Tecfidera Linked to Case of PML Brain Infection

A patient taking the multiple sclerosis drug Tecfidera has died of a rare brain infection, known as progressive multifocal leukoencephalopathy (PML), which has plagued a number of similar drugs that work by lowering the immune system response. 

The drug maker Biogen announced on Wednesday that an unidentified patient died from a PML brain infection after taking Tecfidera, the first known case associated with the medication.

Progressive multifocal leukoencephalopathy (PML) is a rare and often deadly brain infection that is believed to be caused when some immunosuppressant drugs disable the immune system enough for the JC virus to take hold. The JC virus then attacks brain tissue, causing cognitive brain problems, motor control and speech problems, and in many cases results in death.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

The infection problems have been linked to other MS drugs, including Biogen’s Tysabri, which was recalled shortly after it was introduced in 2004 and then re-introduced in 2006 with stricter guidelines for usage due to the risk of PML. At least 400 cases of PML have been linked to Tysabri, about a quarter of whom have died from the ailment.

Until now, Tecfidera had not been associated with PML. Other drugs associated with the brain infection, such as Tysabri and Gilenya, have been restricted by the FDA, and it is unclear whether Tecfidera will face new restrictions following the latest development.

Even though there were no recorded previous cases, Tecfidera already carried a PML warning, noting that it was a likely side effect of how the drug suppressed the immune system, so it is unclear whether the FDA will see a need to take action.

Tecfidera (dimethyl fumarate) is an oral multiple sclerosis treatment approved by the FDA in March 2013. It is specifically approved for MS patients suffering relapses. Biogen has warned that PML may be more likely in patients suffering low white blood cell counts, and the patient who died of PML while taking the drug fell into that parameter, company officials said.

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

BioZorb Lawsuit Alleges Breast Tissue Marker Failed, Requiring Surgical Removal
BioZorb Lawsuit Alleges Breast Tissue Marker Failed, Requiring Surgical Removal (Posted yesterday)

A BioZorb lawsuit has been filed by several breast cancer survivors after the BioZorb implants moved out of place and failed to dissolve int he body, requiring surgical removal.

Fairness Hearing For Philips CPAP Recall Medical Monitoring Settlement Set for October
Fairness Hearing For Philips CPAP Recall Medical Monitoring Settlement Set for October (Posted yesterday)

A U.S. District Court judge has scheduled a fairness hearing for October in order to determine whether final approval should be granted to a $25 million Philips CPAP recall settlement agreement, which would pay former users $25 million to pay for future medical monitoring needs.