were warned to watch for vision changes. We intend to pursue cases on behalf of individuals seriously injured by both Enbrel and Remicade, a similar biological product, manufactured and sold by Centocor, Inc.

Call Toll Free 1-888-696-7900 For Further Information

[1] Jon L. Gelman, who practices in Wayne, NJ, wrote Workers’ Compensation Law (West Group 2003), is a contributing member/author of the advisory board of Modern Workers Compensation (West Group 2001) & is a former national Vice-President of the Workplace Injury Litigation Group. Jon L. GelmanIn August one of the first cases was filed against the manufacturer of the biological product, Enbrel (etanercept). Enbrel (etanercept) was approved by the U.S. Food and Drug Administration on November 2, 1998, as a second-line agent for the treatment of juvenile rheumatoid arthritis. At the time Enbrel was co-marketed by Immunex, Corp. (in 2001 Amgen, Inc. bought Immunex Crop. of Seattle and Enbrel for some $16 billion, the largest biotech buyout ever) and Wyeth-Ayerst Pharmaceuticals. Although Enbrel has been touted in the press and through marketing as a wonder "drug", it is a potent product whose long term effects and mechanism of action are not known or fully understood. The adverse effects that are known, are serious and fatal. Patients have neither been warned adequately of these risks nor their severity. 

Embrel Is Injected Subcutaneously
Enbrel Is Injected Subcutaneously Enbrel is a biological product (a genetically engineered antibody), which reduces the actions of chemicals in the body that are involved in inflammatory and immune responses. Specifically, Enbrel inhibits the action of tumor necrosis factor, a component of the body's natural defenses against serious infection. Enbrel is injected subcutaneously twice weekly by trained patient. Although the scientific literature to date demonstrates a positive response by many sufferers of rheumatoid arthritis prescribed Enbrel, in post marketing reports serious infections and sepsis, nervous system disorders such as multiple sclerosis, seizures, blood disorders, tuberculosis, SLA, inflammation of the nerves of the eyes, and fatalities, have all been reported with the use of Enbrel. The long-term effect of TNF antagonists in the development of infection, malignancy and autoimmune disease is currently unknown. 

Serious Infections & Deaths
Serious Infections & Deaths In just the initial five months following licensure of Enbrel, post-marketing reports documented thirty serious infections including six deaths. Subsequently, on May 10, 1999, a "Dear Health Care Professional" letter was sent out which added to the warnings section of the labeling, a warning about infections and sepsis and advised, among other things, not to give if there is a new infection and to use caution if there is a history of recurring infections, and to stop Enbrel if serious infection arises. On October 10, 2000, a second "Dear Health Care Professional" letter was sent out to health care professionals providing inter alia, that "[r]are cases of central nervous system disorders, including demyelinating disorders such as multiple sclerosis, myelitis, and optic neuritis; have been reported in patients with rheumatoid arthritis who have received Enbrel therapy… [and that] rare cases of pancytopenia, including aplastic anemia, some with a fatal outcome, have been reported in patients with rheumatoid arthritis who have received Enbrel therapy." The FDA followed suit, and in January 2002, it issued a warning about serious nervous system problems that could be caused by Enbrel, involving demyelination, producing MS and other conditions; patients were warned to watch for vision changes. We intend to pursue cases on behalf of individuals seriously injured by both Enbrel and Remicade, a similar biological product, manufactured and sold by Centocor, Inc.

Call Toll Free 1-888-696-7900 For Further Information

[1] Jon L. Gelman, who practices in Wayne, NJ, wrote Workers’ Compensation Law (West Group 2003), is a contributing member/author of the advisory board of Modern Workers Compensation (West Group 2001) & is a former national Vice-President of the Workplace Injury Litigation Group. Jon L. Gelman, , Voice: 973.696.7900, Fax: 973.696.7988, e-mail: jon@gelmans.com, Internet: www.gelmans.com., Voice: 973.696.7900, Fax: 973.696.7988, e-mail: jon@gelmans.com, Internet: www.gelmans.com.

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