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Natalizumab 6 articles

FDA issues alert about serious brain infection in patient taking MS drug

A patient treated with the multiple sclerosis (MS) drug Gilenya (fingolimod) has developed a rare and serious brain infection known as progressive multifocal leukoencephalopathy (PML), the Food and Drug Administration (FDA) warned. This is the first case of PML reported following the administration of Gilenya in a patient who had not previously received Tysabri (natalizumab), an MS drug that is associated with a higher risk of PML. PML is a rare and serious brain infection caused by the John Cunningham (JC) virus that damages the fatty covering of the brain called the myelin. PML is usually leads to death or ... Read More

Virus linked to rare but serious brain infection with MS, Crohn’s drug

Testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of Multiple Sclerosis (MS) or Crohn’s disease, the Food and Drug Administration (FDA) said in a safety notice to doctors. The FDA issued a safety alert last April, informing doctors that it was reviewing a possible link between PML and Tysabri. Patients who are prescribed Tysabri are encouraged to be tested for anti-JC virus antibodies. The Stratify JCV Antibody ELISA test, when used with other ... Read More

MS, Crohn’s drug linked to serious brain infections

The Food and Drug Administration (FDA) is alerting doctors and patients that Tysabri (natalizumab), a drug used to treat multiple sclerosis (MS) and Crohn’s disease, has been linked to a rare but serious brain infection known as progressive multifocal leukoencephalopathy (PML). The alert includes updated prescribing information about the risk for PML, and revised labeling that includes a table summarizing the rates of PML with Tysabri according to the number of infusions, or how long the drug is taken or the duration of exposure, and information on a newly identified PML risk factor. The new prescribing information and labeling informs ... Read More

MS, Crohn’s drug linked to numerous cases of serious brain infection

The Food and Drug Administration is updating health care professionals about a medication used to treat patients with relapsing forms of multiple sclerosis (MS) and moderately to severely active Crohn’s disease. New safety information indicates that the risk of developing a rare but life-threatening brain infection known as progressive multifocal leukoencephalopathy (PML) increases with the number of infusions received of Tysabri (natalizumab). The announcement updates a September 2009 warning about PML associated with use of the Tysabri. Since 2006, Tysabri has only been available through the Tysabri Outreach Unified Commitment to Health, also known as the TOUCH Prescribing Program. The ... Read More

Rheumatoid Arthritis drug linked to serious neurological disorder

The Food and Drug Administration (FDA) has received a third case of a serious and often fatal neurological disorder known as progressive multifocal leukoencephalopathy (PML) in a patient with rheumatoid arthritis (RA) treated with the drug Rituxan (rituximab). The report has led the agency to inform rheumatological health care professionals that patients with RA who have received Rituxan are at an increased risk of PML. Physicians should consider the risks in any patient treated with Rituxan who presents new onset neurological manifestations. The FDA advises consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated. ... Read More

Serious neurological disorder linked to MS, Crohn’s drug

A medication used to treat multiple sclerosis (MS) and Crohn’s disease has been linked to a serious and usually fatal neurological disorder, according to an alert issued to neurological health care professionals and their patients by the Food and Drug Administration (FDA). Natalizumab, marketed as Tysbri, was approved by the FDA in 2004 to treat relapsing forms of MS. In 2008, the FDA approved the drug’s use for moderately to severely active Crohn’s disease. From July 2006, when Tysabri marketing resumed, to September 8, 2009, there were 13 reported cases of Tysabri-related progressive multifocal leukoencephalopathy (PML) confirmed worldwide in patients ... Read More