By Richard Lenti
The Food and Drug Administration has issued an alert concerning the multiple sclerosis drug fingolimod, after a patient in Europe developed a rare and serious brain infection while taking the medication. Fingolimod is sold under the brand name Gilenya by Novartis (NYSE:NVS).
The agency says that this is the first reported case of the disease progressive multifocal leukoencephalopathy (PML) in a patient receiving Gilenya, who had not previously been on Tysabri (natalizumab), an intravenous MS drug previously associated with a higher risk of PML.
“Patients should not stop taking Gilenya without first discussing any questions or concerns with their health care professionals,” the FDA said in a statement posted on its website.
“We are providing this alert while we continue to investigate the PML case, and we are working with Gilenya’s manufacturer, Novartis, to obtain and review all available information about this occurrence. We will communicate our final conclusions and recommendations after our evaluation is complete.”
Read more at National Pain Report.
(1) Reader Comment
November 12, 2012
October 08, 2012
September 12, 2012
July 23, 2012
Oh boy...Your right we hate to hear this. You know why people in pain
Doesn't the 1.5 billion is spent a year give credence to its possitive
Many MS drugs cause PML and deaths too these drugs all need t
I knew him when he was breaking in at a couple of Los Angeles TV stati
Saying there is a 'twist' is the worst type of spoile