FDA Alerts

Rare Brain Infections Tied to MS Rx
FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS).
Case of Rare Brain Infection Reported in MS Patient Taking Tecfidera
FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died.
FDA Investigating Rare Brain Infection in Patient Taking Gilenya (fingolimod)
The US Food and Drug Administration (FDA) is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod).
FDA Approves new Multiple Sclerosis Treatment
The US Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
FDA Approves New Multiple Sclerosis Drug
The US Food and Drug Administration approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).
Cardiovascular Monitoring With Gilenya
The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya ( fingolimod ).
Potential Dangers of Multiple Sclerosis Treatment
The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency ( CCSVI ).
FDA approves Botox to treat specific form of urinary incontinence
The U.S. Food and Drug Administration today approved Botox ( onabotulinumtoxinA ) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.
FDA Drug Safety Communication: Tysabri
The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy ( PML ), a rare but serious brain infection, associated with use of Tysabri ( natalizumab ) for the treatment of multiple sclerosis (MS) and Crohn's disease.