Recently the Food and Drug Administration (FDA) issued a public health advisory to inform patients and health care providers about the suspended
Recently the Food and Drug Administration (FDA) issued a public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (nataluzimab) the drug meant to treat relapsing forms of multiple sclerosis (MS) which was approved by the FDA in 2004.
FDA supports the decision to voluntarily suspend marketing of the drug as well as the use of the product in clinical trials. However, it is believed that the drug has a promising role to play in treating multiple sclerosis.Patients being treated with Tysabri have been asked to contact their physician to discuss appropriate alternative treatments while the reports are being evaluated.
A single fatality and one possible case of progressive Multifocal leukoencephalopathy (PML) have been reported in patients receiving Tysabri for MS. However, this adverse effect was not reported when trials were conducted before the marketing phase. Post-marketing studies have facilitated the rapid reporting and response to this new information.
Because Tysabri was just recently approved, these patients have only received at most a few doses of Tysabri and the FDA says it will maintain a close contact with the company during the process to study the relationship between Tysabri and the two serious adverse events.
