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Tysabri PML, Liver Damage & Infection Lawsuit

Some users of the antibody natalizumab—sold under the brand name Tysabri (previously Antegren)—have developed a devastating brain disease, a potentially fatal liver disease, or a serious infection. If you or your loved one took Tysabri and you believe it caused some serious, negative side effect, you need a sympathetic advocate who will represent only your interests—and who will make the process of obtaining compensation for your injuries as painless as possible. The Rottenstein Law Group knows this, and we want you to believe it. We might be the Tysabri law firm you are looking for.

What Is Tysabri and What Is It Prescribed For?

Tysabri is the brand name for the drug natalizumab. Coproduced and sold by the American pharmaceutical company Biogen Idec and the Irish pharmaceutical company Élan Corporation, Tysabri was approved by the FDA as treatment for multiple sclerosis (MS) in 2004 and as a treatment for Crohn’s Disease in 2008. Biogen Idec and Élan make $1 billion per year on Tysabri sales.

An artificial monoclonal antibody, Tysabri prevents certain white blood cells from passing into certain organs by interfering with the alpha-4 integrin receptors necessary for that process. Tysabri prevents MS lesions by stopping immune cells (T-lymphocytes) from passing into the brain. In patients with Crohn’s Disease, the drug prevents white blood cells from afflicting the small intestines.

The side effects this prescription drug causes prompted the FDA to issue a Tysabri recall announcement in 2005, but it was put back on the market one year later. If you have used Tysabri and experienced adverse effects, contact the Rottenstein Law Group. We’re on top of the issues involved in Tysabri lawsuits and Tysabri class action lawsuits.

Potential Side Effects Include a Fatal Brain Disease

In 2005, Tysabri’s manufacturers pulled the drug off the market because three users contracted Progressive Multifocal Leukoencephalopathy (PML), a fatal brain disease characterized by inflammation of the brain’s white matter at multiple locations.

Tysabri was rereleased in 2006. Because of the risks the drug poses, the FDA requires that it come with a “black box” warning, the agency’s most serious alert. The FDA also now only allows Tysabri to be distributed under its Tysabri Outreach Unified Commitment to Health (TOUCH) program.

Since Tysabri’s rerelease in 2006, the FDA has tracked the increasing instances of PML. By April, 2011, the Tysabri label was revised again to inform the public that 1.5 Tysabri users per thousand will contract PML, and 21 people had died of Tysabri-related PML by 2011.

PML destroys a portion of its victims’ brain cells, thereby impairing transmission of electrical signals in the brain. Symptoms of this disease include:

  • Weakness;
  • Impaired speech;
  • Vision loss;
  • Paralysis; and
  • Cognitive deterioration.

An MRI can detect PML, but—other than blood plasma transfusions to cycle the drug out of the body—no known treatment exists. Patients usually die within four months of being diagnosed.

Because of the risks Tysabri poses, the FDA requires that it come with a “black box” warning, the agency’s most serious alert. The FDA also now only allows Tysabri to be distributed under its Tysabri Outreach Unified Commitment to Health (TOUCH) program.

Since Tysabri’s rerelease in 2006, the FDA has tracked the increasing instances of PML. By April, 2011, the Tysabri label was revised again to inform the public that 1.5 Tysabri users per thousand will contract PML, and 21 people had died of Tysabri-related PML by 2011.

Tysabri generally weakens the immune system to opportunistic infections. Clinical trials reveal evidence of patients who contracted: pneumonia, serious urinary tract infections, gastroenteritis, vaginal infections, tooth infections, tonsillitis, and herpes. Tysabri can also cause liver toxicity (hepatotoxicity). Symptoms include elevated serum hepatic enzymes and elevated total bilirubin within six days of the initial infusion. In extreme cases, liver transplants are necessary and death can occur.

RLG’s Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that getting satisfaction shouldn’t be just more hardship. That’s why we do everything we can to streamline the process, and we will file a Tysabri lawsuit on your behalf if necessary.

If you have taken Tysabri and experienced adverse side effects, contact RLG today.

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