Humira: A Medical Breakthrough Or Another Dangerous Drug?

HUMIRA A MEDICAL BREAKTHOUGH OR ANOTHER DANGEROUS DRUG? Humira (generic name: adalimumab) is an injectable, man-made protein (antibody) that blocks the inflammatory effects of tumor necrosis factor alpha that is believed to be the source of pain and disability associated with a variety of conditions. Humira remains one of the most profitable drugs presently on the market with more than $6.5 billion in annual sales. WHAT IT'S USED FOR? Humira has been approved by the FDA to treat the following conditions: 1 Rheumatoid arthritis Psoriatic arthritis 3 Ankylosing spondylitis 4 Plaque psoriasis Juvenile idiopathic arthritis 6 Chron's disease Humira is given by subcutaneous (under the skin) self-injection once every two weeks. Patients may be advised by their doctor to inject Humira every week if every 14 days is not enough. Humira was discovered through a collaboration between BASF Bioresearch Corporation (Worcester, Massachuetts, a unit of BASF) and Cambridge Antibody Technology HUMIRA'S BUMPY ROAD WITH LABELING CHANGES & FDA COMPLIANCE IT 2002, December 31 HUMIRA approved by FDA for treatment of rheumatoid arthritis 2003 Launched HUMIRA for rheumatoid arthritis and continued clinical studies for additional indications %$4 2005 Launched HUMIRA for psoriatic arthritis. Exceeded $1 billion in annual sales for the first time 2006 Submitted HUMIRA for the Crohn's disease indication and launched it. Also during the same year, a JAMA article was released concluding that TNF blockers increase risk of cancers by 300% $$$ 2007 Launched HUMIRA for Crohn's disease in the United States, submitted HUMIRA for global regulatory approval for psoriasis - the fifth new HUMIRA disease indication at this time, achieved more than $3 billion in worldwide HUMIRA sales 2008 The FDA first communicated about the increased risk of cancer associated with use of TNF blockers. This release was in response a large number of reports of cancer in children and young adults. The cancer reports were submitted to the FDA's Adverse Event Reporting System 2009 Food and Drug Administration requires Black Box cancer warnings on the labels of TNF blockers. After its analysis of TNF blockers, the administration concluded that there was a growing risk of lymphoma and cancer associated with the drugs in both children and adolescents 2010 Humira sends letter to medical providers communicating risk of Histoplasmosis. Also during the year, label is modified to reflect risk of neurological injury and MS April 2011 The FDA released a Communication because of more surfacing reports showing HTCL in people taking TNF blockers (including Humira). The FDA updated the product label warning for Humira to include a warning about HSTCL September 2011 The FDA ordered Abbott to included 'Black Box' warnings related to the risk of 'serious infections' including: active tuberculosis, invasive fungal infections, bacterial, viral and other infections due to opportunistic pathogens The most serious adverse reactions to Humira as reported to the FDA include: serious infections, neurologic events and malignancies Abbott's patent on Humira continues through December, 2016 DANGEROUS HUMIRA SIDE EFFECTS FROM Serious Infections Humira has been associated with serious infections; to include tuberculosis, various pathogenic viruses, bacterial sepsis, bacterial pathogens Legionella and Lysteria, and fungal infections. Such fungal infections are often fatal and include histoplasmosis, blastomycosis, and coccidioidomycosis. Tragically, many of these cases go undiagnosed and are often only discovered postmortem Cancer Lymphoma (a blood cancer of the immune system), leukemia, and skin cancer have been reported among people using Humira. Medical literature has also reported that Humira can increase the risk of the development of these and other cancers. Many of these cases are fatal. Moreover, some patients taking Humira have developed a very rare type, but most typically fatal, form of cancer known as hepatosplenic T-cell lymphoma (HSTCL) Brittle Bones If your Humira experience, or that of someone you know, has included problems with bones fracturing or otherwise becoming brittle or weak, we may be able to help. Please call or fill out the submission form for more information Optic Neuritis Multiple Sclerosis Transverse Myelitis Neuropathy Sponsored by Rosenfeld Injury Lawyers www.RosenfeldinjuryLawyers.com created by MilkWhale Sources: FDA.gov / Humira.com/ Wikipedia.org / Drugs.com/Webmd.com %24 HUMIRA A MEDICAL BREAKTHOUGH OR ANOTHER DANGEROUS DRUG? Humira (generic name: adalimumab) is an injectable, man-made protein (antibody) that blocks the inflammatory effects of tumor necrosis factor alpha that is believed to be the source of pain and disability associated with a variety of conditions. Humira remains one of the most profitable drugs presently on the market with more than $6.5 billion in annual sales. WHAT IT'S USED FOR? Humira has been approved by the FDA to treat the following conditions: 1 Rheumatoid arthritis Psoriatic arthritis 3 Ankylosing spondylitis 4 Plaque psoriasis Juvenile idiopathic arthritis 6 Chron's disease Humira is given by subcutaneous (under the skin) self-injection once every two weeks. Patients may be advised by their doctor to inject Humira every week if every 14 days is not enough. Humira was discovered through a collaboration between BASF Bioresearch Corporation (Worcester, Massachuetts, a unit of BASF) and Cambridge Antibody Technology HUMIRA'S BUMPY ROAD WITH LABELING CHANGES & FDA COMPLIANCE IT 2002, December 31 HUMIRA approved by FDA for treatment of rheumatoid arthritis 2003 Launched HUMIRA for rheumatoid arthritis and continued clinical studies for additional indications %$4 2005 Launched HUMIRA for psoriatic arthritis. Exceeded $1 billion in annual sales for the first time 2006 Submitted HUMIRA for the Crohn's disease indication and launched it. Also during the same year, a JAMA article was released concluding that TNF blockers increase risk of cancers by 300% $$$ 2007 Launched HUMIRA for Crohn's disease in the United States, submitted HUMIRA for global regulatory approval for psoriasis - the fifth new HUMIRA disease indication at this time, achieved more than $3 billion in worldwide HUMIRA sales 2008 The FDA first communicated about the increased risk of cancer associated with use of TNF blockers. This release was in response a large number of reports of cancer in children and young adults. The cancer reports were submitted to the FDA's Adverse Event Reporting System 2009 Food and Drug Administration requires Black Box cancer warnings on the labels of TNF blockers. After its analysis of TNF blockers, the administration concluded that there was a growing risk of lymphoma and cancer associated with the drugs in both children and adolescents 2010 Humira sends letter to medical providers communicating risk of Histoplasmosis. Also during the year, label is modified to reflect risk of neurological injury and MS April 2011 The FDA released a Communication because of more surfacing reports showing HTCL in people taking TNF blockers (including Humira). The FDA updated the product label warning for Humira to include a warning about HSTCL September 2011 The FDA ordered Abbott to included 'Black Box' warnings related to the risk of 'serious infections' including: active tuberculosis, invasive fungal infections, bacterial, viral and other infections due to opportunistic pathogens The most serious adverse reactions to Humira as reported to the FDA include: serious infections, neurologic events and malignancies Abbott's patent on Humira continues through December, 2016 DANGEROUS HUMIRA SIDE EFFECTS FROM Serious Infections Humira has been associated with serious infections; to include tuberculosis, various pathogenic viruses, bacterial sepsis, bacterial pathogens Legionella and Lysteria, and fungal infections. Such fungal infections are often fatal and include histoplasmosis, blastomycosis, and coccidioidomycosis. Tragically, many of these cases go undiagnosed and are often only discovered postmortem Cancer Lymphoma (a blood cancer of the immune system), leukemia, and skin cancer have been reported among people using Humira. Medical literature has also reported that Humira can increase the risk of the development of these and other cancers. Many of these cases are fatal. Moreover, some patients taking Humira have developed a very rare type, but most typically fatal, form of cancer known as hepatosplenic T-cell lymphoma (HSTCL) Brittle Bones If your Humira experience, or that of someone you know, has included problems with bones fracturing or otherwise becoming brittle or weak, we may be able to help. Please call or fill out the submission form for more information Optic Neuritis Multiple Sclerosis Transverse Myelitis Neuropathy Sponsored by Rosenfeld Injury Lawyers www.RosenfeldinjuryLawyers.com created by MilkWhale Sources: FDA.gov / Humira.com/ Wikipedia.org / Drugs.com/Webmd.com %24