September 18, 2013 — The Boston Globe reports that a Tysabri lawsuit has been filed by Kimberly A. Yout, a woman who alleges that drug-makers failed to warn that the risk of PML increases the longer a patient uses Tysabri.
She was diagnosed with a rare brain infection called Progressive Multifocal Leukoencephalopathy (PML) after taking Tysabri to treat Multiple Sclerosis (MS). She now suffers from slurred speech, unsteady gait, blindness in one eye, and cognitive impairment that makes independent living impossible.
There are at least six other Tysabri lawsuits pending in Massachusetts and three other states. Plaintiffs are seeking compensation from drug-makers Biogen Idec and Elan for failing to adequately warn about the risk of PML. More than 118,000 people have used Tysabri, and about 395 cases of PML have been confirmed, including 92 deaths.
Biogen Idec pulled Tysabri off the market in 2005 after receiving reports of PML in Tysabri patients, including two deaths. The drug was re-introduced in 2006 with stronger warnings and a “risk management” program that trains physicians to monitor patients for signs of PML.
Despite the risk of PML, regulators maintain that the benefits of Tysabri outweigh the risk for most people. In August 2013, the FDA published a Safety Communication to warn about one case of PML in a patient being treated with another MS drug called Gilenya.
Tysabri and PML (Brain Infection)
PML is an infection of the white matter in the brain that can cause permanent brain damage and death. It is caused by the JC virus, which is normally suppressed in the immune system but can cause PML in people on immunosuppressant drugs, such as Tysabri.
Risk-factors for PML on Tysabri include:
- People who have taken immunosuppressant drugs before
- People who have used Tysabri for at least two years.
- People who are infected with the JC virus