Humira Side Effects
Important Information You Should Know About Humira
As the United States Supreme Court observed in its recent case of Wyeth v. Levine, 129 S.Ct.1187, 1197-98 (2009), "it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market." Sadly, Abbott has not taken that message, or legal requirement, to heart.
Since approving Humira in 2002, the FDA has continuously required Abbott Laboratories, the maker of Humira, to dramatically increase the warnings on its drug label to more accurately describe the real risks, often life threatening, of using its blockbuster drug. The new, increased warnings are designed to more truthfully alert physicians and patients to the risks involved with using this powerful drug. Post marketing reports and medical literature have drawn a link between the use of Humira and the following:
Humira has been associated with serious infections including 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. Many of these cases go undiagnosed and are often only discovered postmortem.
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. Moreoever, in late 2009, almost seven years after Humira was first approved, the FDA ordered Abbott to strengthen the Black Box warnings, mentioning the increased risk of lymphoma and other malignancies in children and adolescent patients treated with Humira. 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).
Hepatitis B and Liver Problems / Failure
Abbott, in March 2011, began warning of Humira causing Hepatitis B infection in people carrying the virus in their blood. In addition, Humira can cause liver problems that lead to liver failure and death.
Abbott was recently required to warn about the risks of taking Humira in conjunction with the following prescription medications:
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.