FDA investigating PML in patient taking MS drug

FDA investigating PML in patient taking MS drug
The U.S. Food and Drug Administration is investigating the possible association between a rare brain infection and the multiple sclerosis drug Gilenya (fingolimod), according to a drug safety alert issued by the agency.

(HealthDay)—The U.S. Food and Drug Administration is investigating the possible association between a rare brain infection and the multiple sclerosis (MS) drug Gilenya (fingolimod), according to a drug safety alert issued by the agency.

The FDA posted its public alert after a patient in Europe diagnosed with possible MS developed progressive multifocal leukoencephalopathy (PML) after taking the drug. The patient had not previously taken Tysabri (natalizumab), which is associated with a higher risk of PML.

This is the first reported case of PML, which usually leads to death or severe disability, in a patient taking Gilenya and not previously treated with Tysabri. The drug manufacturer, Novartis, reports that about 71,000 patients have taken the drug to treat relapsing forms of MS.

"Patients should not stop taking Gilenya without first discussing any questions or concerns with their ," the agency stated. "The FDA is providing this alert while continuing to investigate the PML case, and is working with Gilenya's manufacturer, Novartis, to obtain and review all available information about this occurrence. The FDA will communicate its final conclusions and recommendations after the evaluation is complete."

More information: More Information

add to favorites email to friend print save as pdf

Related Stories

FDA clears safety test to screen Tysabri patients

Jan 20, 2012

(AP) -- The Food and Drug Administration on Friday approved a new diagnostic test to help identify patients who have an increased risk of developing a rare brain infection while taking Biogen Idec's multiple sclerosis drug ...

FDA issues multiple sclerosis drug alert

May 14, 2012

(HealthDay) -- The multiple sclerosis drug Gilenya (fingolimod) should not be given to patients with certain pre-existing or recent heart conditions or stroke, or those taking certain medications to correct ...

Leukoencephalopathy risk factors ID'd for MS drug

May 17, 2012

(HealthDay) -- Drug company researchers say they've determined which multiple sclerosis patients are most vulnerable to developing a rare brain infection while taking a powerful drug called Tysabri (natalizumab).

Recommended for you

Determine patient preferences by means of conjoint analysis

15 hours ago

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

User comments