The U.S. Food and Drug Administration (FDA) recently announced that it added new information to the label for Tecfidera (dimethyl fumarate) regarding progressive multifocal leukoencephalopathy (PML). The FDA based its decision on a report of a multiple sclerosis (MS) patient who, while being treated with Tecfidera, developed PML then died.
The patient was a 54 year-old woman with MS. She had been using it for four and a half years and was not taking other drugs that affected her immune system. She had no medical conditions that would predispose her to PML.
PML is a rare and serious brain infection caused by the John Cunningham (JC) virus.
The JC virus is a common virus that, though harmless in most people, can cause PML in some patients who have weakened immune systems. PML has diverse symptoms that may include:
- progressive weakness on one side of the body
- clumsiness
- vision problems
- confusion
- changes in thinking, personality, memory, and orientation.
- The progression of deficits can lead to severe disability or death.
The FDA stated:
“Patients taking Tecfidera should contact their health care professionals right away if they experience symptoms that concern them, such as new or worsening weakness; trouble using their arms or legs; or changes to thinking, eyesight, strength or balance. Health care professionals should stop Tecfidera if PML is suspected.”
This is the third time in three years that Tecfidera has been under public scrutiny.
- In 2013, The Wall Street Journal reported that although the drug manufacturer said a woman’s death was not the result of taking Tecfidera, they were investigating the death of a woman who died after 5-½ weeks of taking the drug.
- In 2014, the Journal of Neurology published an article indicating a patient suffered severe Deep Vein Thrombosis (DVT) that if it had not been resolved, could have caused death. The Journal noted that the FDA warning label had not included DVT as a possible serious side effect.
- In 2015, the FDA changed the label to reflect the PML risk discussed in this post.
Harman Law LLC is currently investigating deaths and serious injuries related to Tecfidera.
If you have experienced serious side effects or know someone who has died while taking or after taking the MS drug Tecfidera, contact the dangerous drug attorneys at Harman Law LLC to learn your legal rights and eligibility for compensation. We offer a no cost, no obligation initial consultation to patients and families of patients. Call 1-888-55-HARMAN or fill out the “Quick Connect” form at the top right of this page.
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