Research shows the multiple sclerosis drug dimethyl fumarate—sold under the brand name Tecfidera in the United States and Fumaderm elsewhere—might cause a fatal brain disease known as progressive multifocal leukoencephalopathy (PML).
What Is Tecfidera and What Is It Prescribed For?
Tecfidera is the brand name for the drug dimethyl fumarate, which is made and sold by the Massachusetts-based pharmaceutical company Biogen Itec, Inc. The U.S. Food and Drug Administration (FDA) approved Tecfidera in March 2013 to treat relapsing forms of multiple sclerosis. Doctors can prescribe it 120 mg and 240 mg delayed-release tablets.
Scientists are unsure of Tecfidera’s mechanism of action. They believe that it activates a DNA transcription factor protein called the “Nuclear factor (erythoroid-derived 2)-like 2” (Nrf2) pathway. Transcription factor proteins bind with DNA to regulate information that’s transmitted to cell structures. Nrf2 helps cells create proteins that defend against “oxidative stress,” which is an imbalance in the body’s ability to detoxify and repair cell damage caused by numerous ailments like multiple sclerosis.
Tecfidera Might Cause Progressive Multifocal Leukoencephalopathy Side Effects
Shortly after the FDA approved Tecfidera in March 2013, medical officials in Germany and the Netherlands reported one case each of patients taking dimethyl fumarate over a period of several years and developing PML. Two articles in the New England Journal of Medicine discussed the case in Germany and the one in the Netherlands. Biogen Itec’s own researchers issued a response claiming that it knew of two other cases of PML but disagreeing that dimethyl fumarate was responsible.
PML is a fatal brain disease characterized by inflammation of the brain’s white matter at multiple locations. It destroys a portion of its victims’ brain cells, thereby impairing transmission of electrical signals in the brain. Symptoms of this disease include:
- Impaired speech;
- Vision loss;
- Paralysis; and
- Cognitive deterioration.
An MRI can detect PML, but—other than blood plasma transfusions to cycle the drug out of the body—no known treatment for advanced cases exists. Patients usually die within four months of being diagnosed, but the German and Dutch patients both survived.
RLG’s Tecfidera Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Tecfidera lawsuit on your behalf if necessary. RLG will also keep you up to date on any Tecfidera class action lawsuits, FDA Tecfidera warnings, and Tecfidera FDA recall announcements. If you or a loved one has taken Tecfidera and believe it caused an injury, contact RLG today.