Humira (also known as adalimumab) is a Tumor Necrosis Factor (TNF) Inhibitor that is indicated for the treatment of the following autoimmune diseases: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and plaque psoriasis.
Humira is administered subcutaneously and works by blocking tumor necrosis factor, a protein that is naturally released by certain cells of the immune system. TNF’s primary roll in the body is to regulate immune responses in order to defend the body against infectious diseases and foreign materials. TNF promotes an inflammatory response, which initiates the healing process.
People with autoimmune disease produce extra amounts of TNF, leading to pain, inflammation and cell damage as the immune system mistakenly starts attacking healthy tissue. Humira blocks the TNF, which might help relieve the symptoms of the underlying disease, but at the same time compromises the immune system and its ability to do its job.
Consequently, Humira has been associated with a plethora of devastating, even deadly, side effects.
Humira was approved by the FDA in December 2002, and launched by Abbott Laboratories in 2003 with a label, designed for physicians, that warned of little more than the risk of tuberculosis. Since that time, the label has been changed and warnings and risks added, as mandated by the FDA, over 20 times and the length of the label has grown 4-fold. The Black Box warnings have greatly expanded. A guide for patients was finally added, but with only limited information.
Unlike the warnings in 2003, Humira’s label now warns of serious opportunistic infections, malignancies, nervous system disorders including multiple sclerosis, heart failure, and a multitude of problems with drug-interactions.
Black Box of the label was strengthened to include a serious risk of opportunistic infections including histoplasmosis and bacterial sepsis, and the risk of lymphoma and other cancers in children and young adults. (Nov 2009 Label)
In the Warnings Section under Full Prescribing Information, after years of stating that taking Humira concomitantly with Methotrexate and other immunosuppressants was just fine, the increased risk of infection leading to hospitalization and even death in those that do so is added. (Nov 2009 - Methotrexate & Histoplasmosis Warning)
Also in the Warnings Section under Full Prescribing Information, the seriousness and difficulty in diagnosing histoplasmosis and other opportunistic infections is highlighted, as well as the recommended treatment.(Nov 2009 - Methotrexate & Histoplasmosis Warning)
The risk of acute or chronic leukemia is added to Section 5.2 Malignancies.(Nov 2009 - Leukemia Warning)
Under Adverse Events, incidences of patients reporting new onset or worsening psoriasis is added to Section 6.2 Postmarketing Experience. (Nov 2009 - Psoriasis)
The risk of hepatosplenic T-cell lymphoma (HSTCL), an extremely rare cancer, is added to the Black Box.(March 2011 Label - Black Box)
Section 2.5 Monitoring And Assessing Safety was added, advising that patients should be tested for TB before and during treatment with Humira.(March 2011 Label - Section 2.5)
Sections 5.1 and 5.11 were strengthened to include the risk of increased serious infection when taking Humira concomitantly with Abatacept in patients with RA.(March 2011 Label - Section 5.1)
The statement that had been included in all previous labels, “the role of TNF and cancer is not know,” is removed in Section 5.2 Malignancies. The malignancy risk is now outlined to include lymphoma, non-melanoma skin cancer, and cancer risk in children and young adults. (March 2011 Label - Section 5.2)
The risk of acute liver failure is added to Section 6.1 Adverse Reactions – Clinical Studies Experience. (March 2011 Label - Section 6.1)
Humira Safety Information and Links
Full Prescribing Information:
Important Update to the Prescribing Information:
Current Medication Guide:
Important Changes to the Medication Guide:
* Bongartz, T, and AJ Sutton, and MJ Sweeting, and I Buchan, and EL Matteson, and V Montori. "Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials." JAMA : The Journal of the American Medical Association 295 (2006): 2275-2285