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Published: April 1st, 2011
Potential side effects of Humira may increase the risk of serious and potentially life-threatening injuries, including fungal infections and cancers, as well as a possible risk of permanent nerve damage that may result in multiple sclerosis, transverse myelitis, optic neuritis, neuropathy or other problems.
STATUS OF HUMIRA LAWSUITS: Product liability lawyers are evaluating whether individuals may be entitled to compensation through a Humira lawsuit for vision problems or nerve damage that may have been caused by Humira.
MANUFACTURER: Abbott Laboratories, Inc.
OVERVIEW: Humira (adalimumab) is a tumor necrosis factor blocker, also known as TNF blocker, which is approved for treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis, which was previously called juvenile rheumatoid arthritis.
HUMIRA NERVE DAMAGE AND VISION PROBLEMS Adverse event reports have suggested that Humira may increase the risk of nerve damage, which could cause:
- Optic Neuritis or Vision Impairment
- Multiple Sclerosis
- Transverse Myelitis
Lawsuits over Humira have alleged that Abbott downplayed the risk of nerve damage from Humira, including a risk of Central Nervous System (CNS) demyelination and harm to the optic nerve. While other drugs in the same class, such as Enbrel and Remicade, contain warnings about the risks, Abbott has not provided adequate warnings to physicians and consumers, which could have prevented serious injury and permanent nerve damage.
During clinical trials, at least three cases of demyelination with Humira use were reported, compared to no reported cases among those taking a placebo. Of those nerve damage problems, two involved optic neuritis on Humira, which could result in vision loss or sight problems.
In addition, an analysis of FDA adverse event reports during the first two years Humira was on the market identified at least 9 reports of neurological problems with Humira, including two cases of optic neuritis. Since that time, a number of similar Humira problems have been reported. It is widely accepted that the number of such problems reported to the FDA likely only represent between 1% and 10% of all actual adverse events.
HUMIRA CANCER SIDE EFFECTS: A study published in the May 17, 2006 issue of the Journal of the American Medical Association (JAMA) indicated that Humira side effects could increase the risk of developing cancer. Warnings have been added to the prescribing information about the possible cancer risk.
In August 2009, the FDA announced a Humira black box cancer warning after investigating the potential association between Humira and Lymphoma and other cancers among children and young adults using TNF blockers.
Approximately half of the cancers seen in children and young adults taking TNF blockers were lymphomas, including bother Hodgkin’s and non-Hodgkin’s lymphoma, which is a cancer of cells in the immune system. Lymphoma is not a recognized complication of JIA (Juvenile Idiopathic Arthritis) or of Crohn’s disease. Other cancers reported included leukemia, melanoma and solid organ cancers.
HUMIRA FUNGAL INFECTIONS: A number of users who were receiving TNF blockers, such as Humira, have experienced fungal infections, such as histoplasmosis, blastomycosis and cocciioidmycosis. In several of these cases the infection resulted in death.
In September 2008, the FDA issued an alert to healthcare providers to provide new information about the risk of Humira fungal infections. At that time the agency also indicated that new information will be added to the Humira black box warning to ensure that doctors and consumers are aware of the risk, especially for those who live in or visit areas where fungus is prevalent.
Unfortunately, many cases of fungal infections from Humira go undiagnosed by doctors, since the symptoms are similar to the flu. Symptoms could include cough, fever, fatigue, loss of weight, sweating and shortness of breath.