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Tysabri (Natalizumab) Injury Lawyers

Keywords: Tysabri | Lawyer | Liver Failure | Lawsuit | Damage | Attorney | Injury | Victim | PML | MS | Chron's

The Tysabri injury lawyers and attorneys at our firm are evaluating potential lawsuits involving injuries caused by this extremely dangerous drug.  Tysabri has been tied to serious liver damage and a fatal brain disorder called progressive multifocal leukoencephalopathy (PML), and may have a link to the development of the skin cancer melanoma.  Our Tysabri injury lawyers have a great deal of experience with this drug, and  are dedicated to making sure that Biogen Idec Inc. and Elan corp. are held accountable for the injuries cased by Tysabri.

 
Tysabri, manufactured by Biogen Idec Inc. and Elan Corp., is considered a last-resort treatment for Multiple Sclerosis (MS).  It was first pulled from the market in 2005 after being linked to a fatal brain infection, but in 2006 the Food & Drug Administration (FDA) decided the benefits in slowing MS relapses outweighed the risks. In addition to its use as a treatment for MS, Tysabri won U.S. approval as a treatment for Crohn's disease, a gastrointestinal disorder, in January 2008. Our Tysabri injury lawyers believe the FDA erred in these decisions, and it is our contention that this defective medication is too dangerous to be used to treat any condition.

Tysabri Liver Damage

The Tysabri injury lawyers at our law firm are offering free consultations to anyone who sustained liver damage as a result of Tysabri. In February 2008, Biogen sent a letter to healthcare providers warning that Tysabri had caused significant liver damage in some patients.  According to the Tysabri warning, this liver damage occurred within six days of the first dose of Tysabri.  According to the Biogen Idec letter to healthcare providers posted on the FDA website, Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. The FDA also advised physicians to inform patients that Tysabri may cause liver injury.

 
An FDA advisory panel had apparently discussed the potential liver risks of Tysabri in late 2007  when considering whether it should be approved for Crohn's disease The liver risk was put into the drug's package insert label in January 2008 when the FDA approved Tysabri for the treatment of moderate to severe Crohn's disease.  Our Tysabri injury lawyers believe that the liver danger associated with Tysabri is just another example of the dangers posed by this drug, and another reason why it should not be on the market.

 
Tysabri and PML

Our law firm has, and is, currently representing patients who developed a fatal brain disorder known as PML as a result of Tysabri.  In 2005, Biogen Idec and Elan voluntary suspended sales of Tysabri.  The FDA said the suspension was the result of  reports from Biogen Idec of one confirmed, fatal case and one additional case of PML in patients receiving Tysabri for MS.  Both patients were enrolled in a long-term Tysabri clinical trial and had been taking Tysabri for more than two years.

PML is a rare and usually fatal viral disease that is characterized by progressive damage or inflammation  of the white matter of the brain at multiple locations. It occurs almost exclusively in people with severe immune deficiency. PML is a demylinating disease in which the myelin sheath covering the axons of nerve cells is gradually destroyed, impairing the transmission of nerve impulses. It affects the white matter, which is mostly composed of axons from the outermost parts of the brain. Symptoms include weakness or paralysis, vision loss, impaired speech, and cognitive deterioration. Most patients die within four months of onset.

Anita Smith Tysabri Case

In 2005, the Tysabri injury lawyers at our firm were retained by the estate of Anita Smith, a patient who died from a confirmed case of PML while taking Tysabri.  Our firm commenced an action against Biogen and Elan for the wrongful death of the 46-year-old wife and mother of two. In February 2000, Smith was diagnosed with multiple sclerosis (MS). By April 2002, she was enrolled in a clinical trial involving the MS drug, Tysabri along with 1,200 other patients.

In November 2004, while Anita Smith’s health was rapidly deteriorating and she was experiencing severe neurological problems, Tysabri gained a coveted “fast-track” approval from the FDA. Anita Smith took her last IV infusion of Tysabri in January 2005. On February 24, 2005 she died of the brain infection known as PML; the same disease that killed other Tysabri patients.  Four days later, Tysabri sales were halted. 

 
Despite the death of Anita Smith and other Tysabri patients, Elan and Biogen Idec would not give up on this defective drug.  In 2006, the FDA approved a request from Biogen Idec and Elan Corp. to reintroduce Tysabri.  Since then, Tysabri has become one of the companies' best selling medications, exposing thousands to the risk of PML.

 
Tysabri and Melanoma

The Tysabri injury lawyers at our firm are also investigating a possible link between Tysabri and the onset of melanoma - a type of skin cancer.  In February 2008, just weeks after Tysabri had been approved for the treatment of Crohn's disease, a letter was published in “The New England Journal of Medicine” detailing two MS patients who developed the skin cancer shortly after starting Tysabri injections.  The letter was written by Timothy K. Vartanian, MD, PhD, chief of the multiple sclerosis division at Beth Israel Deaconess Hospital and associate professor of neurology at Harvard Medical School, and two of his colleagues

Both of the women treated by Vartanian and colleagues had existing moles that became malignant after they started Tysabri treatment. The first patient, a 46-year-old woman, had had a mole on her shoulder for a long time.  Following her first Tysabri injection, changes were noticed in the mole.  It was found to be malignant melanoma with metastatic spread to her regional lymph nodes.  That patient has recently experienced a relapse of her melanoma. The second patient, a 45-year-old woman, had a mole on the back of her eye. Her doctors had monitored this mole for years, as MS patients undergo regular eye exams. The mole had been stable and unchanged since 1999.  After several Tysabri injections, the mole changed and was eventually diagnosed as ocular melanoma.

Legal Help for the Victims of Tysabri Injuries

If you or a loved one developed PML, liver damage or any other condition possibly associated with Tysabri, you have valuable legal rights.  Please contact one of our experienced Tysabri injury lawyers by filling out our online form or calling us at 1-800-LAW-INFO (1-800-529-4636).

TysabriRSS Feed

Tysabri Now Linked to Severe Liver Damage

Feb 27, 2008 | Parker Waichman Alonso LLP
Tysabri, a controversial drug used to treat Multiple Sclerosis (MS) manufactured by Biogen Idec Inc. and Elan Corp. has been linked to serious liver damage.  This liver failure can occur within six days of the first dose of Tysabri. Tysabri, which was removed from the market in 2005 then reintroduced in 2006, has also been tied to a fatal brain infection and may even be associated with the onset of the skin cancer melanoma.A Food and Drug Administration (FDA) advisory panel had apparently...

Tysabri Waltzes through FDA Advisory Panel by 12-0

Mar 9, 2006 | Newsinferno News Staff
When sales of Tysabri were suspended on February 28, 2005, many critics of the highly controversial MS drug, with potentially fatal side-effects, hoped that would end the saga of a medication that many experts believed should never have been approved in the first place. That, however, was only the beginning of the story. Almost immediately, efforts began to resurrect the drug since, in the multi-billion dollar world of pharmaceuticals, it has been proven time and time again that there is life...

Tysabri - Opponents of MS Drug Linked to Potentially Fatal Brain Disease Locked In Emotional Debate with Desperate Patients before FDA Advisory Panel

Mar 8, 2006 | Newsinferno News Staff
Normally, the decision as to whether a prescription drug should be approved for marketing is based on scientific evidence and clinical studies. Emotional pleas are simply not part of the usual risk-benefit equation.In the case of the controversial MS drug Tysabri, however, nothing has ever happened in the normal or usual way. Thus, as an independent FDA advisory panel in Washington DC grapples with the issue of whether it should recommend the “re-approval” of Tysabri, desperate MS...

FDA Official Still Wary About MS Drug

Mar 7, 2006 | AP
Some patients who take a promising multiple sclerosis drug will likely die of a rare brain infection if the medicine, Tysabri, is allowed back on the market following its withdrawal last year over safety concerns, a Food and Drug Administration official said Tuesday.The manufacturers of the drug, Tysabri, voluntarily withdrew it from the market in February 2005 after two patients in clinical trials died of a rare brain infection called progressive multifocal leukoencephalopathy, or PML. An FDA...

Anti-inflammatory Drugs Potentially Deadly Side Effect Found To Be Rare

Mar 3, 2006 | www.sciencedaily.com
Scientists have completed an extensive study of more than 3,000 patients who received a promising anti-inflammatory drug, natalizumab, that was linked to three cases of a serious brain infection in large clinical trials halted in early 2005.The new study found no new cases of progressive multifocal leukoencephalopathy (PML) and confirmed the three previously identified cases of PML associated with use of the drug. One fatal and one nonfatal case of PML occurred in a trial using natalizumab as a...

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