In 2002, Abbott Labs introduced Humira to the marketplace as an injectable treatment for several medical conditions that primarily affected children and young adults. As a tumor necrosis factor inhibitor (TNF blocker), Humira joined a family of drugs that was designed to kill the TNF cells. TNF blockers are thought to reduce inflammation that is responsible for causing pain related to an underlying condition.
Humira was originally approved by the FDA for treatment of:
- Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Chrohn’s Disease
- Plaque Psoriasis
- Chronic Psoriasis
While Humira was intended to treat inflammatory conditions related to specific conditions, it was soon discovered that use of Humira had a variety of unintended consequences in some patients when the drug destroyed other cells in the body that were not related to the source of the patients pain.
Were Humira Warnings Sufficient for Patients To Make Well Informed Decisions?
The very nature of Humira, and the entire class of TNF Blockers, carries substantial risk of complications to the patient. In fact, the risk of medical complications and side effects related to Humira usage is extensive. However, the majority of these complications have been communicated to consumers and doctors by Abbott in the form of advisory statements and drug labeling.
Abbott did not timely disclose all potential Humira side effects to consumers.
Almost as soon as Humira was released to market, the FDA began receiving consumer complaints related to neurological problems in patients taking Humira. At least nine reports were made to the FDA (and communicated to Abbott) concerning neurological injury in patients taking Humira during its release to market in 2002 and 2003.
While the number of complaints may seem insignificant, given the severity of the complaints, compounded with the similarity of reactionary symptoms, the clinical findings should have been alarming given the small testing group.
Yet, even with the early stage complaints of neurological injury, Abbott continued to mass-market Humira without disclosing the risk of vision problems and brain injury to its users. Today, a sizable number of Humira users have permanent neurological injuries that, until recently, were considered unexplainable as Abbott never readily communicated Humira’s additional risks to consumers or the medical community.
Learn about the progression of Humira warnings here.
Vision Loss and Optic Nerve Damage with use of Humira
Even as consumers noted vision problems during the clinical trials of Humira, the potential complication was never relayed to consumers or their physicians. Two clinical trial patients were diagnosed with optic neuritis, an inflammation of the optic nerve, that results in pain and impaired vision.
While some cases of optic neurotis can be treated and vision regained, optic neuritis is a complex condition to diagnose. Further, when physicians were unaware of Humira’s risk for vision problems, treatment may have been delayed— thereby exacerbating the damage.
Today, numerous lawsuits have been filed against Abbott by patients who have suffered permanent vision loss following their use of Humira.
Demyelination Disease / Neurological Injury Following Use of Humira
The full extent of the neurological risks that were known by Abbott at the time Humira was brought to market is still unknown. But, at the very least, there were indications of demyelination complications in patients in Humira’s clinical trials.
While the alleged demylination injuries related to Humira vary in their severity, the injuries stem from the destruction of protective nerve covering (myelin sheath) that encompassed nerve fibers in the brain and spinal cord. When the myelin sheath is destroyed, nerve impulses slow or even stop, causing neurological impairment such as:
- Vision loss
- Hearing loss
- Loss of sensation
- Muscle spasms
- Brittle bones / fractures
- Loss of coordination
Demyelinating injuries are generally progressive in nature and most physicians stress the importance of seeking treatment for the condition as soon after the onset of the symptoms as feasible.
Interestingly, while other TNF Blockers (including Remicade and Enbrel) acknowledged the possibility of demyelination, no such warnings were provided to consumers or prescribing physicians regarding similar injuries with Humira use. As a consequence, many Humira users were exposed to risks that they may never have anticipated or informed of.
Legal Claims Related To Humira Use
With an annual cost of more than $17,000, the cost for a course of Humira treatment is not cheap! Thus far, Humira has been a golden goose for it’s Chicago-based manufactured Abbott Labs. In 2010, Humira posted sales of more than $6.5 billion and is forecast by some pharmaceutical analysts to become the world’s most lucrative drug within the next 5 years.
While the economics behind Humira prove little consolation for the people whom have been negatively impacted by the drug, the sales figures may provide some insight into the resistance on the part of Abbott for aggressively marketing a drug without adequate consumer warnings.
Humira left a group of young people with devastating demylination injuries and vision problems. In the majority of injured Humira users, they will likely require medical care and suffer disability for many years.
Don’t go it alone. As the medical evidence begins to accumulate regarding the impact of Humira on its users, The Humira complication attorneys at Rosenfeld Injury Lawyers has established contacts with some of the most respected doctors who are in the most advantageous position to both evaluate our clients’ injuries and refute claims made by Abbott in defense of these allegations.
If you believe you have suffered an adverse reaction including: Neurological injury or vision loss, Hepatosplenic T-cell lymphoma (HSTCL) or brittle bones (fractures) following use of Humira, we would like to talk with you concerning your legal options. We offer free case evaluations and can answer many of the questions you surely must have.
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