Tysabri (Natalizumab) is a drug used to treat relapsing multiple sclerosis (MS) to reduce flare-ups and slow the progression of physical disability as well as to treat Crohn’s disease in adults. This drug belongs to a class of drugs known as immune-modulators, designed to work by stopping immune system cells from damaging the body. Manufactured by Biogen Idec Inc. and marketed with Elan Corp PLC, Tysabri has been shown to prevent relapse, cognitive decline and vision loss associated with MS.
Tysabri received approval from the FDA in November 2004 for the treatment of relapsing MS and for the treatment of moderately to severely active Crohn’s disease in January 2008. Tysabri is given as an intravenous injection usually prescribed for use every 28 days.
However, not long after the FDA initially approved Tysabri, it was recalled after cases of PML (progressive multifocal leukoencephalopathy) were reported, including at least two deaths. The drug was reintroduced in 2006 after the drug maker included a risk minimization program (TOUCH) with mandatory patient registration and periodic follow-up to quickly identify any possible cases of PML.
PML is a rare and fatal brain infection believed to be caused when immune-suppressant drugs disable the immune system.
The makers of Tysabri are facing a number of product liability lawsuits brought over severe brain infections linked to PML. At least 395 cases of PML have been linked to Tysabri and 95 of those patients have died. The number of Tysabri lawsuits continues to grow. Patients and family members of individuals who have died allege that the manufacturer failed to adequately warn consumers or the medical community about the potential risk of PML from Tysabri use.
The risk for PML increases with the number of doses received. A recent study suggested that smoking appears to increase the likelihood of developing neutralizing antibodies to Natalizumab, which cause the drug to have little, if any, therapeutic effect in MS. The study was presentedat the recent MS Boston 2014, the 2014 Joint Americas and European Committees for Treatment and Research in Multiple Sclerosis.
Signs and symptoms include severe urinary tract infections, headaches, joint pain/weakness in arms and legs, clumsiness, memory loss, vision problems, loss of language, anxiety, depression and liver toxicity.
If you have been harmed by Tysabri use, you may be entitled to compensation for your damages. Contact one of our Gacovino Lake attorneys at 800-246-HURT (4878) for more information.