Tysabri Side Effects May Lead To Liver Failure Lawsuits
Tysabri | Lawyers, Lawsuits | Side Effects: Fatal Brain Injury, Liver Damage, Liver Failure, Brain Disorder, Multifocal Leukoencephalopathy, PML
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 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.
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 infusions. The letter was written by Timothy K. Vartanian, MD, PhD, chief of the multiple sclerosis division at Beth Deaconess Hospital and associate professor of neurology at Harvard, 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 infusion, 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 infusions, 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).