Tysabri (generic: natalizumab) is a prescription medication intended for adult patients with relapsing forms of multiple sclerosis (MS). Tysabri treatment helps to slow the worsening of physical disability that is common in patients with MS and decreases the occurrence of flare-ups. However, the introduction of a Tysabri regimen may coincide with catastrophic complications. Recent studies suggest that patients who take Tysabri may significantly increase their risk of developing progressive multifocal leukoencephalopathy (PML), a rare brain infection that has become synonymous death and severe disability.
If you or a loved one has been injured by Tysabri, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Tysabri Lawsuit Overview
Biogen Idec, the oldest independent biotech firm in the world, developed Tysabri approximately seven years ago. However, it was not until November 23, 2004 that this revolutionary medication received the U.S. Food and Drug Administration’s (FDA’s) approval for the treatment of relapsing forms of multiple sclerosis. Through a unique mechanism of action, Tysabri exhibits a propensity for the reduction of flare-ups and slows the worsening of physical disability.
While the causes of multiple sclerosis remain ambiguous, it is believed that an autoimmune response by white blood cells is responsible for the deterioration of nerve cells in the central nervous system. Once a white blood cell crosses the blood-brain barrier, it no longer protects the body from harmful bacteria and viruses. Subsequently, the transition to the nervous system may witness white blood cells attack the myelin sheath surrounding nerve cells. Severe damage to these cells may disrupt proper brain functions and cause the symptoms of MS.
However, natalizumab, the active ingredient found in Tysabri, targets the specific molecules that are responsible for removing white blood cells from the circulatory system. By preventing α4-integrins from bonding with molecules on the lining of the circulatory system, Tysabri prohibits white blood cells from affecting cells in the central nervous system. Therefore, by preventing white blood cells from attacking nerves in the central nervous system, Tysabri may treat symptoms associated with MS.
However, the same mechanism of actin responsible for the treatment of MS may result in catastrophic complications. Recent studies suggest that the introduction of Tysabri may coincide with the development of progressive multifocal leukoencephalopathy (PML), a rare brain infection that has become synonymous death and severe disability. Patients who use Tysabri may significantly increase their risk of developing PML. Due to the severity of PML, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation regarding their potential Tysabri lawsuit.
Progressive Multifocal Leukoencephalopathy
PML is a rare disorder in which the coating (myelin) of some brain nerve fibers gets damaged. If these nerves sustain enough damage, brain functionality may be severely impaired. Serious cases may witness a lack of brain functioning all together and may ultimately result in the death of the individual diagnosed with it. Although JCV is a common virus that is generally harmless and does not cause symptoms in people whose immune systems function normally, it can cause PML in people with weakened immune systems. Causes of a weakened immune system may include human immunodeficiency virus (HIV) infection, leukemia or lymphoma, or taking a medication such as Tysabri.
FDA Safety Announcement
According to an FDA Safety Announcement, testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) or Crohn’s disease.
201 cases of PML have been reported among approximately 96,582 patients treated with Tysabri worldwide through January 4, 2012.
New data have identified the presence of anti-JCV antibodies as a risk factor for developing PML in Tysabri-treated patients. The Stratify JCV Antibody ELISA test, which can detect these antibodies, was cleared by the FDA on January 20, 2012.
Do I Have a Tysabri Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Tysabri lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Tysabri, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.