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progressive multifocal leukoencephalopathy 11 articles

MS drug Tecfidera linked to liver injury

The safety label of the top-selling oral multiple sclerosis (MA) drug Tecfidera has been updated to include new warnings of potential liver injury that could require hospitalization, drug maker Biogen Inc. reported. A total of 14 cases of liver injury were reported out of about 230,000 patients treated with the MS drug. Symptoms included significant elevations above normal of serum aminotransferases and bilirubin. Signs of liver injury resolved in patients after treatment with Tecfidera was discontinued, and none resulted in liver failure, liver transplant, or death. The new warning is listed under the Warnings and Precautions section under the prescribing information ... Read More

Study links MS, psoriasis drug ingredient to deadly brain infection

Two letters published in the April 9 issue of the New England Journal of Medicine (JAMA) are blaming the deaths of two patients on an active ingredient in a new drug used to treat multiple sclerosis (MS) and psoriasis. The ingredient, dimethyl fumarate, is thought to work by decreasing inflammation and preventing nerve damage that may cause symptoms of MS and rashes from psoriasis. Dimethyl fumarate is an ingredient in the drugs Tecfidera and Psorinovo. The JAMA letters have linked the ingredients to the deaths of two European women who developed progressive multifocal leukoencephalopathy, or PML, a type of brain ... Read More

FDA adds brain infection risk to MS drug Tecfidera

New warnings have been added to the safety label of the multiple sclerosis (MS) drug Tecfidera after a man taking the drug developed a rare brain infection that led to his death. The label change comes just one week after the Food and Drug Administration (FDA) issued a safety alert involving the risk. The patient was taking Tecfidera, also known as dimethyl fumarate, when he developed progressive multifocal leukoencephalopathy, or PML, and later died. The patent was not taking any other drugs that would have affected his immune system or thought to be associated with PML. PML is a rare ... Read More

FDA warns of possible risk of serious brain infection with MS treatment

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, prompting the Food and Drug Administration (FDA) to issue a safety alert. The patient who died was not taking any other drugs that would affect the immune system or drugs thought to be associated with PML, thus the agency is updating the safety label of Tecfidera to include a warning for possible PML. PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is ... Read More

FDA panel questions whether bowel disease drug increases risk of deadly brain infection

A Food and Drug Administration (FDA) advisory panel is questioning the safety of Takeda Pharmaceutical’s inflammatory bowel disease drug candidate vedolizumab, claiming the drug could cause patients to develop a rare but deadly brain infection. The panel is set to rule on Dec. 9 whether to recommend the drug be approved for marketing in the United States. The medication fared well in clinical trials as a treatment for ulcerative colitis and Crohn’s disease, but experts say the drug carries the risk of progressive multifocal leukoencephalopathy (PML), a life threatening brain disease that affects immune deficient patients. No patients in clinical ... Read More

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