Tecfidera Brain Infection Results in FDA Warning Label Update

Federal drug regulators have ordered a label update for the multiple sclerosis drug Tecfidera, adding new information about a patient who died as a result of a rare brain infection, known as progressive multifocal leukoencephalopathy (PML). 

The FDA issued a drug safety communication on November 25, confirming a report from Biogen Idec last month regarding the Tecfidera PML death. It is the first confirmed case of the deadly brain infection linked to Tecfidera.

In Biogen’s report to the FDA, the drug maker noted that the patient had been taking Tecfidera for four years. They also noted that the patient had a very low number of lymphocytes, which are a type of white blood cell that help the body fight off infections.

Did You Know?

Change Healthcare Data Breach Impacts Millions of Customers

A massive Change Healthcare data breach exposed the names, social security numbers, medical and personal information of potentially 100 million Americans, which have now been released on the dark web. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.

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 brain infections have been linked to Tysabri, about a quarter of whom have died from the ailment.

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 from Tecfidera 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.

Even though there had been no cases, Tecfidera already carried a warning about the risk of progressive multifocal leukoencephalopathy. However, the FDA is now requiring the drug maker to provide additional information about this recent death, so that patients and doctors are aware of the risk associated with the medication.

The FDA also recommended that healthcare professionals educate patients to be on the look out for potential symptoms of a Tcfidera brain infection, which may include:

  • Progressive weakness on one side of the body
  • Sudden clumsiness
  • Vision problems
  • Changes in thinking, memory and orientation
  • Confusion and personality changes

The FDA recommends patients be taken off Tecfidera immediately at the first sign of PML and that an appropriate diagnostic evaluation be conducted.

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

Ozempic and Rybelsus Side Effects Led to Ileus, Nausea and Vomiting, Lawsuit Alleges
Ozempic and Rybelsus Side Effects Led to Ileus, Nausea and Vomiting, Lawsuit Alleges (Posted 2 days ago)

A Kentucky man's lawsuit claims Ozempic and Rybelsus side effects led to multiple trips to the emergency room due to nausea, vomiting and other reactions to his intestinal muscles being unable to push food through his digestive tract.

Multi-Day Suboxone Lawsuit Status Conference Being Held To Review Census Protocol and Procedures
Multi-Day Suboxone Lawsuit Status Conference Being Held To Review Census Protocol and Procedures (Posted 2 days ago)

Lawyers will be meeting with the MDL judge presiding over all Suboxone tooth decay lawsuits on October 4 and 5, 2024, to finalize information needed to select a group of representative cases for bellwether discovery and trial.

Bard Settlement Reached To Resolve Hernia Mesh Lawsuits, With “Multi-Year” Payout Structure
Bard Settlement Reached To Resolve Hernia Mesh Lawsuits, With “Multi-Year” Payout Structure (Posted 3 days ago)

Lawyers have reached a confidential settlement agreement to resolve tens of thousands of Bard hernia mesh lawsuits after six years of litigation, but individuals must still agree to participate and settle their claims.